sildenafil-citrate and Erectile-Dysfunction

Cyclic guanosine monophosphate (cGMP), an important intracellular second messenger, mediates cellular functional responses in all vital organs. Phosphodiesterase 5 (PDE5) is one of the 11 members of the cyclic nucleotide phosphodiesterase (PDE) family that specifically targets cGMP generated by nitric oxide-driven activation of the soluble guanylyl cyclase. PDE5 inhibitors, including sildenafil and tadalafil, are widely used for the treatment of erectile dysfunction, pulmonary arterial hypertension, and certain urological disorders. Preclinical studies have shown promising effects of PDE5 inhibitors in the treatment of myocardial infarction, cardiac hypertrophy, heart failure, cancer and anticancer-drug-associated cardiotoxicity, diabetes, Duchenne muscular dystrophy, Alzheimer's disease, and other aging-related conditions. Many clinical trials with PDE5 inhibitors have focused on the potential cardiovascular, anticancer, and neurological benefits. In this review, we provide an overview of the current state of knowledge on PDE5 inhibitors and their potential therapeutic indications for various clinical disorders beyond erectile dysfunction.

Topics: Cyclic GMP; Erectile Dysfunction; Humans; Male; Neoplasms; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

Erectile dysfunction (ED) is one of the most common urologic problems in men worldwide, with an approximately high incidence rate, significantly affecting patients' quality of life and their sexual partners.. Due to the association of this disorder with essential diseases such as cardiovascular disease and diabetes, its prevention and treatment are vital for overall human physiologic and psychological health. Along with reviewing the history of treatment and current methods, we seek new approaches to curb this issue in the future.. In this review, investigations were based on the focus of each section's content or conducted on an ad hoc basis. Searches were performed in Scopus and PubMed.. In recent years, many treatments for ED have been reported besides oral administration of phosphodiesterase 5 inhibitors such as sildenafil and tadalafil (approved by the Food and Drug Administration). Common oral medications, intracavernous injections, herbal therapies (eg, herbal phosphodiesterase 5 inhibitors), and topical/transdermal medications are routine ED treatment approaches. Moreover, some novel medications are innovative candidates for completing ED's treatment protocols: stem cell injection, low-intensity extracorporeal shock wave therapy, platelet-rich plasma injection, gene therapy, amniotic fluid matrices, rho-kinase inhibitors, melanocortin receptor antagonists, maxi-K channel activators (ie, large-conductance calcium-activated potassium channels), guanylate cyclase activators, and nitric oxide donors.. Due to the importance of this complicated problem in men's society, a faster course of treatment trends toward new methods is needed to increase efficiency. Combining the mentioned treatments and attentively examining their efficacy through programmed clinical trials can be a big step toward solving this global problem.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Quality of Life; Sildenafil Citrate; Tadalafil; United States

Topics: Continuous Positive Airway Pressure; Erectile Dysfunction; Humans; Male; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sleep Apnea, Obstructive

Nowadays, Oral phosphodiesterase type 5 inhibitors (PDE5Is) are widely used for the treatment of erectile dysfunction (ED). However, these drugs have become abused among some men for recreational use to enhance their sexual performance.. To shed a light on the recreational use of oral PDE5Is.. A literature review was performed in the PubMed, Medline Medical Subject Heading, Science Direct, Scopus, Cochrane Library, EMBASE, CINAHL, Academic Search Complete, Google scholar, Egyptian Knowledge Bank (EKB) databases, Medline, Embase, and Chem ID using the keywords; sexual health, erectile dysfunction, recreational use/abuse, phosphodiesterase type 5 inhibitors, sildenafil, tadalafil, vardenafil, avanafil, and adverse effects.. Overall, 52 studies were retained for review out of 166 papers. Twenty-two studies that assessed the prevalence of the problem were investigated including 25,279 men from different countries. Most of these studies were cross-sectional studies that depend on multiple questionnaires representing the extent as well as the attitude of the recreational use of PDE5Is.. Oral PDE5Is have become used among some men for recreational use to enhance their sexual performance. To counteract the possible side effects of such abuse, the media, as well as health authorities, should be aware of the potential adverse effects of such abuse and strengthen the regulatory activity to protect the customers from such risks. Mostafa T, Alghobary MF. Recreational Use of Oral PDE5 Inhibitors: The Other Side of Midnight. Sex Med Rev 2022;10:385-395.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Migraine, a common chronic primary headache, has been found to be associated with a high risk of erectile dysfunction (ED).. The present study aims to summarize all the evidence related to this topic and demonstrate a quantified result on the association between migraine and ED, which has not been reported in the literature.. MEDLINE, Excerpta Medica Database, and Cochrane Library were systematically searched for identifying the eligible studies (2000-2021). This study was registered in the PROSPERO (ID: CRD42021248013).. The combined effects were synthesized with the relative risks (RR) or standard mean differences (SMD) with 95% confidence intervals (CI).. 6 trials with a total of 51,657 participants were included, of which 6,175 were men with migraine. The pooled analysis indicated that migraine was associated with a significantly higher risk of ED as compared to the non-migraine general population (RR = 1.63, 95%CI: 1.34 to 2.0, P < .001). Consistently, men with migraine have a significantly lower IIEF-5 score than healthy controls (SMD = -3.64, 95%CI: -6.4 to -0.89, P = .01). Stratification analysis on the mean age indicated that the association between migraine and ED was much stronger in the migraine patients with age < 40 years (RR = 32.29, 95% CI: 6.41-162.64, P < .001; I. ED is a common disease among migraine men, especially those patients whose age is under 40 years old. It shows a 32-fold increased risk of ED compared to the healthy controls. Migraine-induced ED may be correlated with multiple factors, that is, chronic illnesses, chronic pain, and psychosocial causes (like anxiety and depression). Since phosphodiesterase-5 inhibitors (ie, sildenafil) might induce or exacerbate migraine, thus it is not recommended to prescribe these drugs for patients with migraine-mediated ED.. The present study provides evidence that migraine is associated with a significantly high risk of ED, especially in those aged < 40 years. The pathophysiological mechanisms of this action deserve further study. He W, Yang Y, Liang H, et al. Migraine Is Associated With High Risk of Erectile Dysfunction: A Systematic Review and Cumulative Analysis. J Sex Med 2022;19:430-440.

Topics: Adult; Erectile Dysfunction; Humans; Male; Migraine Disorders; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

Lodenafil is a class of drugs called an inhibitor of PDE5 which also include a wide range of other erectile medicines, such as sildenafil, tadalafil and vardenafil. It is part of a new generation of PDE5 inhibitors that includes udenafil and avanafil. Lodenafil is a prodrug manufactured in the form of lodenafil carbonate, the carbonate dimer that divides in the body into two active drug lodenafil molecules. The oral bioavailability of this formulation is higher than that of the parent drug. This article discusses, by a critical comprehensive review of the literature on lodenafil in terms of its description, names, formulae, elemental composition, appearance, and therapeutic uses. The article also discusses the methods for preparation of lodenafil, its physical-chemical properties, analytical methods for its determination, pharmacological-toxicological properties, and dosing information.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Erectile dysfunction (ED) is a substantial cause of dissatisfaction among many men. This discontentment has led to the emergence of various drug treatment options for this problem.. Unfortunately, due to various interactions, contraindications, and side effects, systemic therapies such as phosphodiesterase-5 inhibitors (including sildenafil, tadalafil, vardenafil, avanafil, etc.) are not welcomed in many patients. These problems have led researchers to look for other ways to reduce these complications.. This article holistically reviews the efficacy of topical prostaglandins and their role in treating ED. We sought to provide a comprehensive overview of recent findings on the current topic by using the extensive literature search to identify the latest scientific reports on the topic.. In this regard, topical and transdermal treatments can be suitable alternatives. In diverse studies, prostaglandins, remarkably PGE1 (also known as alprostadil), have been suggested to be an acceptable candidate for topical treatment.. Numerous formulations of PGE1 have been used to treat patients so far. Still, in general, with the evolution of classical formulation methods toward modern techniques (such as using nanocarriers and skin permeability enhancers), the probability of treatment success also increases. Hamzehnejadi M, Tavakoli MR, Homayoun F et al. Prostaglandins as a Topical Therapy for Erectile Dysfunction: A Comprehensive Review. Sex Med Rev 2022;10:764-781.

Topics: Alprostadil; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Prostaglandins; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Erectile dysfunction (ED) is a substantial cause of dissatisfaction among many men. This discontentment has led to the emergence of various drug treatment options for this problem.. Unfortunately, due to various interactions, contraindications, and side effects, systemic therapies such as phosphodiesterase-5 inhibitors (including sildenafil, tadalafil, vardenafil, avanafil, etc.) are not welcomed in many patients. These problems have led researchers to look for other ways to reduce these complications.. This article holistically reviews the efficacy of topical prostaglandins and their role in treating ED. We sought to provide a comprehensive overview of recent findings on the current topic by using the extensive literature search to identify the latest scientific reports on the topic.. In this regard, topical and transdermal treatments can be suitable alternatives. In diverse studies, prostaglandins, remarkably PGE1 (also known as alprostadil), have been suggested to be an acceptable candidate for topical treatment.. Numerous formulations of PGE1 have been used to treat patients so far. Still, in general, with the evolution of classical formulation methods toward modern techniques (such as using nanocarriers and skin permeability enhancers), the probability of treatment success also increases.

Topics: Alprostadil; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Prostaglandins; Sildenafil Citrate

The concepts of drug repurposing and Sildenafil or blue pill are tightly linked over the years. Indeed, in addition to its initial clinical application as an anti-hypertensive drug in the pulmonary system, Sildenafil is also known for its beneficial effects in erectile dysfunction. Moreover, evidence has been accumulated to support its value in anti-cancer therapy, either alone or in combination with other clinically efficient chemotherapy drugs. In this review, we focused on the old and recent in vitro and in vivo studies demonstrating the cellular and molecular rationale for the application of Sildenafil in combination therapy in various types of cancer. We emphasized on the different molecular targets as well as the different signaling pathways involved in cancer cells. The pro-apoptotic effect of Sildenafil through nitric oxide (NO)/ phosphodiesterase type 5 (PDE5)-dependent manner seems to be one of the most common mechanisms. However, the activation of autophagy, as well as the modulation of the anti-tumor immunity, constitutes the other pathways triggered by Sildenafil. Overall, the studies converged to reveal the complexity of the anti-cancer potential of Sildenafil. Thus, through our review, we aimed to present an updated and simplified picture of such repurposing of Sildenafil in the field of oncology.

Topics: Erectile Dysfunction; Humans; Male; Neoplasms; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Phosphodiesterase 5 inhibitors (PDE5I) represent the first-line treatment in the management of post-operative erectile dysfunction (ED) after pelvic oncological surgery. The aim of our study is to evaluate the available evidence on the efficacy of PDE5Is, including new formulations and penile rehabilitation post-pelvic surgery.. A systematic review of the literature was performed until May 2020. The following databases were searched: Scopus, Medline and Web of Science. The MeSH search was conducted by combining the following terms: 'erectile dysfunction', 'radical prostatectomy' 'pelvic' 'bladder' 'phosphodiesterase' inhibitors' 'avanafil' 'sildenafil' 'tadalafil' 'lodenafil' 'mirodenafil' 'udenafil' 'vardenafil' 'sublingual' 'orodispersible' 'penile' 'rehabilitation'.. Sildenafil, Tadalafil, vardenafil and Avanafil improve EF compared with placebo in men with all levels of ED severity after radical prostatectomy with good tolerability. No specific recommendations can be suggested regarding the superiority of a drug over the other. The optimal dose, continuous vs. on-demand and duration of treatment, is still under investigation. In vitro and preclinical studies suggest the possible role for lodenafil, mirodenafil and oro-dispersible formulations in patients undergoing oncological pelvic surgery. Few studies demonstrated the efficacy of udenafil in improving ED after rectal surgery or radical prostatectomy. Complete recovery of EF after surgery is still an unmet need in the field of penile rehabilitation after pelvic surgery.. PDE5Is have a crucial role in the management of post pelvic surgery of ED. New drugs and new formulations have shown excellent results in patients with ED; however, data in patients after surgery is still scarce. Further well designed RCT should clarify the role of these new compounds and oro-dispersible formulations in the management of ED in patients undergoing pelvic surgery.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Prostatectomy; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Sildenafil, approved two decades ago, is the inhibitor of phosphodiesterase 5 (PDE5). First of all, it was designated for angina pectoris, but soon it showed a wonderful efficacy in erectile dysfunction (ED) and then pulmonary arterial hypertension (PAH). Due to the distribution of phosphodiesterase (PDE) in almost all organs, maybe it effects other diseases. Hence, a great number of investigations began to understand the role of PDEi in different organs. Preliminary research on sildenafil in cell culture and animal models has yielded promising results. Soon, a greater number of animal researches and clinical trials joined them. The results disclosed sildenafil can have beneficial effects in each organ such as heart, liver, kidney, brain, and intestines. Furthermore, it has significantly improved the prognosis of organ ischemia in various animal models. Clinical trials in several diseases, such as recurrent spontaneous miscarriage, fatty liver disease, bronchopulmonary dysplasia (BPD), heart failure, and premature ejaculation (PE) brought promising results. Although some clinical trials are available on the effects of sildenafil on various diseases, further studies on humans are needed to consolidate the ultimate effects of sildenafil. The aim of this review was to describe the effects of sildenafil on each organ and explain its mechanisms of action. Further, other PDE inhibitors such as tadalafil and vardenafil have been briefly discussed in parts of this review.

Topics: Erectile Dysfunction; Heart; Humans; Lung; Male; Pulmonary Arterial Hypertension; Sildenafil Citrate

Combining 2 first-line treatments for erectile dysfunction (ED) or initiating other modalities in addition to a first-line therapy may produce beneficial outcomes.. To assess whether different ED combination therapies were associated with improved outcomes compared with first-line ED monotherapy in various subgroups of patients with ED.. Studies were identified through a systematic search in MEDLINE, Cochrane Library, and Scopus from inception of these databases to October 10, 2020.. Randomized clinical trials or prospective interventional studies of the outcomes of combination therapy vs recommended monotherapy in men with ED were identified. Only comparative human studies, which evaluated the change from baseline of self-reported erectile function using validated questionnaires, that were published in any language were included.. Data extraction and synthesis were performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.. A meta-analysis was conducted that included randomized clinical trials that compared outcomes of combination therapy with phosphodiesterase type 5 (PDE5) inhibitors plus another agent vs PDE5 inhibitor monotherapy. Separate analyses were performed for the mean International Index of Erectile Function (IIEF) score change from baseline and the number of adverse events (AEs) by different treatment modalities and subgroups of patients.. A total of 44 studies included 3853 men with a mean (SD) age of 55.8 (11.9) years. Combination therapy compared with monotherapy was associated with a mean IIEF score improvement of 1.76 points (95% CI, 1.27-2.24; I2 = 77%; 95% PI, -0.56 to 4.08). Adding daily tadalafil, low-intensity shockwave therapy, vacuum erectile device, folic acid, metformin hydrochloride, or angiotensin-converting enzyme inhibitors was associated with a significant IIEF score improvement, but each measure was based on only 1 study. Specifically, the weighted mean difference (WMD) in IIEF score was 1.70 (95% CI, 0.79-2.61) for the addition of daily tadalafil, 3.50 (95% CI, 0.22-6.78) for the addition of low-intensity shockwave therapy, 8.40 (95% CI, 4.90-11.90) for the addition of a vacuum erectile device, 3.46 (95% CI, 2.16-4.76) for the addition of folic acid, 4.90 (95% CI, 2.82-6.98) for the addition of metformin hydrochloride and 2.07 (95% CI, 1.37-2.77) for the addition of angiotensin-converting enzyme inhibitors. The addition of α-blockers to PDE5 inhibitors was not associated with improvement in IIEF score (WMD, 0.80; 95% CI, -0.06 to 1.65; I2 = 72%). Compared with monotherapy, combination therapy was associated with improved IIEF score in patients with hypogonadism (WMD, 1.61; 95% CI, 0.99-2.23; I2 = 0%), monotherapy-resistant ED (WMD, 4.38; 95% CI, 2.37-6.40; I2 = 52%), or prostatectomy-induced ED (WMD, 5.47; 95% CI, 3.11-7.83; I2 = 53%). The treatment-related AEs did not differ between combination therapy and monotherapy (odds ratio, 1.10; 95% CI, 0.66-1.85; I2 = 78%). Despite multiple subgroup and sensitivity analyses, the levels of heterogeneity remained high.. This study found that combination therapy of PDE5 inhibitors and antioxidants was associated with improved ED without increasing the AEs. Treatment with PDE5 inhibitors and daily tadalafil, shockwaves, or a vacuum device was associated with additional improvement, but this result was based on limited data. These findings suggest that combination therapy is safe, associated with improved outcomes, and should be considered as a first-line therapy for refractory, complex, or difficult-to-treat cases of ED.

Topics: Adrenergic alpha-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Antioxidants; Combined Modality Therapy; Drug Therapy, Combination; Equipment and Supplies; Erectile Dysfunction; Extracorporeal Shockwave Therapy; Folic Acid; Humans; Hypoglycemic Agents; Male; Metformin; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Treatment Outcome; Vitamin B Complex

PDE type 5 inhibitors (PDE5Is), such as sildenafil, tadalafil and vardenafil, are a class of drugs used to prolong the physiological effects of NO/cGMP signalling in tissues through the inhibition of cGMP degradation. Although these agents were originally developed for the treatment of hypertension and angina, unanticipated side effects led to advances in the treatment of erectile dysfunction and, later, pulmonary arterial hypertension. In the last decade, accumulating evidence suggests that PDE5Is may confer a wider range of clinical benefits than was previously recognised. This has led to a broader interest in the cardiovascular therapeutic potential of PDE5Is, in conditions such as hypertension, myocardial infarction, stroke, peripheral arterial disease, chronic kidney disease and diabetes mellitus. Here, we review the pharmacological properties and established licensed uses of this class of drug, along with emerging therapeutic developments and possible future indications.

Topics: Cardiovascular Diseases; Erectile Dysfunction; Humans; Hypertension; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil

The purpose of this study was to compare the relative safety and efficacy of different types of phosphodiesterase type 5 inhibitors (PDE5-Is) with tamsulosin for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostate hyperplasia (BPH) (BPH-LUTS) with or without erectile dysfunction (ED).. We use the Stata version 13.0 to conduct the network meta-analysis (NMA) with a random effects model of the Bayesian framework. The International Prostate Symptom Score (IPSS), Maximum Urinary Flow Fate (. Seven RCTs including 531 participants with seven interventions were analyzed. The results of NMA SUCRA showed that compared with different doses or types of PDE5-Is combined with tamsulosin (0.4 mg qd), the sildenafil (25 mg qd) combined with tamsulosin (0.4 mg qd) group had the greatest probabilities of being the best in the achievement of improving IIEF. The sildenafil (25 mg 4 days per week) combined with tamsulosin (0.4 mg qd) group had the greatest probabilities of being the best in the achievement of improving. This meta-analysis indicates that sildenafil combined with tamsulosin is the best effective and tolerated treatment option for BPH-LUTS with or without ED. Further RCTs are strongly required to provide more direct evidence.

Topics: Bayes Theorem; Databases, Factual; Drug Therapy, Combination; Erectile Dysfunction; Humans; Lower Urinary Tract Symptoms; Male; Network Meta-Analysis; Phosphodiesterase 5 Inhibitors; Prostatic Hyperplasia; Safety; Sildenafil Citrate; Tadalafil; Tamsulosin; Treatment Outcome

Priapism is an adverse drug reaction (ADR) associated with phosphodiesterase type 5 inhibitors (PDE5is) in the treatment of erectile dysfunction.. The purpose of this study was to identify the true data about PDE5i-associated priapism to properly counsel patients.. We queried the U.S. Food and Drug Administration (FDA) Adverse Reporting System Public Dashboard to identify cases of drug-induced priapism among medications commonly associated with priapism. Next, a systematic review and analysis of publications describing cases of drug-induced priapism were carried out.. The main outome of this study is incidence of PDE5i-induced priapism.. We found 411 cases of drug-induced priapism secondary to Viagra, Cialis, or Levitra reported to the Food and Drug Administration since 1998. Compared with PDE5is, drug-induced priapism was 2.6 (n = 1,065) and 2.0 times (n = 817) more commonly reported for second-generation antipsychotics and the antidepressant/sleep aid trazodone, respectively. A total of 240 manuscripts describing cases of drug-induced priapism in patients with non-sickle cell disease were identified. PDE5i-induced priapism accounted for only 2.9% (n = 7) of drug-induced priapism cases. Second-generation antipsychotics (33.8%), a group of "other" medications (11.3%), and alpha-adrenergic antagonists (8.8%) accounted for the greatest percentage of published drug-induced priapism cases.. Extensive counseling about priapism as an ADR for PDE5i for the routine treatment of erectile dysfunction is likely unnecessary.. The study used national-level data to identify drug-induced priapism cases. Reported and published cases of drug-induced priapism may reflect more severe and atypical cases of this ADR, which may have underestimated our results.. PDE5i-induced priapism is a rare event. Drug-induced priapism should be attributed to a wider spectrum of medications that can cause this condition. Rezaee ME, Gross MS. Are We Overstating the Risk of Priapism With Oral Phosphodiesterase Type 5 Inhibitors? J Sex Med 2020;17:1579-1582.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Priapism; Sildenafil Citrate; Tadalafil

Erectile dysfunction (ED) is a common and costly urologic condition with increasing prevalence as men age. Cost-effectiveness of ED therapies and whether cost-effectiveness varies for different populations of men remains underexplored.. To review and summarize available published data on the economic evaluation of ED therapies and to identify gaps in the literature that still need to be addressed.. All relevant peer-reviewed publications and conference abstracts were reviewed and incorporated.. There are a number of medical and surgical treatment options available for ED. The economic evaluation of phosphodiesterase-5 inhibitors, particularly sildenafil, has been well described. However, minimal research has been conducted to assess the cost-effectiveness of intracavernosal injections, intraurethral suppositories, penile prosthesis surgery, vacuum erection devices, and other emerging therapies in men with different causes of ED.. Available economic evaluations of ED therapies are dated, do not reflect present-day physician, pharmaceutical, and device costs, fail to account for patient comorbidities, and may not be generalizable to today's ED patients. Substantial research is needed to evaluate the cost-effectiveness of ED treatments across different patient populations, countries, and reimbursement systems. Rezaee ME, Ward CE, Brandes ER, et al. A Review of Economic Evaluations of Erectile Dysfunction Therapies. Sex Med Rev 2019;8:497-503.

Topics: Cost-Benefit Analysis; Erectile Dysfunction; Health Care Costs; Humans; Male; Penile Prosthesis; Sildenafil Citrate; Urological Agents

The field of sexual medicine, in reference to the science of the sexual response and the clinical management of sexual dysfunctions, has evolved remarkably in the last 25 years. Erection biology has been central in driving this progress and is measured considerably by the discovery, study, and clinical translation of a simple gaseous molecule, nitric oxide, which is operative in the penis. Nitric oxide functions extraordinarily as a neurotransmitter and molecular signal transducer. It is now well understood to be the principal molecular mediator of penile erection and to be a critical element involved in dysregulatory mechanisms of erection disorders ranging from erectile dysfunction to priapism. It is most familiarly associated with the scientific development of oral medications for treating erectile dysfunction, which has modernized the clinical management of this condition.

Topics: Erectile Dysfunction; Humans; Male; Nitric Oxide; Nitric Oxide Synthase Type I; Nitric Oxide Synthase Type III; Penile Erection; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

The FDA approval of Viagra (sildenafil) for the on demand treatment of erectile dysfunction (ED) through relaxation of the corporal and cavernosal vascular smooth muscle that results in an increase in blood flow to the corporal tissues stemmed from 2 decades of research, mainly at academic centers. This culminated in the finding of the nitric oxide/cGMP pathway as the mediator of penile erection, followed by some years of basic studies and clinical validation at Pfizer. Further on, new translational laboratory and animal research from our group initiated a second phase when we proposed an alternative therapeutic schedule and mechanism of action for PDE5 inhibitors (PDE5i) in both corporal veno-occlusive dysfunction (CVOD) and Peyronie's disease (PD), specifically, continuous long-term administration (CLTA) to achieve sustained levels of cGMP within the penis. Due to the extended half-life of the long-acting PDE5i, tadalafil, this new alternative encompasses preferentially daily administration, although shorter half-life PDE5i, like sildenafil and vardenafil work too, depending on the duration, dose, and frequency of their administration This novel use was initially supported by showing the antifibrotic/antioxidant effects of nitric oxide and cGMP, produced by the induction of iNOS, as a mechanism of defense against collagen deposition in the localized fibrotic plaque of PD in an avascular tissue, the tunica albuginea. Our studies on iNOS and the progressive diffuse fibrosis occurring in the smooth muscle in CVOD, led to proposing the CLTA of PDE5i for maintaining sustained cGMP levels both in PD and in CVOD in order to halt or regress the penile fibrosis. In CVOD, we showed that PDE5i protect the corporal smooth muscle and reduce myofibroblast activation and number, counteracting the underlying corporal tissue pathology that causes CVOD, and potentially ameliorating long-term CVOD or even curing it. This review is focused on this novel PDE5i anti-fibrotic therapeutic concept.

Topics: Animals; Arterial Occlusive Diseases; Cyclic GMP; Disease Models, Animal; Drug Evaluation, Preclinical; Erectile Dysfunction; Humans; Male; Muscle, Smooth; Nitric Oxide Synthase Type II; Penile Induration; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Translational Research, Biomedical

The serendipitous discovery of sildenafil (Viagra [sildenafil citrate]) as a treatment for erectile dysfunction (ED) is one of the most fascinating drug development stories of our time. When sildenafil was approved by the U.S. Food and Drug Administration in 1998, it revolutionized the treatment protocol for men with ED, once considered a psychological issue or an inevitable part of aging.. To review the discovery of sildenafil and its role in changing the field of sexual medicine in the context of the epidemiology and history of treatment for ED.. For this narrative review, a literature search was conducted to identify essential articles and was supplemented by author observations from a historical perspective.. A broad overview of ED and its past, current, and future treatments.. ED is a prevalent condition for which medical treatment had been limited to genitally localized interventions, including surgery, vacuum pumps, injectable therapies, and intraurethral suppositories. The discovery of sildenafil provided a safe, oral pharmacotherapy for the treatment of ED, sparking greater understanding of the science behind ED and its role in men's overall health.. The approval of sildenafil initiated a global conversation about ED that had profound implications for patients, methods of clinical practice, and academic sexual medicine. These changes will catalyze continued advances in ED treatment. Goldstein I, Burnett AL, Rosen RC, et al. The serendipitous story of sildenafil: an unexpected oral therapy for erectile dysfunction. Sex Med Rev 2019;7:115-128.

Topics: Coitus; Drug Development; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Quality of Life; Sildenafil Citrate; Treatment Outcome

With the wide use of sildenafil in kidney-transplanted patients, it is vital to recognize the effectiveness and safety in clinical practice.. Full-text articles involving the application of sildenafil after renal transplantation searched out in multiple databases were reviewed. All the meta-analyses were performed with Review Manager 5.0 software and bias analysis of the studies were conducted to examine the quality of articles. In addition, to estimate possible publication bias, funnel plot and the Egger's test were used.. Finally 7 articles eventually satisfied the inclusion criteria. The penetration ability and maintenance frequency in sildenafil group were much larger than those of control group. Except orgasmic function, domains of the International Index of Erectile Function have showed larger scores in sildenafil group than those of control group. No significant difference of the concentration of cyclosporine was observed between sildenafil and control group.. In conclusion, this study showed that treatment with sildenafil in renal allograft recipients with erectile dysfunction is a valid and safe option.

Topics: Cyclosporine; Erectile Dysfunction; Humans; Immunosuppressive Agents; Kidney Transplantation; Male; Penile Erection; Postoperative Complications; Sildenafil Citrate; Treatment Outcome; Vasodilator Agents

On-demand phosphodiesterase type 5 inhibitor (PDE5i) monotherapy is a first-line treatment for erectile dysfunction (ED), but 30%-40% of patients exhibit little or no response. The success rate of alprostadil therapy is high in these patients, but this treatment requires painful intracavernosal injection.. To systematically review the efficacy and safety of second-line oral pharmacologic combination therapies of ED when PDE5i monotherapy fails.. PubMed and Embase were searched to identify reports providing quantitative data on the treatment of ED in patients failing PDE5i monotherapy.. The measures of erectile function were the International Index of Erectile Function (IIEF) and the Erectile Function Domain (EFD).. Chronic treatment with the PDE5i tadalafil alone or in combination with sildenafil on demand showed similar IIEF-5 score improvements. None of the 3 randomized controlled trials (RCTs) in patients who had failed PDE5i monotherapy found a superior effect on IIEF scores from the combination of androgen plus PDE5i compared with PDE5i monotherapy. Combination therapy with androgen supplementation and PDE5i appears safe. In 1 RCT, combination therapy with PDE5i and an α. For ED, chronic treatment with low-dose PDE5i can be attempted when standard on-demand regimens fail. Combination therapy with androgen supplementation and a PDE5i appears to be safe. The combination of an α

Topics: Administration, Oral; Alprostadil; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Treatment Failure; Treatment Outcome; Vasodilator Agents

Erectile dysfunction (ED) is a common side effect to radical prostatectomies, even with nerve-sparing procedures. To ameliorate the problem so-called "penile rehabilitation" programs have been developed. The most widely used method of this is subscribing sildenafil or other PDE5-inhibitors to patients following surgery. This is based on a theory that these drugs may increase penile oxygenation and provide antiapoptotic factors (primarily NO and cGMP), thus protecting the penile tissue in a period with reduced nerve function following the surgery. Preclinical studies have confirmed the potential of sildenafil in this context and early human trials have suggested that a steady ingestion of sildenafil might protect the structural integrity of the penis. However, subsequent well-designed trials have not been able to confirm the initial findings. This fits well with sildenafil's mechanism of action because it does not actually induce erections or the production of either nitric oxide or cGMP. Rather, the drug enhances effects of an erectile response induced by neurotransmitters from the cavernous nerves. Therefore, sildenafil should no longer be offered as a sole means of penile rehabilitation. Rather, more research is needed, and clinicians need to apply a broader concept of sexual rehabilitation in postprostatectomy ED.

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Prostate; Prostatectomy; Randomized Controlled Trials as Topic; Recovery of Function; Sildenafil Citrate

Sildenafil has had a dramatic influence on the field of sexual medicine over the past 20 years. Not only have phosphodiesterase-5 (PDE5) inhibitors improved the treatment of erectile dysfunction (ED), they have indirectly contributed to the treatment of male factor infertility. A review of the literature between 1998 - 2018 was performed using PubMed with regards to sildenafil and male infertility. Numerous studies have demonstrated sildenafil's safety and efficacy for treating ED. Sildenafil does not alter semen parameters, and, in fact, may positively affect semen parameters. Sildenafil is helpful for treating ED caused by the psychological stress of infertility treatments. Sildenafil has improved the treatment of ED and may have a benefit on semen parameters. This has aided in the management of male factor infertility, and has contributed to hundreds of thousands of pregnancies that would have been more difficult, as it was before its advent.

Topics: Erectile Dysfunction; Humans; Infertility, Male; Male; Phosphodiesterase 5 Inhibitors; Sexual Behavior; Sildenafil Citrate; Sperm Motility

Erectile dysfunction (ED) is a relatively frequent disease that negatively impacts the overall quality of life, well-being, and relationships. Although the use of phosphodiesterase 5 inhibitors (PDE5is) has revolutionized the treatment of ED, a high percentage of ED patients discontinue PDE5i treatment.. (i) To analyze the reasons for patient dissatisfaction leading to PDE5i discontinuation; (ii) analyze the pharmacokinetics of new formulations focusing on the time needed to reach an effective plasma concentration of PDE5is (T. An online PubMed literature search was conducted to identify English language publications from inception to January 2019.. The main reasons for patient dissatisfaction when using PDE5is on demand are the relatively long T. We conclude that several ODT and ODF formulations can improve the 'discretion' issue because they are taken without water, but they have similar pharmacokinetics to corresponding film-coated tablet formulations. One ODF formulation of sildenafil was characterized by a shorter T

Topics: Administration, Mucosal; Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Humans; Male; Middle Aged; Mouth Mucosa; Patient Compliance; Patient Satisfaction; Phosphodiesterase 5 Inhibitors; Quality of Life; Sexual Behavior; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Sildenafil is the first phosphodiesterase type 5 inhibitor (PDE-5), used in the management of erectile dysfunction (ED). The effectiveness and safety of the original drug have been studied most extensively among ED medications. Sildenafil has been successfully used for ED of different etiology and severity. To date, this PDE-5 remains the drug of choice for many patients with erectile dysfunction.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

Sildenafil, a type 5 phosphodiesterase inhibitor (PDE5-I), is primarily used for treating erectile dysfunction. Sildenafil inhibits the degradation of cyclic guanosine monophosphate (cGMP) by competing with cGMP for binding site of PDE5. cGMP is a secondary messenger activating protein kinases and a common regulator of ion channel conductance, glycogenolysis, and cellular apoptosis. PDE5 inhibitors (PDE-Is) found application in cardiology, nephrology, urology, dermatology, oncology, and gynecology. Positive result of sildenafil treatment is closely connected with its immunomodulatory effects. Sildenafil influences angiogenesis, platelet activation, proliferation of regulatory T cells, and production of proinflammatory cytokines and autoantibodies. Sildenafil action in humans and animals appears to be different. Surprisingly, it also acts differently in males and females organisms. Although the immunomodulatory effects of PDE5 inhibitors appear to be promising, none of them reached the point of being tested in clinical trials. Data on the influence of selective PDE5-Is on the human immune system are limited. The main objective of this review is to discuss the immunomodulatory effects of sildenafil in both patients and experimental animals. This is the first review of the current state of knowledge about the effects of sildenafil on the immune system.

Topics: Adaptive Immunity; Animals; Erectile Dysfunction; Humans; Immune System; Immunity, Innate; Immunomodulation; Male; Models, Animal; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Species Specificity

Spinal cord injury (SCI) is estimated to affect approximately 276,000 individuals in the United States. Since 2010, the mean age of individuals at the time of the SCI has been 42 years, with nearly 80% of cases involving men. This means that individuals with SCI generally are young men who typically place a great deal of importance on normal sexual and reproductive function.. To assess the effect of sildenafil treatment on erectile function and the frequency of ejaculation in men with SCI.. This study was a post hoc analysis of pooled data from two randomized, double-blinded, placebo-controlled, flexible-dose, crossover sildenafil trials conducted in Europe, Australia, and Turkey. Two hundred forty-eight men at least 18 years old with traumatic SCI of at least 6 months' duration, with erectile dysfunction solely attributed to SCI, and in a stable heterosexual relationship were treated sequentially with sildenafil and placebo. Exclusion criteria included taking nitrate therapy, severe cardiac failure, and recent stroke or myocardial infarction. The starting sildenafil dose was 50 mg, taken approximately 1 hour before sexual activity, with subsequent dose adjustment to 100 or 25 mg based on efficacy and safety during treatment. There was a 2-week washout between 6-week treatments.. Change from baseline in International Index of Erectile Function question 3 (frequency of penetration), question 4 (maintaining erection after penetration), question 9 (frequency of ejaculation), and erectile function domain scores; intercourse success; and treatment preference.. All International Index of Erectile Function outcomes, including achieving and maintaining erections and ejaculation frequency, were statistically significantly greater with sildenafil vs placebo, including the subgroup with complete SCI (P < .01 for all comparisons). The percentage of successful intercourse attempts with sildenafil (53% vs 12%) and preference for sildenafil (96% vs 4%) vs placebo were significant (P < .001), including the subgroup with complete SCI. The most common all-cause adverse events with sildenafil were headache (16.1%) and urinary tract infection (11.6%).. Sildenafil significantly improves erections, intercourse success, and ejaculation frequency vs placebo, including in men with complete SCI. Sildenafil is an effective and well-tolerated treatment for sexual dysfunction in men with SCI. The increase in frequency of ejaculation could allow the possibility of having children without medical intervention in this patient population. Ohl DA, Carlsson M, Stecher VJ, Rippon GA. Efficacy and Safety of Sildenafil in Men With Sexual Dysfunction and Spinal Cord Injury. Sex Med Rev 2017;5:521-528.

Topics: Ejaculation; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Spinal Cord Injuries

Radical prostatectomy (RP) is the most common definitive invasive treatment option for localized prostate cancer. Although the different surgical procedures-open RP, laparoscopic RP, and robot-assisted laparoscopic RP-do not differ significantly for the results of postoperative erectile dysfunction (ED) and continence, the fear of losing erectile function (EF) is often an important factor for preoperatively sexually active men when deciding for or against a procedure.. To review the available literature on rehabilitation of EF after RP and to evaluate the value of the "Kiel concept" against different strategies of phosphodiesterase type 5 inhibitor (PDE5i) low-dose treatments.. A review of the available literature up to January 2017 was undertaken using the key terms postsurgical ED, penile rehabilitation," PDE5i rehabilitation, and PDE5i daily dose treatment.. As a main outcome measure we chose reviewed different concepts on the rehabilitation of EF after RP, taking into account the clinical background of the Kiel concept.. The different therapeutic concepts for rehabilitation of EF after nerve-sparing RP are surprising. The most frequently applied method is application of different PDE5is. Despite different studies on efficacy, the issue of an optimal concept remains unresolved. The reason for this, among others, can be found in the difficulty of comparing different studies, which can vary with respect to the degree of nerve sparing, postoperative preservation of nocturnal erections, concomitant morbidity, and the number and experience of surgeons.. In 86% of patients, the Kiel concept has been shown to support rehabilitation of EF after nerve-sparing RP with some form of therapeutic method. The Kiel concept is one therapeutic option among other comparable therapeutic options. Osmonov DK, Jünemann KP, Bannowsky A. The "Kiel Concept" of Long-Term Administration of Daily Low-Dose Sildenafil Initiated in the Immediate Post-Prostatectomy Period: Evaluation and Comparison With the International Literature on Penile Rehabilitation. Sex Med Rev 2017;5:387-392.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Prostatectomy; Sildenafil Citrate

Sildenafil citrate (Viagra®) is a vasoactive agent available worldwide since 1998 for the treatment of male erectile dysfunction. It is a selective phosphodiesterase type 5-enzyme inhibitor able to potentiate the downstream effects of nitric oxide on smooth muscle relaxation and vasodilation through its effects on the cyclic guanosine monophosphate (c-GMP) pathway in the erectile tissue of the penis. When sildenafil is orally administered, it is rapidly absorbed with a maximum plasma concentration achieved within 1 h and has a terminal half-life of between 3 to 6 h. The drug is extensively and rapidly metabolized by the liver, primarily by the CYP3A4 enzyme. Although the drug is well tolerated, specific adverse events have been observed, like flushing, headaches, dyspepsia, and visual disturbances. Liver toxicity related to sildenafil consumption has been considered a very rare event. However, in the last decade, some cases of sildenafil-associated hepatotoxicity have been reported. Furthermore, some hepatic intoxications have been reported after the intake of "natural" or "herbal" aphrodisiac supplements sold through Internet, sex shops, social media, and by word-of-mouth found to contain sildenafil and other phosphodiesterase type 5 (PDE-5) inhibitors. Studies investigating a possible link between sildenafil use and liver damage are limited, and the underlying mechanism responsible for hepatotoxicity is still missing. Studies in animals evidence that the hematopoietic function of the liver may have severely been affected as a result of a probable toxic effect of sildenafil. Here, the studies reporting liver toxicity by sildenafil in humans and in animals are reported and discussed.

Topics: Chemical and Drug Induced Liver Injury; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Urological Agents

This review article describes the differences in efficacy and side effects between available phosphodiesterase type 5 (PDE-5) inhibitors used for treating erectile dysfunction. The most studied PDE-5 inhibitor is sildenafil.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Sildenafil has been evaluated in >16 000 men with erectile dysfunction (ED) in double-blind, placebo-controlled trials.. To assess efficacy and safety of sildenafil in ED by ethnicity (white, black Asian) and age (≤45, 46-60, ≥61 years).. Data were pooled from 38 double-blind, placebo-controlled, flexible-dose trials. Most had starting sildenafil doses of 50 mg once daily, ~1 hour before sexual activity, with adjustment to 100 or 25 mg as needed.. Change from baseline in International Index of Erectile Function erectile function (IIEF-EF) domain score assessed with analysis of covariance and a Global Assessment Question (GAQ; "Did the treatment improve your erections?") at endpoint assessed with logistic regression analysis.. 4120 and 3714 men received sildenafil and placebo, respectively (2740 and 2671 White; 407 and 385 Black; 973 and 658 Asian). For sildenafil vs. placebo groups, overall treatment differences for IIEF-EF domain and GAQ were significant for each ethnic and age group (P<.0001); significant treatment-by-ethnicity and treatment-by-age interactions were also observed for change in IIEF-EF domain scores (P<.05), with differences significantly greater for White vs. Black (P<.0001), White vs. Asian (P=.0163), and Asian vs. Black (P=.0036) men. A significant treatment-by-ethnicity interaction was observed for GAQ (P=.0004). The OR comparison for GAQ was significantly greater (P=.0001) with sildenafil vs. placebo in White (OR=11.2) or Asian (OR=12.4) men vs. Black men (OR=5.1). Adverse-event rates were generally similar, with some age variations.. Sildenafil is effective and well-tolerated regardless of ethnicity or age; however, treatment effects can vary.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Asian; Black or African American; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Sildenafil Citrate; Treatment Outcome; Urological Agents; White People

Erectile dysfunction (ED) is a major care problem worldwide. Tadalafil and sildenafil are the two most common phosphodiesterase 5 inhibitors used to treat ED. This systematic review and meta-analysis were conducted to directly compare tadalafil with sildenafil for the treatment of ED.. We designed a strategy for searching the PubMed, Embase, EBSCO, Web of Science and Cochrane library databases; the reference lists of the retrieved studies were also investigated. A literature review was performed to identify all published randomized or non-randomized controlled trials that compared tadalafil with sildenafil for the treatment of ED and to assess the quality of the studies. Two investigators independently and blindly screened the studies for inclusion. The meta-analysis was performed using RevMan 5.0.. A total of 16 trials that compared tadalafil with sildenafil for the treatment of ED were included in the meta-analysis. In the meta-analysis, tadalafil and sildenafil appeared to have similar efficacies and overall adverse event rates. However, compared with sildenafil, tadalafil significantly improved psychological outcomes. Furthermore, the patients and their partners preferred tadalafil over sildenafil, and no significant difference was found in the adherence and persistence rates between tadalafil and sildenafil. Additionally, the myalgia and back pain rates were higher and the flushing rate was lower with tadalafil than with sildenafil.. Tadalafil shares a similar efficacy and safety with sildenafil and significantly improves patients' sexual confidence. Furthermore, patients and their partners prefer tadalafil to sildenafil. Hence, tadalafil may be a better choice for ED treatment.

Topics: Back Pain; Controlled Clinical Trials as Topic; Erectile Dysfunction; Flushing; Humans; Male; Myalgia; Patient Preference; Phosphodiesterase 5 Inhibitors; Self Efficacy; Sildenafil Citrate; Tadalafil

To date, multidisciplinary approach is commonly used to treat erectile dysfunction (ED), and the first line of ED pharmacotherapy, despite its multiple causes, is phosphodiesterase inhibitors of type 5 (PDE-5). They are considered an effective and well tolerated treatment option [1-4]. Concurrently, sildenafil has the largest evidence base for efficacy and safety [5]. The satisfaction of patients with ED therapy is a complex and personal matter, and there are no clearly established and reliable criteria for showing preferences when choosing a PDE-5. Adherence of patients to the PDE-5 therapy is determined not only by the erectile response and side effects, but also by how well the treatment meets the needs and expectations of patients and how it affects the relationship between the partners. This review examines the tolerability and efficacy of the various types of PDE-5 available for treating ED, with a special emphasis on the patient's preferences, and in particular on the new sildenafil orodispersible films. As an alternative route of drug administration, films quickly dissolve in the mouth [6] and have several advantages, improve sexual health and the sense of psychological well-being of patients and their partners.

Topics: Dosage Forms; Erectile Dysfunction; Humans; Male; Patient Preference; Patient Satisfaction; Phosphodiesterase 5 Inhibitors; Reproductive Health; Sildenafil Citrate

The aim of this study was to assess erection quality with sildenafil vs placebo and adverse events (AEs) according to age (≤45, 46-55 and ≥56 years) in 997 men with erectile dysfunction (ED) using pooled data from four randomized, double-blind, placebo-controlled, flexible-dose trials.. The trials included 6- to 10-week treatment periods. The starting sildenafil dose was 50 mg, taken ~1 hour before sexual activity but not more than once daily, with subsequent adjustment to 100 or 25 mg based on efficacy and safety. Exclusion criteria included blood pressure <90/50 or >170/110 mmHg, taking nitrate therapy or nitric oxide donors, severe cardiac failure/unstable angina or recent stroke or myocardial infarction. Changes from baseline in Quality of Erection Questionnaire (QEQ), International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were analysed.. Improvements in QEQ scores with sildenafil vs placebo were significant (P<.0001) for the overall sample (33.7 sildenafil; 8.1 placebo) and each age group (≤45 years: 38.5 sildenafil, 13.9 placebo; 46-55 years: 34.9 sildenafil, 5.8 placebo; ≥56 years: 26.9 sildenafil, 4.9 placebo). IIEF Erectile Function domain (P<.0001), question 3 (achieving erection; P<.003), and question 4 (maintaining erection; P<.001) scores also improved significantly for the overall sample and each age group. Treatment satisfaction was significantly greater (P<.0001) with sildenafil vs placebo for the overall sample and each age group. The most common AEs with sildenafil were headache, flushing and nasal congestion in all age groups.. Sildenafil significantly improved erection quality across all age groups of men with ED. Efficacy improvements with sildenafil were consistent with the QEQ, IIEF, and EDITS. AEs were comparable across age groups. ClinicalTrials.gov ID: NCT00159900, NCT00147628, NCT00301262, NCT00343200.

Topics: Adult; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Randomized Controlled Trials as Topic; Sildenafil Citrate; Surveys and Questionnaires

The US Food and Drug Administration recently announced the need to evaluate the association between PDE5is and melanoma. We performed a meta-analysis on the association between PDE5i and melanoma using random effects models and examined whether it met Hill's criteria for causality. A systematic search of Medline, EMBASE, and the Cochrane Library from 1998 to 2016 identified three case-control studies and two cohort studies, including a total of 866 049 men, of whom 41 874 were diagnosed with melanoma. We found a summary estimate indicating an increased risk of melanoma in PDE5i users (relative risk = 1.11, 95% confidence interval = 1.02 to 1.22). However, the association was only statistically significant among men with low PDE5i exposure (not high exposure) and with low-stage melanoma (not high stage), indicating a lack of dose response and biological gradient. PDE5i use was also associated with basal cell cancer, suggesting a lack of specificity and likely confounding by ultraviolet exposure. Thus, although this meta-analysis found a statistically significant association between PDE5i and melanoma, it did not satisfy Hill's criteria for causality.

Topics: Aged; Aged, 80 and over; Carcinoma, Basal Cell; Case-Control Studies; Erectile Dysfunction; Humans; Male; Melanoma; Middle Aged; Phosphodiesterase Inhibitors; Risk Factors; Sildenafil Citrate; Skin Neoplasms

To investigate the clinical effect and safety of Wanfeile in the treatment of erectile dysfunction (ED).. Totally 100 ED patients received oral Wanfeile at 100 mg, once every 3 days, for a course of 3 months. We compared the IIEF-5 scores of the patients before and after medication and among the patients with different degrees of ED. We evaluated the total clinical effectiveness of Wanfeile and analyzed adverse reactions.. The total effectiveness rate of Wanfeile was 95.6%. All the patients showed significant improvement in the IIEF-5 scores after treatment as compared with the baseline (P <0.05). Adverse reactions were observed in 5 cases (5.50%), all mild and transient.. Wanfeile is safe and efficacious for the treatment of ED.. 目的: 探讨万菲乐治疗男性勃起功能障碍的临床疗效观察及安全性。方法: 100例ED患者口服100 mg 万菲乐3日1次，3个月为1个疗程，比较治疗前后国际勃起功能指数调查表5个简化问题（IIEF-5）的评分，评估临床总有效率以及观察不良反应。结果: 万菲乐治疗ED患者的临床总有效率达95.6%，不同程度组的ED患者IIEF评分均较治疗前有统计学差异（P<0.05），发生药物不良反应共5例（5.50%），均是一过性的，程度轻微。结论: 万菲乐治疗男性勃起功能障碍是安全有效的。.

Topics: Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Surveys and Questionnaires; Treatment Outcome

To determine the effectiveness of the Phosphodiesterase 5 (PDE5) Inhibitors for the treatment of erectile dysfunction in patients with spinal trauma.. A systematic review and meta-analysis comparing PDE5 inhibitors versus placebo were carried out for clinical trials conducted between 1980 and 2014 that evaluated male patients older than 18 years, diagnosed with spinal cord trauma and erectile dysfunction. We designed a search strategy for Medline, CENTRAL, EMBASE and other electronic sources. Two investigators independently and blindly screened the studies for inclusion. A random effect meta-analysis was performed.. Six studies involving 963 patients were included. Male patients over 18 years with ED attributable or subsequent to traumatic spinal cord injury (SCI) were included from these studies. In 4 of these studies, patients were randomized to the treatment group receiving sildenafil and the comparison group was placebo. Out of the remaining 2 trials, one compared tadalafil against the placebo and the other vardenafil versus placebo. The improvement on SCIs with PDE5 inhibitors was found to be large (standardized mean difference 0.71; 95% CI 0.39-1.03), with a high heterogeneity (I2 = 74.4%).. PDE5 inhibitors are effective for the treatment of erectile dysfunction secondary to SCI.

Topics: Adult; Aged; Carbolines; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Randomized Controlled Trials as Topic; Sildenafil Citrate; Spinal Cord Injuries; Tadalafil; Treatment Outcome; Vardenafil Dihydrochloride; Young Adult

Sexual dysfunction is an important public health problem in men and is associated with reduced quality of life. It is more common in patients with schizophrenia. It is well-established that antipsychotic drugs cause sexual dysfunction with consequences on the quality of life of patients, adherence to treatment, and public health costs. Phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are indicated for the management of erectile dysfunction. However, there is little information on such treatment in schizophrenic patients. This literature review aimed to summarize the current data on the efficacy and tolerability of PDE-5 inhibitors in the erectile dysfunction in schizophrenic patients.. PubMed, PsycInfo and Cochrane databases were searched for studies published until August 2014.. Only 6 studies met the inclusion criteria. Three were randomized, double-blind, cross-over, placebo-controlled trials and three were open studies. Various scales were used to measure erectile and orgasmic function, desire, satisfaction during intercourse, overall satisfaction, quality of life and intensity of schizophrenic symptoms. In the 3 randomized studies (one with sildenafil 25-50 mg, one with lodenafil carbonate 80 mg/j and the last one with tadalafil 10 mg), the rate of participants who completed the trial was high (around 95 %). All three included patients with schizophrenia or schizophrenia spectrum disorders. Patients reported significant improvement on sexual dysfunction. However, no statistical difference was reported between lodenafil and placebo, on different scales, suggesting a very important placebo effect in patients with schizophrenia. All three found a good tolerance of PDE-5 inhibitors. Side effects were rare and were mainly nasal congestion, headaches, nausea and dizziness. There were no major side effects or drug interactions. Considering the 3 open studies, 2 involved sildenafil and one tadalafil. All concluded in improved erectile and orgasmic function, desire, satisfaction during intercourse, overall satisfaction, and even the quality of life when it was studied. However, very few patients were included.. Little data are available on the use of PDE5 inhibitors in schizophrenic patients. The 6 studies included few patients which reduces the power and the scope of their conclusions. There is also an important bias due to the use of self-questionnaires. The methodologies of the studies differ in many aspects which limits the comparability. Inclusion and exclusion criteria, drugs used and scales varied among the studies. However, the management of erectile disorder seems to be a consistent target in an integrative approach for the overall well-being of schizophrenic patients. PDE-5 inhibitors appear to be safe and could improve erectile function in schizophrenic patients.. In total, the current data suggest efficiency and good tolerance of the use of PDE-5 inhibitors in schizophrenic patients with erectile dysfunction. However, further studies focusing on PDE-5 inhibitors are needed to more deeply assess their efficacy and safety in patients with schizophrenia.

Topics: Antipsychotic Agents; Carbonates; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Pyrimidines; Schizophrenia; Sildenafil Citrate; Treatment Outcome

The purpose of this review is to provide an overview of the pharmacology, tolerability, and efficacy of the different phosphodiesterase type 5 (PDE5) inhibitors available for the treatment of erectile dysfunction (ED), with a special focus on the sildenafil orodispersible tablet (ODT) formulation.. A literature search was performed in PubMed, EMBASE, and Cochrane Reviews using the terms erectile dysfunction, patient preference, sildenafil, and PDE5 inhibitors to identify articles published in English between May 1, 2006, and November 18, 2016. A total of 29 studies were included in this review.. There are substantial data in the literature on the use of PDE5 inhibitors for the treatment of ED. Oral PDE5 inhibitors have been found to be efficacious in the treatment of ED based on results from standard tools used to assess treatment outcomes, such as the Global Assessment Questionnaire 1. In addition, PDE5 inhibitors are defined as well tolerated because of the low occurrence of serious adverse effects or discomfort. Mild adverse reactions, compared with a placebo, include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Both the film-coated tablet and ODT formulations of sildenafil with or without water have equivalent systemic exposure. However, use of a sildenafil ODT formulation offers a convenient alternative method of administration that would be advantageous for patients with ED.. According to the published literature, the PDE5 inhibitors are considered an effective and well-tolerated option for the treatment of ED as determined by data generated from standard instruments used in the assessment of treatment outcomes in ED and reported types and severity of adverse effects. The sildenafil ODT formulation, which disintegrates rapidly in the mouth, is an alternative to the solid film-coated tablet formulation that offers administration benefit with the potential to improve treatment adherence, thereby enhancing the sexual health and sense of psychological well-being of patients and their partners.

Topics: Chemistry, Pharmaceutical; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tablets; Treatment Outcome

We carried out a systematic review and meta-analysis to assess the efficacy and safety of phosphodiesterase type 5 (PDE5) inhibitors for treating erectile dysfunction (ED) after bilateral nerve-sparing radical prostatectomy (BNSRP). A literature review was performed to identify all published randomised double-blind, placebo-controlled trials of PDE5 inhibitors for the treatment of ED after BNSRP. The search included the following databases: MEDLINE, EMBASE and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. Six publications involving a total of 1678 patients were used in the analysis, including six RCTs that compared PDE5 inhibitors (tadalafil, sildenafil, avanafil and vardenafil) with placebo. Co-primary efficacy end points: International Index of Erectile Function-Erectile Function (IIEF-EF) domain score [the standardised mean difference (SMD) = 4.04, 95% confidence interval (CI) = 2.87-5.22, P < 0.00001]; successful vaginal penetration (SEP2) [the odds ratio (OR) = 14.87, 95%CI = 4.57-48.37, P < 0.00001]; and successful intercourse (SEP3) (OR = 47, 95%CI = 3-13.98, P < 0.00001) indicated that PDE5 inhibitors was more effective than the placebo. Specific adverse events with PDE5 inhibitors included headache (12.08%), dyspepsia (6.76%) and flushing (6.52%), which were significantly less likely to occur with placebo. This meta-analysis indicates that PDE5 inhibitors to be an effective and well-tolerated treatment for ED after BNSRP.

Topics: Erectile Dysfunction; Humans; Male; Organ Sparing Treatments; Peripheral Nerves; Phosphodiesterase 5 Inhibitors; Postoperative Complications; Prostatectomy; Pyrimidines; Sildenafil Citrate; Tadalafil; Treatment Outcome; Vardenafil Dihydrochloride

Phosphodiesterase type-5 inhibitors (PDE5-Is) have been recommended as first line therapy for erectile dysfunction for patients received nerve-sparing radical prostatectomy for prostate cancer. We examed the efficiency of PDE5-Is and considered the optimal application. Systematic search of PubMed, Embase and the Cochrane Library was performed to identify all the studies. We identified 103 studies including 3175 patients, of which 14 were recruited for systematic review. Compared with placebo, PDE5-Is significantly ameliorated the International Index of Erectile Function-Erectile Function domain score (IIEF) scores (MD 4.89, 95% CI 4.25-5.53, p < 0.001). By network meta-analysis, sildenafil seems to be the most efficiency with a slightly higher rate of treatment-emergent adverse events (TEATs), whereas tadalafil had the lowest TEATs. In terms of IIEF scores, regular regimen was remarkably better than on-demand (MD 3.28, 95% CI 1.67-4.89, p < 0.001). Regular use was not associated with higher proportion of patients suffering TEATs compared with on-demand (RR 1.02, 95% CI 0.90-1.16, p = 0.72). Compared with placebo, PDE5-Is manifested significantly improved treatment outcomes. Overall, regular regimen demonstrated statistically pronounced better potency than on-demand. Coupled with the comparable rate of side effects, these findings support the regular delivery procedure to be a cost-effective option for patients.

Topics: Adolescent; Adult; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Network Meta-Analysis; Phosphodiesterase 5 Inhibitors; Prostatectomy; Prostatic Neoplasms; Sildenafil Citrate; Tadalafil; Treatment Outcome; Young Adult

Phosphodiesterase type 5 (PDE-5) hydrolyzes cyclic guanylate monophosphate (cGMP) specifically to 5' GMP, promoting successful corporeal vascular relaxation and penile erection during sexual stimulation. Oral PDE-5 inhibitors such as sildenafil, vardenafil, tadalafil, and avanafil have provided noninvasive, effective, well-tolerated treatment for erectile dysfunction (ED) patients and, at the same time, stimulated both academic and clinical interests. Lately, some oral PDE-5 inhibitors were released as low-dose preparations with the concept of potential daily administration and long-term use.. To highlight the possible potential implications of low-dose long-term use of PDE-5 inhibitors.. A systematic review was carried out until December 2015 based on a search of all concerned articles in MEDLINE, medical subjects heading (MeSH) databases, Scopus, The Cochrane Library, EMBASE, and CINAHL databases without language restriction. Key words used to assess the outcome and estimates for concerned associations were: PDE-5 inhibitors; erectile dysfunction; low-dose; long-term; sildenafil; tadalafil; vardenafil; avanafil.. Demonstrating different implications for low-dose long-term use of PDE-5 inhibitors.. Low-dose and/or long-term use of PDE-5 inhibitors was shown to put forth beneficial sound effects in different medical implications with potentials that could be extended for different utilities. These implications included sexual, urogenital, cardiovascular, pulmonary, cutaneous, gastrointestinal, and reproductive, as well as neurological disorders. However, it is evident that most potential appliances were carried out experimentally on preclinical studies with off-label indications.. Making use of and exploring low-dose and/or long-term use of several PDE-5 inhibitors for their possible implications seem to be valuable in different medical disorders. Increased knowledge of the drug characteristics, comparative treatment regimens, optimal prescribing patterns, and well-designed clinical trials are needed before these agents can be recommended for use.

Topics: Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Treatment Outcome; Vardenafil Dihydrochloride

Erectile dysfunction is usually of vascular origin and is frequently encountered in men with cardiovascular disease. The introduction of phosphodiesterase-5 inhibitors has revolutionized the management of patients with erectile dysfunction. Currently available phosphodiesterase-5 inhibitors have distinct pharmacokinetic and pharmacodynamic properties, thus permitting for tailoring sexual therapy according to patient characteristics and needs. Phosphodiesterase-5 inhibitors possess vasorelaxing properties and exert systemic hemodynamic effects, which need to be taken into account when other cardiovascular drugs are co-administered. Special caution is needed with alpha-blockers, while the co-administration with nitrates is contra-indicated due to the risk of life-threatening hypotension. This review presents the advent of sexual therapy, describes the mechanism of action and the specific characteristics of commercially available phosphodiesterase-5 inhibitors, summarizes the efficacy and safety of these drugs with special emphasis on the cardiovascular system, and discusses the clinical criteria used for the selection of each drug for the individual patient.

Topics: Cardiovascular Diseases; Drug Incompatibility; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride; Vasodilator Agents

To systematically assess the efficacy and safety of oral sildenafil citrate for post bilateral nerve-sparig radical prostatectomy (post-BNSRP) erectile dysfunction (ED).. The following keywords: sildenafil, radical prostatectomy were used to search in Medline, Pubmed, Web of Science, Cochrane Library, CNKI, WanFang Database. The title, abstract and keywords of each article were independently screened by two reviewers. Randomized controlled trials (RCT) published between 1990 and 2014 were retrieved according to our inclusion and exclusion criteria. The efficacy and safety of oral sildenafil citrate for post-BNSRP ED were systematically assessed by meta-analysis.. Four RCTs with 320 cases were included after literature retrieval and filtering. The potency rates were 32.1% (35/109) and 11.3% (7/62) between sildenafil and placebo groups after meta-analysis and showed statistically significant differences (OR = 4.66, 95% CI: 1.79-12.11). IIEF-5 score in sildenafil group was significant higher than that in the placebo group (WMD: 4.73, 95% CI: 3.26-6.19). In subgroup meta-analysis, the potency rates in high-dose, low-dose sildenafil groups and placebo groups were 30.4% (14/46), 25.0% (10/40) and 4.5% (2/44), respectively. There were statistically significant differences between the high-dose subgroup and placebo group (OR = 9.32, 95% CI: 1.96-44.23), and the low-dose subgroup and placebo group (OR = 6.99, 95% CI: 1.43-34.22). But there was no significant difference between high-dose and low-dose subgroups (OR = 1.31, 95% CI: 0.51-3.40).. Compared with placebo, sildenafil has considerable efficacy for erectile function rehabilitationas as a primary treatment for post-BNSRP ED. There is no significant difference between high-dose and low-dose schedule for its efficacy. However, further studies are required to optimize treatment.

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Prostate; Prostatectomy; Randomized Controlled Trials as Topic; Sildenafil Citrate

Phosphodiesterase (PDE) enzymes are widely distributed throughout the body, having numerous effects and functions. The PDE type 5 (PDE5) inhibitors are widely used to treat erectile dysfunction (ED). Recent, intense preclinical and clinical research with PDE5 inhibitors has shed light on new mechanisms and has revealed a number of pleiotropic effects on the cardiovascular (CV) system. To date, PDE5 inhibition has been shown to be effective for the treatment of idiopathic pulmonary arterial hypertension, and both sildenafil and tadalafil are approved for this indication. However, current or future PDE5 inhibitors have the potential of becoming clinically useful in a variety of CV conditions such as heart failure, coronary artery disease, and hypertension. The present review discusses recent findings regarding pharmacologic treatment of ED and its interaction with the CV system and highlights current and future clinical applications beyond ED.

Topics: Animals; Carbolines; Cardiovascular Diseases; Cardiovascular System; Erectile Dysfunction; Familial Primary Pulmonary Hypertension; Humans; Hypertension, Pulmonary; Male; Phosphodiesterase 5 Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil

It is not known if statins will improve symptoms in patients with established erectile dysfunction (ED).. We carried out a systematic review and meta-analysis to assess the effect of statins on ED.. A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of statins for the treatment of ED. The search included the following databases: MEDLINE, Embase, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. A systematic review and meta-analysis were conducted.. Six publications involving a total of 462 patients were used in the analysis, including three randomized controlled trials (RCTs) that compared statins with placebo and three RCTs that compared statins plus sildenafil with placebo plus sildenafil.. For the comparison of statins (+/- sildenafil) with placebo (+/- sildenafil), the mean International Index of Erectile Function (IIEF-5) (the standardized mean difference [SMD] = 3.23, 95% confidence interval [CI] = -1.65 to 4.80, P < 0.0001) indicated that statins (+/- sildenafil) showed statistically significantly greater improvements in the mean IIEF-5 compared with placebo (+/- sildenafil). For the comparison of statins with placebo, the mean IIEF-5 (SMD = 2.13, 95% CI = -1.46 to 5.73, P = 0.24) indicated that there was no significant difference in erectile function between the statins and placebo. For the comparison of statins plus sildenafil with placebo plus sildenafil, the mean IIEF-5 (SMD = 3.60, 95% CI = 2.64 to 4.56, P < 0.00001), the IIEF domain (SMD = 4.88, 95%CI = 3.01 to 6.74, P < 0.00001), and the global efficacy question (odds ratio = 6.44, 95% CI = 2.92 to 14.23, P < 0.00001) showed that compared with placebo plus sildenafil, statins plus sildenafil clearly improved erectile function.. This meta-analysis indicates that statins (+/- sildenafil) may improve ED compared with placebo (+/- sildenafil).

Topics: Adult; Aged; Double-Blind Method; Drug Therapy, Combination; Erectile Dysfunction; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Treatment Outcome

Sildenafil and other PDE-5 inhibitors have revolutionized erectile dysfunction (ED) treatment. However, a significant number of patients do not respond or present adverse reactions to these drugs. While genetic polymorphisms may underlie this phenomenon, very little research has been undertaken in this research field. Most of the current knowledge is based on sildenafil, thus almost completely ignoring other important pharmacological therapies. Currently, the most promising genes with pharmacogenetic implications in ED are related to the nitric oxide and cGMP pathway, although other genes are likely to affect the responsiveness to treatment of ED. Nevertheless, the small number of studies available opens the possibility of further exploring other genes and phenotypes related to ED. This article provides a comprehensive overview of the genes being tested for their pharmacogenetic relevance in the therapy of ED.

Topics: Animals; Cyclic GMP; Erectile Dysfunction; Humans; Male; Nitric Oxide; Pharmacogenetics; Phosphodiesterase 5 Inhibitors; Piperazines; Polymorphism, Genetic; Purines; Sildenafil Citrate; Sulfonamides

Phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil, tadalafil and vardenafil are first line treatment for erectile dysfunction (ED). These PDE5 inhibitors are known to increase cyclic guanosine monophosphate (cGMP) concentrations in the smooth muscle cells of the corpora cavernosa penis by inhibiting PDE5, leading to smooth muscle relaxation. This mode of action is also believed to result in prostatic smooth muscle relaxation and to improve lower urinary tract symptoms (LUTS). Randomized controlled trials have shown beneficial effects on LUTS and on objective parameters such as maximum urinary flow rate (tadalafil). Based on these data tadalafil was recently approved for treatment of patients with male LUTS; however, the mechanisms leading to improvement of symptoms are still under debate.

Topics: Carbolines; Controlled Clinical Trials as Topic; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Imidazoles; Lower Urinary Tract Symptoms; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Prostatic Hyperplasia; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Urodynamics; Vardenafil Dihydrochloride

Sildenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). A patent was registered for this drug in 1990, which expired in 2010. Since expiration, the drug has been marketed under various trade names or as generic drugs. Numerous clinical trials have been conducted addressing the effectiveness of the drug for erectile dysfunction (ED) and its safety regarding the presence or absence of specific comorbidities. After over 20 years in the market, we need to ask: has the scientific community reached a general consensus as to the overall efficacy and safety of the drug? Can we firmly state that the benefits of the drug outweigh its risks? This review suggests that sildenafil is an effective and easily manageable treatment for erectile dysfunction, both in the absence and in the presence of comorbidities. After two decades of the emergence of sildenafil as a drug of choice for the treatment of ED (and the numerous studies and clinical trials undertaken during this time span), it is now possible to state that the benefits of the drug do outweigh the risks, and represent an significant improvement in the quality of life in men with ED.

Topics: Comorbidity; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Stem cells (SCs) have been investigated for the treatment of erectile dysfunction (ED).. This review covers key disease targets and all 33 preclinical studies, including their use of SC types, animal models, transplantation routes, and outcome assessment methods.. In the past one and half years there have been more stem-cell-for-erectile-dysfunction studies than the prior 8 years combined. These new studies tend to use combinatory treatment approaches by modifying or supplementing SCs with angiogenic or neurotrophic genes or proteins. However, when considering all risks and benefits, these combinatory approaches do not seem more advantageous than single-SC approaches. Another trend is the choice of transplantation routes other than the standard intracavernous (IC) injection. However, with the exception of intravenous injection, these new transplantation approaches are more cumbersome than IC injection and yet offer no evidence of producing better outcomes. In contrast to these variations, a consensus among these studies is the suggestion that paracrine action, as opposed to cellular differentiation, is the principal therapeutic mechanism. In conclusion, IC injection of a single SC type should be the choice protocol for initial clinical trials, and this is clearly the case with two clinical trials that are currently recruiting patients.

Topics: Animals; Clinical Trials as Topic; Diabetes Complications; Disease Models, Animal; Erectile Dysfunction; Evaluation Studies as Topic; Humans; Injections, Intravenous; Male; Myocytes, Smooth Muscle; Organ Specificity; Paracrine Communication; Penile Induration; Piperazines; Postoperative Complications; Prevalence; Prostatectomy; Purines; Radiotherapy; Rats; Sildenafil Citrate; Stem Cell Transplantation; Sulfones; Treatment Outcome

Ischemic priapism is a rare occurrence which can cause severe erectile dysfunction (ED) without timely treatment. This retrospective study reports our experience in treating prolonged ischemic priapism and proposes our further considerations. In this paper, a total of nine patients with prolonged ischemic priapism underwent one to three types of surgical shunts, including nine Winter shunts, two Al-Ghorab shunts and one Grayhack shunt. During the follow-up visit (after a mean of 21.11 months), all patients' postoperative characters were recorded, except one patient lost for death. Six postoperative patients accepted a 25-mg oral administration of sildenafil citrate. The erectile function of the patients was evaluated by their postoperative 5-item version of International Index of Erectile Function Questionnaire (IIEF-5), which were later compared with their premorbid scores. All patients had complete resolutions, and none relapsed. The resolution rate was 100%. Seven patients were resolved with Winter shunts, one with an Al-Ghorab shunt and one with a Grayhack shunt. The mean hospital stay was 8.22 days. There was only one urethral fistula, and the incidence of postoperative ED was 66.67%. Four patients with more than a 72-h duration of priapism had no response to the long-term phosphodiesterase type 5 (PDE-5) inhibitor treatment. These results suggest that surgical shunts are an efficient approach to make the penis flaccid after prolonged priapism. However, the severe ED caused by prolonged duration is irreversible, and long-term PDE-5 inhibitor treatments are ineffective. Thus, we recommend early penile prosthesis surgeries for these patients.

Topics: Adult; Aged; Erectile Dysfunction; Humans; Ischemia; Male; Middle Aged; Penile Prosthesis; Penis; Phosphodiesterase 5 Inhibitors; Piperazines; Priapism; Purines; Sildenafil Citrate; Sulfones; Ultrasonography; Vascular Surgical Procedures

Optimal pharmacologic management of diseases comorbid with erectile dysfunction (ED), such as cardiovascular disease, depression, diabetes, dyslipidemia, hypertension, and benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS), is dependent upon long-term treatment compliance and may be complicated by poor adherence to medication use. ED may contribute to poor adherence to medication use because poor quality erectile function may be an unwanted adverse effect of antihypertensives, antidepressants, and 5-α reductase inhibitors for treatment of BPH/LUTS. Diminished erectile spontaneity, rigidity, and/or sustaining capability also negatively affects mood, self-esteem, and confidence, which compromise motivation to be compliant with medications that treat diseases comorbid with ED.. Literature review was performed to explore the role of ED diagnosis and effective treatment in enhancing overall management of selected ED comorbidities, highlighting the role of medication adherence.. Several PubMed searches were performed.. Diagnosis and successful treatment of concomitant ED may promote improved adherence and management of comorbid diseases. Concomitant ED management may improve treatment outcome, decrease healthcare costs, and possibly prevent or even improve deterioration in medical conditions comorbid with ED. Because ED is a silent marker and predictor of comorbidities, especially cardiovascular disease, earlier diagnosis of ED may provide an opportunity to prevent future cardiovascular events. In men presenting with complaints of ED, screening for, monitoring, and appropriately treating diseases that are comorbid with ED is essential. Screening for and appropriately treating ED is important for enhanced life quality and improved motivation in men with existing ED comorbidities or risk factors.. Appropriate management of ED and its risk factors may have beneficial effects on diseases that are comorbid with ED, and vice versa, most likely via shared pathophysiological pathways. Clinicians may need to consider men's health overall, of which sexual health is a central component, in order to provide optimal disease management.

Topics: 5-alpha Reductase Inhibitors; Affect; Antidepressive Agents; Antihypertensive Agents; Carbolines; Comorbidity; Drug Therapy, Combination; Erectile Dysfunction; Humans; Imidazoles; Long-Term Care; Male; Medication Adherence; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Self Concept; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Sildenafil was the first oral phosphodiesterase type 5 (PDE5) inhibitor introduced as primary therapy for erectile dysfunction (ED). In the 7 years following its market launch, sildenafil was prescribed by more than 750,000 physicians to more than 23 million men worldwide. To date, few studies have evaluated the economic impact of sildenafil in treating ED.. To evaluate the cost-effectiveness and impact of sildenafil on health care costs for patients with ED in multiple countries.. Economic outcomes including cost, cost-effectiveness, cost of illness, cost consequence, resource use, productivity, work loss, and willingness to pay (WTP) were investigated.. Using keywords related to economic outcomes and sildenafil, we systematically searched literature published between July 2001 and July 2011 using MEDLINE and EMBASE. Included articles pertained to costs, WTP, and economic evaluations.. In the last 10 years, 12 studies assessed economic outcomes associated with sildenafil for ED. Most studies were conducted in the United States and the United Kingdom, with one study identified in Canada and one from Mexico. Six studies evaluated cost of illness, cost consequence, or cost of care, and four studies evaluated WTP or drug pricing by country in the United States and the United Kingdom. In the United States and the United Kingdom, costs to health care systems have increased with demand for treatment. Cost analyses suggested that sildenafil would lower direct costs compared with other PDE5 inhibitors. U.S. and U.K. studies found that patients exhibited WTP for sildenafil. The two cost-effectiveness models we identified examined ED sub-groups, those with spinal cord injury and those with diabetes or hypertension. These models indicated favorable cost-effectiveness profiles for sildenafil compared with other active-treatment options in both Mexico and Canada.. The relative value of sildenafil vs. surgically implanted prosthetic devices and other PDE5 inhibitors, is underscored by patients' WTP, and cost-effectiveness in ED patients with comorbidities.

Topics: Adult; Aged; Aged, 80 and over; Canada; Cost-Benefit Analysis; Erectile Dysfunction; Health Care Costs; Humans; Male; Mexico; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; United Kingdom; United States

To determine the efficacy of phosphodiesterase inhibitors for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).. MEDLINE and PubMed were searched from January 1, 2000, to October 31, 2012, using the MeSH terms phosphodiesterase inhibitor, lower urinary tract symptoms, benign prostatic hyperplasia, sildenafil, vardenafil, and tadalafil. Additional articles were obtained from references identified in the original search.. English-language randomized controlled trials and review articles were evaluated.. Men with BPH commonly experience lower urinary tract symptoms (LUTS) such as urgency, frequency, nocturia, and dribbling. α-Adrenergic antagonists have been the mainstay of medical treatment of LUTS but are associated with adverse effects such as orthostatic hypotension, dizziness, and sexual dysfunction. The 5-α reductase inhibitors are associated with sexual dysfunction, and treatment effects may be delayed for 6-12 months. Phosphodiesterase type 5 (PDE-5) inhibitors are effective for the treatment of erectile dysfunction (ED), and large-scale epidemiologic studies suggest a strong link between LUTS and ED. The available PDE-5 inhibitors (sildenafil, tadalafil, and vardenafil) have shown efficacy in the treatment of LUTS in several randomized controlled trials in men with and without concomitant ED.. PDE-5 inhibitors consistently reduce LUTS associated with BPH. These medications may offer advantages over conventional therapies such as rapid onset of action, fewer adverse effects, and enhanced sexual function. Quality of life improvements have also been realized in men with BPH who receive PDE-5 inhibitors.

Topics: Adrenergic alpha-Antagonists; Carbolines; Drug Resistance; Drug Therapy, Combination; Erectile Dysfunction; Humans; Imidazoles; Lower Urinary Tract Symptoms; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Prostate; Prostatic Hyperplasia; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Phosphodiesterase type 5 inhibitors (PDE5-Is) are currently the first-line therapy for erectile dysfunction (ED), but available studies investigating the comparative effects of different PDE5-Is are limited.. To compare the efficacy and safety of different classes of oral PDE5-Is for ED.. A systematic search was performed in PubMed, Cochrane Library, and Embase to identify randomized controlled trials that compared different PDE5-Is or PDE5-Is with a placebo for ED. The methodological quality of included studies was appraised with the Cochrane Collaboration bias appraisal tool, and the quality of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation system.. A total of 118 trials (31 195 individuals) were included. There was no major difference in the results between the traditional meta-analysis and the network meta-analysis. Network meta-analysis demonstrated that PDE5-Is were superior to placebo to improve erectile function. Compared with tadalafil (relative risk [RR]: 0.61; 95% confidence interval [CI], 0.33-0.90) and vardenafil (RR: 0.63; 95% CI, 0.35-0.92), avanafil was less effective on Global Assessment Questionnaire question 1. Tadalafil was more effective than vardenafil (mean difference [MD]: 1.49; 95% CI, 0.50-2.50) and udenafil (MD: -1.84; 95% CI, -3.31 to -0.33) as measured by the erectile function domain of the International Index of Erectile Function. For all efficacy outcomes, the absolute effects and the rank tests indicated that tadalafil and vardenafil were the most effective agents. After adjusting for dosage, the conclusion remained the same. Safety analysis showed there was no major difference among different agents.. In recommended doses, oral PDE5-Is are more effective than placebo for ED, and tadalafil seems to be the most effective agent, followed by vardenafil. PDE5-Is are generally safe and well tolerated, and there is no major difference on the safety profile.

Topics: Administration, Oral; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Odds Ratio; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Risk Assessment; Risk Factors; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

As men age, there is an increase in the frequency of pathologic diseases affecting the genitourinary tract. Most notable among these changes are the rising prevalence of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). The pathogenesis of these conditions seems to be multifactorial and includes age-related changes in the nervous system and neuroregulatory factors, such as nitric oxide and RhoA/Rho-kinase. Various pharmacologic agents that target these pathways, such as α-blockers and PDE-5is, underscore the contribution of neuroregulatory factors on the development of LUTS/BPH and ED.

Topics: Age Factors; Aged; Aged, 80 and over; Aging; Carbolines; Disease Progression; Erectile Dysfunction; Humans; Imidazoles; Lower Urinary Tract Symptoms; Male; Men's Health; Middle Aged; Neurotransmitter Agents; Piperazines; Prognosis; Prostatic Hyperplasia; Purines; Receptors, Neurotransmitter; Risk Assessment; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Topics: Animals; Erectile Dysfunction; Headache; Humans; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Several randomized controlled trials (RCTs) on phosphodiesterase type 5 inhibitors (PDE5-Is) have showed significant improvements in both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in men affected by one or both conditions, without a significant increase in adverse events. However, the results are inconsistent.. Perform a systematic review and meta-analysis of available prospective and cross-sectional studies on the use of PDE5-Is alone or in combination with α1-adrenergic blockers in patients with LUTS/benign prostatic hyperplasia (BPH).. A systematic search was performed using the Medline, Embase, and Cochrane Library databases through September 2011 including the combination of the following terms: LUTS, BPH, PDE5-Is, sildenafil, tadalafil, vardenafil, udenafil, α-blockers, and α1-adrenergic blocker. The meta-analysis was conducted according to the guidelines for observational studies in epidemiology.. Of 107 retrieved articles, 12 were included in the present meta-analysis: 7 on PDE5-Is versus placebo, with 3214 men, and 5 on the combination of PDE5-Is with α1-adrenergic blockers versus α1-adrenergic blockers alone, with 216 men. Median follow-up of all RCTs was 12 wk. Combining the results of those trials, the use of PDE5-Is alone was associated with a significant improvement of the International Index of Erectile Function (IIEF) score (+5.5; p<0.0001) and International Prostate Symptom Score (IPSS) (-2.8; p<0.0001) but not the maximum flow rate (Q(max)) (-0.00; p=not significant) at the end of the study as compared with placebo. The association of PDE5-Is and α1-adrenergic blockers improved the IIEF score (+3.6; p<0.0001), IPSS score (-1.8; p = 0.05), and Q(max) (+1.5; p<0.0001) at the end of the study as compared with α-blockers alone.. The meta-analysis of the available cross-sectional data suggests that PDE5-Is can significantly improve LUTS and erectile function in men with BPH. PDE5-Is seem to be a promising treatment option for patients with LUTS secondary to BPH with or without ED.

Topics: Adrenergic alpha-Antagonists; Carbolines; Drug Therapy, Combination; Erectile Dysfunction; Humans; Imidazoles; Lower Urinary Tract Symptoms; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Prostatic Hyperplasia; Purines; Pyrimidines; Sildenafil Citrate; Sulfonamides; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

The scale at which erectile dysfunction (ED) medicines are obtained outside of the official health system rivals and possibly exceeds legitimate sales. According to literature a high-risk segment of this market is occupied by adulterated food supplements. The principle adulterants identified were structural analogues of the registered ED drugs sildenafil, tadalafil, and vardenafil. Currently, at least 46 different analogues have been reported and still more are expected. The intellectual origin of analogues was found in patent literature which described the drug discovery process. Patent literature offers a flexible approach to synthesize hundreds of analogues. Most of the analogues currently known had long been disclosed in patent literature. Screening for (new) analogues is best carried out by using advanced LC-MS/MS techniques that focus on marker fragment ions. Analogues are experimental drugs in essence because most have no known efficacy or safety profile. Their use in seemingly harmless food supplements is expected to cause serious adverse effects. However, few reports have emerged in literature on actual harm. Considering the exposure to analogues and their adverse effects being unknown a gross underreporting of complaints is expected.

Topics: Carbolines; Chemistry Techniques, Analytical; Cyclic Nucleotide Phosphodiesterases, Type 5; Dietary Supplements; Drug Contamination; Erectile Dysfunction; Humans; Imidazoles; Ions; Male; Models, Chemical; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Erectile dysfunction (ED) is a common sexual disease in male patients with multiple sclerosis (MS). Sildenafil citrate is considered as an effective drug in the treatment of male ED in the general population, but it has not been systematically reviewed in patients with MS.. To assess the efficacy and safety of sildenafil citrate for ED in patients with MS.. We searched the Cochrane (November 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4 of 4, 2011), MEDLINE (PubMed) (January 1966 to November 2011), EMBASE (January 1974 to November 2011) and the China Biological Medicine Database (CBM) (1979 to November 2011). We searched trials registers and conference proceedings and contacted pharmaceutical company and authors of included studies for additional data. There were no language restrictions.. Randomised controlled trials comparing sildenafil citrate with placebo or no treatment for ED in patients with MS.. Two review authors independently selected articles for inclusion, extracted data and assessed trial quality. Disagreements were resolved by discussion between review authors. Authors of included studies were contacted for additional information. Results were presented as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CI).. Two randomised controlled trials involving a total of 420 patients were identified. Both trials investigated the short-term efficacy and safety of sildenafil citrate for ED in patients with MS. Patients taking sildenafil citrate were more likely to improve their ability to achieve and maintain an erection measured by International Index of Erectile Function and achieve vaginal penetration ( (RR 1.28, 95%CI 0.92 to 1.78) and complete intercourse measured by Sexual Encounter Profile diary (RR RR 1.38, 95%CI 1.00 to 1.90). and receive A global well respond measured by Global Assessment Question (RR 2.72, 95%CI 1.40 to 5.28) was reported. One trial showed sildenafil citrate is effective in quality of life improvement, while the other trial did not find any significant difference between both groups. Both included trials were judged as high risk of attrition bias. Adverse events were also reported: the most common were headache, flushing, rhinitis, visual disturbances and dyspepsia. Two patients suffered serious adverse events: one with coronary artery disease requiring triple bypass surgery and one with a cerebrovascular accident.. There is limited evidence to support sildenafil citrate as an effective treatment for ED in patients with MS. Future well designed randomised, double blinded, placebo-controlled trials with long-term duration are needed.

Topics: Erectile Dysfunction; Humans; Male; Multiple Sclerosis; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Vasodilator Agents

There is limited evidence for the management of sexual dysfunction and/or hyperprolactinemia resulting from use of antipsychotics in patients with schizophrenia and spectrum. The aim of this study was to review and describe the strategies for the treatment of antipsychotic-induced sexual dysfunctions and/or hyperprolactinemia. The research was carried out through Medline/PubMed, Cochrane, Lilacs, Embase, and PsycINFO, and it included open labels or randomized clinical trials. The authors found 31 studies: 25 open-label noncontrolled studies and 6 randomized controlled clinical trials. The randomized, double-blind controlled studies that were conducted with adjunctive treatment that showed improvement of sexual dysfunction and/or decrease of prolactin levels were sildenafil and aripiprazole. The medication selegiline and cyproheptadine did not improve sexual function. The switch to quetiapine was demonstrated in 2 randomized controlled studies: 1 showed improvement in the primary outcome and the other did not. This reviewed data have suggested that further well-designed randomized controlled trials are needed to provide evidence for the effects of different strategies to manage sexual dysfunction and/or hyperprolactinaemia resulting from antipsychotics. These trials are necessary in order to have a better compliance and reduce the distress among patients with schizophrenia.

Topics: Adult; Antipsychotic Agents; Aripiprazole; Drug Substitution; Drug Therapy, Combination; Erectile Dysfunction; Female; Humans; Hyperprolactinemia; Male; Piperazines; Psychotic Disorders; Purines; Quinolones; Schizophrenia; Schizophrenic Psychology; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sulfones; Vasodilator Agents

Phosphodiesterase (PDE) enzymes are widely distributed throughout the body, having numerous effects and functions. The use of on demand PDE5 inhibitors (-Is) for the treatment of erectile dysfunction (ED) has recently obtained approval for chronic daily dosing for the same indication. There are published data supporting the use of PDE5-Is for the treatment of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Additional reports suggest benefit by these agents in patients with chronic heart failure, pulmonary hypertension, essential hypertension, and for the treatment of ischemia. Various central nervous system disorders have been described as targets by PDE5-Is. Sildenafil may have a potential therapeutic indication as a cognitive enhancer in age-related cerebral conditions. There is preclinical evidence for further investigation of the use of PDE5A -Is to improve recovery of cerebral function in humans after stroke by enhancing angiogenesis, neurogenesis and improving neurologic function. Sildenafil delays intestinal ulceration by an increase in the secretion of mucus/fluid and a decrease in hypermotility, and has a protective effect in reducing gastric damage. Larger scale, well designed clinical trials are needed to ascertain the safety, efficacy and cost-effectiveness of PDE5-Is in the future treatment of both urologic and non-urologic diseases. In this review, potential applications of PDE5-Is on urologic, cardiovascular, gastrointestinal, and central nervous system disorders will be updated.

Topics: Animals; Cardiovascular Diseases; Central Nervous System Diseases; Erectile Dysfunction; Female; Gastrointestinal Diseases; Humans; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Urologic Diseases

Sildenafil (Viagra) citrate has been well accepted by physicians and patients for its reliable efficacy and safety in the treatment of erectile dysfunction (ED) ever since its introduction into clinical andrology in China 10 years ago. It has been proved effective for various ED subgroups, regardless of causes, severity and age. Recent studies show that sildenafil also benefits patients with premature ejaculation, either used alone or in combination with other therapies.

Topics: China; Erectile Dysfunction; Humans; Male; Piperazines; Premature Ejaculation; Purines; Sildenafil Citrate; Sulfones

Psychotropic drugs are associated with sexual dysfunction. Symptoms may concern penile erection, lubrication, orgasm, libido, retrograde ejaculation, sexual arousal, or overall sexual satisfaction. These are major aspects of tolerability and can highly affect patients' compliance.. To determine the effects of different strategies (e.g. dose reduction, drug holidays, adjunctive medication, switching to another drug) for treatment of sexual dysfunction due to antipsychotic therapy.. An updated search was performed in the Cochrane Schizophrenia Group's Trials Register (3 May 2012) and the references of all identified studies for further trials.. We included all relevant randomised controlled trials involving people with schizophrenia and sexual dysfunction.. We extracted data independently. For dichotomous data we calculated random effects risk ratios (RR) with 95% confidence intervals (CI), for crossover trials we calculated Odds Ratios (OR) with 95% CI. For continuous data, we calculated mean differences (MD) on the basis of a random-effects model. We analysed cross-over trials under consideration of correlation of paired measures.. Currently this review includes four pioneering studies (total n = 138 , duration two weeks to four months), two of which are cross-over trials. One trial reported significantly more erections sufficient for penetration when receiving sildenafil compared with when receiving placebo (n = 32, MD 3.20 95% CI 1.83 to 4.57), a greater mean duration of erections (n = 32, MD 1.18 95% CI 0.52 to 1.84) and frequency of satisfactory intercourse (n = 32, MD 2.84 95% CI 1.61 to 4.07). The second trial found no evidence for selegiline as symptomatic treatment for antipsychotic-induced sexual dysfunction compared with placebo (n = 10, MD change on Aizenberg's sexual functioning scale -0.40 95% CI -3.95 to 3.15). No evidence was found for switching to quetiapine from risperidone to improve sexual functioning (n = 36, MD -2.02 95% CI -5.79 to 1.75). One trial reported significant improvement in sexual functioning when participants switched from risperidone or an typical antipsychotic to olanzapine (n = 54, MD -0.80 95% CI -1.55 to -0.05).. We are not confident that cross-over studies are appropriate for this participant group as they are best for conditions that are stable and for interventions with no physiological and psychological carry-over. Sildenafil may be a useful option in the treatment of antipsychotic-induced sexual dysfunction in men with schizophrenia, but this conclusion is based only on one small short trial. Switching to olanzapine may improve sexual functioning in men and women, but the trial assessing this was a small, open label trial. Further well designed randomised control trials that are blinded and well conducted and reported, which investigate the effects of dose reduction, drug holidays, symptomatic therapy and switching antipsychotic on sexual function in people with antipsychotic-induced sexual dysfunction are urgently needed.

Topics: Antipsychotic Agents; Benzodiazepines; Cross-Over Studies; Drug Substitution; Erectile Dysfunction; Female; Humans; Male; Olanzapine; Piperazines; Purines; Randomized Controlled Trials as Topic; Selegiline; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sulfones; Vasodilator Agents

The global burden of erectile dysfunction (ED) is increasing. It is estimated that 8-19% of men in Europe have ED and that by 2025 the prevalence of ED worldwide will reach 322 million. The gold standard therapy for ED is an oral phosphodiesterase type 5 (PDE5) inhibitor, but they are not suitable for everyone; approximately 25% of patients do not respond to this therapy and it is contraindicated in others, e.g. those with vascular disease. When PDE5 inhibitors are not suitable, available options include intraurethral and intracavernosal alprostadil - a synthetic vasodilator chemically identical to the naturally occurring prostaglandin E(1) indicated for the treatment of ED. Intraurethral alprostadil is delivered by the Medicated System for Erection (MUSE).- a single-use pellet containing alprostadil suspended in polyethylene glycol administered using an applicator. It is recommended that intraurethral alprostadil be initiated at a dose of 500 μg, as it has a higher efficacy than the 250 μg dose, with minimal differences with regard to adverse events. Data from key clinical studies of intraurethral alprostadil show that it has a fast onset of effect and a good safety profile, with no occurrences of priapism, fibrosis (as seen with intracavernosal injection) or the typical systemic effects observed with oral ED pharmacological treatments. Intraurethral alprostadil has been associated with high patient preference, acceptance rates and quality of life versus intracavernosal injection due to its ease of administration. Evidence has shown that combination treatment with sildenafil may be a possible efficient alternative when single oral or local treatment has failed. Intraurethral alprostadil can be administered in all patients irrespective of ED origin and should be the first option in patients with ED for whom therapy with PDE5 inhibitors has failed or is contraindicated.

Topics: Alprostadil; Drug Administration Routes; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Urethra; Vasodilator Agents

The introduction of oral phosphodiesterase-5 inhibitors (PDE5Is) in the late 1990s and early 2000s revolutionized the field of sexual medicine and PDE5Is are currently first-line monotherapy for erectile dysfunction (ED). However, a significant proportion of patients with complex ED will be therapeutic non-responders to PDE5I monotherapy. Combination therapy has recently been adopted for more refractory cases of ED, but a critical evaluation of current combination therapies is lacking. A thorough PubMed and Cochrane Library search was conducted focusing on the effectiveness of combination therapies for ED in therapeutic non-responders to PDE5I therapy. Journal articles spanning the time period between January 1990 and December 2010 were reviewed. Criteria included all pertinent review articles, randomized controlled trials, cohort studies and retrospective analyses. References from retrieved articles were also manually scanned for additional relevant publications. Published combination therapies include PDE5I plus vacuum erectile device (VED), intraurethral medication, intracavernosal injection (ICI), androgen supplement, α-blocker or miscellaneous combinations. Based on this review, some of these combination treatments appeared to be quite effective in preliminary testing. Caution must be advised, however, as the majority of combination therapy articles in the last decade have numerous limitations including study biases and small subject size. Regardless of limitations, present combination therapy research provides a solid foundation for future studies in complex ED management.

Topics: Adrenergic alpha-Antagonists; Adult; Aged; Alprostadil; Carnitine; Combined Modality Therapy; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vacuum

Erectile dysfunction (ED) is an important worldwide health issue that has a significant negative impact on the quality of life and life satisfaction of both the affected individual and his partner. Here we review the prevalence of ED in Asia, associated factors that may influence sexual attitudes and sexual behaviours, and randomized clinical trials (RCTs) of phosphodiesterase-5 (PDE-5) inhibitors to evaluate the clinical efficacy and safety of PDE-5 inhibitors in Asian men. We searched for English-language articles in MEDLINE and PubMed from January 2000 to September 2010. Our results showed that the overall reported prevalence rate of ED in Asia ranged widely, from 2% to 88%. This finding indicates that ED is a common and major health problem in this region. However, sociocultural and economic factors in Asia prevent people from seeking and obtaining appropriate medical care. We found reports on five kinds of PDE-5 inhibitors for the management of ED: sildenafil, vardenafil, tadalafil, udenafil and mirodenafil. The results of RCTs showed that these five PDE-5 inhibitors are more effective than placebo in improving erectile function in Asian men with ED and that these drugs have similar efficacy and safety profiles.

Topics: Adult; Aged; Asia; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug-Related Side Effects and Adverse Reactions; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Prevalence; Purines; Pyrimidines; Pyrimidinones; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfonamides; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Erectile dysfunction may affect 30% to 50% of men aged 40 to 70 years, with age, smoking, and obesity being the main risk factors, although 20% of cases have psychological causes.. We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of phosphodiesterase inhibitors in men with erectile dysfunction of any cause? What are the effects of phosphodiesterase inhibitors on erectile dysfunction in men with diabetes, with cardiovascular disease, with spinal cord injury, and with prostate cancer or undergoing prostatectomy? What are the effects of drug treatments other than phosphodiesterase inhibitors in men with erectile dysfunction of any cause? What are the effects of devices, psychological/behavioural treatments, and alternative treatments in men with erectile dysfunction of any cause? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).. We found 81 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.. In this systematic review we present information relating to the effectiveness and safety of the following interventions: alprostadil (intracavernosal, intraurethral, topical), cognitive behavioural therapy, ginseng, papaverine, papaverine plus phentolamine (bimix), papaverine plus phentolamine plus alprostadil (trimix), penile prostheses, phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil), psychosexual counselling, vacuum devices, and yohimbine.

Topics: Double-Blind Method; Erectile Dysfunction; Humans; Phosphodiesterase Inhibitors; Prostatectomy; Sildenafil Citrate; Tadalafil

Phosphodiesterase type 5 (PDE5) inhibitors are the first line drugs for treatment of erectile dysfunction. Sildenafil (Viagra(R)), tadalafil (Cialis(R)), and vardenafil (Levitra(R)) are from the same class of drugs that inhibit PDE5. Transient visual symptoms such as change in color perception and increased light sensitivity are well-known adverse effects of these drugs and occur in 3-11% of sildenafil users. Vision-threatening (serious) ocular complications, such as nonarteritic ischemic optic neuropathy and cilio-retinal artery occlusion have rarely been reported in PDE5 inhibitor users.. To highlight and analyze the most recently published case literature on serious ocular complications of PDE5 inhibitors.. Search of the peer-reviewed English literature was conducted using Medline. The following databases also were searched: Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Global Health, and MD Consult. The causality assessment of the reported adverse drug reactions was analyzed by applying both the World Health Organization (WHO) Probability Scale and the criteria utilized by the National Registry of Drug-Induced Ocular Side Effects.. To scientifically and objectively find out if PDE5 inhibitors are associated with vision-threatening ocular complications.. Eight case reports of serious PDE5 inhibitor-associated ocular complications were identified since January 2006 until February 2011. Case reports included cases of anterior and posterior nonarteritic ischemic optic neuropathy, central retinal vein occlusion, cilio-retinal artery occlusion, acute angle closure glaucoma and optic atrophy after sildenafil use.. There is lack of conclusive evidence to indicate a direct cause-effect relationship between PDE5 inhibitor use and vision-threatening ocular events. Men who use PDE5 inhibitors appear to suffer vision-threatening complications at the same frequency as the general population. However, minor visual adverse effects occur in 3-11% of users and they are transient and reversible.

Topics: Adult; Aged; Child; Erectile Dysfunction; Female; Glaucoma, Angle-Closure; Humans; Male; Middle Aged; Optic Atrophy; Optic Neuropathy, Ischemic; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Retinal Artery Occlusion; Retinal Vein Occlusion; Sildenafil Citrate; Sulfones; Vision Disorders

In recent years, new tools for the study of molecular biology and genetics have resulted in significant contributions to the scientific community. The potential use of genetic variations as biomarkers in the management of current and future conditions is generating considerable excitement in health care for disorders such as erectile dysfunction (ED).. This review briefly describes the molecular and genetic mechanisms involved in ED and provides an overall view of the literature relevant to possible relationships between genetic factors and ED.. This is a narrative review of studies on the potential influence of polymorphisms on the risk of developing ED.. We reviewed genetic association studies involving polymorphisms and the ED phenotype.. There is growing evidence for the influence of genetic polymorphisms on the risk of ED and on the interindividual variability in sildenafil treatment.. Although this field is still in its infancy, genetic association studies aimed at defining a molecular basis for ED have provided some important evidence that a patient's genotype may be used in the future to assess risk, as well as to plan treatment and prevention programs in the clinic.

Topics: Erectile Dysfunction; Genetic Markers; Humans; Male; Nitric Oxide Synthase Type III; Peptidyl-Dipeptidase A; Phosphodiesterase 5 Inhibitors; Piperazines; Polymorphism, Genetic; Purines; Sildenafil Citrate; Sulfones

To review special safety topics associated with sildenafil and to document the tolerability of 50- and 100-mg doses, overall and by age, in men with erectile dysfunction (ED).. Data were collated from 67 double-blind placebo-controlled (DBPC) trials (> 14,000 men) conducted by the manufacturer and from the manufacturer's postmarketing safety database (39,277 patients). The DBPC data were stratified by dose, starting dose and age (> or = 65 and > or = 75 years). Special safety topics included cardiovascular risk, priapism, non-arteritic anterior ischaemic optic neuropathy (NAION), impaired renal and hepatic function, drug interactions (i.e. nitrates, cytochrome P3A4 inhibitors, other ED therapies and alpha-blockers) and incorrect use.. Sildenafil was well tolerated at a dose of 50 or 100 mg in men with ED, overall, in those aged > or = 65 years, and in those aged > or = 75 years. Analyses of the databases did not reveal any causal link between sildenafil and cardiovascular events, or any new safety risks relating to cardiovascular events, priapism, NAION, hearing loss or drug interactions. In the small number of men with moderate impairment of renal function or hepatic function who were treated with sildenafil in DBPC trials, the safety profile was similar to that in men with no impairment of renal or hepatic function. Overdose with sildenafil was rare in the ED population. No new safety issues, emerging trends or adverse reactions were identified in conjunction with overdose, dependence, abuse or misuse.. This collated review confirms generally the good tolerability and established safety profile of sildenafil 50 and 100 mg in men with ED and reveals no new safety issues.

Topics: Aged; Cardiovascular Diseases; Dose-Response Relationship, Drug; Double-Blind Method; Drug Interactions; Drug Overdose; Erectile Dysfunction; Hearing Disorders; Humans; Kidney Diseases; Liver Diseases; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Priapism; Product Surveillance, Postmarketing; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Treatment Outcome

Tadalafil, a long-acting phosphodiesterase-5 inhibitor (PDE-5) is the most recent oral agent to receive FDA approval for the treatment of pulmonary arterial hypertension (PAH).. With several new agents emerging for the treatment of PAH, this article reviews tadalafil, the compound and its properties, clinical evidence supporting its use, and the role of tadalafil in the current treatment approach for patients with PAH.. A broad PubMed literature search was performed to identify the most current data on the use of tadalafil for PAH.. Tadalafil received FDA approval in 2009 following the recently published pivotal trial that demonstrated that the use of tadalafil 40 mg once daily was well tolerated, improved exercise capacity and quality of life measures and reduced time to clinical worsening in PAH patients. As the second PDE-5 inhibitor to gain approval for PAH, clinical properties such as its long half-life leading to once-daily dosing and possibly improved compliance, as well as potential cost benefit, may distinguish tadalafil from sildenafil in the widespread treatment of PAH.

Topics: Carbolines; Erectile Dysfunction; Half-Life; Humans; Hypertension, Pulmonary; Male; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Pulmonary Artery; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Vasodilator Agents

To evaluate the effectiveness of sildenafil versus continuous positive airway pressure (CPAP) for patients with erectile dysfunction (ED) and obstructive sleep apnea (OSA).. This is a meta-analysis of a randomized controlled trial. The main outcome measures for effectiveness were the percentage of successful intercourse attempts, International Index of Erectile Function (IIEF) domain scores (erectile function, EF) and the satisfaction levels of the patients and their partners with the treatment for ED.. Two randomized controlled trials totaling 70 patients were included. Meta-analysis results are as follows: after 12 weeks of treatment, patients under sildenafil demonstrated a significant advantage over under CPAP in terms of the percentage of successful intercourse attempts [OR = 3.24, 95% CI (2.37-4.43)], EF scores [WMD = 3.57, 95%CI (1.68-5.45)], and the satisfaction levels of the patients and their partners with the treatment for ED [OR = 3.56, 95% CI (1.27-9.98)].. Current clinical studies might confirm that both therapeutic methods were safe and effective, but sildenafil was superior to CPAP in the treatment of ED in men with OSA. We conclude that new therapeutic agents or a combination of the two methods should be studied further.

Topics: Chi-Square Distribution; Confidence Intervals; Continuous Positive Airway Pressure; Erectile Dysfunction; Humans; Male; Odds Ratio; Patient Satisfaction; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sleep Apnea, Obstructive; Sulfones; Vasodilator Agents

Counterfeit drugs are inherently dangerous and a growing problem; counterfeiters are becoming increasingly sophisticated. Growth of the counterfeit medication market is attributable in part to phosphodiesterase type 5 inhibitor (PDE5i) medications for erectile dysfunction (ED). Millions of counterfeit PDE5is are seized yearly and account for the bulk of all counterfeit pharmaceutical product seizures. It has been estimated that up to 2.5 million men in Europe are exposed to illicit sildenafil, suggesting that there may be as many illegal as legal users of sildenafil. Analysis of the contents of counterfeit PDE5is shows inconsistent doses of active pharmaceutical ingredients (from 0% to > 200% of labelled dose), contaminants (including talcum powder, commercial paint and printer ink) and alternative ingredients that are potentially hazardous. In one analysis, only 10.1% of samples were within 10% of the labelled tablet strength. Estimates place the proportion of counterfeit medications sold over the Internet from 44% to 90%. Of men who purchase prescription-only medication for ED without a prescription, 67% do so using the Internet. Counterfeit PDE5is pose direct and indirect risks to health, including circumvention of the healthcare system. More than 30% of men reported no healthcare interaction when purchasing ED medications. Because > 65% actually had ED, these men missed an opportunity for evaluation of comorbidities (e.g. diabetes and hypertension). Globally, increased obstacles for counterfeiters are necessary to combat pharmaceutical counterfeiting, including fines and penalties. The worldwide nature of the counterfeit problem requires proper coordination between countries to ensure adequate enforcement. Locally, physicians who treat ED need to inform patients of the dangers of ordering PDE5is via the Internet.

Topics: Attitude to Health; Counterfeit Drugs; Erectile Dysfunction; Humans; Internet; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Risk Factors; Risk-Taking; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) is the most common sexual problem in men. The incidence increases with age and affects up to one third of men throughout their lives. It causes a substantial negative impact on intimate relationships, quality of life, and self-esteem. History and physical examination are sufficient to make a diagnosis of ED in most cases, because there is no preferred, first-line diagnostic test. Initial diagnostic workup should usually be limited to a fasting serum glucose level and lipid panel, thyroid-stimulating hormone test, and morning total testosterone level. First-line therapy for ED consists of lifestyle changes, modifying drug therapy that may cause ED, and pharmacotherapy with phosphodiesterase type 5 inhibitors. Obesity, sedentary lifestyle, and smoking greatly increase the risk of ED. Phosphodiesterase type 5 inhibitors are the most effective oral drugs for treatment of ED, including ED associated with diabetes mellitus, spinal cord injury, and antidepressants. Intraurethral and intracavernosal alprostadil, vacuum pump devices, and surgically implanted penile prostheses are alternative therapeutic options when phosphodiesterase type 5 inhibitors fail. Testosterone supplementation in men with hypogonadism improves ED and libido, but requires interval monitoring of hemoglobin, serum transaminase, and prostate-specific antigen levels because of an increased risk of prostate adenocarcinoma. Cognitive behavior therapy and therapy aimed at improving relationships may help to improve ED. Screening for cardiovascular risk factors should be considered in men with ED, because symptoms of ED present on average three years earlier than symptoms of coronary artery disease. Men with ED are at increased risk of coronary, cerebrovascular, and peripheral vascular diseases.

Topics: Aged; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Risk Reduction Behavior; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Topics: Antihypertensive Agents; Contraindications; Coronary Disease; Drug Interactions; Drug Therapy, Combination; Erectile Dysfunction; Female; Humans; Hypertension, Pulmonary; Hypotension; Imidazoles; Male; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Topics: Endothelium-Dependent Relaxing Factors; Erectile Dysfunction; Humans; Male; Models, Molecular; Nitrates; Nitric Oxide; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Structure-Activity Relationship; Sulfones; Vasodilator Agents

Erectile dysfunction (ED) is a well-known entity with determined risk factors, which generally has a negative impact on quality of life. Obstructive sleep-disordered breathing (SDB), often referred to as obstructive sleep apnea, stands among the possible risk factors for ED.. Literature review suggests that SDB induces a spectrum of abnormalities in neural, hormonal, and vascular regulation that may contribute to the development of ED. While more studies are required to imply SDB as a risk factor for ED, several case series and expert opinion have contributed evidence for a causal relationship.. In clinical practice, men presenting with symptoms of sexual dysfunction often have concomitant sleep disorders requiring treatment. There is now evidence to suggest that treating SDB may be an effective treatment for ED. It is the authors' opinion that patients with erectile dysfunction would benefit from a sleep evaluation.

Topics: Aged; Cardiovascular Diseases; Continuous Positive Airway Pressure; Diabetes Mellitus, Type 2; Erectile Dysfunction; Humans; Hypertension; Kidney Failure, Chronic; Male; Middle Aged; Obesity; Phosphodiesterase Inhibitors; Piperazines; Prevalence; Pulmonary Disease, Chronic Obstructive; Purines; Quality of Life; Risk Factors; Sildenafil Citrate; Sleep Apnea, Obstructive; Sulfones

To answer the clarion call for more innovation and productivity in Pharmaceutical research, the application of the ValueNet Work methodology to the indication switch for Viagra, from an anti-hypertensive to the treatment for male erectile dysfunction, was undertaken to ascertain the usefulness of this approach for Pharmaceutical research in identifying both tangible and intangible value drivers, and for the identification of strong value-creating relationships within this research area. Through the identification of participants, tangible and intangible deliverables, and the analysis of their interactions in the indication switch for Viagra, an insight into value drivers for the Pharmaceutical industry was revealed that has an impact on Pharmaceutical innovation and productivity. This methodology, in pinpointing value inflection points holds promise in analysing other aspects of research.

Topics: Drug Discovery; Drug Industry; Efficiency, Organizational; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Research; Research Design; Sildenafil Citrate; Sulfones; Vasodilator Agents

A definitive role of testosterone in erectile function has been controversial; however, recent evidence is becoming available which substantiates a key function for this hormone. Testosterone deficiency is associated with a decline in erectile function and testosterone levels are inversely correlated with increasing severity of erectile dysfunction. Erectile dysfunction can be caused by multifactorial pathologies. In particular, erectile dysfunction may be the first symptom of cardiovascular disease. Animal studies have demonstrated that castration causes vascular smooth muscle cell atrophy, venous leakage, adipocytes in the subtunical space, loss of elastic fibers and increase in collagen deposition. Testosterone increases the expression of nitric oxide synthase and phosphodiesterase type 5, both principal enzymes involved in the erectile process. Testosterone replacement alone in hypogonadal men can restore erectile function. A significant proportion of men who fail to respond to a PDE5 inhibitor are testosterone deficient. Testosterone replacement therapy can convert over half of these men into phosphodiesterase type 5 responders. It is now recommended that testosterone levels should be assessed in all patients with erectile dysfunction.

Topics: Animals; Erectile Dysfunction; Humans; Hypogonadism; Male; Nitric Oxide; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone

The immediate objective of phosphodiesterase type 5 (PDE5) inhibitor treatment is to restore the ability of a man to achieve and/or maintain an erection adequate for sexual intercourse. As erectile dysfunction (ED) generally develops in the second half of life, the ultimate objective generally is not procreation, but quality of sexual life. Indeed, ED is known to impair quality of life considerably; two-thirds of men report that ED has impaired their self-esteem and nearly a third claim that it has damaged the relationship with their partner. It follows that the therapeutic success of PDE5 inhibition has an important subjective component, which is compounded by the subjective nature and complexity of sexual life in humans. This makes it very difficult for physicians to be certain that they have selected the optimal therapy for a couple, even after a thorough evaluation. The 2007 European Association of Urology Guidelines stress the importance of educating the patient and claim that 'the patient will choose the final drug after his own experience'. However, PDE5 inhibitors are typically used twice a week, so a patient would have to spend approximately 3 months trying the various compounds and dosages to achieve adequate exposure to all three PDE5 inhibitors; this would seem an unrealistic strategy in normal clinical practice. The acknowledgement that the patient has an important role in therapeutic decisions for ED has fuelled interest in the concept of patient preference. It has been established that patient preference depends on three factors, i.e. personal characteristics, e.g. age, duration of ED, frequency and dynamics of sexual relations, and the characteristics of their partners, e.g. age, menopausal status and level of interest in sexual activity and medication profile. Medication features of interest include efficacy in terms of quality of erection, consistency of effects, rapid onset of action, long duration of action, side-effect profile and route of administration; drug costs must also be considered if the medicinal product is not reimbursed.

Topics: Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Self Concept; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

This article considers the process of re-classification of prescription drugs from prescription-only medications to over-the-counter (OTC) prescription drugs.. The recent change in classification for emergency contraception and simvastatin is explored in detail with similarities and differences being considered for a similar argument to be made for sildenafil.. The benefits for patients, physicians and other healthcare professionals are considered in detail.. We raise concerns about recently developed and existing patient group directions that, although extensive in their assessment, may omit to identify significant contributory factors which would necessitate appropriate medical intervention.. While the decision for re-classification to OTC would depend on a number of factors, we argue that, with the proviso of proper assessments being made, sildenafil should be made available as an OTC medication.. The safety and use of OTC medications for erectile dysfunction at a time when many first line prescription agents are reaching generic status.

Topics: Consumer Product Safety; Erectile Dysfunction; Female; Humans; Male; Nonprescription Drugs; Pharmaceutical Services; Phosphodiesterase Inhibitors; Piperazines; Practice Guidelines as Topic; Prescription Drugs; Purines; Sildenafil Citrate; Sulfones

The majority of men with spinal cord injury (SCI) require chronic treatment for erectile dysfunction (ED), but most of them, prior to taking phosphodiesterase type 5 (PDE5) inhibitors, stopped therapy due to side-effects or low compliance rate.. Analysis of literature on oral PDE5 inhibitors in individuals with SCI and ED in order to evaluate how much their release changed the management of ED in SCI subjects and what remains to be seen of their potential or limits.. Questionnaires on sexual function.. 18 internationally published clinical studies that enrolled SCI males treated with at least one of the PDE5 inhibitors were analyzed.. The small numbers of papers with large and diverse outcome measures did not consent a meta-analysis of treatment results. 705 used sildenafil, 305 vardenafil and 224 tadalafil. Median age was less than 40 years. Only 1 study excluded tetraplegic individuals. For measures of ED evaluated, 11 out of 13 studies reported a significant statistical improvement with PDE5 inhibitors versus placebo or erectile baseline (P < 0.01, or p < 0.005). The most frequent predicable factor for the therapeutic success of PDE5 inhibitors was upper motoneuron lesion. Statistical impact on ejaculation success rates was shown in at least one paper for all PDE5 inhibitors (p < 0.05). Overall, 15 patients, (7 using sildenafil), discontinued the therapies due to drawbacks. Only 1 sildenafil study reported a follow-up maximum of 24 months.. Literature suggests that all oral PDE5 inhibitors represent a safe and effective treatment option for ED caused by SCI. Further research is needed on head-to-head comparative trials and SCI patient preference for these drugs; their impact on ejaculation and orgasm function, their early use after SCI for increasing the recovery rate of a spontaneous erection, and their effectiveness and tolerability in the long-term are still to be investigated.

Topics: Administration, Oral; Adolescent; Adult; Aged; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Reproduction; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Tadalafil; Triazines; Vardenafil Dihydrochloride; Young Adult

To critically review the physiological roles of phosphodiesterase-5 (PDE5), to explain and support the putative impact and clinical significance of PDE5 inhibitors (PDE5-Is) in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED), both highly prevalent in men aged > or =50 years, as PDE5-Is are very effective as a first-line therapy for ED, and attractive for further physiological functional investigations.. We searched Medline for peer-reviewed articles in English, from 1991 to 2008, to provide a critical contemporary review of PDE5 pertaining to the potential interest of findings supporting a role for PDE5-Is in LUTS due to BPH. The selection of papers was based on the relevance of subject matter. A critical analysis of available fundamental and clinical data is reported.. Several studies assessed the role of the nitric oxide/cGMP signalling pathway in the regulation of the prostate tone, with the support of clinical observations. PDE5-Is can also represent a potential mode of action allowing the targeting of transcriptional activity implicated in the regulation of the progression of the inflammatory process involved in BPH. PDE5-Is can inhibit human stromal cell proliferation of the prostate mediated by cGMP accumulation. New targeting hypotheses of pathophysiological processes are also reported.. There is evidence that LUTS and ED are strongly linked. This analysis of the regulatory basis of PDE5 biology could indicate several directions of investigation. However, it is necessary to devise well-designed large prospective studies that would produce significant data before this approach becomes a standard of care.

Topics: Aged; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatic Hyperplasia; Prostatism; Purines; Quality of Life; Quinazolines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

To summarize and compare evidence on harms in sildenafil- and placebo-treated men with erectile dysfunction (ED) in a systematic review and meta-analysis.. Randomized placebo-controlled trials (RCTs) were identified using an electronic search in MEDLINE, EMBASE, PsycINFO, SCOPUS, and Cochrane CENTRAL. The rates of any adverse events (AEs), most commonly reported AEs, withdrawals because of adverse events, and serious adverse events were ascertained and compared between sildenafil and placebo groups. The results of men with ED were stratified by clinical condition(s). Statistical heterogeneity was explored. Meta-analyses based on random-effects model were also performed.. A total of 49 RCTs were included. Sildenafil-treated men had a higher risk for all-cause AEs (RR = 1.56, 95% CI: 1.38, 1.76), headache, flushing, dyspepsia, and visual disturbances compared with placebo-treated men. The magnitude of excess risk was greater in fixed- than in flexible-dose trials. The rates of serious adverse events and withdrawals because of adverse events did not differ in sildenafil vs placebo groups. A higher dose of sildenafil corresponded to a greater risk of AEs. The increased risk of harms was observed within and across clinically defined specific groups of patients.. There was a lack of RCTs reporting long-term (>6 months) harms data. In short-term trials, men with ED randomized to sildenafil had an increased risk of all-cause any AEs, headache, flushing, dyspepsia, and visual disturbances. The exploration of different modes of dose optimization of sildenafil may be warranted.

Topics: Administration, Oral; Clinical Trials as Topic; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Alprostadil; Carbolines; Causality; Clinical Protocols; Erectile Dysfunction; Fibrosis; Humans; Male; Nurse's Role; Penile Prosthesis; Penis; Phosphodiesterase Inhibitors; Piperazines; Postoperative Care; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Time Factors; Vasodilator Agents

In contrast to the impressive advances in somatic research of erectile dysfunction (ED), scientific literature shows contradictory reports on the results of psychotherapy for the treatment of ED.. Authors conducted a meta-analysis to evaluate the effectiveness of psychological interventions for the treatment of ED compared to oral drugs, local injection, vacuum devices, or other psychological intervention.. Distinct sources of randomized controlled trials (RCTs) were searched: electronic databases (between 1966 and 2007), cross checking of references, and contact with scientific societies.. For dichotomous outcomes the pooled relative risks were calculated and for continuous outcomes mean differences between interventions. Statistical heterogeneity was addressed.. Eleven RCTs involving 398 men met the inclusion criteria.. There is evidence that group therapy improves ED. Focused sex group therapy showed greater efficacy than control group. Men randomized to receive psychotherapy plus sildenafil showed significant improvement of ED and were less likely than those receiving only sildenafil to drop out. Regarding to the effectiveness of psychological interventions for the treatment of ED compared to local injection and vacuum devices no difference was found.

Topics: Adult; Combined Modality Therapy; Erectile Dysfunction; Humans; Injections; Male; Middle Aged; Patient Satisfaction; Penis; Phosphodiesterase Inhibitors; Piperazines; Psychotherapy; Psychotherapy, Group; Purines; Randomized Controlled Trials as Topic; Sex Counseling; Sildenafil Citrate; Sulfones; Treatment Outcome; Vacuum

Although detrimental impact on sexual function following radiotherapy (RT) and brachytherapy decreases the quality of life of prostate cancer survivors, the etiology, pathophysiology, prophylaxis and treatment of this condition has not yet been fully clarified. We reviewed the published literature in terms of etiology, treatment and possible prevention of erectile dysfunction (ED) following RT and/or brachytherapy.. We have reviewed the literature through a MEDLINE search. Prostate cancer, erectile dysfunction, radiotherapy, brachytherapy, treatment and quality of life were used as keywords.. Both RT and brachytherapy result in high rates of ED. Although arterial damage seems to be the main cause of ED after RT, exposure of neurovascular bundle to high levels of radiation dose has been also implicated in some studies with brachytherapy. The radiation dose received by the corpora cavernosa at the crurae of the penis may also be important in the etiology of ED. The most important predictive factor of ED following RT is the treatment modality. Intensity-modulated radiotherapy and vessel-sparing prostate radiotherapy are new techniques but those treatments may not guarantee complete preservation of the erectile function. Patients need to be correctly informed on the possible sequela of radiation-based treatments on their sexual well-being while planning their treatment. Patients should also be informed about the possible treatment modalities for ED, which may develop in due course.

Topics: Brachytherapy; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatic Neoplasms; Purines; Recovery of Function; Sildenafil Citrate; Sulfones

To evaluate the effect of sildenafil citrate on each item of the 14-item Self-Esteem And Relationship (SEAR) questionnaire, which is used to measure self-esteem, confidence, satisfaction with sexual relationship, and overall relationship satisfaction in men with erectile dysfunction (ED).. Data were combined from two 12-week, double-blind, placebo-controlled, flexible-dose sildenafil trials having identical protocols, one conducted in the USA and the other in Mexico, Brazil, Australia and Japan. All men had ED and were aged >or=18 years. Response categories of each SEAR item used a 4-week reference period and were based on a five-point scale (1, almost never/never; 2, a few times; 3, sometimes; 4, most times; 5, almost always/always). The difference (sildenafil vs placebo) in the change from baseline to week 12 was evaluated with a Wilcoxon rank sum test using ridit analysis, and an analysis of covariance model that included treatment group, centre, study and baseline item score.. Compared with the 274 patients receiving placebo, the 279 receiving sildenafil reported significantly greater mean and median improvements (P < 0.001) in each of the 14 SEAR items. The probability of increased psychosocial benefit from baseline to week 12 was higher with sildenafil for each SEAR item, and ranged from 0.60 ('My partner was unhappy with the quality of our sexual relations'[item reverse-scored]) to 0.72 ('I was satisfied with my sexual performance'). Across all items, the mean (sd) probability was 0.67 (0.04) that a randomly selected patient in the sildenafil group would have a more favourable change relative to a randomly selected patient in the placebo group.. Sildenafil produced substantial and meaningful improvements at the item-specific level. This analysis complements previously published work on self-esteem, confidence and relationship satisfaction.

Topics: Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Multicenter Studies as Topic; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Randomized Controlled Trials as Topic; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

Sildenafil was the first oral compound to be approved for the treatment of erectile dysfunction. In this paper, we review the current knowledge of the effects of sildenafil on myocardial infarction and sudden cardiac death. The first factor we examine is the sexual activity itself. As several studies have shown, the relative risk for an acute coronary syndrome during intercourse is not very high. Several studies examining the effects of sildenafil on mortality have been published during recent years. The great majority of these studies found that sildenafil is not an extra risk factor for an acute coronary syndrome or sudden cardiac death. In 1997, the rate of myocardial infarction in men 55-64 years of age was 1542 per 1,000000 in the US. According to this, the expected number of deaths as a result of myocardial infarction in patients 55-64 years of age receiving sildenafil, in the 24-hour period after use, from late March 1997 to mid November 1998, should have been 52. Instead, the number of reported deaths were only 15. One very optimistic finding was that sildenafil not only does not increase mortality, but in fact 'preconditions' the heart and has a cardioprotective effect. Besides, many studies have shown that sildenafil does not reduce the exercise tolerance in men with known coronary artery disease. As far as BP is concerned, the differences before and after the use of sildenafil are not clinically significant. The only contraindications for sildenafil are co-administration with alpha-adrenoceptor antagonists or with nitric oxide donors. According to the most recent studies, isoform 5 of phosphodiesterase has also been detected in the myocardium and controls the soluble pool of 3', 5'-cyclic guanosine monophosphate (cGMP). Sildenafil is very specific for cGMP but it may increase cyclic adenosine monophosphate in the myocardium indirectly. This does not occur with small therapeutic doses of the drug. There is some dispute regarding the association of sildenafil with arrhythmias, where the available evidence is not clear. However, there are suspicions that sildenafil may cause sympathetic activation. The overall conclusion is that sildenafil is a safe drug and that its appropriate use does not seem to increase the risk for myocardial infarction or sudden cardiac death.

Topics: Death, Sudden, Cardiac; Erectile Dysfunction; Humans; Male; Middle Aged; Myocardial Infarction; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction occurs extensively among patients with arterial hypertension. We investigated the safety of sildenafil for patients with and without antihypertensive medication. Our study included data from 35 double-blind, placebo-controlled, and randomized investigations, with a total of 8115 patients. The term of therapy was between 6 weeks and 6 months, for both the sildenafil group (5-200 mg, n=4819) as well as the placebo group (n=3296). We studied the adverse events in the men who received 1 or more hypertensives (n=2388), and in those who took no antihypertensive medication (n=5727). Our findings disclosed equal frequency of adverse events in both groups, without influence by the number of different antihypertensives administered. The occurrence of AEs associated with blood pressure was slight, and was comparable between the individual groups. These results support the conclusion that sildenafil is also well tolerated by patients taking one or more antihypertensives. Patients being treated with alpha blockers should be stable on this therapy in order to minimize the possibility of orthostatic hypotension. An initial dose of 25 mg should furthermore be considered for these patients.

Topics: Antihypertensive Agents; Drug Interactions; Erectile Dysfunction; Humans; Hypertension; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction (ED) is the inability to achieve and maintain an erection. Erectile function is dependent upon complex interactions of neural and vascular pathways. A major neurotransmitter that facilitates erectile function is nitric oxide. Treatment of ED has expanded to include effective oral agents. Previous ED treatments have consisted of intracavernosal injection, transurethral dilators, and vascular constriction devices. Clinical management of ED will be presented with some discussion on the prostatectomy client.

Topics: Alprostadil; Erectile Dysfunction; Humans; Injections; Male; Muscle Contraction; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vacuum; Vasodilator Agents

Review the literature on phosphodiesterase type 5 inhibitors (PDE5-Is), addressing critical issues in their current and future use, assessing unanswered questions, and identifying research needs.. A MEDLINE search was conducted on PDE5-Is, with emphasis on clinical trials and experience, for interpretation and analysis of their present and future role.. Although approximately 40 million patients with erectile dysfunction have been treated successfully worldwide with the three available PDE5-Is, inappropriate instructions, lack of follow-up, and lack of patient-centered care models are the main reasons for "non-response," leading to drop-out rates of >50%. Patients with severe neurologic damage, diabetes mellitus, or severe vascular disease may be resistant to PDE5-Is. Preservation of corporal smooth muscle with chronic administration of PDE5-Is has been reported and substantial evidence indicates that these drugs have beneficial effects on endothelium and cardiovascular function; sildenafil has been approved for the treatment of idiopathic pulmonary hypertension. Improvement of lower urinary tract symptoms in men with benign prostatic hyperplasia after PDE5-I administration has been also suggested.. The data indicate the necessity for (1) exploration of the pharmacologic characteristics of the three PDE5-Is; (2) research on their pharmacologic differences because some actions seems to be drug-specific; (3) development of alternative management strategies, such as chronic, low, everyday doses of PDE5-Is, if the monthly cost is affordable; and (4) clinical trials on use of PDE5-Is to treat other chronic conditions. The door for innovative therapeutic approaches will open, specifically for cross-risk factor treatment with PDE5-Is or their use in combination treatments or new multimodal pills that take advantage of drugs that exert pleiotropic vascular actions.

Topics: Animals; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Erectile dysfunction is a common multi-factorial complication of diabetes mellitus. Numerous strategies have been tried to overcome this diabetic complication. In recent years, phosphodiesterase type 5 (PDE-5) inhibitors have been introduced in the management of erectile dysfunction.. The objective of this review was to assess the effect of PDE-5 inhibitors on the management of erectile dysfunction in diabetic men.. Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library.. Randomised controlled trials, in which treatment with PDE-5 inhibitors was compared to control, in diabetic patients with erectile dysfunction.. Two reviewers independently extracted data and assessed trial quality.. Eight randomised controlled trials were identified. A total 976 men were allocated to receive a PDE-5 inhibitor and 741 were randomised to the control groups. Overall, 80% of the participants suffered from type 2 diabetes mellitus. The weighted mean difference (WMD) for the International Index of Erectile Function (IIEF) questions 3 and 4 (frequency of penetration during and maintaining erection to completion of intercourse) was 0.9 (95% CI 0.8 to 1.1) and 1.1 (95% CI 1.0 to 1.2) at the end of the study period, in favour of the intervention group. The WMD for the IIEF erectile dysfunction domain at the end of the study period was 6.6 (95% CI 5.2 to 7.9) in favour of the PDE-5 inhibitors arm. The relative risk (RR) for answering "yes" to a global efficacy question ( "did the treatment improve your erections?") was 3.8 (CI 95% 3.1 to 4.5) in the PDE-5 inhibitors compared with the control arm. The WMD between the percentage of successful attempts in the PDE-5 inhibitors and in the control arm was 26.7 (95% CI 23.1 to 30.3). Mortality was not reported in any of the included trials. Adverse cardiovascular effects were reported in one study. Headache was the most frequent adverse event reported, flushing was the second most common event, with upper respiratory tract complaints and flu like syndromes, dyspepsia, myalgia, abnormal vision and back pain also reported in a descending order of frequency. The overall risk ratio for developing any adverse reaction was 4.8 (CI 95% 3.74 to 6.16) in the PDE-5 inhibitors arm as compared to the control.. Sufficient evidence exists that PDE-5 inhibitors form a care that improves erectile dysfunction in diabetic men.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Diabetic Angiopathies; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Psychotropic drugs are associated with sexual dysfunction. Symptoms may concern penile erection, lubrication, orgasm, libido, sexual arousal or overall sexual satisfaction.. To determine the effects of different strategies (e.g. dose reduction, drug holidays, adjunctive medication, switching to another drug) for treatment of sexual dysfunction due to antipsychotic therapy.. We searched the Cochrane Schizophrenia Group's Register (June 2006), the Cochrane Library (Issue 2, 2005), MEDLINE (1966-8/2005), PsycLIT (1974-8/2005), EMBASE (1980-8/2005) and references of all identified studies for further trials. We contacted relevant pharmaceutical companies and authors of trials.. We included all relevant randomised controlled trials involving people with schizophrenia and sexual dysfunction.. Working independently, we extracted data. For dichotomous data we calculated random effects odds ratios (OR) with 95% confidence intervals (CI) and, where appropriate, the number needed to treat (NNT) on an intention-to-treat basis. For continuous data we calculated weighted mean differences on the basis of a random effects model. We analysed crossover trials under consideration of correlation of paired measures.. Currently this review includes two pioneering crossover studies (total n=42 men, duration 2-3 weeks). They reported significantly more erections sufficient for penetration when receiving sildenafil compared with when receiving placebo (n=32, WMD 3.20 CI 1.83 to 4.57), a greater mean duration of erections (n=32, WMD 1.18 CI 0.52 to 1.84) and frequency of satisfactory intercourse (n=32, WMD 2.84 CI 1.61 to 4.07). The second trial found no evidence for selegiline as symptomatic treatment for antipsychotic-induced sexual dysfunction compared with placebo (n=10, WMD change on Aizenberg's sexual functioning scale -0.40 CI -3.95 to 3.15).. We are not confident that crossover studies are appropriate for this participant group. Sildenafil may be a useful option in the treatment of antipsychotic-induced sexual dysfunction in men with schizophrenia, but this conclusion is based only on one small short trial. Further well designed, conducted and reported trials are urgently needed.

Topics: Antipsychotic Agents; Cross-Over Studies; Erectile Dysfunction; Female; Humans; Male; Piperazines; Purines; Randomized Controlled Trials as Topic; Selegiline; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction affects more than 30 million men in The United States. Since the FDA approved the use of Sildenafil, prescription of this medication has been raising. Adverse events of Sildenafil includes: fatigue, dyspnea, and hypotension. Reported adverse cardiac events associated with the medication use include myocardial infarction, ventricular tachycardia, angina and death, raising concerns about the safety of this agent in patients with coronary artery disease. Published guidelines regarding the management of cardiac patients with erectile dysfunction suggest that Sildenafil may be hazardous in patients with ischemic heart disease. In patients using Sildenafil, myocardial infarctions have been reported to the Food and Drug Administration. Now, we report a patient with myocardial infarction after taking 100 mg of Sildenafil without sexual activity.

Topics: Aged; Erectile Dysfunction; Humans; Male; Myocardial Infarction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Type 5 phosphodiesterase inhibitors (5-PDEI), which have been applied as the basic medication for erectile dysfunction, are now being studied in various areas of clinical medicine (pulmonology, cardiology, gastroenterology, gynecology etc.) This systematic literature review is dedicated to 5-PDEI, the state of the problem, the prospects of clinical application of sildenafil, and is based upon 450 literature sources from MEDLINE database (from 1954 to June 2006) and the Cochrane Collaboration database (from 1977 to March 2005) found by key words sildenafil, phosphodiesterase, and 5-PDEI. The issues of physiology and pathophysiology of 5-PDEI, the historical background of their creation, the appropriateness and efficacy of sildenafil in pulmonary arterial hypertension are considered in Part I of the review.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Analgesics, Opioid; Cyclic Nucleotide Phosphodiesterases, Type 5; Dopamine; Endothelium, Vascular; Erectile Dysfunction; Humans; Hypertension, Pulmonary; Male; Organ Specificity; Phosphodiesterase Inhibitors; Piperazines; Platelet Aggregation; Pulmonary Circulation; Purines; Serotonin; Sildenafil Citrate; Sulfones

Erectile dysfunction frequently represents a neurovascular complication of diabetes mellitus, and it has been calculated that almost 50% of diabetic men will have erectile dysfunction within 6 years after diagnosis. Penile endothelial and smooth muscle cell dysfunction are due to molecular pathway abnormalities (i.e., activation of PKC, increased oxidative stress and overproduction of advanced-glycosylation end products). The response rate to oral drug therapies, such as sildenafil, is lower than in most other groups. Because therapeutic alternatives (i.e., intracavernous injections with vasoactive agents) are not curative, clinical trials aimed to demonstrate rehabilitative effects with daily phosphodiesterase type-5 inhibitors are ongoing. If this approach proves successful, it will determine many advantages over the intracavernosal treatment and potentially induce sexual rehabilitation.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Cyclic Nucleotide Phosphodiesterases, Type 5; Diabetes Complications; Endothelium, Vascular; Erectile Dysfunction; Humans; Male; Models, Biological; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Normal sexual function is a biopsychosocial process and relies on the coordination of psychological, endocrine, vascular, and neurological factors. Recent data show that psychological factors are involved in a substantial number of cases of erectile dysfunction (ED) alone or in combination with organic causes. However, in contrast to the advances in somatic research of erectile dysfunction, scientific literature shows contradictory reports on the results of psychotherapy for the treatment of ED.. To evaluate the effectiveness of psychosocial interventions for the treatment of ED compared to oral drugs, local injection, vacuum devices and other psychosocial interventions, that may include any psycho-educative methods and psychotherapy, or both, of any kind.. The following databases were searched to identify randomised or quasi-randomised controlled trials: MEDLINE (1966 to 2007), EMBASE (1980 to 2007), psycINFO (1974 to 2007), LILACS (1980 to 2007), DISSERTATION ABSTRACTS (2007) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2007). Besides this electronic search cross checking the references of all identified trials, contact with the first author of all included trials was performed in order to obtain data on other published or unpublished trials. Handsearch of the International Journal of Impotence Research and Journal of Sex and Marital Therapy since its first issue and contact with scientific societies for ED completed the search strategy.. All relevant randomised and quasi-randomised controlled trials evaluating psychosocial interventions for ED.. Authors of the review independently selected trials found with the search strategy, extracted data, assessed trial quality, and analysed results. For categorical outcomes the pooled relative risks (RR) were calculated, and for continuous outcomes mean differences between interventions were calculated as well. Statistical heterogeneity was addressed.. Nine randomised (Banner 2000; Baum 2000; Goldman 1990; Kilmann 1987; Kockott 1975; Melnik 2005; Munjack 1984; Price 1981; Wylie 2003) and two quasi-randomised trials (Ansari 1976; Van Der Windt 2002), involving 398 men with ED (141 in psychotherapy group, 109 received medication, 68 psychotherapy plus medication, 20 vacuum devices and 59 control group) met the inclusion criteria. In data pooled from five randomised trials (Kockott 1975; Ansari 1976; Price 1981; Munjack 1984; Kilmann 1987), group psychotherapy was more likely than the control group (waiting list - a group of participants who did not receive any active intervention) to reduce the number of men with "persistence of erectile dysfunction" at post-treatment (RR 0.40, 95% CI 0.17 to 0.98, N = 100; NNT 1.61, 95% CI 0.97 to 4.76). At six months follow up there was continued maintenance of reduction of men with "persistence of ED" in favour of group psychotherapy (RR 0.43, 95% CI 0.26 to 0.72, N = 37; NNT 1.58, 95% CI 1.17 to 2.43). In data pooled from two randomised trials (Price 1981; Kilmann 1987), sex-group psychotherapy reduced the number of men with "persistence of erectile dysfunction" in post-treatment (RR 0.13, 95% CI 0.04 to 0.43, N = 37), with a 95% response rate for sex therapy and 0% for the control group (waiting list - no treatment) (NNT 1.07, 95% CI 0.86 to 1.44). Treatment response appeared to vary between patient subgroups, although there was no significant difference in improvement in erectile function according to mean group age, type of relationship, and severity of ED. In two trials (Melnik 2005; Banner 2000) that compared group therapy plus sildenafil citrate versus sildenafil, men randomised to receive group therapy plus sildenafil showed significant reduction of "persistence of ED" (RR 0.46, 95% CI 0.24 to 0.88; NNT 3.57, 95% CI 2 to 16.7, N = 71), and were less likely than those receiving only sildenafil to drop out (RR 0.29, 95% CI 0.09 to 0.93). One small trial (Melnik 2005) directly compared group therapy and sildenafil citrate. It found a significant difference favouring group therapy versus sildenafil in the mean difference of the IIEF (WMD -12.40, 95% CI -20.81 to -3.99, N = 20). No differences in effectiveness were found between psychosocial interventions versus local injection and vacuum devices.. There was evidence that group psychotherapy may improve erectile function. Treatment response varied between patient subgroups, but focused sex-group therapy showed greater efficacy than control group (no treatment). In a meta-analysis that compared group therapy plus sildenafil citrate versus sildenafil, men randomised to receive group therapy plus sildenafil showed significant improvement of successful intercourse, and were less likely than those receiving only sildenafil to drop out. Group psychotherapy also significantly improved ED compared to sildenafil citrate alone. Regarding the effectiveness of psychosocial interventions for the treatment of ED compared to local injection, vacuum devices and other psychosocial techniques, no differences were found.

Topics: Combined Modality Therapy; Erectile Dysfunction; Humans; Male; Penis; Piperazines; Prostaglandins E; Psychotherapy; Psychotherapy, Group; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Vasodilator Agents

There is still considerable controversy concerning the issue of testosterone replacement therapy. This is because testosterone replacement therapy is not a 'risk-free' treatment and a randomized controlled trial to evaluate safety of prolonged testosterone replacement therapy is not available, nor is it likely to be in the near future. However, recent testosterone delivery systems, such as the 1% gel (Testogel, Androgel and Testim), have proven to have a good physiologic profile, allowing constant monitoring of the possible complications and prompt discontinuation in the event of adverse effects. The aim of this paper is to provide a comprehensive review of the available testosterone preparations to treat male hypogonadism, with special interest in the treatment of ageing men and late-onset hypogonadism. In addition, the experimental and clinical data on the effect of testosterone on sexual function domains is reviewed along with the indication for the combination therapy of androgens with pro-erectile drugs, for example, type 5 phosphodiesterase inhibitors.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug Delivery Systems; Erectile Dysfunction; Gels; Hormone Replacement Therapy; Humans; Hypogonadism; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone

Obstructive sleep apnoea, characterised by repetitive occlusion of the upper airway during sleep, is recognised as a risk or even an aetiological factor for erectile dysfunction. On the other hand, sleep-disordered breathing has been reported by many patients with erectile dysfunction. Sildenafil, a very commonly used erectile dysfunction treatment, could, at least theoretically, exacerbate sleep apnoea by interfering with pharyngeal muscle tone, nasal patency and gas exchange in the lung. A recent safety study suggested a detrimental effect of oral sildenafil on respiratory events in patients with obstructive sleep apnoea. Given the inconclusiveness of evidence on pathophysiological mechanisms and the paucity of relevant clinical data the safety risk of sildenafil administration in patients with obstructive sleep apnoea should be questioned. More clinical trials are needed to clarify this issue.

Topics: Animals; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sleep Apnea, Obstructive; Sulfones

Depression and erectile dysfunction (ED) clearly are associated. Although urologists and psychiatrists have long recognized that antidepressant medications affect erectile function negatively, the interplay between the two conditions remains underappreciated. Psychiatrists may be reluctant to question a patient in detail about ED, and urologists seldom perform a formal assessment of the presence of depression in patients who have ED. This article gives a quick overview of the relationship between these two conditions and provides the clinician with the knowledge required to effectively manage ED with comorbid depression.

Topics: Antidepressive Agents; Depression; Erectile Dysfunction; Humans; Hypogonadism; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Sildenafil citrate improves erectile function in men with erectile dysfunction (ED) by selectively inhibiting cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), which is present in all vascular tissue. Sildenafil also has a weaker inhibitory action on PDE6, located in the rod and cone photoreceptors. Modest, transient visual symptoms, typically blue tinge to vision, increased brightness of lights, and blurry vision, have been reported with sildenafil use and occur more frequently at higher doses. Visual function studies in healthy subjects and in patients with eye disease suggest that sildenafil does not affect visual acuity, visual fields, and contrast sensitivity. Transient, mild impairment of color discrimination can occur around the time of peak plasma levels. Spontaneous postmarketing reports of visual adverse events, including nonarteritic anterior ischemic optic neuropathy (NAION), have been reported during the 7 years that sildenafil has been prescribed to more than 27 million men worldwide. However, because men with ED frequently have vascular risk factors that may also put them at increased risk for NAION, a causal relationship is difficult to establish. No consistent pattern has emerged to suggest any long-term effect of sildenafil on the retina or other structures of the eye or on the ocular circulation.

Topics: Color Vision Defects; Controlled Clinical Trials as Topic; Erectile Dysfunction; Humans; Male; Optic Neuropathy, Ischemic; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents; Vision Disorders; Visual Acuity; Visual Fields

Radical prostatectomy has been the time-honoured and standard treatment option for prostate cancer. Erectile dysfunction (ED) is one of the common quality-of-life issues following radical prostatectomy. The recovery of potency following radical prostatectomy varies from 16% to 86%. Although major modifications in surgical technique appear to be promising, the reported ED rates are still high. The time period required for the recovery of erectile function after surgery varies from 6 to 24 months. During this period of neuropraxia lack of natural erections produces cavernosal hypoxia. This cavernosal hypoxia has been implicated as one of the most important factors in the pathophysiology of ED. Cavernosal hypoxia predisposes to cavernosal fibrosis, ultimately producing venous leak and long-term ED. Interruption of this cascade of events has been the major challenge for physicians. Physicians have several options available for the treatment of ED. However, oral treatment options have quickly become established as first-line treatment options. Sildenafil has been most extensively studied in the radical prostatectomy population. In patients who do not respond to oral therapy alone, standard treatment options (intracavernosal injections, vacuum constriction devices and intraurethral alprostadil) are useful. Use of penile prostheses is one of the oldest treatment options available for the treatment of ED but is used only as a last resort. Initial attempts to promote the earlier recovery of erectile function appear to be promising. However, further confirmatory studies are essential. The roles of gene transfer and growth factors are still in experimental stages. In this review we discuss the epidemiology, pathophysiology and treatment options available for ED following radical prostatectomy.

Topics: Administration, Oral; Aged; Algorithms; Alprostadil; Carbolines; Combined Modality Therapy; Drug Therapy, Combination; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Practice Guidelines as Topic; Prostatectomy; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Some of the highest rates of erectile dysfunction are seen in patients with renal failure, especially those on dialysis. The treatment of erectile dysfunction has been revolutionized in the last decade by the introduction of sildenafil. The literature on sildenafil in dialysis patients is here reviewed. Sildenafil seems to be both safe and effective in the treatment of sexual dysfunction in the dialysis population.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Renal Dialysis; Sildenafil Citrate; Sulfones

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adrenergic alpha-Antagonists; Alprostadil; Ejaculation; Erectile Dysfunction; Humans; Injections, Intralesional; Male; Penile Erection; Penile Implantation; Phosphodiesterase Inhibitors; Piperazines; Psychotherapy; Purines; Reproductive Techniques, Assisted; Selective Serotonin Reuptake Inhibitors; Sildenafil Citrate; Sulfones

In less than 20 years, the first selective type 5 phosphodiesterase inhibitor, sildenafil, has evolved from a potential anti-angina drug to an on-demand oral treatment for erectile dysfunction (Viagra), and more recently to a new orally active treatment for pulmonary hypertension (Revatio). Here we describe the key milestones in the development of sildenafil for these diverse medical conditions, discuss the advances in science and clinical medicine that have accompanied this journey and consider possible future indications for this versatile drug.

Topics: Angina Pectoris; Cerebrovascular Circulation; Erectile Dysfunction; Heart Failure; Humans; Hypertension, Pulmonary; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction occurs commonly in untreated and treated hypertensive patients, impairing adherence to treatment and quality of life. Furthermore, it is a marker for enhanced risk for cardiovascular disease. Phosphodiesterase type 5 (PDE5) inhibitors, sildenafil, vardenafil, and tadalafil, provide effective treatment of erectile dysfunction. They reduce blood pressure in healthy patients: sildenafil 100 mg, -3.7/-3.6 mm Hg; vardenafil 20 mg, -7.5/-8 mm Hg; and tadalafil 20 mg, -1.6/-0.8 mm Hg. Greater declines in blood pressure with a PDE5 inhibitor may be observed in treated and untreated hypertensive patients. The additive effect of PDE5 inhibitors with one or multiple antihypertensive drugs is modest. alpha(1)-Blockers, except tamsulosin, may result in larger declines in blood pressure and cause orthostatic hypotension. Thus, caution should be exercised by using the lowest doses of proportional, variant(1)-blockers and PDE5 inhibitors in combination. Nitrates in combination with PDE5 inhibitors cause a profound decline in blood pressure and are contraindicated.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Antihypertensive Agents; Blood Pressure; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Dose-Response Relationship, Drug; Drug Therapy, Combination; Erectile Dysfunction; Humans; Hypertension; Hypotension; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vascular Resistance

Three different phosphodiesterase 5 (PDE5) inhibitors are currently available for the treatment of erectile dysfunction: sildenafil, vardenafil and tadalafil. The differences between these 3 are limited: tadalafil has a long duration of action, while vardenafil has a rapid onset of action after intake. Various studies have suggested that there is an improvement in the partners' sex lives when men use a PDE5 inhibitor for erectile dysfunction. The introduction of PDE5 inhibitors has renewed the interest in PDE inhibitors in general, for example in the treatment of pulmonary hypertension. In the near future PDE inhibitors may be used for various disorders as chronic obstructive pulmonary disease, benign prostatic hyperplasia, hypertension and coronary heart disease.

Topics: Carbolines; Coronary Disease; Erectile Dysfunction; Humans; Hypertension; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatic Hyperplasia; Pulmonary Disease, Chronic Obstructive; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

During many years, the symptom of erectile dysfunction was a matter for the urologist or the sexologist without efficacious treatment. Since 1999, the unexpected efficacy of sildenafil initially tested as a coronary vasodilatator emphasized the major role of an endothelial dysfunction potentially corrected by type 5 phosphodiesterase inhibitors (5-PDEI), which are able to reinforce the NO-dependant vasodilatation of cavernous arteries. Due to the medicalisation and the mediatisation of erectile dysfunction during the past five years, this symptom is now a matter for the cardiologist. The first reason was the query of cardiovascular safety of 5-PDEI. American and Britannic registries have established a good cardiovascular tolerability of these drugs including in patients with coronary heart disease according to the respect of contraindication in cases of coprescription with nitrates. The second was the association of erectile dysfunction with many cardiovascular risk factors concerned by the cardiologist. The third reason was the observation that erectile dysfunction could be a potential marker to identify patients with silent myocardial ischemia and relevant coronary artery disease. The Princeton consensus provides guidelines to help the cardiologist in the evaluation of patients with erectile dysfunction according to the cardiovascular risk level. Henceforth, erectile dysfunction should be considered by the cardiologist as "a sound of silence" of myocardial ischemia and should encourage to more aggressive evaluation and treatment of cardiovascular risk factors.

Topics: Cardiology; Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Physician's Role; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones

The question "extents of sexual activity", especially for a cardiac patient, seems enigmatic for patient himself and his physician. Cardiac patient's prejudice is that limitation of sexual activity is necessary to avoid complications like myocardial infarction. This misconception worsens quality of life of patient which is already limited. In this kind of situations, a physician is supposed to answer lots of questions. Patient's risk status should be interpreted and stratified by further examinations, before deciding to treat. Pharmacological and rehabilitative modalities can be applied when indicated, on the other hand, majority of the patients are classified as low risk status that are assumed to be safe. A routine follow- up is recommended for this kind of patients by 6 months intervals, regardless the patient is under medication or not.

Topics: Erectile Dysfunction; Humans; Male; Myocardial Infarction; Piperazines; Purines; Sexual Behavior; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Adult; Alprostadil; Apomorphine; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Penile Erection; Penile Prosthesis; Piperazines; Purines; Sex Counseling; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Yohimbine

Phosphodiesterase type 5 (PDE5) inhibitors effectively enhance the erectile function of the patients with erectile dysfunction (ED). The use of sildenafil citrate is expanding to a broader extent. Pulmonary artery hypertension has become a new indication of sildenafil. Sildenafil could improve the epithelial function in several vascular conditions in clinical trials. This article reviews the recent advances on basic and clinical studies of ED and sildenafil. On animal models, sildenafil could resume the cavernous epithelial function, up-regulate the protein expression of phosphorylated endothelial NO synthase (eNOS), reverse the decreased intracavernosal pressure (ICP) induced by pudendal artery blood flow restriction or hypoxia. In clinical studies, over 50% of ED patients receiving sildenafil got a fully rigid erection (grade 4 erection). And the same percentage of post-nerve-sparing radical prostatectomy patients receiving sildenafil obtained penile rehabilitation and spontaneously resumed erection sufficient for sexual intercourse. Sildenafil treatment has contributed to the normalization of self-esteem, confidence and sexual harmony in men with ED. All this suggests that a whole rehabilitation from erectile to psychosocial function may become a new goal of ED therapy.

Topics: Animals; Erectile Dysfunction; Humans; Male; Mice; Penis; Phosphodiesterase Inhibitors; Piperazines; Purines; Rats; Sildenafil Citrate; Sulfones

We aimed to determine whether erectile function (EF) and assessments of erection hardness correlate positively with measures of psychosocial outcomes (ie, emotional well-being, sexual satisfaction, and satisfaction with erectile dysfunction [ED] treatment) in men treated with sildenafil citrate (Viagra; Pfizer Inc, New York, NY). Data were collected from 33 worldwide phase 2, 3, and 4 sildenafil clinical trials, which included almost 10,000 men with ED. Most of these trials were randomized, double-blind, and placebo-controlled (n = 27) and were undertaken to assess doses of 50 mg adjustable to 25 mg or 100 mg, depending on efficacy and tolerability (n = 32). Doses were taken approximately 1 hour before anticipated sexual activity but not more often than once daily. EF was assessed with use of the EF domain of the International Index of Erectile Function (IIEF) and with assessments of erection hardness (Erection Hardness Grading Scale [EHGS] and IIEF Q2 [the frequency of erections hard enough for penetration]). Change (baseline to end point) in emotional well-being in men treated for ED was assessed with the Self-Esteem and Relationship (SEAR) questionnaire, which consisted of the Confidence domain (ie, the Self-Esteem subscale and Overall Relationship subscale) and the Sexual Relationship domain. End point treatment satisfaction (overall, speed of onset, and duration of action) was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). The IIEF was used to assess change and end point sexual satisfaction by means of the Intercourse Satisfaction domain, Q7 (frequency of satisfactory sexual intercourse), and the Overall Satisfaction domain (ie, Q13, satisfaction with sex life, and Q14, satisfaction with sexual relationship). In men treated with sildenafil for ED, scores for measures of EF (IIEF EF domain, IIEF Q2) and the percentage of erections graded completely hard and fully rigid (EHGS grade 4) correlated positively with scores for measures of psychosocial outcomes (SEAR emotional well-being, IIEF sexual satisfaction, and EDITS ED treatment satisfaction), indicating that when EF improved and erection hardness increased, these measures of psychosocial function also improved.

Topics: Clinical Trials as Topic; Emotions; Erectile Dysfunction; Humans; Male; Patient Satisfaction; Penile Erection; Personal Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexuality; Sildenafil Citrate; Sulfones

Sildenafil citrate (Viagra; Pfizer Inc, New York, NY) relaxes vascular smooth muscle, resulting in modest reductions in blood pressure that are insufficient to stimulate a reflex increase in heart rate. These blood pressure reductions are similar for healthy men and men with coronary artery disease (CAD) or who use antihypertensive drugs. Sildenafil does not affect the force of cardiac contraction, and cardiac performance is unaffected. Sildenafil is mildly vasodilating in the coronary circulation and does not increase the risk of ventricular arrhythmia. During exercise and recovery, sildenafil does not cause clinically significant alterations in hemodynamic parameters in men with CAD, and it has no negative effects on coronary oxygen consumption, ischemia, or exercise capacity. Clinical trial data from >13,000 patients, 7 years of international postmarketing data, and observational studies of >28,000 men in the United Kingdom and 3813 men in the European Union reveal that (1) there are no special cardiovascular concerns when sildenafil is used in accordance with product labeling and (2) the risk for serious events such as myocardial infarction or death is not increased. However, because safety has not been established in patients with recent serious cardiovascular events, hypotension or uncontrolled hypertension, or retinitis pigmentosa, physicians should consult their current local prescribing information before prescribing sildenafil for these patients. Among men with erectile dysfunction treated with sildenafil, the adverse event profile is similar overall to that in men with comorbid cardiovascular disease (CVD), it is similar between those with and without CAD, and it is similar between those who take and those who do not take antihypertensive drugs (regardless of the number or class). In a controlled interaction study of sildenafil and amlodipine, the mean additional reduction in supine blood pressure was 8 mm Hg systolic and 7 mm Hg diastolic. Sildenafil should be used with caution in patients who take alpha-blockers because coadministration may lead to symptomatic hypotension in some individuals. When sildenafil is coadministered with an alpha-blocker, patients should be stable on alpha-blocker therapy before initiating sildenafil treatment and sildenafil should be initiated at the lowest dose. Also, in the absence of information specific to mixed alpha/beta blockers, such as carvedilol and labetalol, similar care should be taken as for alpha-blo

Topics: Cardiovascular Diseases; Cardiovascular Physiological Phenomena; Cardiovascular System; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Although oral type 5 phosphodiesterase inhibitors are considered as first-line therapy for the majority of causes of erectile dysfunction, because of their high efficacy, ease of use, and acceptable safety profile, there are some who fail to respond, mainly because of end-organ failure. This communication reviews the management of sildenafil failures in light of recent advances.. Sildenafil failures can be attributed to either lack of efficacy or side effects; issues may involve the physician, patient, and his partner. Physicians may contribute to sildenafil failure and discontinuation because of inadequate instructions, lack of adequate follow-up, suboptimal dosing, lack of adequate trial, and insufficient clarification about safety issues. Studies have demonstrated that progression of endothelial dysfunction and diminished cavernosal smooth-muscle content are recognized organic factors which cause end-organ dysfunction and ultimately treatment failure.. Proper counseling, medication optimization, and modifying associated risk factors can provide success in men who had initially failed sildenafil therapy for erectile dysfunction. Other treatment modalities that may be considered when sildenafil failure occurs include vacuum devices, intraurethral, and intracavernosal administration of vasoactive drugs alone or combined with sildenafil. Penile prosthesis implantation is considered as a last resort, if all first-line and second-line therapies fail.

Topics: Counseling; Dose-Response Relationship, Drug; Drug Resistance; Erectile Dysfunction; Humans; Male; Muscle, Smooth, Vascular; Penile Implantation; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Failure; Vasodilator Agents

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Time Factors; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Cardiovascular (CV) risk factors are associated with an increased risk of erectile dysfunction (ED). In men with diabetes mellitus (DM), pooled from clinical trials of sildenafil treatment for ED, this retrospective analysis determined efficacy and safety, overall and in subgroups with additional CV risk (i.e., hypertension, dyslipidemia, and smoking).. From the manufacturer's database of worldwide research, 12-week data from men with DM were pooled from randomized, double-blind, placebo-controlled trials of flexible-dose sildenafil (25, 50, or 100 mg, PRN) for ED.. Question 3 (achieving an erection), question 4 (maintaining an erection), and the Erectile Function domain of the International Index of Erectile Function; percentage of successful intercourse attempts according to patient event logs; and response to a global efficacy question (GEQ). Differences between groups were determined using logistic regression (percentage of responders according to GEQ) and analysis of covariance (all other outcomes).. Inclusion criteria were met by 11 trials and by 974 men with DM and ED who were randomized to placebo (n = 482) and sildenafil (n = 492) within the selected trials. For all outcomes, overall and regardless of additional CV risk, the benefit was greater for sildenafil versus placebo (p < or = 0.0001), including 3-fold more men responding that sildenafil treatment improved their erections (62% vs. 18%) and a more than doubling of the mean +/- standard error percentage of successful sexual intercourse attempts (52.6 +/- 5.0 vs. 22.4 +/- 5.1). Adverse events were mild to moderate and included (sildenafil vs. placebo) headache (5% vs. 2%), flushing (7% vs. 2%), and dyspepsia (4% vs. 0%), which is consistent with the profile in the general population of men treated with sildenafil for ED.. This retrospective analysis of pooled data showed that sildenafil was well tolerated and improved erectile function and intercourse success in men with ED and DM, regardless of additional CV risk factors.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Diseases; Coitus; Diabetes Complications; Dyslipidemias; Erectile Dysfunction; Humans; Hypertension; Logistic Models; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Sildenafil Citrate; Smoking; Sulfones; Surveys and Questionnaires; Treatment Outcome

Topics: Antipsychotic Agents; Erectile Dysfunction; Female; Humans; Male; Monoamine Oxidase Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Research; Research Design; Schizophrenia; Selegiline; Sexual Dysfunctions, Psychological; Sildenafil Citrate; Sulfones; Treatment Outcome

Erectile dysfunction (ED) is a highly prevalent disease associated with aging as well as with several risk factors including hypertension, heart disease, obesity, dyslipidemia, diabetes, hypogonadism, drugs-related, and pelvic surgery. Many of these factors are components of the metabolic syndrome, a multiplex risk factor for cardiovascular disease (CVD). ED shares common risk factors with CVD. Endothelial dysfunction seems to be the early underlying pathophysiology across both conditions. The efficacy, tolerability and cardiovascular safety of sildenafil has been evaluated in numerous large, randomized, doubleblind, placebo-controlled clinical studies in the broad population of men with ED including men with several co-morbid conditions. Sildenafil is effective in several specific patient populations including the difficult-to-treat subpopulations such as diabetes mellitus and after radical prostatectomy. It is associated with rapid onset of action--within 14 minutes for some men--and an extended duration of action for up to 12 hours. Sildenafil improves quality of life and satisfaction for treated men and is well tolerated with a favorable safety profile. New data suggest that sildenafil has beneficial effects in several chronic conditions. It has been approved for the treatment of idiopathic pulmonary hypertension. Numerous articles have suggested that it improves endothelial function and a possible role on premature ejaculation or treatment of lower urinary tract symptoms has been suggested.

Topics: Dose-Response Relationship, Drug; Ejaculation; Erectile Dysfunction; Health Status; Humans; Male; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Time Factors; Treatment Outcome; Urinary Tract

More than 70% of elderly men (>or=65) remain sexually active, and more than 40%, according to one estimate, are dissatisfied with their sex lives. Declining sexual function and a reluctance to seek medical attention with advancing age are cross-cultural observations. Normal erection is largely dependent on intact function of the central and peripheral nervous systems and the penile vascular endothelium. Consequently, chronic conditions (e.g., cardiovascular disease, diabetes mellitus) and lifestyle factors (e.g., smoking) that have adverse effects on the vascular endothelium and central and peripheral nervous systems, as well as on endocrine function or connective tissues within the corpus cavernosum of the penis, can attenuate erectile function. Because of these associations, assessment of sexual function in elderly men often reveals not only erectile dysfunction (ED) but also other reversible conditions. An expanding array of noninvasive options is available to assist the clinician in individualizing ED therapy to the unique health and lifestyle needs of each elderly ED patient and his partner. These treatment alternatives include the phosphodiesterase type 5 inhibitors sildenafil, vardenafil, and tadalafil, as well as other oral medications, such as alpha-adrenoceptor antagonists and topical vasoactive or testosterone therapy.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Aged; Aging; Chronic Disease; Erectile Dysfunction; Humans; Life Style; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone; Vasoconstrictor Agents

To describe the urologic and sexual complications of male survivors of sexual torture, including prevalence, sequelae, diagnosis, and treatment.. Through chart reviews, we identified all male survivors of torture who had been treated for physical and/or psychological symptoms due to sexual trauma at the Boston Center for Refugee Health and Human Rights at Boston Medical Center between January 1, 2001 and January 1, 2002. Of the 72 men seen, 20 (28%) were survivors of sexual trauma. Our study focused on genital trauma leading to urologic and/or sexual dysfunction. Therefore, all cases of male genital trauma that had been referred to the urology department (3 of 20) were selected for this review.. The patients presented with chronic genital and erectile pain, lower urinary tract symptoms, and sexual dysfunction. The diagnostic workup included history, physical examination, and ultrasonography. Treatment included steroid injections for chronic pain and oral erectogenic agents for sexual dysfunction.. The apparent prevalence and severity of the physical and mental sequelae to sexual trauma make it an important area for screening when treating survivors of torture. Our study is the first of its kind to document urologic complications of sexual torture in a foreign-born U.S. cohort of tortured men, including prevalence, diagnosis, and treatment. The proposed use of steroid injections in the clinical treatment of these patients has not been previously reported.

Topics: Adult; Africa; Anal Canal; Boston; Burns, Electric; Cohort Studies; Electroshock; Erectile Dysfunction; Genitalia, Male; Humans; Male; Middle Aged; Pain; Piperazines; Prisoners; Purines; Rape; Refugees; Sex Offenses; Sildenafil Citrate; Sulfones; Survivors; Torture; Triamcinolone; Urethral Stricture; Urinary Tract; Wounds, Nonpenetrating

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Alprostadil; Clinical Trials as Topic; Cohort Studies; Cyclic Nucleotide Phosphodiesterases, Type 5; Double-Blind Method; Erectile Dysfunction; Humans; Injections; Male; Penis; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Postoperative Complications; Prospective Studies; Prostatectomy; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Erectile dysfunction (ED) affects up to 50% of men, between 40 and 70 years of age. In the first major trial of sildenafil in ED, at 24 weeks, improved erections were reported by 77 and 84% of men taking sildenafil 50 and 100mg, respectively. Subsequently, sildenafil has been reported to be effective in men with ED associated with diabetes and prostate cancer, and in psychogenic ED. Sildenafil is safe in men with coronary artery disease, provided it is not used with the nitrates (a contraindication). The most commonly reported adverse effects with sildenafil are headache, flushing and dyspepsia. Vardenafil is more potent and more selective than sildenafil at inhibiting phosphodiesterase-5. Vardenafil is similarly effective to sildenafil in the treatment of ED. The only advantage that vardenafil has over sildenafil is that it does not inhibit phosphodiesterase-6 to alter colour perception, a rare side effect which sometimes occurs with sildenafil. Tadalafil has a longer duration of action than sildenafil and vardenafil. Tadalafil is similarly effective as sildenafil in the treatment of ED. In comparison studies, tadalafil is preferred to sildenafil (50/100mg) by men with ED, possibly because of its longer duration of action. Of the phosphodiesterase inhibitors, tadalafil may displace sildenafil as the drug of choice among men with ED.

Topics: Carbolines; Controlled Clinical Trials as Topic; Cross-Over Studies; Erectile Dysfunction; Humans; Imidazoles; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Significant advances in the pharmacologic treatment of erectile dysfunction (ERD) have occurred in recent years, most notably the introduction of sildenafil, the first oral selective phosphodiesterase type 5 (PDE5) inhibitor, in 1998. Sildenafil quickly gained acceptance by the medical community and the public because of its broad efficacy for different types of ERD and its ease of use. Two PDE5 inhibitors, vardenafil and tadalafil, have since joined sildenafil to compete in the ERD market. A review was conducted by the Drug Information Service of a pharmacy benefits manager (PBM) to determine the relative merits and place in therapy of commonly used ERD drugs as part of drug formulary management process and decision making by the Pharmacy & Therapeutics (P&T) committee.. To provide readers with a comprehensive clinical monograph on ERD drugs written from a managed care perspective.. The PBM clinical monograph is designed to provide health plans with an evidence-based review of drugs, therapeutic classes, and disease states with a managed care focus. For each therapeutic class or disease review, an extensive and thorough literature search of MEDLINE is conducted for efficacy, safety, effectiveness, and humanistic and economic data. Drug/disease-state databases (UptoDate online, MICROMEDEX), U.S. Food and Drug Administration clinical reviews, key Internet sites, medical/pharmacy-related news sites, clinical guidelines, and AMCP dossiers are also reviewed. Formulary drug monographs prepared by the Drug Information Service of the PBM include a critical analysis and summary of disease-oriented and patient-oriented clinical outcomes, effectiveness, and humanistic data. Additional data considered and included in the formulary review process are clinical attributes, patent expirations/generic competition, off-label or pending indications, and pharmacoeconomic data.. Despite the lack of head-to-head comparative studies, all 3 PDE5 inhibitors appear to have equivalent efficacy in the treatment of general ERD and ERD associated with diabetes and postprostatectomy. Sildenafil has additional efficacy data in the management of ERD associated with spinal cord injury and antidepressant medications. Tadalafil has the longest duration of action (up to 36 hours); this feature can be both beneficial (greater sexual spontaneity) or possibly detrimental (greater exposure to drug, delayed adverse events). All 3 PDE5 inhibitors appear to be generally well tolerated and have similar contraindications and warnings. However, vardenafil is the only PDE5 inhibitor with a cardiac conduction precaution. Alprostadil products are recommended in current ERD guidelines as second-line therapy for those who have not responded or cannot take the oral PDE5 inhibitors. Overall, higher clinical efficacy rates are achieved with intracavernous than with transurethral administration.. A large amount of clinical efficacy and safety data has been published since the market launch of sildenafil in 1998. Sildenafil has the greatest body of efficacy and safety evidence. No comparative studies have been conducted with any of the PDE5 inhibitors. Differences in study populations, primary end points, and measurement tools make comparisons difficult. However, all PDE5 inhibitors appear to be roughly equivalent in efficacy, with minor differences in adverse event profiles. Until more comparative data are available, economic considerations will be a significant factor in choosing ERD products for formulary inclusion.

Topics: Carbolines; Drug Information Services; Erectile Dysfunction; Formularies as Topic; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Sildenafil is widely used to treat erectile dysfunction (ED). Because many patients with ED have cardiovascular diseases, doctors and patients are concerned over the safety of Sildenafil in patients with cardiovascular diseases. The review focuses on the safety of sildenafil for ED patients with cardiovascular diseases.

Topics: Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction is common and closely associated with age and risk factors for cardiovascular disease. The oral selective inhibitors of phosphodiesterase type 5 (PDE5) have become the treatments of choice, owing to their convenience, general safety, and broad-spectrum effectiveness. For the same reasons, they have greatly simplified the workup. Thus, the general practitioner has gradually replaced the urologist for the initial management of erectile dysfunction and the proper evaluation of cardiac status before starting treatment with the PDE5 inhibitors. The following review provides a practical approach for the management of erectile dysfunction in primary care.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Contraindications; Drug Interactions; Erectile Dysfunction; Humans; Interprofessional Relations; Male; Phosphodiesterase Inhibitors; Physicians, Family; Piperazines; Practice Patterns, Physicians'; Purines; Risk Factors; Sildenafil Citrate; Sulfones

Viagra has become the first line drug for the treatment of erectile dysfunction since it was first introduced in 1998. Its efficacy and safety have been sidely acclaimed as being definite. This article presents a brief review about the advances in the studies of Viagra, including its therapeutic effect and safety, its protection of penile health, and its promotion of self-esteem and sexual relationship.

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Personal Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

More than 30 million men are estimated to have erectile dysfunction (ED) in the United States. Worldwide, ED is estimated to affect more than 150 million men, and that number is expected to exceed 300 million men by the year 2025. The prevalence of ED ranges from 7% in men aged 18-29 years to 85% in men aged 76-85 years. In addition, a recent report showed that 68% of patients with ED aged 18 years and older have at least one comorbid diagnosis of hypertension, hyperlipidaemia, diabetes or depression, and research suggests that ED may be an early indicator of systemic vascular disease. Viagra (sildenafil citrate), the first-in-class phosphodiesterase type 5 (PDE5) inhibitor, was introduced in 1998 for the treatment of ED. In the 7 years since its market launch, more than 750,000 physicians have prescribed sildenafil to more than 23 million men, helping establish an excellent safety and efficacy record. Clinical studies have demonstrated that sildenafil successfully treats ED of varied organic, psychogenic or mixed aetiology, and is effective in men with ED and comorbidities such as hypertension, hyperlipidaemia, diabetes or depression. Sildenafil was a breakthrough medication that addressed a previously unfulfilled medical need. The impact of sildenafil has stimulated academic, clinical and industrial research to better understand the nature of sexual function and develop better treatment and management for sexual dysfunctions such as ED. With the advent of other erectogenic therapies for the treatment of ED, this 7-year update will focus on the unique history and development of sildenafil, its current use and applications and its future directions and indications. Special emphasis is placed on the impact of sildenafil on our understanding of sexual health and on the extensive safety and efficacy data that have been amassed from numerous clinical trials.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Diseases; Drug Interactions; Erectile Dysfunction; Female; Humans; Male; Piperazines; Purines; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sulfones; Vasodilator Agents

Sildenafil is an orally effective therapy for the treatment of men with erectile dysfunction (ED). It is a specific and selective inhibitor of phosphodiesterase type 5 (PDE5). This paper reviews the researches on the pharmacokinetics, the onset and duration of the action of Sildenafil.

Topics: Animals; Erectile Dysfunction; Female; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Rats; Sildenafil Citrate; Sulfones

Therapy of erectile dysfunction has been revolutionised in recent years, as specific pharmacological inhibitors of phosphodiesterase 5 (PDE5), such as sildenafil, tadalafil, or vardenafil, were shown to be highly effective in the treatment of erectile dysfunction. They dilate arterial smooth muscle cells of the corpora cavernosa, which express PDE5 abundantly, by inhibiting the breakdown of 3'5'-cyclic guanosine monophosphate. Despite theoretical concerns of a reduced myocardial tolerance to ischaemia or promoting cardiac arrhythmias, randomised trials and retrospective analyses do not support an increased cardiac risk with oral treatment. Therapeutic doses of PDE 5 inhibitors exhibit slight blood pressure lowering effects, and do not appear to compromise coronary blood flow in coronary artery disease. However, the combination of PDE5 inhibitors with any nitric oxide donor is absolutely contraindicated because of potentially life-threatening hypotension. Before prescribing medication for erectile dysfunction, any patient with cardiovascular disease should be evaluated for a potential risk of a cardiovascular event during sexual activity according to the Princeton Consensus Panel. When a stable cardiac condition can be achieved (low risk group), oral treatment for erectile dysfunction may be appropriate.

Topics: Administration, Oral; Apomorphine; Blood Pressure; Cardiovascular Diseases; Contraindications; Dopamine Agonists; Drug Interactions; Erectile Dysfunction; Humans; Hypotension; Male; Nitric Oxide Donors; Patient Selection; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Assessment; Sildenafil Citrate; Sulfones

Since the worldwide introduction of sildenafil in 1998, 23 million patients with ED have been treated with the drug, and the accumulated experiences have proved its safety and efficacy. This article presents a review about the action mechanism and metabolic process of sildenafil, with a particular focus on the application of sildenafil to ED diagnosis, the curative effect of its daily use on ED, the standard treatment, combined therapy and progressive protocol with sildenafil for ED and its complications, along with such safety aspect as its effect on the sight.

Topics: Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Diabetes Complications; Diabetic Neuropathies; Diagnosis, Differential; Erectile Dysfunction; Humans; Imidazoles; Male; Nitric Oxide; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Recent studies have highlighted the relation between erectile dysfunction (ED) and cardiovascular disease. In particular, the role of endothelial dysfunction and nitric oxide in ED and atherosclerotic disease has been elucidated. Given the large number of men receiving medical treatment for ED, concerns regarding the risk for sexual activity triggering acute cardiovascular events and potential risks of adverse or unanticipated drug interactions need to be addressed. A risk stratification algorithm was developed by the First Princeton Consensus Panel to evaluate the degree of cardiovascular risk associated with sexual activity for men with varying degrees of cardiovascular disease. Patients were assigned to 3 categories: low, intermediate (including those requiring further evaluation), and high risk. This consensus study from the Second Princeton Consensus Conference corroborates and clarifies the algorithm and emphasizes the importance of risk factor evaluation and management for all patients with ED. The panel reviewed recent safety and drug interaction data for 3 phosphodiesterase (PDE)-5 inhibitors (sildenafil, tadalafil, vardenafil), with emphasis on the safety of these agents in men with ED and concomitant cardiovascular disease. Increasing evidence supports the role of lifestyle intervention in ED, specifically weight loss and increased physical activity, particularly in patients with ED and concomitant cardiovascular disease. Special management recommendations for patients taking PDE-5 inhibitors who present at the emergency department and other emergency medical situations are described. Finally, further research on the role of PDE-5 inhibition in treating patients with other medical or cardiovascular disorders is recommended.

Topics: Age Distribution; Aged; Angina Pectoris; Cardiovascular Agents; Cardiovascular Diseases; Comorbidity; Coronary Disease; Drug Interactions; Erectile Dysfunction; Humans; Incidence; Male; Middle Aged; Piperazines; Prognosis; Purines; Risk Assessment; Severity of Illness Index; Sildenafil Citrate; Sulfones; Survival Rate

The field of erectile dysfunction (ED) has been revolutionised over the last two decades. Several treatment options are available today, most of which are associated with high efficacy rates and favourable safety profiles. A MEDLINE search was undertaken in order to evaluate all currently available data on treatment modalities for ED. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are currently the first-choice of most physicians and patients for the treatment of ED. PDE5 inhibitors have differences in their pharmacological profiles, the most obvious being the long duration of action of tadalafil, but there are no data supporting superiority for any one of them in terms of efficacy or safety. Sublingual apomorphine has limited efficacy compared with the PDE5 inhibitors, and its use is limited to patients with mild ED. Treatment failures with oral drugs may be due to medication, clinician and patient issues. The physician needs to address all of these issues in order to identify true treatment failures. Patients who are truly unresponsive to oral drugs may be offered other treatment options.Intracavernous injections of alprostadil alone, or in combination with other vasoactive agents (papaverine and phentolamine), remain an excellent treatment option, with proven efficacy and safety over time. Topical pharmacotherapy is appealing in nature, but currently available formulations have limited efficacy. Vacuum constriction devices may be offered mainly to elderly patients with occasional intercourse attempts, as younger patients show limited preference because of the unnatural erection that is associated with this treatment modality. Penile prostheses are generally the last treatment option offered, because of invasiveness, cost and non-reversibility; however, they are associated with high satisfaction rates in properly selected patients. All treatment options are associated with particular strengths and weaknesses. A patient-centred approach based on patient needs and expectations is necessary for the management of ED. The clinician must educate the patient and provide a supportive environment for shared decision making. The management strategy must be supplemented by careful follow-up in order to identify changes in patient health and relationship/emotional status that may necessitate treatment optimisation.

Topics: Administration, Oral; Alprostadil; Apomorphine; Carbolines; Constriction; Contraindications; Dopamine Agonists; Drug Combinations; Enzyme Inhibitors; Erectile Dysfunction; Humans; Imidazoles; Male; Papaverine; Patient Satisfaction; Penile Prosthesis; Penis; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Purines; Regional Blood Flow; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Failure; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Erectile dysfunction is a common ailment in middle-aged and old men. The management of ED has entered a new stage since sildenafil was used to treat ED in 1998. Sildenafil became the first-line treatment for its efficacy and safety. In recent years, new PDE5 inhibitors--vardenafil and tadalafil came into market in succession, providing more options available for oral therapy. This review is about the development of preclinical and clinical medicine research on the three PDE5 inhibitors, and provide information for clinical choices.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Differences in the clinical pharmacology of the 3 currently available oral phosphodiesterase-5 (PDE5) inhibitors, sildenafil, vardenafil, and tadalafil, are largely determined by their clinical pharmacokinetics as well as their PDE inhibitory activity profile. This review comparatively discusses the major characteristics of the pharmacokinetic profile of all 3 PDE5 inhibitors, including bioavailability and rate of absorption, Biopharmaceutical Classification System categorization, elimination mechanisms, and metabolic profile including active metabolites, as well as the drug-drug interaction potential and modification of pharmacokinetic properties under selected physiologic and pathophysiologic conditions. The review is aimed at providing comparative clinical pharmacology data to allow for scientifically rational, evidence-based prescribing and dosing decisions regarding the clinical use of these medications for the treatment of erectile dysfunction.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Animals; Biological Availability; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Cytochrome P-450 CYP3A; Drug Interactions; Erectile Dysfunction; Humans; Imidazoles; Male; Metabolic Clearance Rate; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Sildenafil citrate is a drug commonly used to manage erectile dysfunction. It is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H -pyrazolo[4,3-d]pyrimidin-5-yl)-4 ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate (C22H30N6(O4)S). It is a highly selective inhibitor of cyclic guanine monophosphate-specific phosphodiesterase type 5. In late March through mid-November 1998, the US Food and Drug Administration (FDA) published a report on 130 confirmed deaths among men (mean age, 64 years) who received prescriptions for sildenafil citrate, a period during which >6 million outpatient prescriptions (representing about 50 million tablets) were dispensed. The US FDA recently reported that significant cardiovascular events, including sudden cardiac death, have occurred in men with erectile dysfunction who were taking sildenafil citrate. These reports have raised concerns that sildenafil citrate may increase the risk of cardiovascular events, particularly fatal arrhythmias, in patients with cardiovascular disease. In the past few years, the cardiac electrophysiological effects of sildenafil citrate have been investigated extensively in both animal and clinical studies. According to extensive data available to date, sildenafil citrate has been shown to pose minimal cardiovascular risks to healthy people taking this drug. Some precautions are needed for patients with cardiovascular diseases. However, the only absolute contraindication for sildenafil citrate is the concurrent use of nitrates. This article is intended to review sildenafil citrate's cardiovascular effects, as well as current debates about its arrhythmogenic effects.

Topics: Adult; Aged; Arrhythmias, Cardiac; Blood Pressure; Cardiovascular Diseases; Death, Sudden, Cardiac; Electrophysiology; Erectile Dysfunction; Heart Rate; Humans; Male; Middle Aged; Myocardial Contraction; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Vasodilator Agents

In the recent few years, especially since the introduction of phosphodiesterase-5 inhibitor, sildenafil, most researchers have focused their researches on biochemistry and physiology of erectile function. New progress has been made made in basic and clinic researches on pharmacotherapy for ED. In this article, the putative molecular or cellular mechanism of actions of the available centrally and peripherally acting drugs are reviewed, providing details about the current and most explosive area of drug research and development in erectile dysfunction.

Topics: Animals; Apomorphine; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Rats; Sildenafil Citrate; Sulfones; Yohimbine

Phosphodiesterase 5 inhibitors are recommended as first-line treatment of erectile dysfunction in many guidelines, because of their convenience, higher efficacy, and less side-effects. Since its first launch in 1998, sildenafil has been currently the best investigated phosphodiesterase 5 inhibitor with respect to long-term trails and quantity. Clinical trials showed the efficacy of sildenafil compared with placebo in many of the groups of patients who have ED, including those with cardiovascular disease, diabetes mellitus, depression, radical prostatectomy and dialysis. Typically the adverse effects reported in patients from clinical trials of sildenafil have been mild to moderate, and commonly include flushing and dyspepsia and transient visual disturbances. This article summarized recent reports on efficacy and safety of phosphodiesters 5 inhibitors in the treatment of erectile dysfunction.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Safety; Sildenafil Citrate; Sulfones

Understanding patient preferences can be important in ensuring full benefit is derived from treatment for erectile dysfunction (ED). They seem to be important in determining whether patients continue treatment in the medium and long term. In clinical practice, discontinuation rates beyond a year are relatively high. Factors such as spontaneity, "naturalness", and onset and duration of action may all influence preference. This article discusses a number of studies looking into patient preferences for a particular class of treatment method over another, and also for individual treatments within classes. In general, patients appear to prefer oral treatments to others such as penile implant surgery, vacuum-pump therapy, apomorphine, and intracavernosal injection. In some studies, men have also shown preferences for particular oral phosphodiesterase-5 (PDE5) inhibitors over others. Providing patients with full information on the pros and cons of treatment options can help ensure patients are treated with a therapy that fits more closely with their wishes, and ensure continuation of treatment for optimal efficacy.

Topics: Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Patient Education as Topic; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Safety; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

The rate of erectile dysfunction after radical retropubic prostatectomy is from 10% to 100%. The prevalence of erectile dysfunction after nerve-sparing radical prostatectomy is more than one third. In the patients who had undergone bilateral NS, 72% responded to sildenafil, 71.7% and 59.7% responded to 20 mg and 10 mg of vardenafil respectively. For all randomized patients who received tadalafil, the mean percentage of successful penetration attempts was 54% and the mean percentage of successful intercourse attempts was 41%. For the subgroup with evidence of postoperative tumescence these values were 69% and 52%, respectively. No head-to-head trials have been performed with sildenafil, vardenafil and tadalafil in treatment of erectile dysfunction after radical prostatectomy.

Topics: Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Erectile dysfunction (ED) affects the sexual lives of millions of men. The first-line oral pharmacotherapy for most ED patients is phosphodiesterase type-5 (PDE-5) inhibitors, of which three are available. Sildenafil is the most widely prescribed oral agent for ED and has a very satisfactory efficacy-safety profile in all patient categories. Tadalafil and vardenafil were introduced in the European Union and in the United States in 2003 and 2004, respectively. The three PDE-5 inhibitors share many pharmacological and clinical characteristics, and each has unique features. This review, which is based on the contemporary literature on PDE-5 inhibitors, describes the chemical, pharmacological, and clinical features of sildenafil, vardenafil, and tadalafil. The first section reviews the pathophysiology of penile erection and PDE-5 inhibitor pharmacology. The second section summarizes data regarding efficacy and safety of the three drugs in treating ED in the general population as well as in selected patient categories.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Cancer of the prostate (CAP) is one of the most common malignancies affecting North American men with about 215,000 new cases and 35,800 CAP related deaths annually. The most prevalent intervention for localized CAP is radical prostatectomy (RP) with 10-year survival rates approaching 90%. Studies of men in post-RP recovery indicate that 44% to 75% experience sexual dysfunction and more than 60% experience distress in reaction to sexual dysfunction problems. These findings are increasingly significant as prostate specific antigen testing continues to increase CAP detection rates, resulting in more and younger post-RP patients confronting sexual dysfunction.. A MEDLINE database search was performed for articles published from 1966 to September 2004.. Despite effectiveness 30% to 50% of patients who turn to sexually assistive aids after RP discontinue use within a year. This suggests that the achievement of physical responsiveness to an aid is necessary but it is not a sufficient factor in long-term sexual adaptation. Current research exploring this gap between effectiveness and ongoing use supports a broader perspective of sexual dysfunction emphasizing several factors, including perceptions of inadequacy, anxieties in regard to performance and depression in each member of the couple, overly enthusiastic expectations, partner physical/emotional readiness to resume active sex, the meaning to the couple of using a sexual aid and the quality of the nonsexual relationship of the couple.. Our findings reveal the need to explore broader strategies for improving patient coping ability and adaptation. They also point to the need to explore the role of resumed satisfying sexuality in overall quality of life following treatment.

Topics: Adaptation, Psychological; Adult; Aged; Aged, 80 and over; Alprostadil; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Platelet Aggregation Inhibitors; Prevalence; Prostatectomy; Prostatic Neoplasms; Purines; Risk Factors; Sildenafil Citrate; Stress, Psychological; Sulfones; Vacuum Curettage

Viagra (sildenafil citrate) has been proven as the first choice of treatment for erectile dysfunction (ED) due to its producing rigid, sustained erection and rapid onset of action. In recent years, more and more studies on efficacy of Viagra focused on the improvement of overall sex life, as well as the psychological impact on the ED patients. Using several psychological assessment tools such as erectile dysfunction inventory of treatment satisfaction (EDITS), self-esteem and relationship (SEAR) questionnaire, psychological impact of erectile dysfunction (PIED) scores, these studies found that Viagra treatment significantly improved the following psychological factors: satisfaction of both ED patients and their partners with sexual intercourse and sexual relationship, confidence and self-esteem of the patients, desire for intimacy and sexual intercourse. The significant increased frequency of sexual intercourse attempts and improvement of health-related quality of life were also seen in the patients receiving Viagra treatment. Thus, Viagra produces the better erection and then promotes the better sex cycle.

Topics: Erectile Dysfunction; Humans; Male; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Phosphodiesterase-5 (PDE-5) inhibitors are a well-established, first-line therapy for erectile dysfunction (ED). Extensive clinical trials and clinical experience established the highly significant efficacy and the safety of this class of drugs in the treatment of ED.Furthermore, the efficacy of PDE-5 inhibitors has been established in men with ED with a broad range of etiologies and comorbidities. The future of PDE-5 inhibitors includes the expansion of indications such as the treatment of pulmonary hypertension and the potential of treatment of symptomatic BPH.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Forecasting; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

The increased expression and activity of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase complex has emerged as a major common factor in the etiology of all forms of cardiovascular diseases since the upregulation of intravascular NADPH oxidase results in the formation of superoxide (O(2)(-)), which in turn promotes vasculopathy. An ever-increasing number of drugs commonly used in cardiovascular medicine have been shown to influence NADPH oxidase expression and activity. These include nitric oxide donors, nitroaspirin, eicosanoids, phosphodiesterase inhibitors, corticosteroids, antioxidants, and specific inhibitors. The objective of this review is to discuss these drugs in relation to the mechanisms underlying their effects on NADPH oxidase activity and the expression and therapeutic implications of these effects.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Eicosanoids; Erectile Dysfunction; Glucocorticoids; Humans; Male; NADPH Oxidases; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Up-Regulation

Erectile dysfunction (ED) is a common disease in male populations, and the morbidity is increasing. Currently, sildenafil is the first line oral therapy in the treatment of erectile dysfunction, and widely used by the patients from different areas, who are variable in ages, etiologies and degrees of severity, and by the patients with different diseases such as cardiovascular problems, diabetes mellitus and nephropathy. The drug manifests the effectiveness and well tolerance. In this paper, we review and summarize some relevant articles published to share information with the medical colleagues.

Topics: Administration, Oral; Adolescent; Adult; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

The recent reports of non-arteritic anterior ischemic optic neuropathy (NAION) occurring shortly after ingestion of erectile dysfunction agents have raised the question of whether these agents have a cause-and-effect relationship to NAION. The nature of optic nerve head blood flow and the various factors that influence it, the systemic vascular effects of these agents, and the clinical features of NAION lead me to believe that these agents are contributory factors. Patients with the appropriate risk factors should, therefore, be warned of this possibility and advised to refrain from using these agents.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Optic Disk; Optic Neuropathy, Ischemic; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Erectile function is determined by tight regulation of relaxation or contraction of corpus cavernosal smooth muscle, which is the result of a long and complex chain of molecular events. Control of erectile function resides in signaling pathways of the central and peripheral nervous system, as well as intracellular events in the penile smooth muscle. Vascular events resulting in erection have long been understood, and the role of the signaling pathways of the central and peripheral nervous systems in erectile function and dysfunction has become increasingly clear over the last decade. This knowledge has led to the development and current availability of effective oral treatments for erectile dysfunction, the selective phosphodiesterase type 5 (PDE5) inhibitors-sildenafil, vardenafil and tadalafil. In the past few years we have seen an elucidation of the molecular events involved in erectile function and dysfunction and the detailed mechanisms of action by which the specific PDE5 inhibitors work. A review of those mechanisms helps to explain the success of the currently available PDE5 inhibitors and the differences between them and suggests new approaches for developing potential future novel therapies or refinements to existing structures that may improve their efficacy, selectivity and safety profiles.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug Interactions; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Currently, 3 phosphodiesterase 5 (PDE5) inhibitor agents are available worldwide for the treatment of erectile dysfunction (ED): sildenafil, vardenafil, and tadalafil. Each of these agents is effective across a broad range of etiologies, including vasculogenic ED in men. Because PDE5 enzyme is found within the vascular smooth muscle cells in the walls of systemic arteries and veins, PDE5 inhibitors are mild vasodilators associated with small (and in general, clinically insignificant) decreases in blood pressure. However, because of the synergistic decrease in blood pressure (both systolic and diastolic) in the presence of organic nitrates, these 3 agents are contraindicated in patients receiving organic nitrates. The duration of interaction between a PDE5 inhibitor and nitrate administration depends on the specific drug being studied. The interaction between sildenafil or vardenafil and nitroglycerin is no longer observed by 24 hours. A preliminary study with sildenafil and sublingual nitroglycerin suggested the interaction is no longer observable by 4 hours. The interaction between tadalafil and nitroglycerin has dissipated by 48 hours after tadalafil administration. This is consistent with the longer elimination half-life of the drug. When PDE5 inhibitors are administered to patients with hypertension who are taking most antihypertensive agents (eg, beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium antagonists, diuretics), there are usually small additive decreases in blood pressure without a significant increase of adverse events. Some patients develop orthostatic hypotension when PDE5 inhibitors are used in conjunction with an alpha-blocker (typically for hypertension or for urologic conditions, such as benign prostatic hypertrophy). Precautions are necessary for all 3 of the PDE5 inhibitors regarding this potential interaction. Some studies suggest that the interaction is less relevant clinically if the patient has been undergoing long-term alpha-blocker therapy. Several analyses have suggested that PDE5 inhibitors do not increase myocardial infarction rates or death rates compared with placebo controls or expected rates from age-matched populations. In contrast, recent studies have shown that PDE5 inhibitors may have therapeutic potential for a host of cardiovascular diseases. In general, these agents, when used appropriately, are highly safe and effective.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adrenergic alpha-Antagonists; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug Interactions; Erectile Dysfunction; Humans; Imidazoles; Male; Nitroglycerin; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Phosphodiesterase type 5 (PDE5) inhibitors have revolutionized the treatment of erectile dysfunction (ED). Those safe and effective agents were originally developed for their cardiovascular effects and were incidentally found to enhance erections. Since the introduction of the first PDE5 inhibitor, sildenafil, in 1998, there has been concern about the effects of these agents on the heart and their safety in patients with cardiovascular disease. The concerns focused on the effects on blood pressure and heart rate, cardiac electrophysiology, and cardiovascular adverse events in clinical trials. Since there are currently three PDE5 inhibitors, attention has been given to class effects as well as unique individual safety and adverse events. Since these drugs are mild vasodilators, all three have blood pressure-lowering effects. These effects are usually mild and produce few symptoms. When combined with the nitric oxide donor nitroglycerine, however, blood pressure drops may be profound and life threatening. All three agents are contraindicated with nitrates. Cardiac electrophysiology effects, especially as manifested by changes in the QT interval, have been studied. None of the three agents are dangerously associated with QTc prolongation, although vardenafil has a warning for patients at risk for QTc prolongation. In evaluating cardiovascular adverse events in clinical trials, no signal to danger can be convincingly cited. Indeed, with the vasodilator effects of these drugs, many studies point to the improved exercise tolerance and coronary dilation in patients taking PDE5 inhibitors. PDE5 inhibitors are effective in treating ED, and their safety profile is excellent. There do not appear to be significant cardiovascular safety issues in the man with satisfactory cardiac and performance status.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Blood Pressure; Carbolines; Clinical Trials as Topic; Coronary Artery Disease; Cyclic Nucleotide Phosphodiesterases, Type 5; Electrophysiology; Erectile Dysfunction; Heart Rate; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Chronic heart failure (HF) is an increasingly common cardiovascular disorder. The goal of health-care providers is to optimize quality of life in this population, including sexual health. Up to 75% of patients with HF report erectile dysfunction (ED). As HF is a condition with distinct physiologic sequelae, some unique organic and psychological factors contributing to ED in this patient population have been identified, along with risk factors common to the development of coronary artery disease, HF and ED. This review describes contributing factors to ED in the setting of HF and highlights treatment considerations for this distinct patient population.

Topics: Adrenergic beta-Antagonists; Angioplasty, Balloon; Depression; Digoxin; Diuretics; Endothelium, Vascular; Erectile Dysfunction; Exercise; Heart Failure; Humans; Male; Piperazines; Purines; Sexual Behavior; Sildenafil Citrate; Sulfones

Laboratory experiments indicate that the nitric oxide erectile pathway is testosterone-dependent. Castration induces erectile dysfunction (ED) and reduction in nitric oxide synthase and in phosphodiesterase type 5 (PDE5) in the erectile tissue. Furthermore, castration causes apoptosis adversely affecting smooth muscle content and penile hemodynamics leading to veno-occlusive dysfunction. Testosterone therapy reverses these structural, biochemical, and physiological changes. In humans, testosterone therapy improves erectile function in men with hypogonadism. However, the efficacy of testosterone monotherapy may not be adequate because of the multifactorial nature of the pathophysiology of ED.. Preliminary data from a number of studies have been reviewed.. There are emerging evidence-based benefits to using the combination of testoterone and PDE5 inhibitors. A recently published multicenter, randomized, placebo-controlled study evaluated the safety and efficacy of testosterone gel 1% plus sildenafil vs. placebo gel plus sildenafil, in producing an erectile response in hypogonadal men who had failed prior sildenafil alone for ED. Screening yielded a prevalence of hypogonadism in ED patients who failed prior sildenafil. Following randomization, the double-blinded treatment phase was 12 weeks. Testosterone therapy with testosterone gel significantly improved erectile function in response to sildenafil. In addition, it significantly improved orgasmic function and patient satisfaction.. It is important to screen all men with ED for hypogonadism, especially those with a history of inadequate response to prior PDE5 inhibitors. The combination of testosterone plus PDE5 inhibitors may be considered for the treatment of ED in men with low to low-normal testosterone levels, who had inadequate response to prior treatment with PDE5 inhibitors alone.

Topics: Androgens; Drug Therapy, Combination; Erectile Dysfunction; Gels; Humans; Hypogonadism; Male; Models, Animal; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone

Radical prostatectomy is a frequently used treatment option for prostate cancer; however, prostatectomy is often associated with significant morbidity, including erectile dysfunction (ED).. To analyze the efficacy of sildenafil citrate in treating ED after radical prostatectomy.. MEDLINE and CANCERLIT (1998 to January 2004) were searched for English language articles using the key words prostatectomy, sildenafil, and phosphodiesterase inhibitors. Eleven studies fulfilled the inclusion criteria: primary, discrete data sets of postprostatectomy patients with ED treated with sildenafil monotherapy.. Sample sizes ranged from 13 to 198 (mean age, 61 +/- 3 years). Treatment durations were 4 weeks (or more than four doses) to 1 year, and sildenafil dosing was in the recommended range (25-100 mg). Seven studies reported a response rate (range, 14%-53%) for an end point consistent with the primary analysis outcome (erection sufficient for vaginal intercourse); the combined estimate of probability of response was 35% (95% confidence interval [CI], 24%-48%). There was strong evidence for a lower response rate after non-nerve-sparing (range, 0%-15%) versus nerve-sparing surgery (range, 35%-75%; combined odds ratio [OR] = 12.1; 95% CI, 5.5-26.6) but not after unilateral (range, 10%-80%) versus bilateral nerve-sparing surgery (range, 46%-72%; combined OR = 2.21; 95% CI, 0.75-6.54).. The results of these studies demonstrate that with sildenafil, more than one third of patients with postprostatectomy ED achieved erection sufficient for intercourse. The odds of responding improved 12-fold with preservation of at least one neurovascular bundle. Early treatment failure does not necessarily imply lack of efficacy in the future, and patients should be encouraged to continue trying sildenafil, titrating up to 100 mg as needed.

Topics: Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Postoperative Complications; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men. At present, first-line oral pharmacotherapy for most patients with ED is a phosphodiesterase type 5 (PDE-5) inhibitor, of which three are currently available worldwide. Sildenafil (Viagra, Pfizer) has a very satisfactory efficacy-safety profile in all patient categories. The first PDE-5 inhibitor to reach the market, it is now the most widely prescribed oral agent for ED. Tadalafil (Cialis, Lilly ICOS) and vardenafil (Levitra, Bayer/GlaxoSmithKline) were introduced to the European Union and the US in 2003 and 2004, respectively. These three PDE-5 inhibitors share many characteristics, but each has unique features. This review describes the chemical, pharmacologic and clinical features of sildenafil, vardenafil and tadalafil as oral first-line treatments for ED. First, we describe the physiology of penile erection and PDE-5 inhibitor pharmacology, including chemistry, PDE selectivity, pharmacokinetics, and possible drug interactions. We then summarize data on the efficacy and safety profiles of the three PDE-5 inhibitors for the treatment of ED in the general population, in patients with diabetes mellitus and in men that have undergone bilateral nerve-sparing retropubic radical prostatectomy.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Aging in men is accompanied by a decrease in libido and sexual activity. Recently, it has been demonstrated that a significant proportion of men >60 yr of age has biochemical hypogonadism. Hypoandrogenism, which is associated with other conditions that negatively influence erectile activity, may be an important cofactor in the induction of erectile dysfunction and in the response to phosphodiesterase type 5 (PDE5) inhibitors in aging. In these patients, administration of 50 mg sildenafil or 3 mg apomorphine has no influence on erectile function. Recently we showed that, in hypogonadal subjects, testosterone treatment might stimulate endothelial and neuronal production of vasoactive substances like nitric oxide (NO). Furthermore it can improve endothelial repair mechanisms by increasing bone marrow-derived endothelial progenitor cell (EPC) number in the peripheral circulation. Finally, the normal response to pharmacological stimulation with apomorphine or sildenafil, observed in hypogonadal men treated with testosterone, indicates a positive role of this hormone in the central and peripheral control of erection, confirming the possible positive influence on endothelial function and PDE5 expression. Therefore, we suggest measuring plasma testosterone levels in aged men with erectile dysfunction and recommend treating them barring clinical contraindications. Testosterone plus PDE5 inhibitors may be beneficial in improving erectile function in hypogonadal men with erectile dysfunction who were unresponsive to PDE5 inhibitors alone.

Topics: Adult; Aged; Aged, 80 and over; Clinical Protocols; Drug Therapy, Combination; Endothelium, Vascular; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone

Sildenafil citrate is marketed under the trademark name Viagra and is widely used to treat male erectile dysfunction; therapeutic uses of this medication for other diseases related to vascular dysfunction are emerging. When used as recommended, the drug has a strong clinical efficacy and safety profile in a broad spectrum of the male population. Its widespread use and effects of long-term exposure to the drug due to particular treatment regimens or inappropriate use mandate an ongoing update of its molecular mechanism, pharmacological profile and associated safety issues. This review focuses on biochemical and pharmacological features of sildenafil, the active component in Viagra, interaction of sildenafil with phosphodiesterase 5, pharmacokinetic parameters, action in smooth muscle, side effects, safety profile and prospects for other uses.

Topics: Area Under Curve; Erectile Dysfunction; Humans; Male; Metabolic Clearance Rate; Molecular Structure; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Rapid (premature) ejaculation (RE) is a very common sexual disorder. This condition may be primary or secondary to underlying disease. Control of RE has been primarily focused on behavioural therapy, topical anaesthetics, tricyclic antidepressants and selective serotonin reuptake inhibitors; however, an approved treatment does not exist. Recently, a number of clinical trials have studied the potential effectiveness of the phosphodiesterase (PDE)-5 inhibitor sildenafil in the treatment of RE. Results of most of these studies have been encouraging. Available data indicate that there is clinical, anatomical, physiological, pharmacological and genetic evidence to explain the efficacy of PDE5 inhibitors in RE. The rationale for the use of PDE5 inhibitors in the treatment of RE could be due to possible peripheral and central mechanisms. Possible peripheral ejaculation retarding capabilities may include modulation of the contractile response of the vas deferens (VD), seminal vesicles (SV), prostate and urethra, induction of a state of peripheral analgesia, and prolongation of the total duration of erection. Possible central mechanisms may involve lessening of the central sympathetic output. Furthermore, there is evidence from knockout mice to explain the efficacy of PDE5 inhibitors in RE. Mice lacking the gene for endothelial nitric oxide synthase develop a condition similar to RE. On the other hand, mice lacking the gene for heme oxygenase-2 develop a condition similar to delayed ejaculation. This review also discusses the findings against the use of these agents in RE. In conclusion, a review of the literature suggests the potential usefulness of PDE5 inhibitors as a promising line of therapy in RE but further studies are needed.

Topics: Animals; Clinical Trials as Topic; Ejaculation; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction is a common, age-dependent functional disturbance of men associated to various comorbidities. Interdisciplinary cooperation with neurologists in cases of a suspected neurological aetiology and with psychiatrists in cases with normal organic diagnostic findings is necessary. Hormone replacement and psychotherapy can cure certain patients. Oral pharmacotherapy is the most effective therapy for erectile dysfunction with the highest patient preference. Oral PDE-5-inhibitors (sildenafil, tadalafil, vardenafil) are superior in effectiveness to centrally acting drugs (apomorphin, yohimbine). Local pharmacotherapy (MUSE, ICI) is a second line therapy in cases of failure or contraindications for oral pharmacotherapy. Vacuum therapy and operative procedures (penile implants) complete the therapeutic options of erectile dysfunction.

Topics: Erectile Dysfunction; Humans; Imidazoles; Male; Patient Care Management; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Psychotherapy; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Erectile dysfunction (ED) is an inability to attain or maintain an erection sufficient for satisfactory sexual intercourse. It is an undertreated and underdiagnosed condition that can be due to vasculogenic, neurogenic, hormonal and psychogenic factors. Effective treatment of ED should restore quality of life and allow patients to return to the sex life they had before. Current therapeutic options include non-pharmacological treatments, locally administered drugs and oral therapies. The oral phosphodiesterase-5 (PDE5) inhibitors are considered first-line treatments of ED and have revolutionized ED management in the last five years. Three PDE5 inhibitors are currently available, sildenafil, vardenafil and tadalafil. They are all effective with similar efficacy and good safety profiles. However, tadalafil has the added benefit of a broad window opportunity offering patients more freedom to choose when to initiate sexual activity.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Molecular Structure; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vacuum; Vardenafil Dihydrochloride; Vasodilator Agents

Topics: Adrenergic alpha-Antagonists; Androgens; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phytotherapy; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents; Yohimbine

No head-to-head studies have been conducted with the phosphodiesterase type 5 (PDE5) inhibitors to date. Results of noncomparative studies, however, suggest that tadalafil and vardenafil hydrochloride are at least as effective as sildenafil citrate in improving erections and increasing the number of successful intercourse attempts in men with erectile dysfunction (ED) at all levels of severity. By facilitating a sexual response, PDE5 inhibitors lend naturalness to sexual activity and may permit couples to return to their previous sexual lifestyle. By providing a broader window of opportunity, a longer-acting PDE5 inhibitor such as tadalafil adds to the variety of options currently available in managing ED with PDE5 inhibitors. This option offers increased flexibility by minimizing the need to plan sexual activity; allowing more time for intimacy or romance before sexual intercourse; and reducing the pressure on the patient to perform.

Topics: Adult; Drug Evaluation; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Patient Participation; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Clinical evidence in men with erectile dysfunction (ED) shows that the phosphodiesterase type 5 (PDE5) inhibitors sildenafil citrate, tadalafil, and vardenafil hydrochloride have favorable safety and efficacy profiles. However, as mild vasodilators, the PDE5 inhibitors are also associated with hemodynamic effects that may be clinically significant, especially when treating men with ED who have comorbid cardiovascular disease. Hemodynamic studies have shown that therapeutic dosages of the PDE5 inhibitors produce only mild and transient changes in mean systolic and diastolic blood pressure and heart rate in healthy men as well as those with ischemic heart disease or chronic stable angina. Overall, PDE5 inhibitors are safe and effective in most patient populations, including men with ischemic cardiovascular disease or those receiving anti-hypertensive agents, and men with diabetes or those who have undergone nerve-sparing retropubic radical prostatectomy. With the entry of three novel PDE5 inhibitors into the therapeutic armamentarium for ED, differentiating properties of the new agents may confer clinical benefits that physicians as well as patients and their partners should consider when selecting a PDE5 inhibitor.

Topics: Antihypertensive Agents; Cardiovascular Diseases; Diabetes Complications; Drug Interactions; Erectile Dysfunction; Humans; Imidazoles; Male; Nitrates; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Impairment of erectile function compromises quality of life in millions of men and their partners, many of whom prefer to suffer in silence. It is important to maintain an elevated index of clinical suspicion in patients with erectile dysfunction (ED) risk factors (e.g. hypertension, diabetes, coronary heart disease). There remains a high rate of voluntary discontinuation of therapy associated with most treatment modalities. Since the introduction of sildenafil, a greater awareness and openness regarding the epidemiology and treatment of male erectile dysfunction has emerged. The development of newer and potentially more efficacious phosphodiesterase type 5 (PDE5) inhibitors will serve to treat an even greater number of patients, allowing once daily and more convenient dosing. An increased understanding of the physiological principles of penile erection has allowed the development of novel oral pharmacological therapies. The new agents offer a potential benefit in a broader range of patients and clinical situations. They may provide a more acceptable alternative than other more invasive options (intracavernosal/urethral injection, implant surgery). The dopamine agonist apomorphine acts on the central control of penile erection to allow a sublingual preparation to produce a prompt response. It is not contraindicated in patients on nitrate medication for coronary artery disease, or in patients with depression or on antidepressants. As with any other treatment, the clinician's responsibility in the care of ED patients does not end with the writing of a prescription. Adequate education and follow-up are needed to optimize the efficacy and safety of oral ED therapy. Furthermore, patients and their partners need to be advised that the agents are not effective in the absence of sexual stimulation. Communicating with both the patient and his partner in a discreet, non-judgmental manner that fosters the physician-patient alliance can facilitate the recognition and treatment of ED.

Topics: Administration, Oral; Adrenergic alpha-Antagonists; Adult; Clinical Trials as Topic; Dopamine Agonists; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Piperazines; Purines; Risk Assessment; Sildenafil Citrate; Sulfones; Treatment Outcome

Dramatic advances in the management of erectile dysfunction have occurred over the past decade. Oral therapy with vasoactive agents has emerged as first-line treatment and has transformed both the manner in which the public views erectile dysfunction and the way health care providers deliver care. Whereas an extensive investigation was previously common in the management of erectile dysfunction, recent treatment guidelines promote a more minimalist, goal-oriented approach. In this article, we review the physiology of erection, and the pathophysiology, diagnosis and clinical management of erectile dysfunction. We also present the existing evidence for the efficacy of 3 phosphodiesterase inhibitors, the most widely used class of agents for erectile dysfunction.

Topics: Erectile Dysfunction; Humans; Imidazoles; Male; Penile Erection; Phosphodiesterase Inhibitors; Physical Examination; Piperazines; Purines; Sildenafil Citrate; Sulfones; Triazines; Vardenafil Dihydrochloride

Topics: Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilation; Vasodilator Agents

Since the introduction of the phosphodiesterase type 5 (PDE-5) inhibitor sildenafil in 1998, there has been a fundamental change in the treatment of erectile dysfunction (ED). Sildenafil has already been used by over 20 million men in over 100 countries, with a death rate similar to that of general population. The success rate of sildenafil amounts to an average of over 80%, and sildenafil has become the first choice for patients with ED. The development of two new PDE-5 inhibitors, vardenafil and tadalafil, has added to the options for the treatment of ED. In this review, a comparison is made of the pharmcodynamics, pharmacokinetics and adverse reactions between the three PDE-5 inhibitors to assess their efficacy and safety.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men worldwide. Many drugs are now available for the treatment of ED, with oral pharmacotherapy representing the first-line option for most patients. Sildenafil citrate, an inhibitor of the enzyme phosphodiesterase type 5 (PDE5), is the most widely prescribed oral agent and has a very satisfactory efficacy-safety profile in all patient categories. Tadalafil (Cialis; Eli Lilly & Co., ICOS) and vardenafil (Levitra; Bayer Pharmaceuticals, GlaxoSmithKline) are new PDE5 inhibitors that have recently been approved worldwide. Both have been associated with significant positive efficacy-safety profiles. Apomorphine sublingual is a dopamine D1 and D2 receptor agonist, which has been approved for marketing in Europe. It is best selected for treating patients with mild-to-moderate ED, but it is seldom used in clinical practice due to its limited efficacy and side effects, particularly nausea. Patients who do not respond to oral pharmacotherapy or who are unable to use it are appropriate candidates for intracavernosal and intraurethral therapy. The efficacy of second-line treatment is high, but the attrition rate remains significant. For the purpose of this review, clinical and pharmacological analysis focuses on the recent advances in the field of oral therapy, including PDE5 inhibitors and sublingual apomorphine.

Topics: Administration, Oral; Administration, Sublingual; Adult; Aged; Apomorphine; Carbolines; Comorbidity; Cross-Over Studies; Cytochrome P-450 CYP3A; Cytochrome P-450 Enzyme System; Dopamine Agonists; Double-Blind Method; Drug Interactions; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Multicenter Studies as Topic; Nitric Oxide; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Second Messenger Systems; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Erectile dysfunction (ED) is a common problem in men over 40-50 years of age. Risk factors include: diabetes, lipid abnormalities, smoking, hypertension, obesity, and lack of physical activity. Oral phosphodiesterase-5 inhibitors appear effective and safe in most cardiac patients.

Topics: Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Patient Education as Topic; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones

Sexual medicine has evolved greatly in the past several years, to a large extent because of the introduction of the phosphodiesterase-5 (PDE5) inhibitor, Viagra (sildenafil citrate), as a highly effective oral therapy for erectile dysfunction.. Recent literature pertaining to the development and clinical applications of sildenafil citrate was reviewed.. The emergence of PDE5 inhibitor therapy for erectile dysfunction represents a major scientific and clinical breakthrough, and it has impacted on the field in such prominent areas as scientific discovery, clinical management, and public health awareness of sexual health disorders.. The development of sildenafil citrate has had a major role in advancing the field of sexual medicine.

Topics: Erectile Dysfunction; Humans; Male; Molecular Biology; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

The data in the literature on the relationship between sexual activity, with and without the use of sildenafil, and the occurrence of cardiovascular events (ventricular arrhythmias, nonfatal myocardial infarction, stroke and death) have been reviewed in patients with heart disease. To date, only patients with ischemic heart disease (IHD) have been investigated. The prevalence of premature ventricular beats during sexual intercourse is similar to that observed during other daily activities. Therefore, sexual activity does not seem to have a relevant arrhythmogenic effect. The incidence of sustained ventricular tachycardia during sexual intercourse in unknown. The relative risk of nonfatal myocardial infarction is 2.7 in males and 1.3 in females; however, the absolute risk appears extremely low and is similar in normal subjects and in patients with and without IHD. The risk appears to be restricted to the 2-hour time period after sexual intercourse. The incidence of stroke during sexual intercourse appears very low, but clear data are lacking. The incidence of death during sexual activity is unknown; the few available data suggest that it is very low. Extramarital sexual intercourse seems to increase the risk of death. The incidence of cardiovascular events after sildenafil administration has been investigated in placebo-controlled studies in patients with IHD. The incidence of nonfatal myocardial infarction, stroke and death did not significantly differ between sildenafil-treated and placebo-treated patients; therefore, sildenafil does not appear contraindicated in subjects with IHD. However, the drug should be administered with caution in patients with recent myocardial infarction or stroke, in those with active coronary ischemia and in patients with episodes of heart failure. The drug is absolutely contraindicated in patients using nitrates.

Topics: Cardiovascular Diseases; Erectile Dysfunction; Female; Heart Rate; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sexual Behavior; Sildenafil Citrate; Sulfones; Vasodilator Agents

A spinal reflex and the L-arginine-nitric oxide-guanylyl cyclase-cyclic guanosine monophosphate (cGMP) pathway mediate smooth muscle relaxation that results in penile erection. Nerves and endothelial cells directly release nitric oxide in the penis, where it stimulates guanylyl cyclase to produce cGMP and lowers intracellular calcium levels. This triggers relaxation of arterial and trabecular smooth muscle, leading to arterial dilatation, venous constriction, and erection. Phosphodiesterase 5 (PDE5) is the predominant phosphodiesterase in the corpus cavernosum. The catalytic site of PDE5 normally degrades cGMP, and PDE5 inhibitors such as sildenafil potentiate endogenous increases in cGMP by inhibiting its breakdown at the catalytic site. Phosphorylation of PDE5 increases its enzymatic activity as well as the affinity of its allosteric (noncatalytic/GAF domains) sites for cGMP. Binding of cGMP to the allosteric site further stimulates enzymatic activity. Thus phosphorylation of PDE5 and binding of cGMP to the noncatalytic sites mediate negative feedback regulation of the cGMP pathway.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Animals; Calcium; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Guanylate Cyclase; Humans; Male; Muscle, Smooth; Penile Erection; Penis; Phosphodiesterase Inhibitors; Phosphorylation; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Administration, Oral; Adult; Carbolines; Combined Modality Therapy; Erectile Dysfunction; Finland; Follow-Up Studies; Humans; Injections, Intralesional; Male; Middle Aged; Piperazines; Purines; Risk Assessment; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome

Development in the management of prostate cancer has placed increased attention on patient quality of life after treatment, particularly sexual function. The incidence of erectile dysfunction (ED) in men following radical prostatectomy has been estimated to range from 16% to 82%. Several factors determine the postoperative incidence of erectile difficulties; these include patient age, degree of cavernosal nerve sparing during surgery, cancer stage, and associated comorbidities. Early initiation of available treatments after radical prostatectomy, such as phosphodiesterase-5 (PDE-5) inhibitors and intracavernosal alprostadil, may improve the speed and degree of recovery of erectile function. Oral PDE-5 inhibitors are recognized as the first line of therapy for men with ED after radical prostatectomy, with reasonable success rates reported for all commercially available PDE-5 inhibitors. In recognition of the neurogenic basis for erectile dysfunction after radical prostatectomy, new strategies have been devised, such as cavernous nerve graft interposition procedures, perioperative neuroprotection measures, and postoperative neurotrophic treatments. Hopefully, these efforts will improve quality of life for patients with prostate cancer. The aim of this article is to review the current modalities of ED management for men with prostate cancer.

Topics: Adult; Brachytherapy; Combined Modality Therapy; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Penile Prosthesis; Piperazines; Prostatectomy; Prostatic Neoplasms; Purines; Quality of Life; Radiotherapy, Adjuvant; Risk Assessment; Severity of Illness Index; Sildenafil Citrate; Sulfones; Treatment Outcome

Atherosclerosis is a general health problem that not only affects the coronary arteries but also (in men) the penile arteries, thus contributing to organic causes of erectile dysfunction (ED) in heart disease patients. These organic causes are intertwined with psychological and pharmacological causes because medication prescribed for heart disease patients may also cause ED. The incidence of ED after myocardial infarction ranges from 38 to 78%. As sexual intercourse involves physical exertion, the medical history, ventricular function determined through echocardiography, and stress testing are used to classify patients into various groups where coital activity represents a greater or lesser cardiovascular risk. The energy requirements for intercourse are not high, ranging from 3.7 metabolic equivalents (METs) of energy expenditure at resting state during the preorgasmic phase to 5 METs during orgasm. The Bruce protocol for exercise stress testing is a six-stage protocol with changes in the slope and speed of the treadmill. As a general rule, a patient who completes the first two stages of the Bruce protocol has a functional capacity greater than 7 METs, which is considered sufficient for sexual intercourse. The physician or cardiologist concerned should institute first-line treatment with oral drugs according to the indications listed below. If sexual activity is not contraindicated, the treatment of choice for ED in heart disease patients is oral therapy with sildenafil, except in those cases in which its use is contraindicated. Specific recommendations are discussed.

Topics: Arteriosclerosis; Erectile Dysfunction; Heart Diseases; Humans; Male; Myocardial Infarction; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adrenergic alpha-Antagonists; Arteriosclerosis; Blood Pressure; Carbolines; Contraindications; Coronary Disease; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug Interactions; Endothelium, Vascular; Erectile Dysfunction; Heart Rate; Humans; Hypotension; Imidazoles; Isosorbide Dinitrate; Male; Molecular Structure; Myocardial Infarction; Nitric Oxide Donors; Nitroglycerin; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilation; Vasodilator Agents

Erection is a neurovascular event that involves spinal and supra spinal pathways. The final common pathway involves the release of nitric oxide (NO) from both endothelial cells and neurons, which acts as a vasodilator causing penile engorgement and erection. NO is degraded by the enzyme phosphodiesterase (PDE) type 5 in the penis. Erectile dysfunction (ED), defined as the persistent inability to achieve and/or maintain an erection sufficient for satisfactory sexual performance, results when the neurovascular pathway is interrupted by medical conditions or drugs. A 15-item self-administered questionnaire, the International Index of Erectile Function (IIEF), is one of the most useful tools to evaluate erectile function (EF) in clinical trials, although of much less use in routine clinical practice. The MMAS (Massachusetts Male Aging Study) was the first major epidemiological investigation to study the prevalence of ED. The study found that ED was three times more common in patients with diabetes mellitus. The aetiopathogenesis of ED in diabetes is multifactorial, with vascular and neural factors being equally implicated. Hyperglycaemia is believed to give rise to biochemical perturbations that lead to these microvascular changes. In the MMAS, ED in diabetes was strongly correlated with glycaemic control, duration of disease and diabetic complications. The incidence increased with increasing age, duration of diabetes and deteriorating metabolic control, and was higher in individuals with type 2 diabetes than those with type 1.ED in men with diabetes often affects their quality of life and, as patients are often reluctant to come forward with their symptoms, a carefully taken history is one of the most useful approaches in identifying affected individuals. The PDE inhibitors have revolutionised the management of ED and oral drug therapy is currently first-line therapy for the condition. These agents act by potentiating the action of intracavernosal NO, thereby leading to a more sustained erection. Sildenafil was the first PDE5 inhibitor to undergo evaluation and has been studied extensively. More recently two other agents, vardenafil and tadalafil, have been introduced. All the drugs have been shown to be effective across a wide range of aetiologies of ED, including diabetes. The drugs have been shown to improve EF domain scores, penetration and maintenance of erection, resulting in more successful intercourse. Their effects are greater at higher doses. Silde

Topics: Adult; Aged; Apomorphine; Diabetes Complications; Erectile Dysfunction; Half-Life; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prevalence; Purines; Quality of Life; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones

The purpose of this review is to examine the biologic, pharmacologic, and clinical differences between the three currently approved phosphodiesterase-5 inhibitors to help the clinician make an educated choice about which medication may be best for any individual patient.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Postprostatectomy erectile dysfunction appears to be initiated by neuropraxia and perpetuated by cavernosal smooth muscle apoptosis. Phosphodiesterase-5 (PDE-5) inhibitor therapy is the current cornerstone of erectile dysfunction (ED) therapy in this population. Although no head-to-head trials have been performed with sildenafil, vardenafil, and tadalafil in this population, there are numerous studies in the general ED population. The results of these studies demonstrate that neither of the new PDE-5 inhibitors met statistical noninferiority to sildenafil. Sildenafil has been studied in a novel primary prevention modality using nightly administration after a bilateral nerve-sparing prostatectomy. In this novel approach, it effected a sevenfold improvement in return of spontaneous, normal erectile function 2 months after drug discontinuation. This effect appears to be mediated by properties unique to sildenafil that include improved endothelial function and neuronal regeneration and neuroprotection. In primary prevention, unlike ED therapy, one has only "one shot" by definition. Therefore, it is even more critical to apply evidence-based medicine.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones

Topics: Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Patient Selection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Topics: Aftercare; Alprostadil; Causality; Communication; Diagnosis, Differential; Erectile Dysfunction; Humans; Male; Medical History Taking; Nurse Practitioners; Nurse-Patient Relations; Nursing Assessment; Papaverine; Patient Education as Topic; Patient Selection; Penile Prosthesis; Phosphodiesterase Inhibitors; Physical Examination; Piperazines; Primary Health Care; Purines; Sex Counseling; Sildenafil Citrate; Sulfones; Vasodilator Agents

Sexual function is an important component of cardiac patients' quality of life and subjective well being. Patients, however, are often uninformed regarding the question of resuming sexual activity after a cardiac event. Recent epidemiologic data reveal that sexual problems are widespread and adversely affect mood, well-being, and interpersonal functioning Erectile dysfunction (ED) is the most commonly recognized and treated sexual dysfunction. It affects > 30% of men 40 to 70 years of age and its prevalence in patients with cardiovascular disease is higher than in the general population. International Guidelines has faced the problem of resuming sexual activity after a cardiac event and of the eventual suitability to the use of sildenafil or other selective inhibitor of cGMP-specific phosphodiesterase type 5 (5-PDE) for the therapy of ED in these patients. The clinical judgment should be based on the integration of clinical and instrumental data, on the evaluation of the compatibility with the foreseen energetic cost of the effort connected to sexual activity and, in case of prescription of 5-PDE inhibitors, on the eventual incompatibility with the therapy undertaken (in particular with nitrates). In the review the main reference points of literature are supplied in order to have the chance of giving motivated technical advice. Finally it is extremely important to face the problem of resuming sexual activity systematically within the cardiac rehabilitation program, with educational sessions, individual or couple conversations, and with the aid of information pamphlets.

Topics: Erectile Dysfunction; Female; Heart Diseases; Humans; Male; Piperazines; Purines; Sex; Sildenafil Citrate; Sulfones

Topics: Adult; Alprostadil; Erectile Dysfunction; Humans; Male; Penile Erection; Penile Prosthesis; Piperazines; Purines; Sildenafil Citrate; Sulfones; Yohimbine

Multiple dramatic consequences follow medullary lesions. Not only are voluntary motor control and sensitivity of the body segment below the lesion lost, but it also becomes impossible to control erection and ejaculation as well as urinary and faecal continency. The first investigations into genito-sexual function in paraplegics have brought about the idea, commonly admitted in the medical world, that this kind of patient is impotent and sterile. Fortunately this idea is disappearing gradually and many data have demonstrated that appropriate treatment is required and some therapies efficient. This is particularly important in the case of the population concerned, namely young men in 70% of the cases, since the usual age bracket at trauma is between 25 and 35 years old. At this time of life, sexual activity is often at its peak, so that the fertility potential becomes erased.

Topics: Adult; Electric Stimulation Therapy; Erectile Dysfunction; Humans; Insemination, Artificial; Male; Papaverine; Paraplegia; Piperazines; Prostaglandins; Purines; Reflex, Abnormal; Sildenafil Citrate; Sperm Motility; Spinal Cord Injuries; Sulfones; Vibration

With the success of Phosphodiesterase (PDE) type 5 inhibitors (i.e., sildenafil, tadalafil, vardenafil) in the treatment of erectile dysfunction (ED), PDEs are considered attractive targets for drug intervention in the urogenital tract.. To review the role of PDEs, which exist as a superfamily of enzymes comprising 11 distinct families, in the urogenital system, focusing on anatomical locations, functions and dysfunctions, potential disorders that could be treated, and any promising new selective PDE inhibitors under development.. Included are (i) abstracts from 2001, 2002, and 2003; (ii) a MEDLINE search from 1996 through December 2003; and (iii) a pipeline search for therapeutics in development. Data from animal experiments are presented when there is a paucity of human data, but with the caveat that the distribution of PDE isozymes in a specific tissue can vary between species.. PDE mRNA and protein have been localized throughout the normal human urogenital tract. Double-blind, placebo-controlled studies suggest possible new clinical roles for sildenafil, including prophylaxis to preserve penile smooth muscle and erectile function after radical prostatectomy, and treatment of ejaculatory delay secondary to serotonergic reuptake inhibitor antidepressant therapy. Open-label studies suggest a potential clinical role for: vinpocetine (a PDE1 inhibitor) in the treatment of incontinence and low-compliance bladder; and sildenafil in the treatment of premature ejaculation, prostate-related lower urinary tract symptoms, and in women who have had unsuccessful in vitro fertilization. Several new orally administered PDE5 inhibitors are in early clinical development for the treatment of ED. Potential indications for PDE inhibitors that are suggested by preclinical data include Peyronie's disease, ureteral colic, male and female birth control, and prevention of preterm labor.. Drug selectivity and differential PDE tissue distribution allow for potential targeted intervention for numerous disorders related to the urogenital tract.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Animals; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Ejaculation; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; RNA, Messenger; Sildenafil Citrate; Sulfones; Tadalafil; Time Factors; Triazines; Urogenital System; Vardenafil Dihydrochloride

As prescription drug expenditures increase, third-party payors are increasingly scrutinizing costs and reimbursement guidelines, such as for medications that treat chronic conditions that are not necessarily directly life threatening (i.e., obesity, nicotine addiction, and erectile dysfunction).. To review the costs and consequences of pharmacy benefit reimbursement policies related to erectile dysfunction therapies, using sildenafil citrate as the case study.. Data and references were found through searches of PubMed and Google.. To meet the varied health needs of a defined population under reasonable resource constraints requires analysis of cost and of the economic and non-economic consequences of a treatment. Based on analysis of sildenafil data, oral therapy of erectile dysfunction provides substantial cost savings when compared with other treatment options and contributes insignificant overall costs to health plans. Regardless, health plans impose controls to limit reimbursement. Because erectile dysfunction is often a precursor to other conditions, such limitations could compromise detection and management of underlying disease (e.g., depressive, cardiovascular, and urogenital). Reimbursement restrictions may also decrease membership satisfaction and re-enrollment rates.

Topics: Adult; Erectile Dysfunction; Health Care Costs; Humans; Insurance, Health, Reimbursement; Insurance, Pharmaceutical Services; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; United States

Erectile dysfunction (ED) is a highly prevalent and often undertreated condition. It may be a symptom of underlying, chronic illness and can have a negative impact on quality of life, psychosocial health, and relationships. The aging of the population, as well as the introduction of new treatment options, such as sildenafil, has led to increased public awareness of this disorder. New oral therapeutic agents are on the horizon. This article provides an overview of the physiology of erection, the pathophysiology of ED, and modern patient evaluation. Management options, including traditional therapeutic approaches as well as the new generation of oral agents, are also presented.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Alprostadil; Apomorphine; Brain; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Penile Prosthesis; Penis; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones

Although the high rate of erectile dysfunction (ED) following prostatectomy is well recognised, the aetiology and pathophysiology have not yet been fully elucidated. We examined the current literature as to aetiology, treatment and possible prevention of ED following prostatectomy.. Review of the literature by a Medline search.. The most important predictors of erectile function are pre-operative erectile function and the nerve sparing nature of the procedure. The former is determined by age and vascular risk-factors whereas the latter is decided by the stage of the tumour and the skill of the surgeon. The value of intraoperative nerve mapping seems limited and the importance of nerve grafting is uncertain. Natural recovery of erection can take as long as 24 months. Patients complain about a lack of professional support. Symptomatic therapy may be applied according to the current general standards of treatment in men with ED.

Topics: Alprostadil; Erectile Dysfunction; Humans; Male; Penile Erection; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Postoperative Complications; Prostatectomy; Prostatic Neoplasms; Purines; Quality of Life; Risk Factors; Sildenafil Citrate; Sulfones; Vacuum; Vasodilator Agents

The incidence of DM is rapidly growing among Americans. DM will rival cancer and heart disease in terms of cost and suffering. The National Institute of Health is tripling the research dollars that are spent on diabetic-related research in an attempt to combat this disease. Urologists are on the front line in the diagnosis and treatment of the complications of DM. The complications of DM that we reviewed in this article, diabetic cystopathy and diabetic ED, can occur in the early stage of DM and often progress in a silent fashion. More awareness and interest are needed to improve our understanding of diabetic complications in urology. Exciting new approaches in the treatment of diabetic cystopathy and ED are being investigated.

Topics: Clinical Trials as Topic; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Erectile Dysfunction; Female; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Urinary Bladder, Neurogenic; Vasodilator Agents

Viagra has had a profound influence on the search for natural products with erectile-dysfunction activity. To date the "natural" equivalent is not in existence but several pure compounds from nature, e.g., Yohimbine, Citrulline, two pyrano-isoflavones, berberine, forskolin and others, have either been re-examined or are new potential candidates. Intense activity exists in the area of testing semi-purified plant extracts for erectile dysfunction activity.

Topics: Animals; Biological Products; Clinical Trials as Topic; Cordyceps; Erectile Dysfunction; Humans; Isoflavones; Magnoliopsida; Male; Penile Erection; Phytosterols; Piperazines; Plant Extracts; Purines; Quassins; Sildenafil Citrate; Sulfones

Erectile dysfunction is a common sequela following potentially curative local treatment for early-stage carcinoma of the prostate gland. With larger studies and longer follow-up, it is clear that erectile dysfunction following prostate brachytherapy is more common than previously reported, with a myriad of previously unrecognized sexual symptoms. Approximately 50% of patients develop erectile dysfunction within 5 years of implantation. Several factors including preimplant potency, patient age, the use of supplemental external-beam irradiation, radiation dose to the prostate gland, radiation dose to the bulb of the penis, and diabetes mellitus appear to exacerbate brachytherapy-related erectile dysfunction. The majority of patients with brachytherapy-induced erectile dysfunction respond favorably to sildenafil citrate (Viagra). Despite reports questioning the potency-sparing advantage associated with brachytherapy, recent elucidations of brachytherapy-related erectile dysfunction may result in refinement of treatment techniques, an increased likelihood of potency preservation, and ultimately, improved quality of life.

Topics: Adult; Aged; Antineoplastic Agents, Hormonal; Brachytherapy; Erectile Dysfunction; Humans; Male; Middle Aged; Neoadjuvant Therapy; Piperazines; Prostatic Neoplasms; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men worldwide. Many drugs are now available for treating ED; oral pharmacotherapy represents the first-line option for most patients with ED. Sildenafil, an inhibitor of the enzyme phosphodiesterase type 5, is currently the most widely prescribed oral agent and has a very satisfactory efficacy-safety profile in all patient categories. Apomorphine SL is a dopamine D1- and D2-receptor agonist which has recently been approved for marketing in Europe. It is best selected for treating patients with mild to moderate ED. Vardenafil and tadalafil are new phosphodiesterase type 5 inhibitors which are expected to be approved this year. Both of them have significant positive efficacy-safety profiles. Patients who do not respond to oral pharmacotherapy or who cannot use it are good candidates for intracavernosal and intraurethral therapy. Alprostadil is the most widely used drug, both for injection therapy and for the intraurethral route. The efficacy of second-line treatment is high but the attrition rate remains significant.

Topics: Administration, Oral; Adrenergic alpha-Antagonists; Alprostadil; Apomorphine; Carbolines; Drug Combinations; Erectile Dysfunction; Humans; Imidazoles; Injections; Male; Papaverine; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

The phosphodiesterase enzymes, of at least 11 types, are ubiquitous throughout the body, and perform a variety of functions. Phosphodiesterase type 5 (PDE5) is the predominant enzyme in the corpus cavernosum, and plays a crucial role in penile erection. Inhibitors of PDE5 are the most effective oral agents in the treatment of erectile dysfunction. Sildenafil, tadalafil, and vardenafil are all potent inhibitors of PDE5 and show the same mechanism of action, although they have some pharmacological differences that may translate into varying clinical effects.

Topics: Administration, Oral; Aged; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prognosis; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Erectile dysfunction (ED) and cardiovascular disease share many of the same risk factors and have some common elements of pathophysiology. Clinically, they often coexist. Another link between the two conditions is that sildenafil, the first oral therapeutic agent effective in treating ED, has been shown to potentiate the hypotensive effects of nitrates, a potentially serious side effect. Nitrates are commonly used in the treatment of coronary artery disease. As such, sildenafil (and, likely, other new phosphodiesterase type 5 [PDE5] inhibitors) is contraindicated in men who use nitrate medications. This article will examine the risk of an acute coronary event during sexual activity, and review an algorithm for evaluating the cardiac risk of a patient with ED. The interaction between PDE5 inhibitors and cardiac medications will be discussed, along with guidelines for using sildenafil in men with cardiac disease.

Topics: Administration, Oral; Aged; Cardiovascular Diseases; Comorbidity; Dose-Response Relationship, Drug; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sildenafil Citrate; Sulfones; Survival Rate

Topics: Aged; Autonomic Nervous System; Erectile Dysfunction; Humans; Intraoperative Complications; Male; Middle Aged; Nerve Growth Factors; Nerve Regeneration; Penile Erection; Penis; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Prostatic Neoplasms; Purines; Quality of Life; Sildenafil Citrate; Sulfones

The availability of efficacious oral drugs has radically changed the diagnostic and therapeutic approach to erectile dysfunction. Complicated examinations as well as invasive treatment options have been widely abandoned. Instead the management of impotent men has become much more pragmatic and focused on the symptom. Consequently only a minority of impotent men needs to be referred to an urologist, which makes the therapy of erectile dysfunction increasingly attractive for general practitioners. However, successful treatment first of all still needs time and a genuine interest in the field of erectile dysfunction. In this article a reasonable diagnostic evaluation of impotent patients in general practice is described. Furthermore indication and use of little or non-invasive therapies are discussed.

Topics: Administration, Oral; Adrenergic alpha-Antagonists; Adult; Age Factors; Aged; Algorithms; Alprostadil; Apomorphine; Cohort Studies; Contraindications; Dopamine Agonists; Erectile Dysfunction; Family Practice; Female; Humans; Male; Meta-Analysis as Topic; Middle Aged; Piperazines; Purines; Risk Factors; Sexual Partners; Sildenafil Citrate; Sulfones; Vasodilator Agents; Yohimbine

Topics: Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Patient Compliance; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

We increasingly recognize that erectile dysfunction (ED) usually arises from a mix of organic and psychogenic causes, yet management of this condition too often neglects the complexity of most cases of ED. While therapy with sildenafil and similar investigational drugs can play an important role in many cases of ED, physicians should recognize and try to address the psychological and interpersonal context in which ED exists in their patients.

Topics: Age Distribution; Aged; Erectile Dysfunction; Follow-Up Studies; Humans; Impotence, Vasculogenic; Male; Middle Aged; Piperazines; Prevalence; Purines; Quality of Life; Risk Factors; Sensitivity and Specificity; Sildenafil Citrate; Sulfones; Treatment Outcome

Efficacy is a deciding factor in the selection of a therapy, also by erectile dysfunction. With PDE-5 inhibitors, efficacy can only be determined using subjective information from the patient. Various methods have been developed to quantify this information. If one attempts to compare Sildenafil, Tadalafil and Vardenafil using currently available data, it is necessary to bear in mind that groups of patients with differing severity of erectile dysfunction and various placebo response rates were examined. In addition, patients for whom Sildenafil did not work were excluded from important studies with Tadalafil and Vardenafil. Taking into consideration these factors, the new drugs show no advantages over Sildenafil. Moreover, detailed data for the counselling of certain patient groups is at present only available for Sildenafil, and there is, in addition, a high degree of patient satisfaction with this drug. The "gold standard" for the therapy of erectile dysfunction is Sildenafil and the effectiveness of all new drugs must be compared to it.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Clinical Trials as Topic; Cyclic Nucleotide Phosphodiesterases, Type 5; Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Imidazoles; Male; Multicenter Studies as Topic; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Initial reports of myocardial infarction and sudden death in men with erectile dysfunction who had taken sildenafil (sometimes in conjunction with nitrates) raised concerns that sildenafil may increase the risk of cardiovascular events in men with erectile dysfunction and vascular disease. A significant body of evidence now indicates that sildenafil generally has a good safety profile in men with erectile dysfunction and cardiovascular disease. Sildenafil therapy does not appear to be associated with ischaemic events either at the time of introduction of therapy or during longer-term use. Rates of discontinuation from sildenafil therapy due to adverse events are similar to placebo in men with cardiovascular disease. Sildenafil does not interact in a potentially hazardous way with antihypertensive or antianginal therapy, with the exception of nitrates. Nitrates should not be administered within 24 hours of sildenafil therapy, and care should be taken to determine whether sildenafil may have been used before nitrates are administered to patients. Sildenafil appears to be generally well tolerated in most patients with chronic, stable cardiovascular disease.

Topics: Antihypertensive Agents; Cardiovascular Diseases; Clinical Trials as Topic; Drug Interactions; Erectile Dysfunction; Hemodynamics; Humans; Male; Nitric Oxide Donors; Piperazines; Purines; Safety; Sildenafil Citrate; Sulfones; Vasodilator Agents

The Food & Drug Administration has recently approved, or is in the process of approving newer drugs such as the phosphodiesterase inhibitors and apomorphine to treat men's health issues including erectile dysfunction. Increasing age results in a gradual hypogonadal state in men, for which different novel delivery systems of androgens are currently offered for the symptomatic patient. As such, many men are presenting to healthcare practitioners for the first time. The age of presentation for erectile dysfunction and andropause often overlaps, typically in the fifties and beyond, therefore, it makes sense to screen for erectile dysfunction in andropause patients and vice versa. Erectile dysfunction is usually a harbinger for other illnesses, such as coronary heart disease and depression. The hypogonadal state, likewise, could be a harbinger for other ill health states in men, including obesity, depression, osteoporosis and possibly memory loss. While the newer treatments for erectile dysfunction and andropause are distinctly different and targeted at symptom relief, the presentation of the patient with erectile dysfunction or andropause offers an excellent opportunity for screening for other health states and health education strategies.

Topics: Androgens; Apomorphine; Dopamine Agonists; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone

Topics: Contraindications; Erectile Dysfunction; Humans; Male; Myocardial Ischemia; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Africa; Erectile Dysfunction; Humans; Male; Middle East; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance. ED may also be an early sign of cardiovascular disease. The main risk factors for coronary heart disease (high LDL, smoking, hypertension, diabetes) and ED are the same. ED after the diagnosis of coronary artery disease or myocardial infarction is also common.. Cardiac and metabolic expenditures during sexual intercourse will vary depending on the type of sexual activity. When oxygen uptake was measured in men, an average metabolic expenditure during stimulation and orgasm of 2.5 metabolic equivalents (METs) was found for woman-on-top coitus, and of 3.3 METs for man-on-top coitus (range 2.0-5.4 METs). However, coital death is rare, encompassing only 0.6% of all sudden death cases. A retrospective case-crossover study has shown that although sexual activity can trigger the onset of myocardial infarction, the relative risk in the 2 h after sexual activity was low (2.5; 95% confidence interval [CI] 1.7-3.7). Sexual activity was a likely contributor to the onset of myocardial infarction only 0.9% of the time. Regular exercise appears to prevent triggering. It has to be cautioned that these reassuring data should not be extrapolated to patients taking sildenafil, if they perform at higher cardiac and metabolic expenditures during coitus. The hemodynamic changes associated with sexual activity may be far greater with an unfamiliar partner, in unfamiliar settings, and after excessive eating and drinking. The Princeton Consensus Table for estimation of cardiovascular risk during sexual intercourse gives a first orientation regarding the question which patients can perform sex safely and which subgroup needs further diagnosis and treatment. PHOSPHODIESTERASE-5 INHIBITORS FOR ED TREATMENT: The introduction of sildenafil has been a valuable contribution to the treatment of ED. Sildenafil acts as a selective inhibitor of cyclic guanosine monophosphate-(cGMP-)specific phosphodiesterase type 5 (PDE 5), resulting in smooth muscle relaxation, vasodilation, and enhanced penile erection. Reported cardiovascular side effects in healthy males are headache, flushing, and < 10% decreases in systolic and diastolic blood pressures. Significant hypotension can be found in patients who are concurrently taking nitrates. On the basis of the pharmacokinetic profile of sildenafil, the co-administration of a nitrate within the first 24 h is likely to produce a severe, potentially lifethreatening hypotensive response and is therefore contraindicated. The risk of precipitating a cardiotoxic, hypotensive, or hemorrhagic event secondary to combining sildenafil (a PDE 5 inhibitor) with specific PDE 3 inhibitors such as milrinone and enoximone or with nonspecific PDE inhibitors such as theophylline and pentoxifylline is unlikely. Sildenafil is pred. Sildenafil is safe in healthy subjects. In a postmarketing study on 6,527 males, no increase of cardiovascular events was found. However, in older males with coronary heart disease, the risk of sildenafil and the risk of physical exercise during sexual intercourse contribute both to fatal outcomes. Of 69 cases reported to the FDA, 46 patients might have had a cardiovascular event, and in twelve a possible interaction with nitrate use has been reported. Sildenafil is absolutely contraindicated in patients taking long-acting nitrates, those with severe aortic stenosis, and patients with hypertrophic obstructive cardiomyopathy (HOCM). No nitrates should be used within 24 h of sildenafil use. Caution is necessary in patients with a combination of antihypertensive medications, and in patients with cardiac insufficiency. A "pre-Viagra" treadmill test to assess for the presence of stress-induced ischemia can be helpful for both the patient and the physician. If the patient can achieve > or = 5 METs without demonstrating ischemia, the risk of ischemia during coitus is low.. If severe hypotension occurs, aggressive fluid resuscitation is the first step, followed by administration of vasoactive drugs and, if necessary, by intraaortic balloon counterpulsation. If unstable angina or myocardial infarctions occurs after the use of sildenafil, the patient is treated according to the guidelines, but without nitrates.. Sexual activity is a cornerstone of quality of life. However, giving the incidence of "occult" cardiovascular disease in patients with ED and the indications and contraindications of PDE 5 inhibitors in patients with cardiovascular diseases, all patients with ED must be evaluated by a cardiovascular specialist.

Topics: Coronary Disease; Drug Interactions; Erectile Dysfunction; Hemodynamics; Humans; Hypotension; Male; Myocardial Infarction; Piperazines; Purines; Risk Factors; Sexual Behavior; Sildenafil Citrate; Sulfones; Vasodilator Agents

Selective inhibitors of phosphodiesterase type 5 prevent the breakdown of cyclic guanosine monophosphate resulting in enhanced penile erection and are used for the treatment of erectile dysfunction. Those agents, by way of vasodilator effects could interact with the systemic vasculature and could potentially affect the cardiac patient. During sexual intercourse, heart rate and blood pressure increase as with other forms of exertion. Stress to the heart during sexual intercourse is similar than that observed during other common daily activities. This article reviews the literature and provides recommendations regarding the evaluation of patients with known or suspected cardiac disease in whom therapy for erectile dysfunction is being considered. Patients who seek therapy for erectile dysfunction should undergo to individualized medical evaluation before a prescription is issued. Patients requiring therapy with long-acting nitrates should not receive prescriptions for phosphodiesterase inhibitors. Patients who are likely to develop angina with sexual exertion should not take phosphodiesterase inhibitors, as they may be tempted to take sublingual nitroglycerin. Stress testing is indicated if exercise capacity is uncertain or if significant myocardial ischemia is suspected.

Topics: Clinical Trials as Topic; Contraindications; Coronary Disease; Drug Interactions; Erectile Dysfunction; Exercise Test; Hemodynamics; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Assessment; Sildenafil Citrate; Sulfones; Vasodilator Agents

Association studies give hint for the fact that the risk to develop cardiovascular disorders such as hypertension or coronary heart disease is influenced by the genotype in single nucleotide polymorphisms (SNPs). Considering the close relationship in the pathophysiology of these diseases and erectile dysfunction (ED), the analysis of the association of genotypes in SNPs and ED stands to reason. In an analysis of ED patients and their genotypes in the GNB3 C825T, the ACE I/D and the NOS3 G894T polymorphisms, there was no evidence for influence of the genotypes on the susceptibility to develop ED. At the same time, a significant variation in drug response to sildenafil dependent on the genotypes in the GNB3 C825T and ACE I/D polymorphisms was demonstrated. In the group of GNB3 825C allele carriers, only 50% of patients showed a positive response, while > 90% of the patients genotype TT responded adequately. In parallel, only 50% of ACE D allele carriers showed a positive response to sildenafil in contrast to men genotype II in the ACE I/D polymorphism, who had a response rate of 75%. Considering cardiovascular side effects under sildenafil treatment, it would be interesting to determine if genetic factors have an impact on the side effect profile of this drug.

Topics: Angiotensin I; Animals; Erectile Dysfunction; Genotype; Humans; Male; Nitric Oxide Synthase; Nitric Oxide Synthase Type III; Phosphodiesterase Inhibitors; Piperazines; Polymorphism, Single Nucleotide; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

To evaluate the long-term effect and safety of sildenafil citrate for the treatment of erectile dysfunction after radical prostatectomy (RP).. The study consisted of 91 patients with erectile dysfunction from our institution who received oral sildenafil citrate after RP. We surveyed these patients using a self-administered questionnaire during the first year of sildenafil citrate use to determine treatment satisfaction, patient compliance, and safety. Those who had responded positively to the drug were surveyed again 3 years later (n = 48). Sildenafil citrate was prescribed at a dose of 50 mg and increased to 100 mg if needed. Data were collected from a self-administered questionnaire using the abridged five-item version of the International Index of Erectile Function questionnaire, referred to as the Sexual Health Inventory of Men, and the Erectile Dysfunction Inventory of Treatment Satisfaction. The patients were stratified according to the type of nerve-sparing (NS) RP procedure they underwent: bilateral NS, unilateral NS, and non-NS.. At 3 years, 31 (71%) of the 43 patients who had returned the second surveys were still responding to sildenafil. Of these 31 respondents, 10 (31%) had augmented their dose from 50 to 100 mg. The dropout rate was 27%; 6 of 12 had discontinued because of the return of natural erections, 5 because of a loss of efficacy, and 1 because his spouse had died. No differences were found in the 1-year and 3-year five-item International Index of Erectile Function (Sexual Health Inventory of Men) and Erectile Dysfunction Inventory of Treatment Satisfaction scores between the NS groups. The most common side effects at 3 years were headache (12%), flushing (10%), and blue or blurred vision (2%). No patient discontinued the drug at 3 years because of side effects.. The results of this study indicate that the vast majority of patients with erectile dysfunction after RP who initially respond to sildenafil continue to do so at 3 years and are satisfied and compliant with the treatment regimen.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adenocarcinoma; Adult; Aged; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug Evaluation; Erectile Dysfunction; Follow-Up Studies; Health Surveys; Humans; Male; Middle Aged; Patient Dropouts; Patient Satisfaction; Penis; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Prostatectomy; Prostatic Neoplasms; Purines; Safety; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Sildenafil citrate (Viagra) is a potent orally active cGMP-specific phosphodiesterase type 5 (PDE5) inhibitor that is effective as a peripheral conditioner in the treatment of male erectile dysfunction (ED) of organic, psychogenic or mixed aetiology. Sildenafil is the first effective oral agent in the management of ED that has had a revolutionary impact on management of ED. The present review has been subdivided into five major sections. Based on the most recent peer-reviewed publications, the first section is aimed at critically evaluating PDE5 selectivity as well as the pharmacokinetics and pharmacodynamics of the drug, mainly to assess the best doses for each group of patients (i.e. adult and elderly men). Effectiveness in a broad spectrum ED population is the subject of the second section of the review, principally reporting post-marketing company-independent results. Safety and tolerability are the key concerns of the third section, with a broad consideration of the most commonly reported adverse events. Special attention has been paid to the cardiovascular safety of the drug, chiefly outlining the positive and potentially protective cardiac effects of sildenafil. Moreover, the impact of sildenafil in special patient populations is considered, namely in men complaining of diabetes mellitus, depression, neurological disorders, renal failure and those who have undergone a radical prostatectomy. Sildenafil and the ageing male has been especially underlined. Finally, the review covers a few new potential applications of sildenafil in ED patients with regard to high-dose treatment and combination therapy. The review ends with several considerations regarding the direct and/or indirect impact of sildenafil over quality of life and quality of partnership.

Topics: Adult; Aged; Contraindications; Diabetes Complications; Drug Administration Schedule; Drug Therapy, Combination; Erectile Dysfunction; Hemodynamics; Humans; Impotence, Vasculogenic; Male; Nervous System Diseases; Phosphodiesterase Inhibitors; Piperazines; Product Surveillance, Postmarketing; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

The development of diagnostical and therapeutical methods of erectile dysfunction opened new possibilities for patients. In our time, andrologists are capable of treating most patients. The ones who cannot be helped are unable to lead sexual life due to physical reasons. The application of hormone examinations, color Doppler and Rigiscan exams help at establishing diagnoses. In the therapy, modern peroral pharmacotherapy is dominant, mainly phosphodiesterase inhibitors and central peroral pharmacon are applied. The means of getting the vasoactive drugs into the body have been extended (subcutan, transdermal, and drugs absorbable through mucosa). Psychotherapy is indispensable at some patients. The surgical solution (mainly prosthesis implantation) can be regarded critically, yet their presence among therapies is necessary. According to authors' opinion, the qualitative development of vasoactive drugs (efficacy extension and side-effect reduction) that can be simply and conveniently applied in the future.

Topics: Administration, Oral; Adrenergic alpha-Antagonists; Alprostadil; Apomorphine; Dopamine Agonists; Erectile Dysfunction; Humans; Imidazoles; Impotence, Vasculogenic; Injections; Male; Nitric Oxide; Papaverine; Phosphodiesterase Inhibitors; Piperazines; Psychotherapy; Purines; Sildenafil Citrate; Sulfones; Triazines; Vacuum; Vardenafil Dihydrochloride; Vasodilator Agents

In some patients with erectile dysfunction (ED) oral, topical or intracavernous drug therapy fails. However, several classes of drugs demonstrate efficacy for ED, creating the potential for pharmacological combinations preferable to implantation of a penile prosthesis.. Preliminary reports suggest that combining oral, topical or intracavernous drugs may salvage patients in whom monotherapy fails.. Agents that lead to activation or increases in cyclic nucleotides (cyclic adenosine monophosphate and guanosine monophosphate) with or without nitric oxide donors or nitrates, or alpha-adrenergic antagonists have been used to treat ED. The phosphodiesterase-5 inhibitor sildenafil has been combined with alprostadil (prostaglandin E1) and administered by either the intraurethral or intracavernous route. Successful intercourse following this combination varies from 47% to 100% when monotherapy with each has failed. The introduction of apomorphine has led to its unapproved use in combination with sildenafil in Europe. Combination strategies may allow lower drug doses and reduced adverse effects.. The encouraging preliminary observations combined with the potential for adverse events provide a scientific rationale for prospective, randomized clinical trials with adequate numbers of subjects.

Topics: Alprostadil; Apomorphine; Dopamine Agonists; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Risk factors for erectile dysfunction (ED) (hypertension, diabetes, smoking, lipid abnormality) are also risk factors for coronary artery disease. However, most cardiologists do not routinely ask about ED and patients often are reluctant or embarrassed to discuss it. We determined how common ED was in a group of patients with chronic stable coronary artery disease.. We administered the validated Sexual Health Inventory for Men (SHIM) 5-item questionnaire, based on the International Index of Erectile Function questionnaire, to 76 men with chronic stable coronary artery disease during routine outpatient cardiology visits. Most of these men had not previously discussed ED with their cardiologist.. The mean patient age was 64 years (range 40 to 82). The questionnaire took about 5 minutes to complete. Of the patients 47% were on beta blockers, 92% statins, 28% diuretics. SHIM score was 21 or less in 53 men (70%), which is indicative of ED. Of the patients 75% had some difficulty achieving erections (question 2) and 67% had some difficulty maintaining an erection after penetration (question 3). The questionnaire reflected successful sildenafil treatment in 4 patients (SHIM scores 23 to 25). If these 4 men are included as having had ED then 57 of 76 (75%) had ED or recent history of ED.. ED is extremely common in men with chronic coronary artery disease (affecting approximately 75%) yet most cardiologists do not ask about it. The SHIM is a useful, quick and inexpensive tool for discussion and diagnosis of ED in this population. Although it is well established that cardiovascular risk factors are associated with erectile dysfunction, once it is present there is mixed information on whether treating the risk factors will treat the ED. Problems appear to be that lifestyle modification in midlife may simply be too late to effect a change, and some antihypertensive and lipid lowering drugs may actually exacerbate ED. Oral therapy for ED, namely the PDE5 inhibitors, is effective and safe in most cardiac and hypertensive patients. Organic nitrates such as nitroglycerin remain a contraindication to the concomitant use of these drugs. Guidelines for treatment of ED in the cardiac patient issued by the American College of Cardiology/American Heart Association and Princeton Guidelines may be useful in the approach to the cardiac patient with ED.

Topics: Comorbidity; Coronary Disease; Diabetic Angiopathies; Erectile Dysfunction; Heart Diseases; Humans; Hypertension; Imidazoles; Life Style; Male; Penile Erection; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Smoking; Sulfones; Triazines; Vardenafil Dihydrochloride

Phosphodiesterase 5 inhibitors are preferred by most men for the oral treatment of erectile dysfunction. In many guidelines, this therapy is recommended as first-line therapy because of convenience, high efficacy, and low rates of side-effects. Sildenafil was the first drug for the treatment of erectile dysfunction, introduced in 1998. There are now two new phosphodiesterase 5 inhibitors, vardenafil and tadalafil, for which approval was recently given in the European Union and is expected this year in the United States.. Sildenafil has proved to be a very effective medicinal product. According to initial studies, vardenafil and tadalafil have demonstrated efficacy comparable to that of sildenafil. However, fewer data are available evaluating the adverse effects of vardenafil and tadalafil, particularly on their long-term use and their use in high-risk groups. Interestingly, vardenafil and tadalafil have a higher potency than sildenafil. Moreover, the long life of tadalafil has been associated with an erectogenic potential of the drug lasting for more than 24 h. The advantage of this is the possibility of a patient engaging in sexual activity more than once after a single administration of the drug.. In the future, in addition to sildenafil, the new phosphodiesterase 5 inhibitors vardenafil and tadalafil will play an important role in the management of erectile dysfunction, depending on the patient's health profile.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

This article examines the relationships among depression, ischemic heart disease, and erectile dysfunction. Depression is an independent risk factor for the development of ischemic heart disease, and depression in the post-myocardial infarction patient is associated with increased morbidity and mortality. Ischemic heart disease and erectile dysfunction are also frequently comorbid and share many common risk factors including age, hypertension, diabetes, dyslipidemia, obesity, sedentary lifestyle, and smoking. Depression and erectile dysfunction often occur together; however, the causal relation may be difficult to determine because erectile dysfunction may be a symptom of depression, social distress accompanying erectile dysfunction may precipitate depressive symptoms, or both conditions may result from a common factor such as vascular disease.

Topics: Adult; Aged; Blood Circulation; Catecholamines; Comorbidity; Depressive Disorder; Erectile Dysfunction; Humans; Hydrocortisone; Male; Middle Aged; Models, Biological; Myocardial Ischemia; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Treatment Outcome

Topics: Erectile Dysfunction; Humans; Male; Penile Prosthesis; Penis; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones

Topics: Aftercare; Causality; Counseling; Diagnosis, Differential; Erectile Dysfunction; Humans; Male; Medical History Taking; Nursing Assessment; Patient Education as Topic; Penile Prosthesis; Phosphodiesterase Inhibitors; Physical Examination; Piperazines; Practice Guidelines as Topic; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Vasodilator Agents

THE CONTEXT: Patients with coronary heart disease are generally males aged more than 55 and in whom the question of sexual activity must be evoked, not only with regard to the risks involved with the sexual act itself but also regarding the management of an eventual erectile dysfunction. POSITIVE DATA: A negative and maximal for the age stress test is of predictive value and can eliminate the hypothesis of recurrent coronary ischaemia during sexual intercourse. Drug-induced effects on the libido and erectile function are known but only led to suspension of treatment in one out 438 patients treated for one year.. In the case of documented erectile dysfunction, the combination of sildenafil nitrate derivatives or NO suppliers is formally contra-indicated because of the risk of hypotension. Post-marketing registers and specific studies in patients with coronary heart disease demonstrate the good haemodynamic and coronary tolerance to sildenafil in this category of patient, so long as the contra-indications are respected. The Princeton Consensus Panel has proposed a therapeutic strategy adapted to each patient and according to their level of risk and its treatment.

Topics: Coronary Disease; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Assessment; Risk Factors; Sildenafil Citrate; Sulfones

Since the early 1980s, research on the mechanisms of penile erection has done much to clarify erectile physiology and pathophysiology. More recent studies have identified the importance of neurochemical mediators in erection. These include the nitric oxide-cyclic guanosine monophosphate (cGMP) cell-signaling system-a complex molecular pathway that mediates smooth muscle relaxation in the corpus cavernosum. Phosphodiesterase 5 (PDE5) inactivates cGMP, which terminates nitric oxide-cGMP-mediated smooth muscle relaxation. Inhibition of PDE5 is expected to enhance penile erection by preventing cGMP degradation. Development of pharmacologic agents with this effect has closely paralleled the emerging science. The prototype of this new therapeutic class of PDE5 inhibitors is sildenafil, which was approved for treatment of erectile dysfunction in 1998. Tadalafil and vardenafil are new agents in this class. These agents have demonstrated improvement in erectile function and have been shown to be well tolerated in diverse populations comprising thousands of men worldwide. Profiles of these 3 PDE5 inhibitors are reviewed herein.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Cardiologists are seeing increasing numbers of patients with erectile dysfunction (ED), which frequently coexists with cardiovascular disease. The pharmacologic profile of the new class of phosphodiesterase (PDE) inhibitors-specifically PDE5 inhibitors-and their potential effects on hemodynamic variables have therefore become significant factors in therapeutic decision making. Most of the published data linking PDE5 inhibitor effects and cardiovascular disease relate to sildenafil, although >or=2 new agents are in various stages of development and clinical trials. Sildenafil and other PDE5 inhibitors act on vascular smooth muscle, predominantly in the corpus cavernosum. PDE5 is not found in cardiomyocytes, and no effect of PDE5 inhibition on cardiac contractility has been demonstrated. On the basis of a safety database comprising thousands of men with ED, sildenafil has demonstrated minimal adverse effects in men with stable ischemia, hypertension, and/or severe coronary artery disease. Sildenafil has modest effects on hemodynamic variables and has been shown to increase coronary artery flow reserve. Alone or combined with >or=1 antihypertensive medication, sildenafil did not increase the incidence of adverse events or hypotensive episodes. Sildenafil-associated decreases in systolic and diastolic blood pressure, the result of its vasodilator activity, have been modest. Sildenafil has decreased both elevated pulmonary vascular resistance and elevated pulmonary artery pressures in patients with pulmonary vascular disease. Beneficial changes in hemodynamics have been observed with the use of sildenafil in patients with congestive heart failure with underlying ischemic and other dilated cardiomyopathies. No association between sildenafil and increased cardiovascular morbidity or mortality has emerged in analyses of clinical trial data.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Blood Pressure; Cardiovascular Diseases; Drug Interactions; Erectile Dysfunction; Hemodynamics; Humans; Male; Muscle, Smooth, Vascular; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) often is caused by endothelial dysfunction and may be a sign that a patient has vascular disease elsewhere in the body. Risk factors for coronary artery disease such as lipid abnormalities, smoking, diabetes, and hypertension also are risk factors for ED. Oral therapy for ED, such as sildenafil, inhibits phosphodiesterase-5 (PDE-5) and the breakdown of cyclic guanosine monophosphate. PDE-5 inhibitors have been shown to be safe and effective for the therapy for ED, but remain contraindicated in patients receiving organic nitrates. These agents are mild vasodilators and are being investigated for their treatment potential for patients with pulmonary hypertension, heart failure, and endothelial dysfunction.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Antihypertensive Agents; Coronary Artery Disease; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug Interactions; Endothelium, Vascular; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones

The prominence of phosphodiesterase-5 (PDE-5) inhibitors in the treatment of male erectile dysfunction and other diseases related to vascular dysfunction mandates a comprehensive understanding of the properties and effects of these compounds. Three potent and selective PDE-5 inhibitors (sildenafil, tadalafil, and vardenafil) have been approved for clinical use. The clinical efficacy and safety profiles of these medications are related to their molecular mode of action, the selectivity for PDE-5, and the pharmacokinetic properties (absorption, bioavailability, time to onset of action, distribution, metabolism, and elimination). These PDE-5 inhibitors share some common properties with regard to mechanisms of action and selectivities for PDE-5. They also have distinctive characteristics that may impact their clinical use. This article focuses on the basic biochemistry of cyclic guanosine monophosphate signaling and the pharmacokinetic parameters that describe characteristics of drug action of these PDE-5 inhibitors in facilitating smooth muscle relaxation, leading to improved penile erectile response or causing side effects.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Dose-Response Relationship, Drug; Drug Evaluation; Erectile Dysfunction; Humans; Male; Metabolic Clearance Rate; Muscle, Smooth; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Signal Transduction; Sildenafil Citrate; Sulfones

Sildenafil citrate, the first internationally approved and widely used oral agent for the treatment of erectile dysfunction (ED), has revolutionized the treatment of ED throughout the past 5 years. This phosphodiesterase type-5 (PDE-5) inhibitor is selective for corpus cavernosum smooth muscle tissue and produces excellent erectile function. Its efficacy and safety over a wide variety of etiologies of ED and severities of ED demonstrates its usefulness in the clinical treatment of these patients. More than 20 million men have been treated worldwide with sildenafil with excellent results. ED caused by difficult-to-treat etiologies such as radical prostatectomy, severe diabetes, and spinal cord injury have demonstrated efficacy. Although sildenafil citrate, like all PDE-5 inhibitors, is contraindicated in patients taking nitrate medications for cardiac disease, it is effective and safe for those cardiovascular patients who are not taking nitrate medications. The incidence of adverse cardiovascular events in patients taking sildenafil does not differ from those of the general population. Investigations into the pharmacologic effect of sildenafil on coronary myocardial tissue further supports the safety of this medication. Sildenafil has been safe and effective in patients taking various medications including multiple antihypertensive drugs, selective serotonin reuptake inhibitors, cardiac, and diabetic medications.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Antihypertensive Agents; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug Evaluation; Drug Interactions; Erectile Dysfunction; Heart Diseases; Humans; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Treatment Outcome

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Apomorphine; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

An essential factor for successful sex counseling by the family doctor is an atmosphere of openness and trust between physician and patient. However, few patients will begin to talk about their sexual problems of their own accord. The physician should therefore allow himself sufficient time for such counseling, be aware of his own limitations, and develop an ear attuned to involuntary remarks by the patient. During talks, only sparse use should be made of technical terms, the better to encourage the patient. The problems most commonly described in the doctor's office are functional disorders with a psychosomatic cause, and triggering factors may vary considerably (a high level of stress at the workplace, social or financial crises, monotonous leisure activities). In view of this, a somatic investigation should always be preceded by careful history-taking.

Topics: Adult; Carbolines; Erectile Dysfunction; Family Practice; Female; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Physician-Patient Relations; Piperazines; Purines; Risk Factors; Sex Counseling; Sex Factors; Sexual Dysfunction, Physiological; Sexuality; Sildenafil Citrate; Sulfones; Tadalafil; Vasodilator Agents

The past several years have witnessed a veritable revolution in our understanding and management of erectile dysfunction. Although surgical implants in the form of penile prostheses continue to be an important part of treatment of end-stage cases, the largest change has been brought about by the introduction of oral medications, such as sildenafil (Viagra). This review addresses the etiology, epidemiology, diagnosis, and treatment of erectile dysfunction in light of the remarkable advances in the field.

Topics: Adult; Age Distribution; Aged; Erectile Dysfunction; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Severity of Illness Index; Sildenafil Citrate; Sulfones; Treatment Outcome; United States; Vasodilator Agents

Since the etiology of erectile dysfunction is frequently related to endothelial dysfunction, a problem in common with much vascular disease, erectile dysfunction disproportionately affects patients with cardiovascular disease. With the development of phosphodiesterase 5 inhibitors, the first of which was sildenafil (Viagra), an effective oral medication became available. The question of safety of these drugs, especially in patients with latent or overt coronary artery disease, is of concern. Sildenafil relaxes smooth muscle and therefore lowers systolic and diastolic blood pressure slightly. With organic nitrates, the drop in blood pressure is potentiated, at times dangerously, thereby making it contraindicated to take nitrates within 24 hours of using sildenafil. In double-blind, placebo-controlled trials, there was no difference between sildenafil subjects and control patients in the incidence of myocardial infarction, cardiovascular, and total deaths. Coronary disease patients with stable angina, controlled on medications, were included in the trials. Therefore, sildenafil, as a drug, is safe in such patients. With a patient with coronary artery disease suddenly engaging in the physical exercise associated with sexual intercourse, there is the danger of increased risk of precipitating myocardial infarction or death. The cardiovascular metabolic cost of sexual activity is reviewed and appears to be approximately at the level of 3-5 metabolic equivalents of exercise. Sexual activity occurs within 2 hours of the onset of an acute myocardial infarction in <1.0% of patients. Although sexual intercourse is estimated to increase the risk of myocardial infarction by a factor of 2x, there is still only a very small increase in risk, a risk acceptable to patients who feel their quality of life will be markedly improved by their ability to engage in sexual activity.

Topics: Coronary Disease; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Adult; Alprostadil; Arginine; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones; Yohimbine

Erectile dysfunction (ED) is a common problem with a prevalence of approximately 50% in men aged 40 to 70. There are several etiologies for ED including vasculogenic, neurogenic, hormonal and/or psychogenic factors; one-fourth of ED cases can be drug-related. Penile erection involves a complex interaction between the CNS and local factors. It is a neurovascular event modulated by psychological and hormonal factors. Pharmacologically, neural modulation and endocrine status are very important to attaining penile erection. There have been several significant advances for the pharmacologic treatment of ED. Treatments include agents that are not only orally effective, but possess either local or central acting mechanisms of action. Apomorphine, a centrally-acting agent, is effective in the treatment of ED. Sildenafil, another orally effective agent, acts by inhibiting cyclic GMP-specific phosphodiesterase Type V. Testosterone can be effective transdermally. Non-orally active agents include alprostadil and papaverine. Phentolamine and trazodone are effective in selected cases. Some agents can interact with other medications. Several pharmacological agents, some with central-acting mechanisms and some with Iocally-acting vascular effects, are therapeutically useful in the treatment of ED.

Topics: Adult; Aged; Alprostadil; Apomorphine; Drug Interactions; Erectile Dysfunction; Humans; Male; Middle Aged; Papaverine; Penile Erection; Phentolamine; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone; Trazodone

Safety data from 546 men with erectile dysfunction (ED) enrolled in three double-blind, placebo-controlled studies conducted in distinct regions of Latin America were pooled and analyzed. The most commonly reported adverse events of all causalities associated with sildenafil treatment were headache (19%), flushing (14%), dyspepsia (6%), and nasal congestion (4%), reflecting the inhibitory effects of sildenafil on cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) in the peripheral vasculature, gastroesophageal sphincter, and nasal mucosa. Visual symptoms were reported in 5.5%, reflecting sildenafil's minor inhibitory effects on cGMP-specific PDE6 in the retina. These adverse events were generally transient and mild, and rarely resulted in discontinuation of sildenafil therapy. Thus, in this representative sample of Latin American men with ED, including those with concomitant stable cardiovascular disease, sildenafil treatment was well tolerated with an incident rate of adverse events similar to reports from other patient populations.

Topics: Adult; Aged; Aged, 80 and over; Double-Blind Method; Erectile Dysfunction; Humans; Latin America; Male; Middle Aged; Piperazines; Placebos; Purines; Randomized Controlled Trials as Topic; Safety; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Antihypertensive Agents; Blood Pressure; Cardiovascular Diseases; Drug Interactions; Erectile Dysfunction; Humans; Male; Nitroglycerin; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Contraindications; Diabetes Mellitus; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones; Transurethral Resection of Prostate

Topics: Algorithms; Cardiovascular System; Coronary Disease; Erectile Dysfunction; Heart Diseases; Humans; Hypertension; Male; Piperazines; Purines; Referral and Consultation; Risk Assessment; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Administration, Oral; Alprostadil; Erectile Dysfunction; Humans; Injections; Male; Penis; Piperazines; Purines; Regional Blood Flow; Self Administration; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Diagnosis, Differential; Erectile Dysfunction; Estrogens; Humans; Liver; Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone; Vasodilator Agents

Topics: Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Vasodilator Agents

Topics: Erectile Dysfunction; Humans; Male; Piperazines; Prostatectomy; Prostatic Neoplasms; Purines; Sildenafil Citrate; Sulfones

Topics: Cystectomy; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Urinary Bladder Neoplasms

Topics: Brachytherapy; Erectile Dysfunction; Humans; Male; Piperazines; Prostatic Neoplasms; Purines; Quality of Life; Radiotherapy Dosage; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Anti-Anxiety Agents; Drugs, Chinese Herbal; Erectile Dysfunction; Humans; Male; Phytotherapy; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Diagnosis, Differential; Erectile Dysfunction; Female; Humans; Male; Marriage; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Adolescent; Adult; Erectile Dysfunction; Humans; Impotence, Vasculogenic; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Phosphodiesterase enzymes convert cyclic GMP and cyclic AMP to the corresponding nucleotide monophosphates. Phosphodiesterase 5 (PDE5) inhibition is now a widely accepted and efficacious therapeutic option for the treatment of erectile dysfunction in men, as a result of extensive clinical experience with sildenafil and other new PDE5 inhibitors. Research in the field continues at a substantial level to identify new, selective PDE5 inhibitors and to investigate their usefulness and activity in other areas. This review summarizes recent clinical trials with PDE5 inhibitors, advances in medicinal chemistry, and other activities and potential applications of this class of compounds.

Topics: Carbolines; Chemistry, Pharmaceutical; Clinical Trials as Topic; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Structure-Activity Relationship; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Topics: Alprostadil; Drug Administration Routes; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Treatment Outcome; Yohimbine

Erectile dysfunction (ED) (impotence) is a widespread, age-related problem, which affects 52% of men between 40 and 70 years of age. It is classified as psychogenic, organic, or mixed psychogenic and organic. ED is not a problem only of men, because the relationship between partners can also be disturbed. Therefore, adequate treatment of ED is needed and the most convenient and simplest way is oral drug therapy. Sildenafil, phosphodiesterase-(PDE)-5-selective inhibitor has been the drug of choice for patients with ED since it has been launched in March 1998. The results of various studies have confirmed the efficacy of the drug in men with ED of various etiologies, as well as the positive effect of sildenafil on the quality of a partnership. The most frequent adverse effects documented with sildenafil usage are headache, flushes, dyspepsia, visual disturbances and nasal congestion/rhinitis. These adverse effects are dose-related, usually transient and mild, with low withdrawal rate. Several studies performed recently have shown that sildenafil is a safe and effective treatment of ED in patients with cardiovascular disease, who do not take nitrates or nitrate donors concomitantly. Other oral medications for ED include apomorphine, phentolamine, yohimbine, trazodone, testosterone and new PDE-5 inhibitors in Phase III clinical trials, such as vardenafil and tadalafil. It is obvious, according to recent data, that the concept of PDE-5 inhibition has a central position in oral pharmacotherapy of ED. However, larger clinical studies of efficacy and safety should be carried out using most of the other above-mentioned oral agents and these may also gain a place in the therapy of ED. There are no studies directly comparing sildenafil and other treatments of ED or assessing its role in combination with other therapies. According to the present knowledge, the quality of life, not only of patients but also of their sexual partners, will be improved significantly with sildenafil usage and this is an important precondition for overall health ofboth. Sildenafil is thus a highly effective peroral treatment for ED in patients without contraindications for its use, which can be considered as the firstline therapy with an acceptable risk-benefit ratio.

Topics: Administration, Oral; Adult; Erectile Dysfunction; Humans; Imidazoles; Intestinal Absorption; Male; Metabolic Clearance Rate; Middle Aged; Phentolamine; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tissue Distribution; Triazines; Vardenafil Dihydrochloride; Yohimbine

This review will summarize the most recent preclinical data from the leading US laboratories regarding the application of gene therapy to the treatment of erectile dysfunction. The implications of these findings in the field of gene therapy in general, and more specifically to the treatment of non-life threatening disorders such as erectile dysfunction, will be outlined.. The preclinical work of several laboratories has clearly documented 'proof-of-concept' for the utility of gene therapy for the treatment of erectile dysfunction. A variety of vectors and several distinct molecular targets have been successfully leveraged. Such observations suggest that numerous potential strategies may exist for gene-based treatments of erectile dysfunction.. The apparent preclinical success of most, if not all, gene-based strategies for the treatment of erectile dysfunction is consistent with the multifactorial regulatory mechanisms governing the erectile process. The bottleneck in the gene therapy clinical development process therefore apparently will not lie in the ability to identify relevant molecular targets that are amenable to gene therapy for erectile dysfunction, but rather in the safety, specificity and longevity of those targets. That is, the next technical hurdle is to find the strategy(ies) that has the best safety profile, the greatest specificity for altering (increasing) intracavernous pressure 'on demand' and, furthermore, the most appropriate (longest?) half-life. While these criteria may correspond to intuition, finding molecular targets that clear these clinical hurdles may place restrictions on the molecular choices for gene transfer.

Topics: Erectile Dysfunction; Genetic Therapy; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

The scientific rationale of pharmacologically inhibiting phosphodiesterase type 5 (PDE5) in the treatment of erectile dysfunction (ED) is reviewed. Published literature on the nitric oxide-cyclic guanosine monophosphate (cGMP) pathway for penile erection and on PDE5 inhibition using sildenafil as the model for pharmacologic PDE5 inhibition are assessed. The key second messenger in the mediation of penile erection is cGMP. PDE5 is the predominant PDE in the corpus cavernosum, and cGMP is its primary substrate. Therefore, in men with ED, elevation of cGMP in corpus cavernosal tissue via selective inhibition of cGMP-specific PDE5 is a means of improving erectile function at minimal risk of adverse events. This approach is validated by the clinical efficacy and safety of sildenafil, the pioneering drug for selective PDE5 inhibitor therapy for ED. Sildenafil exhibits inhibitory potency against PDE5 and a 10-fold lower dose-related inhibitory potency against rod outer segment PDE6, the predominant PDE in the phototransduction cascade in rods. Thus, its pharmacologic profile is predictable, with close correlation between pharmacodynamic and pharmacokinetic properties. Clinically, sildenafil improves erectile function in a large percentage of men with ED. The most common adverse events are due to PDE5 inhibition in vascular and visceral smooth muscle; similar adverse events are expected during therapeutic use of all PDE5 inhibitors. As free sildenafil plasma concentrations approach concentrations sufficient to inhibit retinal PDE6, usually at higher therapeutic doses, transient, reversible visual adverse events can occur, albeit infrequently. Selective inhibition of PDE5 is a rational therapeutic approach in ED, as proved by the clinical success of sildenafil.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Nitric Oxide; Penile Erection; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Although certain risk factors are known to be associated with erectile dysfunction (ED), the demographic and ED characteristics of the population of men with ED are quite diverse. We examined results from randomized trials of sildenafil citrate (Viagra) to ascertain if efficacy differed across various subgroups of men with ED. In addition, we reviewed findings from long-term extension studies and published accounts of sildenafil use in clinical practice to determine if effectiveness is maintained with long-term sildenafil treatment and to determine if effectiveness in the clinic practice setting is consistent with that reported in clinical trials. Data were pooled from 11 double-blind, placebo-controlled, flexible-dose (taken as needed) studies to assess efficacy (N = 2667) of sildenafil in men (aged 23 to 89 years) with ED of broad-spectrum etiology who were not receiving concomitant nitrate therapy. Efficacy evaluations included the International Index of Erectile Function, a global efficacy question ("Did treatment improve your erections?"), and a patient-recorded event log of sexual activity. Significantly improved erectile function was demonstrated for sildenafil compared with placebo for all efficacy parameters analyzed (P <0.02 to 0.0001), regardless of patient age, race, body mass index, ED etiology, ED severity, ED duration, or the presence of various comorbidities. Long-term effectiveness was assessed in 3 open-label extension studies. Of those who continued long-term therapy (1 to 3 years) with sildenafil, >95% of patients reported that they were satisfied with the effect of treatment on their erections, and that treatment had improved their ability to engage in sexual activity. Findings from published accounts of sildenafil use in the clinical practice setting further demonstrated that sildenafil is an effective treatment for a wide range of patients with ED.

Topics: Adult; Aged; Aged, 80 and over; Comorbidity; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Vasodilator Agents

Since its approval in 1998, sildenafil citrate (Viagra) has been shown to be efficacious in >100 clinical trials involving >8000 men with erectile dysfunction (ED). In clinical practice, however, many men do not continue long-term use of sildenafil for a variety of reasons; thus, 6 different aspects of optimizing treatment with sildenafil are described here. (1) Intercourse success rates, considered a reflection of real-world effectiveness, were assessed in 1276 patients with ED. Results indicated that the cumulative probability of achieving intercourse success with sildenafil increased with the number of attempts, reaching a plateau after approximately 8 attempts. (2) A comprehensive disease management approach that included a medical history, physical examination, educational material about ED, modifications of risk factors/lifestyle changes, and counseling resulted in successful intercourse in 74% of 111 patients taking sildenafil. (3) A survey conducted among primary care physicians revealed that almost 50% did not routinely question their patients about ED symptoms, although it is known that most patients would prefer their physician to take the initiative. (4) Overall, 55% of 137 men who were previously not successful with sildenafil became successful after reeducation and counseling, which included information on patient and partner expectations, how to properly take the drug, titration to maximum dose, and a minimum trial of 8 attempts for efficacy assessment. (5) Many men with ED have underlying comorbidities or take multiple medications that are risk factors for ED. Controlling these risk factors in 521 men from a multispecialty clinic led to an overall intercourse success rate of 82%; patients with multiple risk factors were less likely to have intercourse success than men with only 1 risk factor. (6) Finally, treatment satisfaction is a pivotal factor in maintaining long-term ED therapy. In an open-label trial, 82% of 443 subjects reported treatment satisfaction with sildenafil. In summary, these findings highlight how important it is for physicians to take a more comprehensive, proactive approach when treating men with ED, including control of risk factors, instructions on how to properly take the drug, partner involvement, and follow-up visits. Using these recommended measures, most men with ED, including those whose treatment was previously unsuccessful, can be treated successfully with sildenafil.

Topics: Coitus; Double-Blind Method; Drug Interactions; Erectile Dysfunction; Humans; Male; Patient Education as Topic; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Risk Factors; Sildenafil Citrate; Sulfones; Vasodilator Agents

Clinical studies have demonstrated that sildenafil citrate (Viagra) is an effective and well-tolerated oral treatment for erectile dysfunction. Despite its established safety profile, concern about its cardiovascular safety persists among some physicians and the general public. This concern has stemmed primarily from sporadic reports of adverse events published in the literature and sensationalized by the media. However, the only absolute contraindication for sildenafil is concurrent use of nitrates. Because sildenafil has been on the market for 4 years and under clinical investigation for even longer, we can now evaluate its long-term safety in men who have been taking the drug for several years. We review this issue from 3 perspectives. First, we reassess the overall safety profile of sildenafil by reviewing the initial controlled clinical trials and open-label studies. We present new data from patients who have been exposed to sildenafil for up to 4.5 years. We also evaluate the results from independent postmarketing studies. Second, we review the cardiovascular-specific results from the clinical trials, long-term extension, and postmarketing studies. Lastly, we review the specific effects on the visual system based on findings from studies conducted during drug development and post marketing.

Topics: Cardiovascular System; Controlled Clinical Trials as Topic; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Spinal cord injury (SCI) affects a substantial number of men who are young, active, and otherwise healthy. Erectile dysfunction (ED) is a common consequence of SCI. Since its approval, sildenafil citrate (Viagra) has been shown to effectively treat ED of various etiologies. We review the evidence for the efficacy and safety of sildenafil treatment of ED in men with SCI. A literature search identified 2 randomized controlled trials and 4 prospective case series that evaluated sildenafil treatment for ED from SCI. Efficacy was evaluated using an assessment of global efficacy and a more specific assessment of erectile function. For general efficacy, the proportion of patients who reported improved erections and ability to have intercourse was as high as 94%. Up to 72% of intercourse attempts were successful. For measures of erectile function, 5 of the 6 studies showed statistically significant improvements among sildenafil-treated versus placebo-treated patients. Erectile response rates were generally higher in patients with incomplete versus complete SCI and in patients with upper versus lower motor neuron lesions. Nevertheless, a substantial proportion of patients with complete lesions, regardless of level or lower motor neuron lesions, also benefited from sildenafil. Sildenafil was well tolerated. Incidence rates and types of adverse events that occurred in these studies were similar to those published previously. Symptoms of autonomic dysreflexia were not reported in any study. Existing evidence suggests that oral sildenafil is a highly effective and well-tolerated treatment for ED associated with SCI.

Topics: Coitus; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Vasodilator Agents

Erectile dysfunction (ED) and depression are highly prevalent conditions and frequently occur concomitantly in predisposed individuals. Men with ED and depression are also likely to have other comorbid conditions, including diabetes, hypertension, and heart disease. Because ED is also a common adverse effect of some medications for these conditions, patients are frequently noncompliant with treatment. Sildenafil citrate (Viagra) is effective in treating ED of a broad range of etiologies, suggesting that it may be equally beneficial in patients with ED that is associated with depressive symptoms and in those with ED resulting from serotonergic reuptake inhibitor (SRI) antidepressant treatment. We review the results of 3 randomized, placebo-controlled trials and a retrospective analysis of data pooled from 10 clinical trials that examine the efficacy of sildenafil in treating ED associated with depression and as an adverse effect of SRI treatment. The results suggest that sildenafil is efficacious as a first-line treatment for ED in men with untreated minor depression, in men with ED that is refractory to successful SRI treatment of depression, and in those whose depression was successfully treated but who developed ED as a consequence of SRI treatment. Given the complex interrelations among ED, depression, and other comorbid conditions, the key to proper management is a comprehensive evaluation, including sexual function, and an accurate differential diagnosis.

Topics: Antidepressive Agents, Second-Generation; Depression; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Retrospective Studies; Sildenafil Citrate; Sulfones; Vasodilator Agents

Penile erection occurs in response to visual, olfactory, imaginative, and tactile stimuli initiated within the brain and/or on the periphery. Responses to these stimuli are mediated by efferent autonomic outflow originating in the sacral spinal cord and transmitted by the cavernosal and penile nerves. A number of neurotransmitters can play an integral role in corpus cavernosum smooth muscle relaxation, in part regulating penile erection through increased smooth muscle synthesis of the secondary messengers cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). In addition to direct-acting agents, there are indirect-acting smooth muscle-relaxing agents. Phosphodiesterase (PDE) inhibitors such as sildenafil act indirectly and require sexual stimulation and endogenous nitric oxide production to activate the cGMP pathway effectively. In contrast, agents such as prostaglandin E(1) (PGE(1)) act directly on the trabecular smooth muscle, binding to specific e-prostanoid receptors and increasing cAMP synthesis. For this reason the direct-acting agents do not require sexual stimulation for efficacy. Combination pharmacotherapy has been used experimentally to treat erectile dysfunction for 25 years, using combinations of cAMP synthesis augmentors, smooth muscle relaxants and PDE inhibitors, and alpha-blockers administered via intracavernosal injection. The present era of oral pharmacotherapy treatment has resulted in significant awareness in the field of sexual dysfunction; however, a single agent may not be ideal to sustain penile rigidity, especially if comorbidities and severity of erectile dysfunction are accounted for. The rationale for and recent reports on combination therapy are presented in this review.

Topics: Alprostadil; Drug Synergism; Drug Therapy, Combination; Erectile Dysfunction; Forecasting; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Alprostadil; Diabetes Complications; Erectile Dysfunction; Humans; Male; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Since introduction of the PDE-5 inhibitor sildenafil 4 years ago, there has been a fundamental change in the treatment of erectile dysfunction (ED). Intracavernosal or intraurethral injections of vasoactive substances or penile implants as mechanical aids now play hardly any part in it. - The development of the PDE-5 inhibitors vardenafil and tadalafil prompts the question of whether and how these three substances differ in terms of their efficacy and adverse effects. - Sildenafil has proven to be a very effective medicinal product. Studies with a follow-up period of up to 6 years have been conducted. The success rate of sildenafil varies in the group of ED patients with an organic underlying disease from 43% in patients who have undergone radical prostatectomy to 85% in patients with a neurological underlying disease, and amounts to an average 82% (range 43-85%, 100mg). - In an evaluation of spontaneous reports of deaths associated with sildenafil, the FDA concluded that there was no deducible evidence of an increase in the mortality rate among sildenafil users compared to the general population. In fact, fewer deaths associated in time with the ingestion of sildenafil were reported than might have been expected purely statistically on the basis of the normal mortality rate for men in this age group. - According to the initial studies conducted, vardenafil and tadalafil demonstrate efficacy data approximately comparable to those of sildenafil. As yet, insufficient data are available to evaluate the adverse effects of vardenafil and tadalafil, particularly their long-term use and use in high-risk groups. - Sildenafil has already been used by over 20 million men in over 110 countries and is one of the best-studied pharmacological substances available. This adventage in terms of knowledge and safety data makes sildenafil a safe and reliable treatment for patients with erectile dysfunction.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Contraindications; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Prevalence; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

Sexuality remains a vital aspect of life in spite of aging. Advances in impotence research and increased knowledge of the pathophysiology of erection have completely changed the treatment of erectile dysfunction. Before oral therapy, intracavernous injection was considered as the first-line therapy for impotent patients. However, the new simple oral treatment raises the question as to whether intracavernous injection therapy is still a useful tool for treatment of aging men with erectile dysfunction. The efficacy and safety of oral therapy and intracavernous injection are reviewed.

Topics: Administration, Oral; Adult; Aged; Aging; Alprostadil; Erectile Dysfunction; Humans; Injections, Intramuscular; Male; Middle Aged; Penis; Piperazines; Prostaglandins; Purines; Sexuality; Sildenafil Citrate; Sulfones; Vasodilator Agents

It is possible to observe in the aging male an hypotestosteronemia below 3 ng/ml. The indications of an androgenic treatment are discussed with their benefits, risks, contra-indications and choices of molecules. Testosterone-gel seems to be now the first choice for this type of patient. In case of normal testosteronemia and erectile dysfunction, the benefits/risks ratio of sildenafil is very favorable, except when contra-indicated.

Topics: Aged; Aging; Contraindications; Erectile Dysfunction; Humans; Male; Patient Selection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone; Treatment Outcome

This review provides an overview of the pharmacology mechanism of sildenafil. The efficacy and safety of the medicine are briefly summarized. The special conclusion was made for the usage of sildenafil to the particular patients such as those with hypertension or those taking any antihypertensive agent, with cardiovascular disease, with diabetes, with spinal cord injury, after radical prostatectomy and on chronic dialysis. In general, sildenafil is effective and safe for various ED patients.

Topics: Antihypertensive Agents; Diabetes Complications; Drug Interactions; Erectile Dysfunction; Heart Diseases; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Phosphodiesterase type-5 (PDE-5) inhibitors are a new class of vasoactive drugs that have been developed for treatment of erectile dysfunction (ED). The mechanism of action involves active inhibition of the PDE-5 enzyme and resulting increase in cyclic guanosine monophosphate (cGMP) and smooth muscle relaxation in the penis. Sildenafil citrate (Viagra) is a potent and selective PDE-5 inhibitor, which is the first drug in this class to be approved for treatment of ED. More than 10 million men worldwide have been treated with this drug. Sildenafil has been shown to be generally effective in the treatment of ED, although the degree of efficacy varies according to the etiology and severity of the disorder. The drug is well tolerated, with relatively few contraindications (e.g., nitrates) and safety risks. The cardiovascular effects of sildenafil, in particular, have been extensively investigated. The results of recent studies suggest that sildenafil may have an additional role in the treatment of other male and female sexual disorders, such as premature ejaculation and female sexual arousal disorder, although results to date are inconclusive. Two additional agents in this class (tadalafil [Cialis], vardenafil [Levitra]) have been developed recently and are under regulatory review. Tadalafil is a long-acting PDE-5 inhibitor, which is effective for up to 36 hr in the majority of men. Vardenafil has a similar duration of action to sildenafil, but is more potent and selective biochemically. Both drugs appear to be generally safe and well tolerated, with a similar side-effect profile to sildenafil. There are no controlled comparison studies to date. Despite the overall effectiveness of PDE-5 inhibitors in the treatment of ED, significant psychological and interpersonal issues need to be addressed in their clinical use. The potential impact on societal attitudes toward sexuality and sexual dysfunction also warrants consideration.

Topics: Carbolines; Clinical Trials as Topic; Cyclic GMP; Erectile Dysfunction; Female; Humans; Imidazoles; Male; Muscle, Smooth; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Topics: Alprostadil; Erectile Dysfunction; Humans; Male; Penile Erection; Penile Prosthesis; Piperazines; Purines; Sildenafil Citrate; Sulfones; Yohimbine

Topics: Age Factors; Aging; Cardiovascular Diseases; Databases, Factual; Diabetes Complications; Endocrine System Diseases; Erectile Dysfunction; Humans; Internet; Male; Morbidity; Nervous System Diseases; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones

In the 3 y since its initial approval, sildenafil has become the most widely used treatment for erectile dysfunction (ED) and has been prescribed to more than 13 million patients worldwide. Significant improvements in erectile function have been demonstrated in double-blind, placebo-controlled studies in diverse patient populations. A significant treatment effect has been shown with sildenafil in men with ED and a history of diabetes, cardiovascular disease, minor depression, spinal cord injury and multiple sclerosis. In addition, promising results have been shown in patients with treated prostate cancer, end-stage renal disease, Parkinson's disease and spina bifida and in multiple-organ transplant recipients. Postmarketing data of the use of sildenafil in clinical practice confirm the efficacy and safety found in clinical trials and high satisfaction with treatment. Public awareness of the common occurrence of ED and the high likelihood of a potentially favorable response to an oral treatment increased dramatically with the introduction of sildenafil. Physicians, however, are still not comfortable with ED management, which negatively affects pharmacotherapy response rates and patients' compliance to treatment. Continuing medical education seems mandatory to overcome existing problems in ED management.

Topics: Erectile Dysfunction; Humans; Male; Piperazines; Product Surveillance, Postmarketing; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

The introduction of safe and effective oral therapies has changed the significance of erectile dysfunction (ED) forever. Seldom has a new drug changed the landscape of pharmacotherapy in so many ways as sildenafil (Viagra, Pfizer). This article highlights the various oral, intracavernosal and intraurethral therapies currently available for ED and evaluates the socio-economic impact of each method.

Topics: Apomorphine; Cost-Benefit Analysis; Dopamine Agonists; Erectile Dysfunction; Humans; Injections; Male; Penis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Urethra

Topics: Clinical Trials as Topic; Erectile Dysfunction; Female; Humans; Male; Piperazines; Purines; Sexual Dysfunctions, Psychological; Sildenafil Citrate; Sulfones; Vasodilator Agents

Diabetic men have a more than 3-fold increased prevalence of erectile dysfunction (ED) compared with nondiabetic men. Erectile function is primarily a vascular phenomenon, triggered by neurologic controls and facilitated by appropriate hormonal and psychological components. Recent advances in the understanding of the physiology of penile vasculature and its role in male sexual performance have influenced the clinical approach to ED. The pathophysiological alterations leading to impotence in diabetic men include vasculogenic, neurogenic, and hormonal etiologies. A clinical work-up, including a thorough history and physical examination, is an important aspect of ED management. Biochemical evaluations to rule out secondary causes like hypogonadism and thyroid abnormalities are suggested. Oral medications acting through phosphodiesterase inhibition in penile vasculature have revolutionized treatment of impotence in diabetic men. Because of a high success rate in treating ED of various etiologies, these agents are the treatment of choice for most patients. Safety and efficacy of vacuum-constriction devices, intraurethral suppositories, intracavernosal injections, and other therapies are discussed. A clinical algorithm for the evaluation and management of ED is provided for use in the primary care setting.

Topics: Aged; Algorithms; Alprostadil; Decision Trees; Diabetes Complications; Erectile Dysfunction; Humans; Incidence; Male; Medical History Taking; Middle Aged; Phosphodiesterase Inhibitors; Physical Examination; Piperazines; Prevalence; Primary Health Care; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Topics: Diabetes Complications; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Normal sexual function is a biopsychosocial process; sexual dysfunction almost always has organic and psychological components and requires multidisciplinary, goal-directed evaluation and treatment. Factors such as aging, declining testosterone levels, medical illness, certain medications. and comorbid depressive illness can contribute to sexual dysfunction. Erectile dysfunction is one of the more common male sexual dysfunctions encountered in the clinical setting. Comorbidity between erectile dysfunction and depressive illness is high, but the causal relationship is unclear. The psychosocial distress that often accompanies erectile dysfunction might stimulate the development of depressive illness, or, as some data suggest, depression might cause erectile dysfunction. This article reviews the literature on the relationship between depression and erectile dysfunction, as well as the design of a new study that may provide some answers, and concludes that erectile dysfunction is a common, treatable condition that may cause or be the result of depression. Recent data suggest that sildenafil is an effective treatment for erectile dysfunction in men with comorbid depression. Erectile dysfunction should be considered a multifactorial condition that may require a multidisciplinary approach to treatment, especially when depression is present.

Topics: Adult; Age Factors; Aged; Aging; Antidepressive Agents; Comorbidity; Depressive Disorder; Erectile Dysfunction; Humans; Male; Meta-Analysis as Topic; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; United States

Evaluation of company clinical trial reports could provide information for meta-analysis at the commercial introduction of a new technology.. Clinical trial reports of sildenafil for erectile dysfunction from September 1997 were used for meta-analysis of randomised trials (at least four weeks duration) and using fixed or dose optimisation regimens. The main outcome sought was an erection, sufficiently rigid for penetration, followed by successful intercourse, and conducted at home.. Ten randomised controlled trials fulfilled the inclusion criteria (2123 men given sildenafil and 1131 placebo). NNT or NNH were calculated for important efficacy, adverse event and discontinuation outcomes. Dose optimisation led to at least 60% of attempts at sexual intercourse being successful in 49% of men, compared with 11% with placebo; the NNT was 2.7 (95% confidence interval 2.3 to 3.3). For global improvement in erections the NNT was 1.7 (1.6 to 1.9). Treatment-related adverse events occurred in 30% of men on dose optimised sildenafil compared with 11% on placebo; the NNH was 5.4 (4.3 to 7.3). All cause discontinuations were less frequent with sildenafil (10%) than with placebo (20%). Sildenafil dose optimisation gave efficacy equivalent to the highest fixed doses, and adverse events equivalent to the lowest fixed doses.. This review of clinical trial reports available at the time of licensing agreed with later reviews that had many more trials and patients. Making reports submitted for marketing approval available publicly would provide better information when it was most needed, and would improve evidence-based introduction of new technologies.

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones

To determine the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction.. The MEDLINE, HealthSTAR, Current Contents, and Cochrane Library databases (January 1, 1995, through December 31, 2000); bibliographies of retrieved articles and review articles; conference proceedings abstracts; the Food and Drug Administration Web site; and the manufacturer.. Trials were eligible if they included men with erectile dysfunction, compared sildenafil with control, were randomized, were of at least 7 days' duration, and assessed clinically relevant outcomes.. Two reviewers independently evaluated study quality and extracted data in a standardized fashion.. Twenty-seven trials (6659 men) met the inclusion criteria. In results pooled from 14 parallel-group, flexible as-needed dosing trials, sildenafil was more likely than placebo to lead to successful sexual intercourse, with a higher percentage of successful intercourse attempts (57% vs 21%; weighted mean difference, 33.7; 95% confidence interval [CI], 29.2-38.2; 2283 men) and a greater percentage of men experiencing at least 1 intercourse success during treatment (83% vs 45%; relative benefit increase, 1.8; 95% CI, 1.7-1.9; 2205 men). In data pooled from 6 parallel-group, fixed-dose trials, efficacy appeared slightly greater at higher doses. Treatment response appeared to vary between patient subgroups, although relative to placebo, sildenafil significantly improved erectile function in all evaluated subgroups. In trials with parallel-group design and flexible dosing, men randomized to receive sildenafil were less likely than those receiving placebo to drop out for any reason and no more likely to drop out due to an adverse event or laboratory abnormality. Specific adverse events with sildenafil included flushing (12%), headache (11%), dyspepsia (5%), and visual disturbances (3%); all adverse events were significantly less likely to occur with placebo. Sildenafil was not significantly associated with serious cardiovascular events or death.. Sildenafil improves erectile function and is generally well tolerated. Treatment response seems to vary between patient subgroups, although sildenafil has greater efficacy than placebo in all evaluated subgroups.

Topics: Age Factors; Aged; Dose-Response Relationship, Drug; Dyspepsia; Erectile Dysfunction; Flushing; Headache; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Severity of Illness Index; Sexual Behavior; Sildenafil Citrate; Sulfones; Vasodilator Agents; Vision Disorders

Erectile dysfunction (ED) in men is amenable to correction with Viagra in a majority of patients. The accumulated experience of prescribing Viagra across the broad continuum of men suffering from ED is sufficient for a meaningful assessment of the safety of Viagra in clinical practice. The use of Viagra necessitates caution in cardiac failure and when used within six months of acute myocardial infarction and stroke. It is inadvisable in patients with unstable angina pectoris. The co-administration of Viagra with organic nitrates, for example, glyceryl trinitrate or isosorbide dinitrate, is unsafe. The relative contraindications to Viagra in cardiovascular disease are uncontrolled hypertension and impaired cardiac reserve. With respect to interactions with other drugs, the potential influence on the metabolism of Viagra by medications that affect the cytochrome-P-450 system does not translate into clinical effects. The vasodilatory properties of sildenafil citrate are largely responsible for unwanted effects. The most common side effects are headache, flushing (due to vasodilation), and dyspepsia (due to relaxation of the smooth muscle of the gastroesophageal sphincter with reflux). In the recommended single-dose range (25-100 mg), the use of Viagra for erectile dysfunction, in the absence of contraindications, is extremely safe provided the drug is taken under proper conditions.

Topics: Contraindications; Drug Interactions; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Adult; Aged; Erectile Dysfunction; Humans; Incidence; Male; Middle Aged; Piperazines; Prostatic Neoplasms; Purines; Radiotherapy; Radiotherapy, Computer-Assisted; Radiotherapy, Conformal; Radiotherapy, High-Energy; Sildenafil Citrate; Sulfones

Topics: Alprostadil; Erectile Dysfunction; Genetic Therapy; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostheses and Implants; Psychotherapy; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Cardiovascular Agents; Coitus; Counseling; Erectile Dysfunction; Heart; Heart Diseases; Heart Rate; Humans; Male; Phosphodiesterase Inhibitors; Physician's Role; Piperazines; Purines; Sexual Behavior; Sildenafil Citrate; Sulfones

Oral sildenafil is an effective treatment for erectile dysfunction (ED), which is a common complaint for patients with hypertension and those taking antihypertensive agents. This post hoc subanalysis assessed the efficacy and safety of sildenafil in men with ED who were receiving concomitant antihypertensive medication. Efficacy was assessed in 3414 men (1218 of whom were taking antihypertensive medication) who received sildenafil (5 to 200 mg) or placebo for 6 weeks to 6 months in 10 double-blind, placebo-controlled studies. The significant improvements in erectile function demonstrated by sildenafil-treated patients were comparable in patients taking and those not taking antihypertensive medication. Safety was assessed in 3975 men (1094 of whom were taking one or more antihypertensive agent, classified as a diuretic, beta-blocker, alpha1-blocker, angiotensin converting enzyme inhibitor, or calcium channel blocker), who received sildenafil or placebo in 18 double-blind, placebo-controlled studies. For patients taking sildenafil and antihypertensive medication, the incidence of treatment-related adverse events (34%) was similar to that for sildenafil-treated patients not taking any antihypertensive agent (38%). The incidences of the most common adverse events and of adverse events potentially related to blood pressure decreases (eg, hypotension, dizziness, and syncope) were similar in both sildenafil groups. The number of antihypertensive medications taken from among the five classes had no effect on the adverse event profile of sildenafil. Sildenafil is an effective and well-tolerated treatment for ED in patients taking concomitant antihypertensive medication, including those on multidrug regimens.

Topics: Adult; Aged; Antihypertensive Agents; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones

The prevalence of erectile dysfunction (ED) increases with advancing age, with a particularly high prevalence of ED in elderly patients with diabetes. In the United States it is estimated that approximately 45% of men aged 65 to 69 years have moderate or complete ED. The efficacy and safety of oral sildenafil (VIAGRA) for treating ED in elderly men (aged > or = 65 years or older) were assessed.. We analyzed data obtained from five double-blind, placebo-controlled studies of the efficacy and tolerability of oral sildenafil taken as required (but not more than once daily) over a 12-week to 6-month period. Two subgroups were evaluated: (i) elderly patients with ED of broad-spectrum etiology (n = 411), and (ii) elderly patients with ED and diabetes (n = 71). Efficacy was assessed using a global efficacy question, questions 3 and 4 of the International Index of Erectile Function (IIEF). and the five sexual function domains of the IIEF.. All efficacy assessments indicated that sildenafil significantly improved erectile function both in elderly patients with ED of broad-spectrum etiology and in elderly patients with ED and diabetes. The most common adverse events were mild-to-moderate headache, flushing, and dyspepsia. The rates of discontinuation due to adverse events were low and were comparable to the rates with placebo.. Sildenafil is an efficacious and well-tolerated treatment for ED in elderly men.

Topics: Aged; Aged, 80 and over; Aging; Double-Blind Method; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Safety; Sildenafil Citrate; Sulfones; Treatment Outcome

Erectile dysfunction is a frequent condition in cardiovascular patients. Since the arrival of oral erection-supporting medication, patients want to know how safe sexual activity is in cardiovascular disease in general and during use of erection-supporting medication in particular. Sexual intercourse with a steady partner causes no more cardiovascular risk than normal daily activities such as ironing, 2 kilometers of walking without climbing, paperhanging, playing golf or gardening. The relative risk of myocardial infarction during sexual activity is not significantly higher than for healthy persons. The incidence of cardiovascular morbidity and mortality is not higher among users of sildenafil. Sildenafil is contraindicated in patients using long-acting nitrates or who may need to use short-acting nitrates, because the combination may cause a sharp fall of the blood pressure. No interactions have been observed with beta-receptor blockers, calcium antagonists, thiazide and loop diuretics and ACE inhibitors. Before prescribing a symptomatic (pharmaceutical) treatment for patients with an erection disorder, attention should be given tot the sexological, psychological and medical backgrounds of the disorder. Secondary prevention of atherosclerotic risk factors is also important: regulation of blood pressure and blood sugar level, hyperlipidaemia and obesity, as well as a change of lifestyle (giving up smoking, adapting of diet and more physical exertion). Patients with a very low cardiac capacity should be advised to refrain from treatment of the erection disorder.

Topics: Cardiovascular Diseases; Contraindications; Drug Interactions; Erectile Dysfunction; Humans; Isosorbide Dinitrate; Male; Netherlands; Nitric Oxide Donors; Nitroglycerin; Phosphodiesterase Inhibitors; Piperazines; Practice Guidelines as Topic; Purines; Sildenafil Citrate; Sulfones

Since its approval by the US Food and Drug Administration in March 1998, sildenafil citrate has been used by millions of men for the treatment of erectile dysfunction. Recent studies and consensus reports have expanded our understanding of its efficacy, safety, contraindications, and drug interactions.. This paper reviews recent studies of the efficacy of sildenafil, its adverse effects and drug interactions, and socioeconomic factors involved in its use, with a focus on specific patient populations (prostate cancer, diabetes mellitus, ischemic heart disease, spinal cord injuries, neurologic disorders).. Clinical studies, case reports, and commentaries and editorials concerning sildenafil published in the international literature between January 1999 and August 2000 were identified through searches of MEDLINE, PREMEDLINE, and International Pharmaceutical Abstracts, using the terms sildenafil, Viagra, and erectile dysfunction.. Sildenafil has demonstrated effectiveness in men with erectile dysfunction associated with prostatectomy, radiation therapy, diabetes mellitus, certain neurologic disorders, and drug therapy (eg, selective serotonin reuptake inhibitors [SSRIs]). It has not been as effective in women with sexual dysfunction, with the exception of SSRI-associated sexual dysfunction. Some disorders unrelated to sexual dysfunction (eg, esophageal motility dysfunction) may also respond to sildenafil. In the general population, sildenafil is considered to have an acceptable tolerability profile; however, patients with moderate to severe cardiovascular disease or those taking nitrate therapy are at increased risk for potentially serious cardiovascular adverse effects with sildenafil therapy. In addition, patients taking drugs that inhibit the cytochrome P450 3A4 isozyme, which metabolizes sildenafil, may experience increased drug concentrations and possible toxicity from normal doses of sildenafil.. Sildenafil is an effective first-line therapy for erectile dysfunction in men. The decision to prescribe this agent should include such considerations as the cost-risk-benefit balance, patient access, drug distribution pathways, and prescription drug coverage.

Topics: Drug Interactions; Erectile Dysfunction; Female; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Optimal therapeutics and the prevention of adverse drug effects begin with complete information. When new drugs are released, the manufacturer's product information is the main and often only readily available source of drug information and, therefore, greatly influences treatment strategies. Thus, it is vital that the information in the package insert is not only complete, but also as relevant as possible for the great diversity of patients that physicians encounter.. To review the product information for sildenafil for comprehensiveness and accuracy, with respect to whether the information is sufficient to facilitate optimal therapeutics and to prevent avoidable adverse events in the wide diversity of patients with erectile dysfunction seen in clinical practice.. Sildenafil package inserts, unpublished information provided by the manufacturer, Food and Drug Administration reports, and articles retrieved through MEDLINE through March 2000.. Deficiencies or inaccuracies persist in the sildenafil product information regarding sildenafil's effects on blood pressure; potential drug interactions with cimetidine, protease inhibitors, some antihypertensive drugs, alcohol, and drugs that may competitively inhibit cytochrome P450 pathways; and recommended sildenafil doses for older patients.. For physicians to practice optimal therapeutics, adequate, clinically relevant drug information is required. Several brief changes and additions in the sildenafil product information would assist physicians in making therapeutic decisions regarding the use of sildenafil in a very diverse patient population and in avoiding preventable adverse events.

Topics: Aged; Drug Interactions; Erectile Dysfunction; Humans; Information Services; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Sildenafil has been registered for the treatment of erectile dysfunction since 1998. World wide a large number of patients were reported, dying of acute heart disease after using sildenafil. Therefore the patient instruction text was adapted. Simultaneous use of sildenafil and nitrates is contraindicated because of serious decrease of the blood pressure. The use of sildenafil can lead to physical stress in patients with a history of heart disease and a treadmill test assessment is advisable. In two years 38 adverse reactions were seen in 25 Dutch patients. The Dutch reports (three cardiovascular deaths since the introduction) also show the dilemmas in the assessment of the safety of sildenafil: is it the underlying disease or is it the drug that causes death? Further research into the adverse reactions has to be done, therefore reporting suspected side effects of sildenafil is important.

Topics: Adverse Drug Reaction Reporting Systems; Arrhythmias, Cardiac; Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Myocardial Infarction; Netherlands; Phosphodiesterase Inhibitors; Physical Exertion; Piperazines; Purines; Retinal Hemorrhage; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) occurs in varying degrees in an estimated 20 to 30 million American men and is associated with adverse effects on quality of life; particularly personal well-being, family and social interrelationships. Research into ED has focused primarily on the physiologic mechanisms of corpus cavernosum smooth muscle relaxation, and penile erection as the end result of smooth muscle relaxation. These processes are mediated by cholinergic, nonadrenergic, noncholinergic (NANC, e.g., nitric oxide), vasoactive intestinal peptide (VIP), and potentially calcitonin gene-related peptide (CGRP) containing nerves. Release of nitric oxide following sexual stimulation from non-adrenergic, non cholinergic nerves and vascular endothelium activates guanylyl cyclase and induces intracellular cGMP synthesis. In turn, cGMP results in lowering intracellular concentrations, inhibits contractility of the penile smooth muscle, and induces an erectile response. Phosphodiesterase type 5 (PDE 5) is the predominant enzyme responsible for cGMP hydrolysis in trabecular smooth muscle. Activation of PDE 5 terminates NO-induced, cGMP-mediated smooth muscle relaxation, and subsequent penile flaccidity. Sildenafil citrate is a potent PDE type 5 reversible and selective inhibitor which blocks cGMP hydrolysis effectively. FDA approval of sildenafil citrate as the first oral agent for ED in males has resulted in significant interest. We discuss the clinical and pharmacologic properties of sildenafil citrate as well as the urologic and cardiac implications.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Cardiovascular Physiological Phenomena; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones

In the three years since its launch, sildenafil citrate (Viagra), an oral agent for the treatment of erectile dysfunction (ED), has been prescribed to more than 10 million patients worldwide and has been further evaluated in clinical studies in diverse patient populations. Significant improvements in erectile function have been demonstrated in double-blind, placebo-controlled trials in patients with ED and underlying diabetes, cardiovascular disease, minor depression, spinal cord injury and multiple sclerosis. Promising results have also been reported for patients with treated prostate cancer, end-stage renal failure, Parkinson's disease, and spina bifida and in multiple organ transplant recipients. Accounts of sildenafil use in clinical practice and postmarketing data reflect clinical trial findings of effectiveness in a broad spectrum of ED aetiologies and overall good tolerability. As in the clinical trials, most adverse events associated with sildenafil use have been transient, mild or moderate effects that rarely lead to treatment discontinuation.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Physician's Role; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Spermatozoa; Sulfones; Treatment Outcome

Despite isolated reports of myocardial infarction and sudden cardiac death in men taking sildenafil for erectile dysfunction, clinical evidence shows the drug to be safe, effective, and well tolerated in most men with coronary artery disease. Nevertheless, caution is advised in specific instances.

Topics: Contraindications; Coronary Disease; Death, Sudden, Cardiac; Drug Interactions; Erectile Dysfunction; Hemodynamics; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Sildenafil is an oral treatment for erectile dysfunction (ED). It acts as an inhibitor of 3',5'-cyclic guanosine monophosphate-phosphodiesterase type 5. An effective treatment for ED is required to produce an erectile response sufficient for satisfactory sexual performance. This has been documented for sildenafil in men with ED of differing aetiologies and baseline severity in various types of clinical trials. Sildenafil treatment is characterised by a good tolerability profile and low treatment digcontinuation rate caused by treatment-related adverse effects. Most of the adverse effects associated with sildenafil are extensions of the pharmacological action of the drug. There is no significant difference in the adverse effect profile (headache, flushing, dyspepsia, nasal congestion and abnormal vision) of this agent as assessed by clinical data obtained either in the pre- and postlaunch periods. Because of its acceptable risk-benefit ratio, sildenafil can be prescribed to a very large group of patients with ED. The reports of serious cardiovascular events associated with the use of sildenafil (including anecdotal reports of deaths) have been very thoroughly analysed. A number of studies have not shown any difference in the risk of serious cardiovascular events in sildenafil- and placebo-treated patients. However, when making a risk-benefit evaluation, certain subgroups of patients need to be considered separately. In particular, sildenafil is contraindicated in patients receiving nitrate therapy. In some other subgroups of patients, the risks and benefits of treatment need to be assessed on an individual basis and it is hoped that additional data will clarify any possible risks associated with sildenafil administration such patients. It is helpful to compare the risk-benefit profile of sildenafil with the characteristics of other oral drugs for ED. According to the preliminary data, apomorphine and phentolamine are possible future options for the treatment of ED; however, there needs to be further clinical evaluation of these agents. Initial data have shown that sildenafil can be successfully combined with intracavernosal injection in patients nonresponders to either therapy. In conclusion, favourable characteristics make sildenafil suitable for the first-line therapy for a substantial proportion of patients with ED.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Clinical Trials as Topic; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Assessment; Sildenafil Citrate; Sulfones

The functional state of the penis, flaccid or erect is governed by smooth muscle tone. Sympathetic contractile factors maintain flaccidity whilst parasympathetic factors induce smooth muscle relaxation and erection. It is generally accepted that nitric oxide (NO) is the principal agent responsible for relaxation of penile smooth muscle. NO is derived from two principal sources: directly from non-adrenergic non-cholinergic parasympathetic nerves and indirectly from the endothelium lining cavernosal sinusoids and blood vessels in response to cholinergic stimulation. The generation of NO from L-arginine is catalysed by nitric oxide synthase (NOS). There has been controversy over the relative prevalence of endothelial or neuronal NOS within the penis of different animal species. This review examines the role of NO in the penis in detail. Established and new treatments for erectile dysfunction whose effects are mediated via manipulation of the NO pathway are also described.

Topics: Animals; Arginine; Erectile Dysfunction; Genetic Therapy; Humans; Male; Muscle Relaxation; Muscle, Smooth, Vascular; Nitric Oxide; Papaverine; Penile Erection; Penis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Advertising; Anti-Obesity Agents; Canada; Decision Making, Organizational; Drug Industry; Drug Prescriptions; Erectile Dysfunction; Female; Health Care Rationing; Humans; Lactones; Life Style; Male; National Health Programs; Obesity; Orlistat; Patient Selection; Phosphodiesterase Inhibitors; Piperazines; Practice Patterns, Physicians'; Purines; Sildenafil Citrate; Sulfones

Topics: Cause of Death; Drug Interactions; Erectile Dysfunction; Female; Heart Diseases; Hemodynamics; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Product Surveillance, Postmarketing; Purines; Risk Factors; Safety; Sexual Dysfunctions, Psychological; Sildenafil Citrate; Sulfones

Neurologic erectile dysfunction presents a diagnostic and treatment challenge to the internist and urologist. Multiple chronic disease modalities and traumatic etiologies exist. Education regarding these conditions and a detailed and thorough history and office work-up are the best resources for the clinician. Treatment can follow the model of proceeding from the least to most invasive procedure (process of care), taking into account patient and partner satisfaction. Because the psychology of grief and loss may enter into treatment of some neurologic conditions (e.g., erectile dysfunction after radical retropubic prostatectomy, spinal cord injury, or chronic diseases), a whole-patient approach encompassing psychotherapy is warranted.

Topics: Chronic Disease; Diabetic Neuropathies; Erectile Dysfunction; Humans; Intervertebral Disc Displacement; Male; Multiple Sclerosis; Parkinson Disease; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Oral drugs are a well-established, first-line therapy for erectile dysfunction. As a result of the success of sildenafil, a plethora of new drugs for erectile dysfunction are on the horizon. Apomorphine and IC351 are in late phase III development. Vardenafil (Bayer, New Haven, CT), a PDE5 inhibitor, and the combination of yohimbine and L-arginine (NitroMed, Boston, MA) are in early phase III development. Early clinical and preclinical studies are investigating new phosphodiesterase inhibitors, cyclic AMP activators, alpha-adrenergic antagonists, dopamine agonists, melanocyte-stimulating hormone, potassium channel modulators, endothelin antagonists, and new nitric oxide donors. The future is bright for this infant field of sexual pharmacotherapy.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Apomorphine; Cardiovascular System; Contraindications; Coronary Disease; Cyclic Nucleotide Phosphodiesterases, Type 5; Dopamine Agonists; Erectile Dysfunction; Heart; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

The grouping together of erectile dysfunction and erectile disorder (i.e. dysfunction with distress) has led to the presentation of incredibly high prevalences (up to 52%). When limited to erectile disorder, two Dutch open population studies, among men aged 40-79 years, show remarkably similar and more realistic prevalences, namely 3 to 10%. Although the 'Leiden Impotence Screening Test' appears to reliably exclude somatic aetiological factors, it would be preferable if the general physician posed such diagnostic questions. It is hoped that the availability of pharmacotherapeutic treatments (notably sildenafil) will not tempt the general physician to join the patient in his inclination to 'somatise' his erectile disorder. Both intracavernosal self-injection therapy and the implantation of an erectile prosthesis give rise to a large proportion of dissatisfied men. In the Netherlands to date, the number of continuation prescriptions for sildenafil equals the number of first prescriptions, which suggests that many men also stop with this therapy. In the Netherlands, health insurance companies only reimburse self-injections and prosthesis implantations. It can be argued that all cost-effective treatments for erectile disorder, including psychosexual therapy, should be reimbursed, or none at all.

Topics: Adult; Aged; Erectile Dysfunction; Humans; Injections; Insurance Coverage; Male; Middle Aged; Netherlands; Papaverine; Patient Satisfaction; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Prevalence; Psychotherapy; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) affects as many as 30 million men in the United States. Its risk factors are similar to those for atherosclerotic heart disease. Physicians should ask male patients--particularly those with cardiovascular disease--about ED and men with confirmed ED about cardiovascular risk factors. Oral sildenafil is an effective therapy for both organic and psychogenic ED; it is contraindicated in patients taking organic nitrates.

Topics: Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones

Topics: Alprostadil; Erectile Dysfunction; Humans; Male; Parkinson Disease; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Review of literature.. To review the physical aspects related to penile erection, ejaculatory dysfunction, semen characteristics, and techniques for enhancement of fertility in spinal cord lesioned (SCL) men.. Worldwide: individuals with traumatic as well as non-traumatic SCL.. Recommendations for management of erectile dysfunction in SCL men: If it is possible to obtain a satisfactory erection but of insufficient duration, then try to use a venous constrictor band to find out if this is sufficient to maintain the erection. Otherwise we recommend Sildenafil. If Sildenafil is not satisfactory then use intracavernous injection with prostaglandin E(1) (some SCL men may prefer cutaneous or intraurethral application). We discourage the implantation of penile prosthesis for the sole purpose of erection. Recommendations for management of ejaculatory dysfunction in SCL men: Penile vibratory stimulation (PVS) to induce ejaculation is recommended as first treatment choice. If PVS fails, SCL men should be referred for electroejaculation (EEJ). Semen characteristics: Impaired semen profiles with low motility rates are seen in the majority of SCL men. Recently reported data gives evidence of a decline in spermatogenesis and motility of ejaculated spermatozoa shortly after (few weeks) an acute SCL. It is suggested that some factors in the seminal plasma and/or disordered storage of spermatozoa in the seminal vesicles are mainly responsible for the impaired semen profiles in men with chronic SCL. Fertility: Home insemination with semen obtained by PVS and introduced intravaginally in order to achieve successful pregnancies may be an option for some SCL men and their partners. The majority of SCL men will further enhance their fertility potential when using either PVS or EEJ combined with assisted reproduction techniques such as intrauterine insemination or in vitro fertilization with or without intracytoplasmic sperm injection.

Topics: Alprostadil; Ejaculation; Electric Stimulation Therapy; Erectile Dysfunction; Humans; Infertility, Male; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Reproductive Techniques; Semen; Sildenafil Citrate; Sperm Motility; Spinal Cord Injuries; Sulfones; Vasodilator Agents; Vibration

The two words that mean sexual dysfunction, impotence and erectile dysfunction (ED), express two different concepts. Impotence is a general male sexual dysfunction that includes libidinal, orgasmic, and ejaculatory dysfunction. ED is the inability to achieve or maintain an erection sufficient to allow satisfactory sexual intercourse and is part of the general male sexual dysfunction termed impotence that includes libidinal, orgasmic, and ejaculatory dysfunction. Uremic men of different ages report a variety of sexual problems, including sexual hormonal pattern alterations, reduction in or loss of libido, infertility, and impotence, conditioning their well-being status. In evaluating and treating sexual dysfunction, a nephrologist must consider factors involved in its pathogenesis, such as hypothalamic-pituitary-gonadal axis alterations, psychological problems related to chronic disease, secondary hyperparathyroidism, anemia, autonomic neuropathy, derangements in arterial supply or venous outflow, and the normal structure of cavernous body smooth muscle cells. The introduction of sildenafil to treat impotent patients has completely changed the approach to evaluating these subjects because this drug is considered an effective well-tolerated treatment for men with ED. In the past, we proposed an algorithm that gave the opportunity to explore the previously mentioned factors using such instrumental interventions as the nocturnal penile tumescence test, penile echo color Doppler, nervous conduction velocity, and cavernous body biopsy, addressed to prescribe needed surgical or medical interventions. The complexity of the proposed algorithm requires many diagnostic procedures and much time and economic resources to localize the pathological lesions responsible for ED. Because of the new oral drug sildenafil, we propose a new algorithm to test the possibility of obtaining an erection and classify patients as responders or nonresponders to the sildenafil test.

Topics: Bromocriptine; Erectile Dysfunction; Humans; Male; Penile Prosthesis; Piperazines; Purines; Renal Dialysis; Sildenafil Citrate; Sulfones; Uremia

Topics: Adrenergic alpha-Antagonists; Alprostadil; Apomorphine; Erectile Dysfunction; Humans; Hypogonadism; Imidazoles; Male; Penile Implantation; Physical Therapy Modalities; Piperazines; Psychotherapy; Purines; Sildenafil Citrate; Sulfones; Testosterone; Triazines; Vacuum; Vardenafil Dihydrochloride; Vascular Surgical Procedures; Vasodilator Agents; Yohimbine

Most studies indicate general satisfaction rates of greater than 80% after radical retropubic prostatectomy. Nonetheless, erectile dysfunction remains the most common problem postoperatively, with rates ranging from 100% to 10% depending on the experience of the surgeon, the frequency with which he or she performs the surgery, the nerve-sparing nature of the procedure, the stage of the disease, and the age and preoperative potency of the patient. The natural recovery of erection function takes as long as 24 months and can be expedited by early treatment with intracorporal injection therapy. The treatment of erectile dysfunction after radical retropubic prostatectomy is highly successful despite the finding that fewer than 50% of patients seek treatment. Sildenafil does not seem to be effective early in the recovery phase but increases in efficacy as the nerves recover from intraoperative injury. Other modalities in the early recovery phase in the order of increasing effectiveness are intraurethral prostaglandin, the vacuum erection device, and intracorporal injection therapy. After 2 years from surgery, the recovery of natural function and improved sildenafil responsiveness are unlikely, and the implantation of a prosthesis is reasonable if other modalities are ineffective or unacceptable for the patient. Animal studies and human trials are underway to examine ways to expedite and maximize the return of erectile function.

Topics: Alprostadil; Blood Vessels; Erectile Dysfunction; Forecasting; Humans; Intraoperative Complications; Male; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Vacuum; Vasodilator Agents

Hypertension is an important risk factor for erectile dysfunction (ED). Consequently, there is a high coincidence between hypertension and ED. Oral sildenafil (Viagra) is an effective treatment for ED in patients with treated or untreated hypertension. The most common adverse events of sildenafil (headache, flushing, hypotension) result from its moderate vasodilating properties. The concomitant use of sildenafil and organic nitrates is contraindicated because it may lead to a potentiation of the decreases in blood pressure and thus cause life-threatening hypotension. In contrast, the concomitant use of sildenafil and different classes of antihypertensive agents (beta-blockers, alpha-blockers, diuretics, ACE inhibitors, calcium antagonists) may lead to additive but not to potentiating blood pressure decreases. Thus, this combination is unlikely to cause clinically significant hypotension or an increased incidence of adverse events. Sildenafil is an effective and well-tolerated treatment for ED in patients taking concomitant antihypertensive medication, including those on multidrug regimens.

Topics: Adult; Aged; Antihypertensive Agents; Blood Pressure; Drug Interactions; Drug Therapy, Combination; Erectile Dysfunction; Hemodynamics; Humans; Hypertension; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Placebos; Posture; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Time Factors

Topics: Cardiovascular Diseases; Depressive Disorder; Diabetes Complications; Erectile Dysfunction; Humans; Hypertension; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatic Diseases; Purines; Sildenafil Citrate; Smoking; Sulfones

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Erectile Dysfunction; Gonadal Steroid Hormones; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Testosterone

Despite the revolutionary introduction of oral erectogenic agents for the treatment of erectile dysfunction, there will always be patients who do not respond to conservative therapy. Penile prosthetic surgery remains an important option for these patients. Mechanical reliability and patient satisfaction have improved significantly throughout the years. This review focuses on the most recent and important updates regarding product enhancements, patient satisfaction studies, and management of intra- and postoperative problems.

Topics: Erectile Dysfunction; Forecasting; Humans; Intraoperative Complications; Male; Patient Satisfaction; Patient Selection; Penile Induration; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Postoperative Complications; Preoperative Care; Purines; Reproducibility of Results; Sildenafil Citrate; Sulfones; Time Factors; Treatment Outcome

Sildenafil (Viagra), a new oral drug for the treatment of erectile dysfunction, was licensed for use across Europe in 1998.. To examine the effectiveness and safety of sildenafil as an oral treatment for erectile dysfunction.. Systematic review and meta-analysis.. All published or unpublished randomised controlled trials comparing sildenafil with a placebo or alternative therapies.. Published studies were sought by computerised searches of electronic databases using the keywords 'sildenafil' and 'Viagra'. A hand search was also done of the British Medical Journal, Lancet, Journal of the American Medical Association, New England Journal of Medicine, British journal of General Practice, Drug, Inpharma and Scrip. An assessment of quality of all identified studies and data extraction was undertaken independently by two researchers. Results were combined in a meta-analysis where appropriate, using RevMan version 3.. Twenty-one trials were identified. All trials showed a statistically significant improvement in erectile or sexual function in patients using sildenafil compared with a placebo. A meta-analysis of 16 trials reporting a global efficacy response showed that men were 3.57 (95% CI = 2.93-4.43) times as likely to have improved erections on sildenafil compared with those on a placebo. The number needed to treat to have one man with improved erections was two. The drug has a relatively safe side-effect profile.. Available research shows that sildenafil is an effective treatment for male erectile dysfunction. Many trial participants had some baseline erectile function and it is probable that in clinical practice, where the erectile function tends to be more impaired, the number needed to treat may be higher.

Topics: Adult; Aged; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Diabetes Complications; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones; Treatment Outcome

There is now significant evidence that erectile dysfunction (ED) can be a symptom of cardiovascular disease, and can act as a marker for disease progression. National Health Service (NHS) prescribing restrictions on treatments for ED have recently been reviewed by the Department of Health, and current arrangements will not change. Unrestricted availability of licensed treatments for ED on the NHS, irrespective of the cause of the ED, may encourage men to present for investigation, enabling early detection of cardiovascular disease. Sildenafil citrate (Viagra), an effective treatment for ED, can also have a direct beneficial effect on cardiovascular disease. Unrestricted NHS availability of ED treatments such as sildenafil could facilitate greater achievement of National Service Framework targets for coronary heart disease.

Topics: Adult; Aged; Algorithms; Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Selection; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Administration, Oral; Adult; Aged; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Erectile Dysfunction; Follow-Up Studies; Humans; India; Male; Middle Aged; Piperazines; Purines; Risk Assessment; Sildenafil Citrate; Sulfones; Treatment Outcome

In treating erectile dysfunction (ED) effectively, a hierarchy of treatments based on efficacy, safety, and other factors can be a valuable instrument for assisting clinical decisions. First-line therapies, in this hierarchy, include sildenafil--the only orally administered erectogenic drug currently available--vacuum constriction devices, and psychological counseling and sexual therapy. Second-line therapies include intracavernous injection and intraurethral suppositories. Third-line therapies include penile implant surgery. This article presents a broad overview of all available therapies, but concentrates on sildenafil as the current paradigm of broadly efficacious, safe, and convenient treatment for ED.

Topics: Counseling; Erectile Dysfunction; Humans; Male; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Contraindications; Erectile Dysfunction; Female; Heart; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

The Internet is changing the way medicine is being practiced and challenging our notions of the doctor-patient relationship. We analyze the development of online prescriptions and propose guidelines for the sale of sildenafil over the Internet.. Using MEDLINE, Medscape and Lexis-Nexis search engines we reviewed pertinent materials from January 1996 to July 1999 focusing on the keywords Viagra, prescription and Internet. The review included press releases, law review articles, case law, medical literature, pending litigation, proposed legislation, and federal and state statutes.. Online prescriptions are an outgrowth of the mail order drug business. This development continues the historic innovations in communications and transportation that have enabled physicians to practice medicine over long distances while maintaining ties to hospitals and other specialists. While the sale of sildenafil over the Internet may be profitable and convenient, it raises a variety of legal, ethical and safety concerns. Many federal and state organizations have addressed the issue without establishing a clear standard.. A clear distinction exists between online prescriptions and pharmacies. While it may be acceptable for sildenafil to be sold over the Internet given current technologies, it must be done within the confines of a traditional doctor-patient relationship. Online prescriptions must be limited to patients who live in states in which the prescribing physician is licensed. Failure to establish a doctor patient relationship in this context breeches ethical standards, and may give rise to potential civil and criminal liabilities.

Topics: Erectile Dysfunction; Humans; Internet; Liability, Legal; Marketing of Health Services; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; United States

Erectile dysfunction is a common and distressing medical condition that is now highly amenable to treatment almost irrespective of the cause. Safe, non-surgical treatments with unequivocal efficacy are psychological therapy, intracorporeal injection of vasoactive drugs, transurethral vasodilators and oral sildenafil, all of which have been reported to have a 50-70% overall response rate. Vacuum constriction devices are acceptable for some, usually older patients and oral yohimbine is thought to have marginal efficacy. Local creams to induce or enhance erectile function are currently being investigated. There is no place for androgen supplementation unless the patient is profoundly hypogonadal. Treatment of hyperprolactinaemia is very effective but is a rare cause of erectile dysfunction. As intercourse may entail an unfamiliar level of physical activity, it is sensible to ensure that the patient is able to climb a flight or two of stairs comfortably without provoking undue breathlessness or chest pain and to provide suitable advice about technique before commencing treatment. Once it is clear to the patients that erectile dysfunction can be satisfactorily overcome, the long-term use of treatments to do so tends to wane. Thus, although the prospect of effective treatment for what had been for many a distressing life sentence has the potential to place new demands on the health service, there is no evidence that restrictions on prescribing will prove economically rational.

Topics: Administration, Topical; Alprostadil; Erectile Dysfunction; Humans; Male; Middle Aged; Nitrates; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Psychotherapy; Purines; Sildenafil Citrate; Sulfones; Testosterone; Vacuum; Vasodilator Agents

The early detection of prostate cancer through the use of prostate-specific antigen screening has resulted in the performance of many more radical prostatectomy procedures as a curative treatment for this disease. Many patients who are candidates for this procedure already suffer from erectile dysfunction, and the incidence of inadequate erections following radical prostatectomy is certainly high. Nerve-sparing procedures during performance of this operation are encouraged as the incidence of erectile dysfunction is lower if one or both nerves are spared. If the patient is already impotent before the procedure, medical treatments with oral agents, intraurethral compounds, or intracorporally injected medications may be more effective with the nerves intact. Early institution of medical therapy, specifically intracorporal injections, after 2 months postoperatively has resulted in a higher incidence of spontaneous return of erections at 1 year. Vacuum erection devices may be successful in restoring erections but extensive practice in their use is necessary, and they may be unappealing to many patients. A penile prosthesis will restore erections if the patient is so motivated for implantation of such a device. These are expensive and require invasive surgery, but satisfaction rates among patients and partners who have used them have been in the range of 85%, the highest satisfaction rate among all of the treatments of erectile dysfunction.

Topics: Age Factors; Costs and Cost Analysis; Erectile Dysfunction; Humans; Male; Papaverine; Penile Implantation; Phosphodiesterase Inhibitors; Piperazines; Prostate-Specific Antigen; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Vacuum

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Animals; Blood Platelets; Cell Adhesion; Cell Adhesion Molecules; Endothelium, Vascular; Enzyme Inhibitors; Epoprostenol; Erectile Dysfunction; Humans; Male; Models, Biological; Neutrophils; Nitric Oxide; Oxidative Stress; Piperazines; Platelet Aggregation; Purines; Sildenafil Citrate; Sulfones

Erectile disfunction (E. D.) is more common in older men but may affect younger men too. Diabetes mellitus, coronary heart disease and hypertension are often associated with E. D. The majority of the patients are treated medically for erectile dysfunction and, recently, oral therapy has become most important since Viagra has been approved. New phosphodiesterase blockers are in preclinical evaluation since then. Phentolamine and apomorphine will become available soon for the treatment of E. D. It is important to know about the etiology of E. D. as well as the mechanisms by which drugs may improve erection in order to decide which drug is appropriate for a particular patient.

Topics: Administration, Oral; Adrenergic alpha-Antagonists; Adult; Apomorphine; Dopamine Agonists; Erectile Dysfunction; Humans; Male; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Purines; Selective Serotonin Reuptake Inhibitors; Sildenafil Citrate; Sulfones; Trazodone; Yohimbine

This paper examined the economic cost of male erectile dysfunction (ED) for a hypothetical managed-care (MC) model.. A prevalence-based cost-of-illness approach was used to estimate the direct medical cost for ED treatment. A treatment plan algorithm was developed from a MC perspective to model the initial treatment selection of various patient groups [vacuum erection device, intracavernosal injection (ICI) therapy, transurethral alprostadil suppository, sildenafil, testosterone replacement therapy, penile prosthesis] and their therapy outcomes during a 3-year period. Overall cost was based on 1998 US dollars. Total direct medical cost of ED considered in this model included the cost of initial physician consultation and evaluation, the cost incurred by patients from various treatment groups (pharmacological and surgical options), as well as the cost related to patients' follow-up for treatment within the 3-year period. Consideration for therapy switches made by patients who failed initial therapy was included as part of the clinical assumptions for this model. Treatment response and expected outcomes (dropouts) were considered for the various treatment options.. A total of 100,000 enrolled members were included in the study.. The total cost of ED was $US3,204,792 for the 3-year period in the hypothetical MC plan. The treatment portion accounted for approximately 80% of the total cost while the cost of medical services and diagnostic tests were minimal in comparison. The 3 year total cost of nonsurgical treatment was $US2,473,045. Costs associated with each treatment alternative were $US81,866 (testosterone transdermal patch), $US51,930 (vacuum erection device), $US384,624 (ICI therapy), $US226,483 (transurethral alprostadil suppository) and $US1,728,142 (sildenafil citrate). Results from the model showed a noticeable trend of decreasing cost patterns over time and reflected the attrition observed for many of the standard medical therapies for ED.. Sildenafil and the vacuum erection device should be considered as first-line management strategies for ED whereas ICI therapy, transurethral alprostadil suppository and penile prosthesis implant should be reserved for second- or third-line therapy. Because costs associated with switches related to successive treatment failures can be high, treatment considerations should, therefore, focus on achieving long term patient satisfaction. The patient's preferred treatment choice, using goal-directed therapy during the initial consultation and evaluation visit, should be used.

Topics: Adult; Aged; Aged, 80 and over; Algorithms; Cost of Illness; Decision Support Techniques; Erectile Dysfunction; Humans; Male; Managed Care Programs; Middle Aged; Penile Implantation; Phosphodiesterase Inhibitors; Piperazines; Prevalence; Purines; Sildenafil Citrate; Sulfones; United States

Sildenafil (Viagra) is a substance for the treatment of erectile dysfunction. Great expectations are connected with its introduction into the market. In this situation the multidimensionality in the control-mechanismus of the sexual reaction and of the satisfaction in the sexual experience are pointed out. These aspects affect the diagnostic and therapeutic competence of psychiatry and psychotherapy in a high degree. Efficient psycho-educative and psychotherapeutic ways of treatment for sexual dysfunction are available. Increased specific knowledge in this area is required by psychiatrists, medical psychotherapists and neuropsychiatrists.

Topics: Combined Modality Therapy; Erectile Dysfunction; Humans; Male; Patient Care Team; Phosphodiesterase Inhibitors; Piperazines; Psychotherapy; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Topics: Clinical Trials as Topic; Drug Design; Erectile Dysfunction; Humans; Male; Muscle Relaxation; Muscle, Smooth, Vascular; Nitric Oxide; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Viagra and in vitro fertilization (IVF) with intraovocyte injection of spermatozoa (ICSI) have revolutionized the treatments of impotence and male sterility. They are able to treat successfully most of the cases whatever is the cause of the problem. The andrologist is tempted to renounce to look for an etiological factor and to treat directly his patient. The risk is to miss a diagnosis such as genital tract obstruction, testicular cancer, gonadotropin deficiency, sperm autoimmunity, coital disorders, or reversible toxin exposures, which could benefit from a specific treatment. Moreover IVF can endanger the woman's health and genetic consequences must not be overlooked if ICSI is performed. Concerning impotence a diagnosis of prolactinoma, diabetes or ischemic cardiopathy must not be missed because Viagra can also have cardio-vascular side-effects. This article reviews some etiological factors responsible for male infertility or impotence. The importance of a global appraisal of the patient is underlined in order not to limit his role to the one of a sperm producer.

Topics: Erectile Dysfunction; Fertilization in Vitro; Humans; Infertility, Male; Male; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sperm Injections, Intracytoplasmic; Sulfones

Topics: Adrenergic Antagonists; Aging; Androgens; Drug Combinations; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Cardiovascular risk factors are commonly associated with erectile dysfunction and should be identified and treated. Patients with cardiovascular diseases should be assessed and counselled regarding their fitness for sexual activity. The danger of concurrent use of sildenafil and nitrates under any circumstances, regardless of age and sex, must be highlighted at all levels of the community. Sildenafil is absolutely contraindicated in patients receiving treatment with long-acting nitrates for ischaemic heart disease. Patients who need sublingual short-acting nitrates infrequently should not be precluded from taking sildenafil, provided they are aware that sildenafil is not to be taken within 24 h of taking the nitrate.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Algorithms; Cardiovascular Diseases; Coitus; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Drug Costs; Drug Prescriptions; Erectile Dysfunction; Health Priorities; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Sweden

The new era of erectile dysfunction (ED) medicine ushered in by the availability of an effective and safe oral medication paves the way toward managing ED in a primary care setting. The Process of Care Model for the Evaluation and Treatment of Erectile Dysfunction was developed to advance new guidelines for the diagnosis and management of ED. This paper discusses these guidelines.

Topics: Erectile Dysfunction; Humans; Male; Models, Nursing; Nurse Practitioners; Nursing Assessment; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Adult; Aged; Contraindications; Coronary Disease; Drug Interactions; Erectile Dysfunction; Humans; Hypertension; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erection is initiated through the parasympathetic nervous system, activation of which overrides the sympathetic tone that maintains the penis in a nonerectile (flaccid) state. This state is maintained mainly through the release of norepinephrine from penile adrenergic nerves. Norepinephrine contracts the vasculature and cavernosal smooth muscle. Arousal/erection is associated with a decrease of norepinephrine release in the penis, with a release of nitric oxide, and with a reduction in penile smooth muscle tone. It is also associated with minor cardiovascular changes. Heart rate increases by 4-8 beats per minute, on average, and the rate-pressure product and oxygen consumption increase by approximately 25%. There may be no changes in systemic venous norepinephrine concentrations; systemic venous epinephrine concentrations increase by about 60%. Drugs initiating or enhancing erection act by inhibiting norepinephrine-induced contraction (e.g., phentolamine) or by enhancing or directly inducing relaxation of the corpora cavernosa and the penile vasculature (e.g., sildenafil). Despite potentially negative hemodynamic actions when given parenterally, oral phentolamine-in doses required for enhancing erection-appears to produce few cardiovascular adverse effects. The hemodynamic effects of sildenafil are small, even in patients with coronary artery disease. However, the effects of the drug on human myocardium have not been conclusively established, and should be further investigated. As judged by available information, the cardiac risk associated with erection, with or without enhancement of drugs currently used for treatment of erectile dysfunction, is low.

Topics: Adrenergic alpha-Antagonists; Animals; Coronary Disease; Erectile Dysfunction; Heart; Humans; Male; Norepinephrine; Penile Erection; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Stable angina pectoris is a common condition associated with chest pain predictable for a given level of exercise. Sexual intercourse does not lead to exaggerated heart rate or blood pressure responses and is interpreted by the heart as one of many forms of activity that may take place in a 24-hour period. Stable angina patients optimally treated are not at significantly increased cardiovascular risk during sexual intercourse. Erectile dysfunction (ED) increases with age and shares similar cardiovascular risk factors with stable angina. Sildenafil citrate can be safely prescribed for stable patients with ED providing they are not taking oral, topical, or sublingual nitrates. Sexual relationships should not be constrained by the diagnosis of angina pectoris provided appropriate medical advice is given on risk status. Family physicians and specialists are able to provide this advice based on their knowledge of the patient and the social circumstances. Impersonal advice is potentially dangerous and should be vigorously discouraged.

Topics: Angina Pectoris; Cause of Death; Coitus; Contraindications; Erectile Dysfunction; Humans; Male; Myocardial Infarction; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones

Sildenafil citrate is the first oral agent approved for the treatment of erectile dysfunction (ED); other oral agents are in the process of development. Because the mechanism of action of many of these agents involves vasodilation, there is a potential for interaction with the cardiovascular system. Sildenafil inhibits phosphodiesterase-5 (PDE-5) which is found in the corpus cavernosum and in the systemic vasculature. Sildenafil causes a mild decrease in systemic arterial pressure ( approximately -8/-5.5 mm Hg); it causes a synergistic and often major decrease in systemic arterial pressure in the presence of organic nitrates (nitric oxide donors). Sildenafil is therefore contraindicated in patients taking organic nitrates. A review was made of clinical trials in populations of men with (1) erectile dysfunction; (2) chronic stable ischemic heart disease and erectile dysfunction; and (3) hypertension and erectile dysfunction. This review showed that sildenafil was effective and not associated with an increase in serious cardiovascular adverse events, myocardial infarction (MI), or death compared with placebo. Although there have been spontaneous reports of death among men using sildenafil, there are limitations to spontaneous-event reporting. In addition. the numbers of such reports are well below the expected numbers of deaths when considering the number of men who have received prescriptions for sildenafil and their age and cardiovascular risk factor profile. Because there is a small but finite risk of having a cardiac event with sexual activity, physicians should discuss with their cardiac patients the risks of sexual activity before prescribing any treatment for ED. In addition, they should evaluate their patients' cardiac status when considering the safety of administering any ED treatment that may have systemic vasodilatory properties and can potentially lower blood pressure. In some cases, exercise treadmill testing may be warranted to determine whether ED patients with coronary artery disease can achieve the physiologic workload (4-6 metabolic equivalents) associated with sexual intercourse.

Topics: Clinical Trials as Topic; Death, Sudden, Cardiac; Erectile Dysfunction; Humans; Male; Myocardial Infarction; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones

Sildenafil is highly effective for treating erectile dysfunction (ED). However, its use has been associated with serious adverse events including myocardial infarctions and strokes, and 130 verifiable plus 112 unverified deaths reported to the US Food and Drug Administration during the 8 months after sildenafil was introduced in the US, and 522 reported deaths during the 13.5 months after its introduction. Moreover, some events have occurred in men taking their first dose of the agent, suggesting that sildenafil, like some drugs that affect blood pressure, may provoke a first-dose reaction. This possibility warrants extra caution to be used when initiating treatment with sildenafil. Such caution is not currently provided by the current dosage guidelines that, for example, recommend the use of sildenafil 50 mg initially for most men between the ages of 18 and 65 years, despite wide differences in bodyweight, age, drug metabolism, health status and usage of other medications. It can be difficult to identify the patient who may be unusually sensitive to the effects of sildenafil. Exercise stress tests have been recommended, but serious adverse events have occurred in men with normal stress tests following the ingestion of sildenafil. Blood pressure monitoring following sildenafil administration will not prevent a serious adverse drug event already in progress. This article discusses the advantages and disadvantages of initiating treatment with a low test dose of sildenafil, performed at home or in the doctor's office. The advantages of this approach include: (i) identifying patients who are highly sensitive to the effects of sildenafil and who may need no higher dose; (ii) minimising adverse effects such as flushing and dizziness that often frighten patients and may affect adherence; (iii) avoidance of major adverse events; and (iv) reassuring patients with ED who remain wary about trying sildenafil therapy.

Topics: Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

In this period we observed seven patients of whom four presented with low flow and three with high flow priapism. In two of the patients with ischemic priapism, simple blood aspiration from the corpora allowed for a quick detumescence, while in the other two cases a derivative intervention (one spongio cavernous and one glans cavernous) had to be performed. In all the three patients with high flow priapism we performed a superselective arteriography that obtained the visualisation of the arteriovenous fistula. These patients restarted their sexual activity after about three months. A six months a patient with low flow priapism restored sexual activity due to sildenafil 50 mg.

Topics: Adult; Aged; Algorithms; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Priapism; Purines; Sildenafil Citrate; Sulfones

Topics: Erectile Dysfunction; Heart Diseases; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Administration, Oral; Alprostadil; Equipment and Supplies; Erectile Dysfunction; Humans; Kidney Failure, Chronic; Male; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vacuum; Vasodilator Agents

There is little question as to the efficacy of sildenafil citrate (Viagra) for the treatment of erectile dysfunction. Two years of post-marketing experience provide data which indicates that the efficacy and safety of sildenafil citrate is consistent with the data obtained in clinical trials. This paper provides an update of the clinical efficacy and safety of sildenafil collected since its market approval in March of 1998. International Journal of Impotence Research (2000) 12, Suppl 4, S62-S66.

Topics: Antihypertensive Agents; Death; Drug Interactions; Erectile Dysfunction; Humans; Male; Myocardial Infarction; Phosphodiesterase Inhibitors; Piperazines; Purines; Safety; Sildenafil Citrate; Sulfones

Because sildenafil (Viagra) is scheduled to be clinically available in the near future, urologists in Japan must prepare for changes in the treatment of erectile dysfunction. The drug will surely influence our current clinical style of diagnosis and treatment of the dysfunction. We herein discuss this issue, referring to favorable and unfavorable effects that will be brought about by the drug. We also propose several future studies that we should do, including those on testosterone replacement therapy. We present results of our experiment using testosterone replacement therapy in aged rats and speculate about the mechanism by which the hormone replacement works in the sex center of the brain.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Animals; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Rats; Sildenafil Citrate; Sulfones; Testosterone

Erectile dysfunction affects a large segment of the male population, and in most cases impaired relaxation of the smooth muscle cells in the corpus cavernosum and the penile arteries is a factor. Sildenafil, a relatively specific vasodilator of the penile circulation, has revolutionized the treatment of impotence. This article describes the biochemistry of erection, outlines the problems that can lead to erectile dysfunction and explains how sildenafil acts to relieve these problems at the cellular and molecular level. Other aspects of therapy, such as potential side effects and absolute and relative contraindications, are also discussed.

Topics: Clinical Trials as Topic; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Diabetes can induce sexual disorders by different mechanisms. These troubles are more frequent in diabetics subjects. Thus, management of sexual impotence is an important aspect of diabetes care. However, most diabetologists are not trained to treat sexual disorders. The recent availability of oral drugs, i. e. Sildenafil (Viagra), has partly simplified the treatment of sexual impotence, particularly in diabetic patients. However, Viagra is efficient in only 60% cases in diabetic subjects. In the remaining cases, intracavernosal injections or vacuum can be used. Since Viagra has been available, more diabetic patients complained with sexual disorders, and ask for treatment of impotence. Cardio-vascular diseases must retain more attention in diabetic patients who are exposed to silencious myocardial ischemia. In such subjects, Viagra is not contra-indicated, but must be used after myocardial explorations, especially if the patients have cardio-vascular risk factors. However, patients and their doctors have been threatened by death cases reported with Viagra in United States. The lack of detailed informations has restrained Viagra's prescription. The following explains how to manage sexual disorders as part of diabetes care, and suggests rules for Viagra's prescription in diabetic patients.

Topics: Cardiovascular Diseases; Contraindications; Diabetes Complications; Diabetes Mellitus; Diabetic Angiopathies; Erectile Dysfunction; Humans; Male; Myocardial Ischemia; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) is defined as the consistent inability to obtain or maintain an erection for satisfactory sexual relations. An estimated 20-30 million men suffer from some degree of sexual dysfunction. The past 20 years of research on erectile physiology have increased our understanding of the biochemical factors and intracellular mechanisms responsible for corpus cavernosal smooth muscle contraction and relaxation, and revealed that ED is predominantly a disease of vascular origin. Since the advent of sildenafil (Viagra), there has been a resurgence of interest in ED, and an increase in patients presenting with this disease. A thorough knowledge of the physiology of erection is essential for future pharmacological innovations in the field of male ED.

Topics: Adrenergic alpha-Antagonists; Cyclic AMP; Cyclic GMP; Dopamine Agonists; Erectile Dysfunction; Genetic Therapy; Humans; Male; Nitric Oxide; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

The past few years have witnessed major developments in the management of male sexual dysfunction. The introduction of the first efficacious and safe oral medication (sildenafil) resulted in the expansion of the patient base and, the change in health care delivery, with erectile dysfunction (ED) entering the primary care physician's practice. New guidelines for the diagnosis and treatment of ED have been developed, including the Process of Care in the USA and the 1st International Consultation on ED sponsored by the World Health Organization. Well-defined algorithms for diagnosis and treatment have been adopted. These recent developments have brought up challenging issues, including the cardiovascular safety of sexual activity, societal changes, internet prescriptions, definition of the patient, expansion of clinical and laboratory research, rise of interest in female sexual dysfunction, and a significant economic impact. The recent developments in male sexual dysfunction continue with the study of new oral medications. Some of these new medications, such as sublingual apomorphine, have a central mode of action, whereas others, such as the phosphodiesterase inhibitor IC351, have a selective peripheral vasodilation-enhancing action.

Topics: Administration, Oral; Cross-Sectional Studies; Erectile Dysfunction; Forecasting; Humans; Incidence; Male; Patient Care Team; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Normal sexual function is a biopsychosocial process; sexual dysfunction almost always has organic and psychologic components, and it requires multidisciplinary, goal-directed evaluation and treatment. Factors such as aging, declining testosterone levels, medical illness, certain medications, and comorbid depressive illness can contribute to sexual dysfunction. Erectile dysfunction (ED) is the most common male sexual dysfunction encountered in the clinical setting. Comorbidity between ED and depressive illness is high, but the causal relationship is unclear, and likely bidirectional. In this article, we review the existing literature on the relationship between depression and ED.

Topics: Comorbidity; Depressive Disorder; Dopamine Agonists; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Numerous advances have been made in our understanding of the evaluation and treatment of erectile dysfunction. Numerous treatment options are currently available. Treatment of this disorder was revolutionized by the introduction of sildenafil, an oral vasoactive agent that has a peripheral mechanism of action, blocking the degradation of cyclic guanosine monophosphate, and thus augmenting the erectogenic effect of sexual stimulation. This agent has proven efficacy in a variety of patient populations, including psychiatric patients. Clinical series suggest that this agent will reverse erectile dysfunction induced by psychoactive agents. Thus, it may play a role in decreasing treatment noncompliance associated with drug-induced sexual dysfunction. Another novel agent that is in development may be of special interest to psychiatrists. Apomorphine is a central dopamine agonist that is believed to act at the level of the paraventricular nucleus of the hypothalamus. As new agents are evolving, our understanding of the neurobiology of sexual function is advancing.

Topics: Apomorphine; Clinical Trials as Topic; Dopamine Agonists; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Up to 30 million men in the United States are affected by some degree of erectile dysfunction (ED). In the Massachusetts Male Aging Study (MMAS) 52% of men between 40 and 70 years of age were found to have some degree of ED. The MMAS and other studies also found that the likelihood of developing ED increases significantly with age. The vast majority of ED is primarily of organic and vascular cause, although psychological factors also play a role in most cases. ED has been shown to compromise overall quality of life and is associated with depression, anxiety, and loss of self-esteem. It may also signal serious underlying disease, including diabetes, hypertension, and cardiovascular disease. Therefore, questions regarding sexual functioning should be a routine part of the medical history. In the early 1990s, with the growing number of nonspecific and effective as well as less invasive tests, a new algorithm was developed that tailored evaluation to the treatment goals of the patient and his partner. This "goal-directed" approach simplifies the management of ED in the primary care setting; the availability of an effective oral agent, as well as a range of other therapeutic options, allows men with ED of all causes to receive effective treatment.

Topics: Age Factors; Algorithms; Clinical Laboratory Techniques; Clinical Trials as Topic; Decision Trees; Drug Interactions; Erectile Dysfunction; Humans; Male; Medical History Taking; Penile Prosthesis; Phosphodiesterase Inhibitors; Physical Examination; Piperazines; Primary Health Care; Product Surveillance, Postmarketing; Purines; Referral and Consultation; Risk Factors; Sex Counseling; Sildenafil Citrate; Sulfones; United States; Vacuum

Erectile dysfunction (ED) is common in men with cardiovascular disease. The introduction of sildenafil citrate, the first oral agent for the treatment of this disorder, has increased awareness about the risks of sexual activity in cardiac patients and raised concerns about the safety of sildenafil in patients being treated for coronary disease. Sildenafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP). Sildenafil acts along the same general pathway as nitric oxide donors to increase cGMP levels and enhance erections. Sildenafil is a modest vasodilator that causes small decreases in systemic arterial pressure and mild preload and afterload reductions. It does not cause major decreases in blood pressure when administered with one or more standard antihypertensive agents. Because PDE5 is also present in small amounts in the systemic vasculature, sildenafil can cause a synergistic and major decrease in pressure when combined with organic nitrates. Use of organic nitrates is the only contraindication to sildenafil use. Data on sildenafil in patients with recent (less than 6 months) myocardial infarction (MI), unstable angina, stroke, and recent life-threatening arrhythmias are not available, so the drug should be used with caution in patients with unstable cardiac conditions. Placebo-controlled and open-label phase 2/3 trials including men with ischemic heart disease did not show an increase in MI or serious cardiovascular events in patients treated with sildenafil versus placebo. None of the serious cardiovascular events reported in these trials were considered treatment related by the investigators. There is a small but finite increased risk of developing ischemia or infarction with sexual activity. Therefore, before prescribing sildenafil or any current or future treatment for ED to patients with known cardiac disease or multiple cardiovascular risk factors, physicians should discuss the potential cardiac risk of sexual activity and perform a complete medical assessment, including an exercise stress test if appropriate.

Topics: Antihypertensive Agents; Contraindications; Drug Synergism; Erectile Dysfunction; Humans; Male; Myocardial Ischemia; Nitrates; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sex Factors; Sildenafil Citrate; Sulfones; Vasodilation; Vasodilator Agents

Erectile dysfunction (ED) is a highly prevalent medical disorder. Nearly 1 of 3 men in the United States between the ages of 18 and 59 years report dissatisfaction with some aspect of their sexual function. These problems contribute to anxiety, depression, loss of self-esteem, and diminished quality of life. The availability of sildenafil, the first safe and effective oral agent for ED, has greatly increased the number of men seeking treatment and shifted much of the management of ED to primary care physicians. As a result, primary care physicians now need to add questions about sexual functioning and satisfaction with sex to their initial patient workups. Patients with ED can be treated by the primary care physician or referred to mental health professionals, endocrinologists, urologists, or sex therapists, depending on the problem presented. First-line treatments that can be easily prescribed and recommended by primary care clinicians include sildenafil, counseling, lifestyle changes, medication changes, and vacuum-constriction devices. The responsibilities of treating patients with ED include educating the patient about sexually transmitted diseases, providing general sex education and counseling to the patient and his partner, and providing a treatment that is appropriate for the cause of the problem. The rewards of treatment will be a happier and more functional patient, an enhanced physician-patient relationship, and great professional satisfaction.

Topics: Erectile Dysfunction; Humans; Life Style; Male; Patient Education as Topic; Phosphodiesterase Inhibitors; Piperazines; Primary Health Care; Purines; Sex Counseling; Sildenafil Citrate; Sulfones; United States; Vacuum

Sildenafil has an excellent safety record in its clinical trials but there have been reports of deaths associated with its usage now that it is in widespread clinical use. Many of these deaths are clearly unrelated to the drug and some may be related to usage where there are clear contradictions to its use. Some deaths may occur because the patients are at risk from cardiac problems but there remains an occasional unexplained death. There is no evidence at present to suggest that sildenafil is a specific causative factor and the research so far has failed to support it as such.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Male sexual dysfunction is a prevalent condition in the population, is a major health problem and has previously been both under diagnosed and under treated. There are now a number of treatments available that are safe and easy to use which provide an effective solution for most presenting patients. Oral drugs have recently become the first-line option for many men with about 60-70% of new presentations achieving success. Those who fail a trial of oral treatments have a number of other options available, which are able to provide erections sufficient for intercourse in many of the oral drug failures. All these options, their indications, side-effects and complications are outlined in this chapter.

Topics: Adrenergic alpha-Antagonists; Adult; Clomipramine; Ejaculation; Erectile Dysfunction; Hormone Replacement Therapy; Humans; Male; Middle Aged; Penile Implantation; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Prostaglandins E; Psychotherapy; Purines; Selective Serotonin Reuptake Inhibitors; Sildenafil Citrate; Sulfones; Testosterone

Hypertension is another predictor of erectile dysfunction (ED). This is further evidence supporting a link between the pathogenesis of atherosclerotic disease and ED. In one study (TOMHS) involving hypertensive patients, the incidence of ED was 14.4%. The drugs used to treat hypertension may cause ED. However, there is little trial-based evidence to indicate which drugs are more likely to cause this side effect. In general, thiazide diuretics and beta-blockers seem to cause ED more often. In contrast, the alpha-blocker, doxazosin, has not been associated with an increased incidence of ED as a side effect. Doxazosin also improves urinary flow in patients with benign prostatic hyperplasia (BPH). This condition is common in elderly men as is hypertension and ED. Therefore, doxazosin may present a special advantage among this group of patients. This alpha-blocker would also be a good choice in patients with impaired glucose tolerance/diabetes because it improves insulin sensitivity. Moreover, ED and hypertension are more prevalent among diabetics. On a more speculative note, doxazosin may potentiate the therapeutic impact of specific treatments for ED.

Topics: Antihypertensive Agents; Diabetes Complications; Doxazosin; Erectile Dysfunction; Humans; Hypertension; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Several drugs have been developed to treat patients with erectile dysfunction (ED). In general, patients prefer orally administered drugs. The use of these drugs (e.g. sildenafil and apomorphine) is reviewed. Because ED is a common problem in men with vascular disease it is important to assess the effect of these drugs on the cardiovascular system. The safe use of these drugs in patients with vascular disease needs to be clearly established in appropriately designed trials.

Topics: Arginine; Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Neurotransmitter Agents; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) is a common problem with a multifactorial aetiology. The treatment of ED has been revolutionised by the introduction of intracavernosal injections some two decades ago. However, the recent development of the orally-administered drug sildenafil (Viagra) has had a major impact on the treatment of ED. We discuss the trials with sildenafil with special reference to cardiovascular risk factors associated with ED.

Topics: Adult; Aged; Cardiovascular Diseases; Diabetes Complications; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Smoking; Sulfones

To review current pharmacologic treatment options for erectile dysfunction.. Relevant literatures from the past two decades regarding the following treatments were reviewed: intracavemous injection, topical therapy, transurethral therapy and oral drugs.. More than 125 originally identified articles were reviewed, and 45 were selected that especially addressed the stated purpose.. Among the pharmacologic treatment options available, intracavemous injection therapy remains the most effective although the drop-out rate is high. Topical creams and gels have not been very successful. Transurethral alprostadil can be more effective if a constriction device is applied at the base of the penis. Oral sildenafil has the highest patient acceptance rate although systemic side effects can be a major drawback.. Effective pharmacotherapies for ED of various etiologies are now available. However, proper evaluation of every patient should be performed before giving treatment so that a number of potentially life-threatening causes of erectile dysfunction would not be missed.

Topics: Alprostadil; Erectile Dysfunction; Humans; Male; Nitric Oxide Donors; Papaverine; Phentolamine; Piperazines; Purines; Sildenafil Citrate; Sulfones

For the estimated 30 million men in the United States with erectile dysfunction (ED), treatment options are varied. What may be the best choice for one individual is not necessarily the right choice for someone else. It is essential that health care professionals have a thorough understanding of all available options so they can help their patients and partners make the best treatment choice for successful sexual satisfaction. A variety of available ED treatment options are outlined here.

Topics: Erectile Dysfunction; Humans; Injections; Male; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Suppositories; Vacuum; Vasodilator Agents

Sildenafil is the first oral therapeutic agent for erectile dysfunction. Sildenafil is a selective inhibitor of cGMP-specific phosphodiesterase (PDE-5). Penile erection involves relaxation of the corpus cavernosum, an event mediated by NO and cGMP. The biological actions of cGMP are terminated by phosphodiesterase enzymes and PDE-5 is the major cGMP metabolising enzyme in this tissue. Sildenafil is relatively safe compared to erection injectables because it does not relax on isolated human corpus cavernosum, and does not cause priapism. Due to the tendency of abuse of sildenafil, its adverse cardiovascular associations with myocardial infaraction, ventricular arrhythmia and hypertension need to be alerted.

Topics: Erectile Dysfunction; Fertility Agents, Male; Humans; Male; Myocardial Infarction; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Cardiovascular Diseases; Contraindications; Drug Interactions; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Metabolic Clearance Rate; Piperazines; Purines; Risk; Sildenafil Citrate; Sulfones

Sildenafil, a selective inhibitor of phosphodiesterase type 5 (PDE5), is the first in a new class of orally effective treatments for erectile dysfunction. During sexual stimulation, the cavernous nerves release nitric oxide (NO), which induces cyclic guanosine monophosphate (cGMP) formation and smooth muscle relaxation in the corpus cavernosum. Sildenafil facilitates the erectile process during sexual stimulation by inhibiting PDE5 and thus blocking the breakdown of cGMP. Sildenafil alone can cause mean peak reductions in systolic/diastolic blood pressure of 10/7 mm Hg that are not dose related, whereas the heart rate is unchanged. Sildenafil and nitrates both increase cGMP levels in the systemic circulation but at different points along the NO-cGMP pathway. The combination is contraindicated because they synergistically potentiate vasodilation and may cause excessive reductions in blood pressure. Erectile dysfunction is a significant medical condition that shares numerous risk factors with ischemic heart disease, and hence a substantial overlap exists between these patient groups. From extensive clinical trials, the most commonly reported cardiovascular adverse events in patients treated with sildenafil were headache (16%), flushing (10%), and dizziness (2%). The incidences of hypotension, orthostatic hypotension, and syncope and the rate of discontinuation of treatment due to adverse events were <2% and were the same in patients taking sildenafil and those taking placebo. Retrospective analysis of the concomitant use of antihypertensive medications (beta blockers, alpha blockers, diuretics, angiotensin-converting enzyme inhibitors, and calcium antagonists) in patients taking sildenafil did not indicate an increase in the reports of adverse events or significant episodes of hypotension compared with patients treated with sildenafil alone. In clinical trials, the incidence of serious cardiovascular adverse events, including stroke and myocardial infarction, was the same for patients treated with sildenafil or placebo. Concurrent disease states, such as renal or hepatic impairment, or concomitant use of inhibitors of the cytochrome P450 isozyme CYP3A4 could increase systemic exposure to sildenafil. Since the US market launch in April 1998, monitoring of spontaneous adverse event reports in association with sildenafil has demonstrated a pattern that is generally consistent with the experience observed during clinical development, with the exception of infre

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Blood Pressure; Cardiovascular System; Clinical Trials as Topic; Drug Interactions; Drug Synergism; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Reference Values; Sildenafil Citrate; Sulfones; Time Factors; Vasodilation

Sildenafil (Viagra) from Pfizer (UK-92,480) is a competitive and selective inhibitor of cyclic GMP specific type 5 phosphodiesterase. Male erectile dysfunction is defined as "the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance". Sildenafil (Viagra) is effective in a significant proportion of patients with erectile dysfunction. Patients should be instructed to take a dose from 25 to 100 mgrs approximately 30 to 60 minutes before sexual activity, but no more than once daily. Sexual stimulation is necessary to produce erectile reaction. The safety and tolerance of sildenafil have been demonstrated. However, prior to initiating treatment with sildenafil, physicians should consider the cardiovascular status of their patients, particularly for patients with unstable coronary heart disease or concomitant treatment with nitrates.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Time Factors

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Contraindications; Enzyme Inhibitors; Erectile Dysfunction; Humans; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction is a common problem affecting men. Sildenafil (Viagra) is the first oral medication approved for the treatment of erectile dysfunction. It has proven to be an effective option in the treatment of erectile dysfunction of different etiologies.

Topics: Clinical Trials as Topic; Contraindications; Drug Synergism; Erectile Dysfunction; Humans; Hypotension; Male; Nitrates; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Phosphodiesterases are enzymes that catalyze the degradation of the cyclic nucleotides, cyclic AMP and cyclic GMP, to the corresponding 5' nucleotide monophosphates. Ten different phosphodiesterase families have been described to date. These enzymes exist as homodimers and there is structural similarity between the different families. However, they differ in several respects like selectivity for cyclic nucleotides, sensitivity for inhibitors and activators, physiological roles and tissue distribution. Interest in these enzymes has increased tremendously, both within the medical community and in the general public as a consequence of sildenafil (Viagra), the medication recently introduced for the treatment of erectile dysfunction. Sildenafil mediates its effects by inhibiting phosphodiesterase 5. Some biochemical and molecular biological aspects of this enzyme are presented here. To achieve satisfactory erection, normal penile innervation is required. Nitrogen monoxide, the transmitter substance in these nerves, activates guanylyl cyclase, thereby increasing cyclic GMP production. The increased levels of cyclic GMP cause relaxation of smooth muscles in penile vessels and this leads to an erection. Erection is dependent on elevated levels of cyclic GMP and sildenafil mediates its effects by inhibiting the degradation of cyclic GMP. Other functions that are mediated by the phosphodiesterases explain visual disturbances, flushing and decreased blood pressure that are some of the side effects seen with sildenafil treatment. Furthermore, the potentially fatal consequence of combining sildenafil and nitrovasodilators is discussed.

Topics: Cyclic GMP; Erectile Dysfunction; Humans; Male; Nucleotides, Cyclic; Penile Erection; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones

Placebo-controlled studies have clearly demonstrated the efficacy of sildenafil in the treatment of erectile dysfunction. It's tolerability cannot yet be judged definitively based on the available information. Some findings indicate that in addition to established contraindications (allergy against the active ingredient, concomitant nitrate and NO-donor treatment, retinitis pigmentosa) factors such as coronary heart disease, advanced age, impaired liver function and drug interactions require special attention by the prescribing physician to secure drug safety.

Topics: Adverse Drug Reaction Reporting Systems; Clinical Trials as Topic; Contraindications; Drug Interactions; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction is a common and multi-factorial disease that strongly impairs the quality of life in men. During the past decade, many new therapeutic strategies have become available. But the need for oral treatment was strongly felt. This need appears to have been fulfilled with the introduction of sildenafil. The drug acts by enhancing smooth muscle relaxant effect of nitric oxide. A number of clinical studies have now proved its safety and efficacy. The drug has shaken social life all over the world and to accept this "magic pill" or not remains the question of individual choice.

Topics: Clinical Trials as Topic; Drug Interactions; Erectile Dysfunction; Humans; Male; Nitric Oxide; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Innovative research in the past 2 decades has shown that the hemodynamics of penile erection involve arterial dilation, sinusoidal expansion, and venous compression. Relaxation of the intracorporeal smooth muscles (trabecular and arteriolar) seems to be the final common pathway that leads to the above events. Neuropharmacologic studies have also established nitric oxide as the principal neurotransmitter for penile erection and confirmed the importance of cyclic adenosine monophosphate and cyclic guanosine monophosphate systems in penile smooth muscle relaxation. Recent years have also witnessed dramatic changes in the therapy of erectile dysfunction. The penile prosthesis, a gold standard of therapy of the 1970s, was replaced in the 1980s by the intracavernous injection and the vacuum constriction device. In the 1990s, two revolutionary concepts in erectile dysfunction therapy were added: transurethral alprostadil and oral sildenafil. However, the tremendous publicity surrounding the recent introduction of sildenafil has also created socioeconomic and ethical dilemmas, especially with regard to insurance coverage and government regulation. Medically, many problems also surfaced when large numbers of erectile dysfunction patients overwhelmed primary care physicians who were unfamiliar with the diagnosis and treatment of erectile dysfunction. This article reviews the advances in penile physiology and the clinical usefulness of topical and oral agents. In addition, a patients' goal-directed approach to the diagnosis and treatment of erectile dysfunction is presented.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Administration, Topical; Erectile Dysfunction; Humans; Male; Muscle, Smooth; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Sildenafil is an oral therapy for erectile dysfunction of a broad range of causes. By selectively inhibiting phosphodiesterase type 5, it allows corpus cavernosum smooth muscle to relax, potentiating erections during sexual stimulation. Blood pressure is reduced transiently by sildenafil, but more marked hypotension may occur during concurrent administration of sildenafil and organic nitrates; this combination is contraindicated. Sildenafil is rapidly absorbed, with dose-proportional peak plasma concentrations within 1 hour of administration. The elimination half-life is 3 to 5 hours. Dosages usually begin at 50mg taken when needed =1 hour before sexual activity no more than once daily. The maximum dose is 100mg when needed once daily and lower doses (e.g. 25mg) may be used in elderly patients and those with hepatic or renal impairment or receiving cytochrome P450 enzyme CYP3A4 inhibitors, such as ritonavir, saquinavir, ketoconazole, erythromycin or cimetidine. More than 3000 patients with erectile dysfunction of organic (e.g. diabetes or spinal cord injury), psychogenic or mixed origin received sildenafil 5 to 100mg or placebo in fixed- or titrated-dose trials. Sildenafil was associated with dose-related improvements in the frequency, hardness and duration of erections and in patients' abilities to achieve and maintain erections adequate for successful sexual intercourse. In titrated-dose trials, the most commonly effective doses were 50 or 100mg, although lower doses were effective in some patients. Sildenafil was significantly more effective than placebo in erectile dysfunction of all tested causes. The efficacy of sildenafil was not affected by patient age (> or < or =65 years) or by antihypertensive or antidepressant medications. The drug was effective in patients with severe erectile dysfunction. Efficacy was maintained in long term (1-year) studies. Sildenafil also appears to improve the quality of life of both patients and their sexual partners. Common adverse events associated with sildenafil were transient and mild or moderate and included headache, flushing, dyspepsia, nasal congestion and abnormal vision. Tolerability was maintained in long term (< or =1 year) studies. No serious sildenafil-related adverse events occurred in clinical trials; cardiovascular events seen in postmarketing surveillance generally occurred in patients with other known risk factors.. Sildenafil is an effective oral treatment in men with erectile dysfunction. It was significantly superior to placebo in improving erections and allowing successful penetrative sexual intercourse. Although its place in disease management is still emerging and there are contraindications to its use, if preliminary positive reports are confirmed, sildenafil will be the pre-eminent first-line therapy for erectile dysfunction.

Topics: Clinical Trials as Topic; Drug Interactions; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Erectile Dysfunction; Forecasting; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

The molecular mechanisms of the effects of sildenafil, a specific inhibitor of cyclic guanosine monophosphate (cGMP) phosphodiesterases are briefly reviewed. The second messenger cGMP as well as its molecular targets (with the exception of the photoreceptor signal transduction machinery) have long played an underdog role compared with cyclic adenosine monophosphate and other signalling molecules such as inositoltrisphosphate. The same holds for guanylyl cyclase, which, albeit being the main effector molecule of the gaseous neurotransmitters carbon monoxide and nitric oxide (NO), has received much less attention relative to its activators and their synthases. Stimulation of the arginine --> NO --> cGMP pathway by bypassing NO-synthase is a well-established pharmacological principle in the treatment of cardiovascular disorders. In contrast, local application of NO-donors or oral feeding of excessive amounts of precursor amino acid L-arginine to treat erectile dysfunction were met with variable success or failure. The advent of a new principle, amplification of the NO-signaling cascade by means of target organ selective phosphodiesterase inhibition, has renewed interest in phosphodiesterases and cGMP.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Aged; Cyclic GMP; Erectile Dysfunction; Humans; Male; Nitric Oxide; Phosphodiesterase Inhibitors; Piperazines; Purines; Signal Transduction; Sildenafil Citrate; Sulfones; Vasodilation

Arterial hypertension is associated with structural and functional alterations of the vessel walls. Because vascular endothelium plays a central role in the control of vascular tone, endothelial dysfunction can also cause certain types of erectile dysfunction. Erectile dysfunction is also a common side effect of certain drugs, including many antihypertensive agents. Physicians should be aware of potential sexual side effects of such drugs and take appropriate steps to alleviate persistent problems. Most important, physicians need to ask patients about sexual function and discuss the possibility of erectile dysfunction caused by antihypertensive therapy. Erectile dysfunction can be effectively treated in most patients, and many treatment options are available. Sildenafil therapy has revolutionized the management of this disorder, but this agent should be used with caution in certain patients taking nitrates.

Topics: Antihypertensive Agents; Contraindications; Erectile Dysfunction; Humans; Hypertension; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Behavior; Sildenafil Citrate; Sulfones

Topics: Animals; Contraindications; Erectile Dysfunction; Humans; Legislation, Drug; Male; Muscle, Smooth; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Cardiovascular Diseases; Clinical Trials as Topic; Drug Interactions; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Assessment; Sildenafil Citrate; Sulfones; United Kingdom

As increasing insight is gained into the aetiology of erectile dysfunction, many men formerly considered as suffering from psychogenic erectile dysfunction are now recognised as suffering from organic disease. As such, these men are currently identified as candidates for aggressive treatment of the organically caused problem.. This article discusses current and recently introduced treatments for erectile dysfunction, highlighting the advantages of each treatment and their position in the therapeutic armamentarium of the general practitioner.. Investigative and treatment modalities have become more varied, such that to treat sexual dysfunction adequately, physicians must constantly keep abreast of new developments.

Topics: Alprostadil; Clinical Trials as Topic; Erectile Dysfunction; Humans; Injections, Intralesional; Male; Penile Implantation; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Sildenafil citrate is the first orally active therapy proved to be effective and safe treatment for erectile dysfunction (ED). Because men with cardiovascular disease are at increased risk of developing ED, and because ED and cardiovascular disease share important risk factors, attention has focused recently on the use of sildenafil in these men. When used in combination with nitroglycerin and other nitric oxide (NO) donors, sildenafil may potentiate major drops in blood pressure. Use of nitrate antianginal agents are an absolute contraindication to sildenafil use. In normotensive men and in men receiving antihypertensive medications evaluated in Phase II/III clinical trials, sildenafil use at the recommended doses (25-100 mg 1 hour before sexual intercourse and no more than once daily) was associated with modest, transient reductions in blood pressure and negligible effects on heart rate. In a more recent study, sildenafil was well tolerated in patients receiving antihypertensive medications and was not associated with major decreases in blood pressure. From the time of its approval in the United States in March 1998 through mid-November 1998, with approximately 6 million prescriptions written, 130 deaths were reported by the US Food and Drug Administration (FDA). Seventy-seven of the men who died had documented cardiovascular events. Sixteen men took or were administered nitroglycerin or an organic nitrate; 3 others had nitroglycerin in their possession. Physician prescribing guidelines issued by the American College of Cardiology/American Heart Association (ACC/AHA) recommend caution when prescribing sildenafil to men with certain cardiovascular conditions, liver or kidney disease, and to those taking medications that may prolong sildenafil's half-life (e.g., erythromycin or cimetidine). Those with known or suspected coronary artery disease may benefit from an exercise test to determine whether resumption of sexual activity with use of sildenafil is likely to be associated with an increased risk of myocardial ischemia.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Antihypertensive Agents; Blood Pressure; Contraindications; Drug Interactions; Erectile Dysfunction; Heart Diseases; Heart Rate; Humans; Male; Nitric Oxide; Nitroglycerin; Phosphodiesterase Inhibitors; Piperazines; Practice Guidelines as Topic; Practice Patterns, Physicians'; Purines; Risk Factors; Sildenafil Citrate; Sulfones; United States; United States Food and Drug Administration; Vasodilator Agents

With the introduction of effective pharmacologic therapies for erectile dysfunction, more men are seeking treatment. The underlying cause of erectile dysfunction is usually a chronic medical illness or a side effect of certain drugs. Less commonly, the problem is psychogenic. Even after optimal treatment of common medical disorders such as diabetes mellitus and hypertension, erectile dysfunction may persist. Pharmacologic treatments, such as the intracavernosal or transurethral administration of alprostadil or the use of the new oral medication sildenafil, may offer patients substantial benefit. Before any of these drugs are prescribed, consideration should be given to existing medical illnesses and medications, partner satisfaction, comfort with the method of administration and the side effect profile.

Topics: Alprostadil; Diagnosis, Differential; Erectile Dysfunction; Humans; Male; Patient Education as Topic; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Teaching Materials; Vasodilator Agents

Topics: Adrenergic alpha-Antagonists; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostate-Specific Antigen; Prostatic Hyperplasia; Prostatic Neoplasms; Purines; Sildenafil Citrate; Sulfones

Penile erection follows relaxation of the corpus cavernosum in which nitric oxide (NO) released during sexual stimulation from non-adrenergic non-cholinergic nerve endings and from endothelial cells of the corpus cavernosum plays a crucial role. Sildenafil (VIAGRA) selectively inhibited phosphodiesterase type 5 (PDE5) activity in the human corpus cavernosum and increased cGMP concentrations in the rabbit cavernosum in the presence of NO. Sildenafil enhanced the NO-dependent relaxation of the isolated human corpus cavernosum and the intracavernosal pressure in the anesthetized dog without affecting systemic blood pressure and heart rate. In the patients with erectile dysfunction, an orally administered sildenafil enhanced the penile rigidity during visual sexual stimulation. Sildenafil did not affect the phenylephrine-induced contraction of the isolated rabbit aorta, but enhanced the relaxant effect of glyceryl trinitrate. The pharmacodynamic interaction with glyceryl trinitrate was also observed in human studies where sildenafil potentiated the hypotensive effect of the nitrate. These results indicate that sildenafil, which enhances the physiological process of penile erection during sexual arousal, is a novel orally effective treatment for erectile dysfunction. It should be noted, however, that sildenafil enhanced the hypotensive effect of glyceryl trinitrate, as a result of inhibition of PDE5 in vascular smooth muscle. Therefore, administration of sildenafil to patients who are using nitrates and NO donors is contraindicated.

Topics: Animals; Blood Pressure; Cyclic GMP; Dogs; Drug Interactions; Erectile Dysfunction; Humans; Male; Nitric Oxide; Nitric Oxide Donors; Nitroglycerin; Penile Erection; Penis; Phosphodiesterase Inhibitors; Piperazines; Purines; Rabbits; Sildenafil Citrate; Sulfones

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adrenergic alpha-Antagonists; Alprostadil; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Papaverine; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Erectile dysfunction, which is common among men with diabetes, leads to significant reduction in quality of life, and as with other complications of diabetes deserves to be treated on the NHS. This article explores the problem of erectile dysfunction and diabetes and the role of sildenafil, which is likely to be the first choice treatment of patients presenting with erectile dysfunction.

Topics: Diabetes Complications; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prevalence; Purines; Quality of Life; Sildenafil Citrate; Sulfones

Topics: Administration, Oral; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Nursing Assessment; Patient Education as Topic; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

Diagnosis of erectile dysfunction is important because sildenafil may not be the proper therapy for patients with underlying major diseases such as coronary sclerosis, arteriosclerosis of the stroke vessels, depression, etc., where erectile dysfunction is just a symptom of the disease.

Topics: Contraindications; Coronary Disease; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Controlled Clinical Trials as Topic; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Depressive Disorder; Diabetes Complications; Erectile Dysfunction; Humans; Hypertension; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Sulfones

There is growing evidence that the field of pharmacotherapy, particularly oral drugs, will be dominant in the future management of sexual dysfunction. Basic research has led to the understanding of the intracellular mechanisms that control penile smooth muscle contractility and therefore erection, opening a vast area for pharmacological intervention. Moreover, the importance of central neurohormonal mechanisms has made these pathways the target for new centrally acting drugs. Given these trends most patients suffering from erectile dysfunction will respond to pharmacological agents in the not so distant future.

Topics: Adrenergic alpha-Antagonists; Alprostadil; Apomorphine; Dopamine Agonists; Erectile Dysfunction; Humans; Male; Muscle Relaxation; Papaverine; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction (ED) is defined as the consistent inability to obtain or maintain an erection for satisfactory sexual relations. Data from the Massachusetts Male Aging Study have indicated that the prevalence of erectile dysfunction of any degree is 39% in 40-year old men, and 67% in those aged 70 years. Effective therapy has been available for some time, but it has commonly involved surgery, external devices or penile self-injection. For many men, these represent unacceptable barriers to seeking therapy. Recently, however, an effective oral medication has become available. This article reviews the physiology and pharmacology of ED. The literature currently available on the effectiveness and safety of various drugs used for ED is summarized, with particular attention to newly available oral agents. Guidelines for work-up and drug treatment of patients with ED are given. Detailed history and physical examination are crucial to the safe and effective treatment of men with erectile impotence. An extensive review of the literature shows that based on safety, effectiveness and ease of use, oral sildenafil citrate is an excellent choice for first-line therapy. Patients who use organic nitrates of any kind in any capacity should not be offered sildenafil. Based solely on effectiveness intracavernosal injection therapy remains the golden standard and should also be offered as an option for first-line therapy for the appropriate patients. Many alternatives are available for men who cannot use sildenafil or injection therapy. A thorough knowledge of existing medications is essential for proper treatment of ED.

Topics: Adrenergic alpha-Antagonists; Aged; Alprostadil; Clinical Trials as Topic; Dopamine Agonists; Drug Interactions; Erectile Dysfunction; Hemodynamics; Humans; Male; Nitrates; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Topics: Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Sexual intercourse involves mild to medium severe physical exertion of the cardiovascular system. The risk of sudden death associated with sexual activity is very low, and so is the risk of developing infarction. In patients with pre-existing ischaemic heart disease sexual activity is safe in case of controlled angina with tolerance of a medium-grade load on examination on a treadmill. After acute myocardial infarction with a non-complicated course sexual activity can be resumed in a familiar environment with a familiar partner after about 10 days. In stabilized anginous patients sildenafil administration is safe assuming that the patient does not take long-acting nitrates and does not need frequent administration of short-term acting nitrates. It is important to avoid nitrates also in the treatment of acute ischaemic conditions in these patients. At present we do not possess adequate information on the clinical importance of influencing sildenafil elimination by competition with other substances excreted by the same route.

Topics: Erectile Dysfunction; Humans; Male; Myocardial Ischemia; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones

Sildenafil (Viagra, Pfizer, Inc.) is a new orally effective therapy for the treatment of men with erectile dysfunction (ED). It is a specific and selective inhibitor of phosphodiesterase Type 5 (PDE5), an enzyme which is an important modulator of smooth muscle relaxation in the corpus cavernosum. In the presence of a sexual stimulus, inhibition of PDE5 results in improved smooth muscle relaxation within the sinusoids of the corpus cavernosum and the penile arteries. This results in improved erections in men with ED. In clinical trials, sildenafil has been found to be effective in improving the erections of large numbers of men with ED secondary to a range of causes. The presence of PDE5 in other tissues such as vascular smooth muscle results in side effects such as headache, flushing, indigestion and nasal congestion. These side effects are dose-dependent and well-tolerated. The introduction of sildenafil in many countries around the world has revolutionised the assessment and treatment of men with ED.

Topics: Animals; Clinical Trials, Phase III as Topic; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones

For the treatment of erectile dysfunction, the authors recommend that prostheses be reserved for cases refractory to all other treatments. Local treatments by injection of erectogenic substances consist of paraverine and prostaglandin E1. A new oral treatment is also available, not with yohimbine or apomorphine, but with sildenafil (viagra).

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Alprostadil; Erectile Dysfunction; Humans; Injections; Papaverine; Penile Prosthesis; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction may have psychological as well as a variety of organic causes. This necessitates in each case a careful medical evaluation. Various commonly used drugs, as well as alcohol and narcotics, may interfere with erection and should, whenever possible, be discontinued before starting treatment. Organic diseases should be identified and, if feasible, specially treated. In the remaining majority of afflicted men, psychological treatment and partner counseling may produce an improvement, but ultimately what is necessary remains an effective and safe medication. The drug, Sildenafil, introduces a new therapeutic principle. During sexual nerve stimulation, nitric oxide (NO) is released from nerves into the cells of the penile erectile bodies. NO activates in turn its "second messenger", the substance cyclic GMP, and the latter induces the vasorelaxation and blood filling of the erectile bodies. Orally administered Sildenafil competitively inhibits phosphodiesterase type 5, which physiologically inactivates cyclic GMP in the erectile bodies. Thus, Sildenafil increases in men with erectile dysfunction the NO-stimulated cyclic GMP concentration and, thereby, improves erection. This new therapy is attractive because 1. Sildenafil is the first pill (for oral use) with established efficacy that benefits most men with insufficient erection; 2. compared with previous therapeutic approaches (such as drug injections in the penis, instillations into the urinary duct, vacuum pumps or even prostheses), Sildenafil is at least as effective, is easy to take and appears well tolerated with no risk of a prolonged erection; 3. remarkably, this medication stimulates erection only during sexual arousal and, thus, has a rather "natural" effect, and 4. side effects (including headache, facial flushing and dyspepsia or epigastric discomfort) were mostly of mild degree and transient, so that only 4% of men interrupted treatment for this reason. Sildenafil does not need to be taken daily, but may be taken, when needed, 1 hour before a planned sexual activity. The new pill has the potential to enliven the boys "wunder horn" with fresh sound.

Topics: Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction is a common condition affecting men over age 50. With the recent increase in public awareness about available therapies, more and more men are seeking help. Primary care physicians usually can prescribe first-line treatments without acquiring additional equipment or staff. Patients who are not satisfied with oral medication, vacuum devices, injection therapy, or intraurethral suppositories may be referred to a urologist for further treatment. Development of new medical therapies is ongoing, and within the next few years, we expect to see the introduction of more medications for treatment of erectile dysfunction. Some agents act peripherally on the penile circulation and others centrally on the portion of the brain involved in producing erections.

Topics: Alprostadil; Enzyme Inhibitors; Erectile Dysfunction; Family Practice; Humans; Male; Middle Aged; Patient Acceptance of Health Care; Piperazines; Purines; Sildenafil Citrate; Sulfones; United States

Viagra, an oral drug taken one hour prior to sexual activity, improves erectile function in the majority of men with erectile dysfunction who receive it. It is not an aphrodisiac and therefore will not work without sexual stimulation. The drug is absolutely contraindicated in patients on organic nitrates, as this combination can lead to severe drops in blood pressure. Patients with heart disease, suspected heart disease and risk factors for heart disease should discuss with their physicians the safety of resuming sexual activity. A cardiac work-up, including exercise treadmill testing, should be considered in appropriate patients.

Topics: Adult; Aged; Contraindications; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vitamins

Topics: Contraindications; Cyclic GMP; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

In March 1998 a totally new type of therapeutic agent, sildenafil citrate (Viagra), was approved by the Food and Drug Administration for marketing in the United States as an oral tablet for erectile dysfunction in men. Extensive media coverage may have overshadowed the actual value and potential limitations of this therapeutic agent. Because sildenafil is a prescription-only medication that may be used in ambulatory and home care patients, home caregivers need to understand its intended use, mechanism and dose, and potential problems that may occur in patients who receive it.

Topics: Community Health Nursing; Drug Interactions; Drug Monitoring; Erectile Dysfunction; Home Care Services; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Diabetes Complications; Diabetes Mellitus; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Piperazines; Prevalence; Purines; Safety; Sildenafil Citrate; Sulfones

Topics: Enzyme Inhibitors; Erectile Dysfunction; Humans; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Drug Interactions; Enzyme Inhibitors; Erectile Dysfunction; Female; Humans; Nitrates; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Aging; Death, Sudden, Cardiac; Drug Interactions; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction is a common but underreported condition. It is to be expected that the number of patients consulting their physician with the complaint of erectile dysfunction will increase considerably with the introduction of sildenafil (Viagra), the first oral drug that enhances penile erection. Sildenafil is an inhibitor of the enzyme phosphodiesterase type 5. It causes erection of the penis by allowing the relaxation of the smooth musculature of the cavernous body to persist. The first clinical results indicate that the treatment with sildenafil is safe and effective in the hands of a sexologically qualified physician. An erection disorder is essentially not more than a symptom which primarily requires causal therapy.

Topics: Adult; Aged; Enzyme Inhibitors; Erectile Dysfunction; Female; Humans; Male; Middle Aged; Penis; Piperazines; Purines; Sexual Dysfunctions, Psychological; Sildenafil Citrate; Sulfones

Erectile function in man depends upon a complex interaction of psychogenic, neurologic, hormonal and vascular factors, and therefore the management of erectile dysfunction (ED) reflects this complexity of control. Therapeutic options include psychological and non-pharmacological approaches as well as drug treatments. The effectiveness of the type-5 cGMP phosphodiesterase inhibitor sildenafil citrate (Viagra) confirms the pivotal role of the NO-cGMP axis in promoting and maintaining erection. Although widely acclaimed, sildenafil leaves many questions unanswered, especially regarding its susceptibility to pharmacokinetic drug interactions, and its safety in patients with ischaemic heart disease and those taking nitrates. In view of the epidemiological link between erectile dysfunction and cardiovascular disease in the elderly, this limitation might have much broader implications. The presently available scientific documentation, although less extensive, indicates that NO donors, such as topically applied nitroglycerin (GTN; for example, 1-2 puffs of an ordinary GTN spray applied to the shaft of the penis), might be a reasonable alternative. Further larger-scale research on the efficacy and tolerability of topical GTN is needed to establish its full therapeutic potential in the treatment of erectile dysfunction.

Topics: Cyclic GMP; Drug Interactions; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Nitric Oxide; Nitric Oxide Donors; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Erectile Dysfunction; Humans; Male; Male Urogenital Diseases; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Alprostadil; Counseling; Erectile Dysfunction; Humans; Male; Penile Prosthesis; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Suction; Sulfones; Vasodilator Agents

Topics: Clinical Trials as Topic; Erectile Dysfunction; Humans; Impotence, Vasculogenic; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Topics: Cardiovascular Diseases; Erectile Dysfunction; Family Practice; Health Promotion; Humans; Male; Men; Phosphodiesterase Inhibitors; Piperazines; Prostatic Neoplasms; Purines; Sildenafil Citrate; Suicide; Sulfones; United States

Topics: Diabetes Complications; Erectile Dysfunction; Family Practice; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

At any one time, around 10% of men are unable to achieve and/or maintain an erection sufficient for satisfactory sexual activity, a condition known as erectile dysfunction. Several mechanical, surgical and medical approaches have been developed for the treatment of this problem but none are ideal. Sildenafil (Viagra-Pfizer), a selective phosphodiesterase inhibitor, is the first licensed oral drug treatment for erectile dysfunction. It was marketed in the UK in October 1998, at which time the Department of Health was advising doctors that they "should not prescribe sildenafil" and that health authorities should not "support the provision of sildenafil at NHS expense to patients requiring treatment for erectile dysfunction, other than in exceptional circumstances". Here we review sildenafil for the management of erectile dysfunction and discuss whether it should be available on the NHS.

Topics: Controlled Clinical Trials as Topic; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Administration, Oral; Adrenergic alpha-Antagonists; Antidepressive Agents, Second-Generation; Apomorphine; Cyclic GMP; Dopamine Agonists; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Phentolamine; Piperazines; Purines; Sildenafil Citrate; Sulfones; Trazodone; Yohimbine

Intracavernous pharmacotherapy of erectile dysfunction has been established for over 10 years, with prostaglandin E1 (PGE1) being the standard substance with the lowest rate of side effects. Recent investigations deal with the identification of intracellular mechanisms of smooth muscle relaxation in cavernous tissue as the most important aspect of penile erection. Nitric oxide and specific phosphodiesterase-isoenzymes seem to play a central role. This resulted in clinical studies with the intracavernous injected nitric oxide-donor linsidomine (SIN 1) and the orally given phosphodiesterase-inhibitor sildenafil. Furthermore new ways of pharmaco-application are tested, e.g. transdermal treatment with nitroglycerin, minoxidil or papaverine, as well as intraurethral injection of prostaglandin E1.

Topics: Alprostadil; Dosage Forms; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Molsidomine; Muscle Relaxation; Muscle, Smooth; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone; Vasodilator Agents

To compare the efficacy and adverse events of sildenafil monotherapy for benign prostatic hyperplasia (BPH) with its FDA-approved counterpart, tadalafil.. In this single-arm self-controlled clinical trial, 33 patients were enrolled. All patients underwent a 6-week treatment with sildenafil, followed by a 4-week washout period and finally a 6-week treatment with tadalafil. Patients were examined on each appointment and post-void residual (PVR) urine, International Prostate Symptom Score (IPSS) and Quality of life index (IPSS-QoL index) were recorded subsequently. Efficacy of each drug regimen was then evaluated by comparing these outcome parameters.. Both sildenafil and tadalafil were shown to improve PVR (both p < .001), IPSS (both p < .001) and IPSS- QoL index (both p < .001) significantly. Sildenafil was more effective than tadalafil in reducing PVR (mean difference (95%CI) = 9.91% (4.11, 15.72), p < .001) and ameliorating IPSS-QoL index (mean difference (95%CI) = 19.3% (4.47, 34.41), p = .027). Moreover, although not significant, sildenafil reduced IPSS more than tadalafil (mean difference (95%CI) = 3.33% (-0.22, 6.87), p = .065). Concurrent erectile dysfunction did not affect responsiveness to therapy with either sildenafil or tadalafil but age was inversely related to post-treatment IPSS in both sildenafil (B = 0.21 (0.04, 0.37), p = .015) and tadalafil (B = 0.14 (0.02, 0.26), p = .021) regimens with a more prominent role in responsiveness to sildenafil (β = 0.31) compared to tadalafil (β = 0.19).. Considering the significantly better improvement of PVR and IPSS-Qol index with sildenafil, this drug can be nominated as a suitable alternative for tadalafil as a BPH treatment, especially in younger patients who don't have any contraindications.

Topics: Erectile Dysfunction; Humans; Lower Urinary Tract Symptoms; Male; Phosphodiesterase 5 Inhibitors; Prostatic Hyperplasia; Quality of Life; Sildenafil Citrate; Tadalafil; Treatment Outcome; Urinary Retention

Since Food and Drug Administration approval of collagenase. A randomized, controlled trial was performed of Peyronie's disease men treated with either collagenase. A total of 40 men were enrolled, with 38 (collagenase. At 3 months posttreatment, collagenase

Topics: Clostridium histolyticum; Collagenases; Erectile Dysfunction; Humans; Injections, Intralesional; Male; Microbial Collagenase; Penile Induration; Penis; Sildenafil Citrate; Treatment Outcome

To compare the efficacy and safety of avanafil as compared with sildenafil in the management of patients with erectile dysfunction.. It was a prospective, randomized, double-blind, two-arm, active-controlled, parallel, multicenter, non-inferiority clinical study carried out in patients with erectile dysfunction for at least 3 months and International Index of Erectile Function - Erectile Function domain score of <26 at enrolment.. A total of 220 patients were randomized to receive either avanafil tablets 100 mg or sildenafil tablets 50 mg in 1:1 ratio. After 4 weeks of treatment, 40.0% of patients in the avanafil group and 45.6% of patients in the sildenafil group required dose escalation to a high dose (avanafil 200 mg/sildenafil 100 mg). The difference in the mean change of International Index of Erectile Function - Erectile Function score from baseline in the two groups increased from week 4 (1.1, 95% confidence interval -0.2 to 2.5) to week 8 (1.4, 95% confidence interval 0.1-2.7) and week 12 (2.1, 95% confidence interval 0.8-3.5), showing non-inferiority at week 4, and superiority at week 8 and week 12. Avanafil showed a faster onset of action as shown by a significantly better response to modified Sexual Encounter Profile 1 in the avanafil group (84.8%) as compared with that in the sildenafil group (28.2%; P < 0.001). Both avanafil and sildenafil were well tolerated by all the patients in the study; the most common adverse event reported during the study was headache in both the groups.. Avanafil is superior to sildenafil in improving the International Index of Erectile Function - Erectile Function domain score at the end of 12 weeks of treatment with the added advantage of faster onset of action.

Topics: Double-Blind Method; Erectile Dysfunction; Humans; Male; Prospective Studies; Pyrimidines; Sildenafil Citrate; Treatment Outcome

Radial wave therapy is commercialized as an option for the management of erectile dysfunction. However, the mechanism of action of the radial waves differs substantially from shock waves, so the evidence gathered for shock wave therapy cannot be extrapolated, and there are very few clinical trials with the radial wave.. To assess the efficacy and safety of radial wave therapy compared with sham therapy for the treatment of moderate and mild to moderate erectile dysfunction.. A randomized, double-blind, sham-controlled clinical trial was realized. Eighty patients with moderate erectile dysfunction, without sickle cell anemia, anticoagulation treatment, comorbidities, or conditions associated with secondary erectile dysfunction were included. The efficacy and safety were assessed at 6 and 10 weeks after randomization. Patients were randomized 1:1 to 1 of 2 arms: (i) 6 weekly sessions of radial wave therapy (RW group) or (ii) 6 weekly sessions of sham therapy (control group). All patients received sildenafil 25 mg.. The primary outcome was the mean change in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 weeks after randomization.. Eighty men were randomized. The average baseline IIEF-EF score was 16.3 (Standard Deviation - SD 3.2), and the median baseline Erection Hardness Score (EHS) was 3 (IQR 1). At 6 weeks after randomization, the mean change in the IIEF-EF score was 3.4 (95% confidence interval [CI] 1.5-5.2) in the RW group and 4.2 (95% CI 2.5-5.9) in the control group. No differences were observed between groups (P value =.742). No change was observed in the median EHS score in the evaluations. No serious adverse events occurred in 2 (5%) patients after radial wave therapy, and in 1 (2.5%) patient after sham therapy.. Knowledge of the effectiveness of radial waves protocols used for the treatment of moderate erectile dysfunction, helps doctors and patients in making decisions about the use of this therapy.. One strength is conducting the study with high methodological standards to minimize risk biases. Our results are limited to the evaluation of 1 specific protocol in moderate and mild to moderate erectile dysfunction.. No difference was found in this study between men with moderate and mild to moderate erectile dysfunction treated with radial waves and men treated with placebo sham therapy. Studies with different protocols of radial waves are necessary. Sandoval-Salinas C, Saffon JP, Martínez JM, et al. Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial. J Sex Med 2022;19:738-744.

Topics: Double-Blind Method; Erectile Dysfunction; Extracorporeal Shockwave Therapy; Humans; Male; Penile Erection; Sildenafil Citrate; Treatment Outcome

The aim of this study was to investigate the impact of the addition of 50 mg daily sildenafil to pentoxifylline-colchicine combination ther-apy on the Peyronie's plaque features in patients with the acute phase of Peyronie's disease (PD).. In this retrospective and non-randomized clinical study, patients were divided into 2 groups as group 1; (n = 107) who received colchicine and pentoxyfillin plus 50 mg daily oral sildenafil, and as group 2; (n = 79) who received only colchicine and pentoxyfillin. Patients were compared in terms of degree of curvature, pain in erection and erectile function at the baseline and at 6-month follow up. Pain in erection and erectile func-tion were evaluated by visual Analogue Scale (EF-VAS), and the shortened version of the International Index of Erectile Function (IIEF-5). Improvement in the degree of curvature and change in EF-VAS scores were primary endpoints of the study. Change in IIEF-5 score was the secondary endpoint of the study.. The two groups were statistically similar in terms of demographics and baseline features of PD. A statistically signifi-cant reduction in degree of curvature and EF-VAS scores was shown in group 1 compared to group 2.There was also a signifi-cantly higher IIEF-5 score in group 1 compared to group 2. No significant side effects were detected in both groups during treatment period.. Adding sildenafil to pentoxifylline-colchicine com-bination treatment seems to improve PD related symptoms in the acute phase PD. PDE5i may contribute to relieve the Peyronie's symptoms in ED patients through their antifibrotic effects.

Topics: Colchicine; Erectile Dysfunction; Humans; Male; Pain; Penile Induration; Penis; Pentoxifylline; Retrospective Studies; Sildenafil Citrate; Treatment Outcome

Sildenafil citrate is approved to treat erectile dysfunction. An orally disintegrating tablet (ODT) of sildenafil citrate that does not require swallowing or administration with fluids has been developed. The bioequivalence and bioavailability of sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets (50 mg) in an open-label, randomized crossover study. Healthy Chinese male subjects (n = 36) were allocated to 1 of 6 sildenafil citrate treatment sequences under fasted conditions, and plasma samples for determination of sildenafil concentrations were collected predose through 14 hours postdose. Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil AUC

Topics: Administration, Oral; Adult; Area Under Curve; Asian People; Biological Availability; Cross-Over Studies; Drug Compounding; Erectile Dysfunction; Fasting; Healthy Volunteers; Humans; Male; Phosphodiesterase 5 Inhibitors; Safety; Sildenafil Citrate; Tablets; Therapeutic Equivalency

Erectile dysfunction is defined as inability to achieve or maintain penile erection sufficient for sexual satisfaction. It is a serious problem that increases by age. The physiology of penile erection depends mainly on nitric oxide release.. Compare the efficacy and safety of oral sildenafil 50 mg alone or in combination with l-arginine 3 g/day orally on the treatment of erectile dysfunction.. Randomized controlled study with two parallel groups of erectile dysfunction patients; One group received sildenafil 50 mg every other day, while the other group received a combination of sildenafil (every other day)/l-arginine on a daily base. Efficacy was assessed using International Index of Erectile Function-5 score at the baseline and after 8 weeks. Side effects were evaluated across the two groups.. The mean age was 56.3 ± 5 and 56.2 ± 4.4 years in sildenafil and combination groups, respectively. International Index of Erectile Function-5 score was comparable between the two groups at the baseline (p value 0.44). International Index of Erectile Function-5 score was improved from 15.3 ± 2.5 at baseline to 19.2 ± 2.3 after treatment, and this was statistically significant with p value <0.0001. The score was slightly better in combination group in which the average International Index of Erectile Function-5 score was (19.8 ± 2.2) vs. (18.5 ± 2.3) in sildenafil group with p value 0.05. Side effects were more or less the same between the two groups except for gastritis which was more common on combination group.. Adding l-arginine to sildenafil demonstrated more efficacy than sildenafil alone for treatment of erectile dysfunction patients.

Topics: Aged; Arginine; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Treatment Outcome

To investigate the efficacy and safety of regular oral use of sildenafil in the treatment of ED.. We randomly divided 334 ED patients into three groups to be treated orally with sildenafil tablets at 50 mg qd (sildenafil regular), sildenafil tablets at 100 mg 30 minutes before intercourse (sildenafil on-demand), and tadalafil tablets at 10 mg qd (tadalafil regular), all for 3 months. Then we recorded the IIEF-5 score and penile erection hardness score (EHS) and adverse reactions and compared them among the three groups of patients.. There were no statistically significant differences among the three groups of patients in age, body mass index, education, ED duration, or baseline IIEF-5 and EHS (P > 0.05). After 3-month medication, both IIEF-5 score and EHS were significantly improved in the three groups of patients as compared with the baseline (P < 0.05), with no statistically significant difference in the IIEF-5 score among the sildenafil regular, sildenafil on-demand and tadalafil regular groups (15.15 ± 2.05 vs 15.55 ± 2.36 vs 15.54 ± 2.27, P > 0.05), but the EHS markedly higher in the sildenafil on-demand than in the sildenafil regular group (3.48 ± 1.80 vs 3.12 ± 1.52, P < 0.05). The effectiveness rates in the sildenafil regular, sildenafil on-demand and tadalafil regular groups were 76.2%, 62.4% and 80.8%, respectively, significantly lower in the sildenafil on-demand than in the other two groups (P < 0.05). Adverse reactions were mild and showed no statistically significant difference in the incidence rate among the three groups (P > 0.05).. Regular use of sildenafil has a therapeutic effect similar to that of tadalafil but better than that of sildenafil on-demand, without more adverse effects.

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Sildenafil Citrate; Tablets; Tadalafil; Treatment Outcome

We evaluated the efficacy and safety of hyperbaric oxygenation therapy to preserve erectile function as part of penile rehabilitation after robot assisted bilateral nerve sparing radical prostatectomy for prostate cancer.. We performed a prospective, randomized, double-blind study from January 2009 to April 2013. Men 40 to 65 years old who underwent robot assisted bilateral nerve sparing radical prostatectomy were randomized 1:1 to the control or the treatment group. Participants were exposed to air as the control or to 100% oxygen as the treatment in hyperbaric conditions. The primary outcome was erectile function at 18 months as measured by IIEF (International Index of Erectile Function). Secondary outcomes were 12-month urinary symptoms, and 18-month sexual, urinary, bowel and hormonal related symptoms as measured by EPIC-26 (Expanded Prostate Index Composite-26). Adverse events and long-term cancer outcomes were monitored. Primary and secondary outcomes in the 2 groups were compared by the independent group t-test, the Wilcoxon rank sum test and the chi-square test of proportion.. A total of 109 potent men were randomized to hyperbaric oxygenation therapy or the control group. A total of 43 men in the air group and 40 in the hyperbaric oxygenation therapy group completed the 18-month followup. No statistically significant differences were observed between the 2 groups on any outcome measure.. This study revealed no difference in erectile recovery in men treated with hyperbaric oxygenation therapy vs placebo. Larger studies involving more diverse comorbidities and different hyperbaric oxygenation therapy regimens are needed to better evaluate the usefulness of hyperbaric oxygenation therapy for penile rehabilitation after radical prostatectomy.

Topics: Adult; Aged; Double-Blind Method; Erectile Dysfunction; Follow-Up Studies; Humans; Hyperbaric Oxygenation; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Prospective Studies; Prostatectomy; Prostatic Neoplasms; Recovery of Function; Sildenafil Citrate; Time Factors; Treatment Outcome

It has not been clearly proved in real practice whether early rehabilitation with phosphodiesterase type 5 inhibitors starting immediately after radical prostatectomy improves erectile function recovery more effectively than delayed treatment with the same regimen. We performed a prospective randomized trial to identify this.. Patients with prostate cancer and an IIEF-5 (International Index of Erectile Function-5) preoperative score of 17 or greater were randomly assigned to receive sildenafil 100 mg regularly twice per week for 3 months immediately after urethral catheter removal as the early group or only 3 months after nerve sparing robot-assisted laparoscopic radical prostatectomy as the delayed group. The study primary end point was the full erectile function recovery rate, defined as an IIEF-5 score of 17 or greater, during the 12 months.. Of the 120 randomized patients the proportion who achieved full recovery was significantly higher during the 12 months in the early group than in the delayed group (β = 0.356, p <0.001, generalized estimating equation). After 9 months postoperatively the proportion of patients who achieved full recovery steadily increased to 41.4% at 12 months in the early group while patients in the delayed group showed no further improvement. Thus, full recovery was achieved in only 17.7% of patients at 12 months. Only early sildenafil treatment independently improved full recovery at 12 months (HR 2.943, p = 0.034).. Our trial provides clinical data to suggest that earlier rehabilitation with phosphodiesterase type 5 inhibitors can contribute to the recovery of erectile function after radical prostatectomy in the clinical setting.

Topics: Erectile Dysfunction; Follow-Up Studies; Humans; Laparoscopy; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Postoperative Complications; Prospective Studies; Prostate; Prostatectomy; Prostatic Neoplasms; Recovery of Function; Robotic Surgical Procedures; Sildenafil Citrate; Time Factors; Treatment Outcome

Due to the chaos in the legislation in the Middle East, male enhancement nutraceuticals may be sold without any registration or evaluation. These products need to be evaluated with respect to safety and efficacy. Furthermore, cultural and social considerations in the Middle East prevent the use of international evaluations schemes for erectile dysfunction.. Evaluating the safety and efficacy parameters of generic and nutraceutical products for erectile dysfunction in the Middle East through a custom-designed, representable and simple system tailored to the regional culture.. 74 healthy male volunteers were enrolled into a comparative, simple randomized, single dose, double blind, and crossover clinical study incorporated with a tailored-designed questionnaire. Safety assessment included laboratory analysis for liver functions and measuring blood pressure.. Subjective data regarding safety and efficacy were assessed from the validated questionnaire. Blood pressure was measured. Blood samples were collected to assess the drug/adulterants concentration and liver and kidney functions.. All tested nutraceuticals showed undeclared Sildenafil citrate in patients. Questionnaire results showed high inter-patient variability with respect to efficacy and comparable safety profile compared to Viagra®.. The validated tailored-designed questionnaire effectively assessed the efficacy and safety of male enhancement products. The male enhancement nutraceuticals, sold in Egypt, claimed to be 100% natural are adulterated and of questionable safety profile.

Topics: Adult; Cross-Over Studies; Dietary Supplements; Double-Blind Method; Drug Contamination; Drugs, Generic; Egypt; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Treatment Outcome

To determine what constitutes a clinically important difference (CID) on the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), an 11-item validated questionnaire assessing treatment satisfaction used in clinical trials for patients with erectile dysfunction (ED).. Erectile Dysfunction Inventory of Treatment Satisfaction data were evaluated from a double-blind, fixed-dose trial of 279 men aged 18-65 years with ED who were treated with sildenafil 50 or 100 mg or placebo. The primary anchor measure was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), which has a 4-point minimal CID. The CID on the EDITS index score was determined using a regression analysis comparing EDITS and IIEF EF scores at the end of the 8-week treatment. A similar analysis was performed for EDITS and the Erection Hardness Score (EHS) instrument, a single-item questionnaire measuring hardness, which was used as a secondary anchor measure.. Erectile Dysfunction Inventory of Treatment Satisfaction and IIEF EF domain scores were highly correlated (Pearson correlation coefficient = 0.75). EDITS total scores across treatments at week 8 averaged (mean ± standard deviation [SD]) 67.5 ± 21.6 (range, 0-100; higher scores indicate greater treatment satisfaction); IIEF EF domain scores averaged 22.2 ± 6.9 (range, 1-30; higher scores indicate higher erectile functioning). The calculated CID for EDITS scores was 9.5 (95% CI, 8.5-10.4; 0.44 SD units), corresponding to a medium effect size. EDITS and EHS instrument scores also correlated highly (Pearson correlation coefficient = 0.64). Placebo-adjusted EDITS mean scores were more than twice the CID, at 23 (95% CI, 17-28) and 28 (95% CI, 23-33) for the 50- and 100-mg doses, respectively.. Approximately 10 points on the EDITS index score is considered a CID. Serving as a benchmark, this finding aids interpretation of the clinical relevance of a difference in mean EDITS index scores between treatments for patients with ED.

Topics: Adolescent; Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Minimal Clinically Important Difference; Patient Satisfaction; Penile Erection; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Surveys and Questionnaires; Young Adult

Patient-reported outcomes, such as the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index, are essential for successful evaluation and treatment of patients with erectile dysfunction.. To enrich interpretation of the EDITS index score and to complement the existing 0 to 100 scoring.. This supplemental analysis evaluated EDITS questionnaire data (11 items; index score range = 0-100; higher scores indicate more treatment satisfaction) after completion of an 8-week double-blinded trial of 279 men 18 to 65 years old with erectile dysfunction randomized to sildenafil 100 mg, sildenafil 50 mg, or placebo. Response options for each EDITS item were grouped into "success" (the 2 most satisfied or favorable responses) and "no success" (the remaining 3 responses). The binary response (success or no success) for each item was expressed as a function of overall EDITS score in a simple logistic regression model with all treatments combined.. Odds ratios and success probabilities (using Wald χ. EDITS index score increases corresponded with significant increases in odds of success in different EDITS aspects (P < .0001 for all comparisons). For instance, a 10-point EDITS index score difference was associated with odds ratios of 11.3, 42.0, 17.7, and 6.8 for overall treatment satisfaction, treatment meeting expectations, satisfaction with treatment quickness, and satisfaction with how long treatment lasts, respectively. For a given EDITS index score, likelihood of success was determined for different aspects of treatment satisfaction. For example, a mean EDITS index score of 78 (sildenafil 100 mg; SD = 18) corresponded to 96%, 88%, 94%, and 88% chances of success for the 4 EDITS items referenced earlier, respectively. Corresponding probabilities for a mean EDITS index score of 50 (placebo; SD = 18) were 3%, less than 0.1%, 1%, and 4%, respectively.. Interpretation of the EDITS index score can be augmented using key aspects of treatment satisfaction as reported by the patient.. This analysis used a well-established anchor-based approach to interpret EDITS index scores. The methodology used and corresponding results are appropriate for clinical practice and clinical trial settings. Limitations include data evaluation only for the Patient EDITS and not the complementary Partner EDITS and use of data from a clinical trial enrolling a well-defined patient population only in stable relationships.. These results enable a meaningful interpretation of EDITS index scores, facilitating decision making by stakeholders for better-informed health care choices. Cappelleri JC, Tseng L-J, Stecher V, Goldstein I. Enriching the Interpretation of the Erectile Dysfunction Inventory of Treatment Satisfaction: Characterizing Success in Treatment Satisfaction. J Sex Med 2018;15:732-740.

Topics: Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Logistic Models; Male; Middle Aged; Odds Ratio; Patient Satisfaction; Sildenafil Citrate; Surveys and Questionnaires; Treatment Outcome; Young Adult

To compare the efficacy and safety of sildenafil 25 mg qd, 25 mg bid or 50 mg qd - on treating lower urinary tract symptoms with benign prostatic hyperplasia (LUTS/BPH).. Men aged > 45 years with LUTS/BPH were randomly assigned to receive sildenafil 25 mg qd (n = 42), bid (n = 41), 50 mg qd (n = 38) or placebo (n = 41) for 8 weeks. Changes from baseline in International Prostate Symptom Score (I-PSS), maximum urinary flow rate (Qmax) and postvoid residual urine volume (PVR) were assessed at week 4 and week 8.. Sildenafil 25 mg qd (-7.3 ± 5.8) and 25 mg bid (-7.0 ± 5.7) exhibited significant improvements of I-PSS compared to placebo (-5.2 ± 6.4) (p = 0.020, 0.025, respectively). In particular, voiding domain was more affected than storage domain. Only sildenafil 50 mg qd improved nocturia significantly (versus placebo, p = 0.027). Quality of life score was improved in all treatment groups. Q. Sildenafil 25 mg qd, 25 mg bid and 50 mg qd are safe and effective to improve LUTS/BPH in long term, along with coexisting ED. In particular, nocturia is most well-controlled by 50 mg qd.

Topics: Aged; Analysis of Variance; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Nocturia; Phosphodiesterase 5 Inhibitors; Prostatic Hyperplasia; Quality of Life; Sildenafil Citrate; Urination

We conducted a prospective study of transient evoked otoacoustic emissions (TEOAEs) and distortion-product otoacoustic emissions (DPOAEs) in men who were taking an oral phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction. Our study group was made up of 30 men (60 ears), aged 34 to 60 years (mean: 50.9). They were randomly divided into three groups; 10 men were given sildenafil (Viagra) at 50 mg twice a week, 10 were given tadalafil (Cialis) at 20 mg twice a week, and 10 were given vardenafil (Levitra) at 20 mg twice a week. All patients took their drug for 3 weeks, for a total of 6 tablets for each patient. Audiometric tests and TEOAE and DPOAE measurements were performed before and after treatment. Post-treatment audiometry demonstrated improvement in hearing in all three groups. However, post-treatment TEOAE amplitudes and DPOAE amplitudes differed among the three groups; they were significantly higher in the sildenafil group at 1.0 kHz and the same in the tadalafil group; in the vardenafil group, the DPOAE amplitude was significantly lower at 3.0 kHz while there was no change in the TEOAE amplitude. We speculate that the possible mechanism for these findings is that PDE5 inhibitors block degradation of cyclic guanosine monophosphate (cGMP) and induce dilation of the cochlear microcirculation, resulting in an increase in cochlear blood flow. We also believe that the decrease in DPOAE amplitudes at 3.0 kHz seen in the vardenafil group may be related to an accumulation of nitric oxide/cGMP complex, which is toxic to the cochlea; however, since there was no change in TEOAE amplitude in the vardenafil group, this influence may be minimal. Further studies are needed to obtain a more comprehensive assessment of the effects of PDE5 inhibitors on hearing with the use of higher doses and longer durations of therapy.

Topics: Adult; Audiometry; Cochlea; Erectile Dysfunction; Hearing; Humans; Male; Middle Aged; Otoacoustic Emissions, Spontaneous; Phosphodiesterase 5 Inhibitors; Prospective Studies; Sildenafil Citrate; Vardenafil Dihydrochloride

A new oro-dispersible film (ODF) formulation of sildenafil has been developed for the treatment of erectile dysfunction (ED) to overcome the drawbacks that some patients experience when taking the conventional film-coated tablet (FCT).. To assess the effectiveness and safety of sildenafil ODF formulation in patients with ED who were using the conventional FCT.. From May 2017 through July 2017, 139 patients with ED were enrolled. Data from penile color-duplex ultrasound, medical history, hormonal evaluation, and patient self-administered questionnaires were collected. All patients were administered sildenafil 100-mg FCT for 4 weeks. Thereafter, they underwent a 2-week washout period and subsequently took sildenafil 75-mg ODF for 4 weeks.. The International Index of Erectile Function (IIEF-15), Hospital Anxiety and Depression Scale (HADS), Patient Global Impressions of Improvement (PGI-I), and Clinician Global Impressions of Improvement (CGI-I) questionnaires were administered and severity of ED was classified as severe (IIEF-15 score ≤ 10), moderate (IIEF-15 score 11-16), or mild (IIEF-15 score = 17-25).. All patients completed the final protocol. Differences in mean IIEF scores for erectile function, orgasmic function, sexual desire, and intercourse satisfaction were significantly in favor of sildenafil 100-mg FCT, whereas the mean score for overall satisfaction was in favor of sildenafil 75-mg ODF. A significant difference in changes in HADS score was found from washout to final follow-up (mean difference = -0.19; P < .01). For the ODF formulation, the median CGI-I score was 3.5 (interquartile range [IQR] = 2.5-4.5) and the median PGI-I score was 3.0 (IQR = 2.0-4.0). The median action time was 20.0 minutes (IQR = 15.0-30.0) and the median mouth time was 60.0 seconds (IQR = 30.0-120.0).. The ODF formulation of a widely known drug, with the same safety and effectiveness of the FCT, was better appreciated by patients in overall satisfaction.. This is the first clinical trial to assess the efficacy of a new formulation of sildenafil in patients with ED. The limitations of the study are related to the methodology used: it was not a case-control study and the patients were not drug-naïve for ED treatment. Therefore, only the "additional" side effects of the ODF formulation compared with FCT are reported.. The new ODF formulation is as efficient and safe as the FCT formulation and offers a new choice of treatment to specialists for more precisely tailored therapy. Cocci A, Capece M, Cito G, et al. Effectiveness and Safety of Oro-Dispersible Sildenafil in a New Film Formulation for the Treatment of Erectile Dysfunction: Comparison Between Sildenafil 100-mg Film-Coated Tablet and 75-mg Oro-Dispersible Film. J Sex Med 2017;14:1606-1611.

Topics: Adult; Aged; Case-Control Studies; Drug Compounding; Erectile Dysfunction; Humans; Libido; Male; Middle Aged; Orgasm; Penile Erection; Sildenafil Citrate; Surveys and Questionnaires; Tablets; Treatment Outcome

To evaluate the safety, efficacy and tolerability of China-made sildenafil citrate (Jinge) in the treatment of ED.. We conducted a multi-center, randomized, double-blind and placebo-controlled clinical trial among 222 ED patients in five urological or andrological clinics of China. The patients were randomly assigned to receive sildenafil citrate (SC, n = 111) or placebo (n = 111) for 8 weeks. We obtained and analyzed the demographic and clinical characteristics of the patients, the scores of International Index of Erectile Function (IIEF), the success rate of sexual intercourse, and the incidence of adverse events.. No statistically significant differences were found between the patients of the SC and those of the placebo group in the mean age (［47.2±11.32］ yr vs ［46.67±13.08］ yr, P>0.05), psychological etiology (27.93% vs 23.42%, P>0.05), organic etiology (21.62% vs 29.73%, P>0.05) or mixed etiology (50.45% vs 46.85%, P>0.05), nor in height, weight, nationality, or history of smoking, drinking or allergy. Compared with the placebo controls, the SC-treated patients showed significant increases in the excellence rate of effectiveness (29.91% vs 78.90%, P<0.01), success rate of sexual intercourse (29.16% vs 63.87%, P<0.01), and total effectiveness rate (34.58% vs 77.98%, P<0.01). The effectiveness rates on organic, psychogenic and mixed types ED were remarkably higher in the SC group (64.52%, 83.33%, and 82.14%) than in the placebo control (46.15%, 21.21%, and 25.00%) (P<0.01). Mild or temporary adverse events were observed in 32 cases in the SC group as compared with 13 in the placebo control.. China-made sildenafil citrate is an effective, safe and well-tolerated drug for ED of different etiologies in the Chinese population.. 目的: 评价国产枸橼酸西地那非（金戈）治疗男性勃起功能障碍（ED）的安全性、有效性和耐受性。方法： 采用多中心、随机、双盲、安慰剂对照研究方法 ，在国内5家医院泌尿外科或男科门诊纳入222例ED患者，随机分为西地那非组（111例）和安慰剂组（111例），进行为期8周的临床治疗观察。以国际勃起功能问卷（ IIEF）评分、性交成功率作为有效性评价指标，以不良事件发生率作为安全性评价指标。结果： 西地那非组和安慰剂组患者年龄分别为（47.20±11.32）岁和（ 46.67±13.08）岁（P>0.05），ED病因分别为心理性（27.93% vs 23.42%）、器质性（21.62% vs 29.73%）和混合性ED（50.45% vs 46.85%）(P均>0.05) ，其他流行病学数据如身高、体重、民族、吸烟、饮酒、药物过敏史等一般情况也均无统计学差异。对主要疗效指标的分析结果显示，西地那非组与安慰剂组对勃起 功能显著有效率分别为78.90%和29.91%（P<0.01)；西地那非组性交成功率和总体疗效分别为63.87%和77.98%，均明显高于安慰剂组的29.16%和34.58%（P均 <0.01)。在对于不同种类ED的治疗上，西地那非对心理性、器质性和混合性ED的有效率分别为64.52%、83.33%和82.14%，明显高于安慰剂组的46.15%、21.21%和 25.00%（P均<0.01)。安全性评价结果显示，共有45例（20.27%）受试者出现了各种不良事件（西地那非组有32例，安慰剂组有13例），所出现的不良事件大多数 为轻度、一过性的。结论： 国产枸橼酸西地那非是一种可治疗各种病因导致ED的安全有效的药物，且患者耐受性较好。.

Topics: Aged; China; Coitus; Double-Blind Method; Drug Compounding; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Smoking; Treatment Outcome

To investigate the safety and efficacy of pancreatic kininogenase combined with sildenafil in the treatment of erectile dysfunction(ED) in type 2 diabetes mellitus (DM) patients in the high-altitude area.. This study included 93 ED patients with type 2 DM, all residents of the Xining area 1500 meters above sea level. We randomly divided them into an experimental group (n = 48) and a control group (n = 45), the former treated with pancreatic kininogenase(120 u, tid) and sildenafil (25 mg, qd at bedtime), while the latter with sildenafil only (25 mg, qd at bedtime).After 4 and 8 weeks of medication, we obtained the penile hemodynamic parameters,IIEF-5 scores, and sexual intercourse satisfaction(SIS) scores and compared them between the two groups of patients.. There were no statistically significant differences in age or DM course between the two groups of patients (P >0.05).Compared with the baseline, both the experimental and control groups showed remarkably improvement inthe IIEF-5 score (8.81 ± 2.06 vs 11.54 ± 7.72 and 8.29 ± 1.91 vs 9.37± 1.65, P <0.05), SIS score (3.35 ± 2.43vs6.83± 2.61and 3.41 ± 2.38 vs 4.92± 2.49, P <0.05), and penile hemodynamic parameters obtained by color duplex Doppler ultrasonography(P <0.05), with significant differences between the two groups in the IIEF-5 score (11.54 ± 7.72 vs 9.37± 1.65, P <0.05) and SIS score (6.83± 2.61 vs 4.92± 2.49, P <0.05) but not in the penile hemodynamic parameters (P >0.05). Even more remarkable improvement was observed at 8 weeks in the experimental and control groups in the IIEF-5 score (19.29± 1.85 and 15.43± 1.74)(P <0.05), SIS score (11.73 ± 2.57 and 6.55± 2.71) (P <0.05), and penile hemodynamic parameters(P <0.05), all with significant differences between the two groups (P <0.05).. Pancreatic kininogenase combined with sildenafil has a better clinical effect than sildenafil alone on ED in type 2 DM patientsin the high-altitude area.. 目的： 探讨胰激肽原酶肠溶片联合西地那非治疗高海拔地区2型糖尿病合并勃起功能障碍(ED)患者的安全性及疗效。方法： 选择青海西宁地区糖尿病合并ED患者93例，随机分成两组，试验组(48例)服用胰激肽原酶肠溶片（120 u，3次/d）联合小剂量西地那非规律服用（25 mg，每晚1次），对照组(45例) 小剂量西地那非规律服用（25 mg，每晚1次），两组治疗4、8周后评价两组阴茎彩色多普勒超声（CDDU）检查、国际勃起功能指数(IIEF-5)、性交满意度。结果： 患者年龄及糖尿病病程两组间均无显著差异(P>0.05)。治疗4周：试验组和对照组治疗前后IIEF-5评分［(8.81±2.06)分 vs (11.54±7.72)分和(8.29±1.91)分 vs (9.37±1.65)分］、SIS［(3.35±2.43)分 vs (6.83±2.61)分和(3.41±2.38)分 vs (4.92±2.49)分］、CDDU均有显著差异(P<0.05)，两组间IIEF-5评分［(11.54±7.72)分 vs (9.37±1.65)分］和SIS［(6.83±2.61)分 vs (4.92±2.49)分］有显著差异(P<0.05)，而CDDU参数无差异(P>0.05)。治疗8周：试验组和对照组治疗前后IIEF-5评分［(8.81±2.06)分 vs (19.29±1.85)分和(8.29±1.91)分 vs (15.43±1.74)分］均有显著差异 (P<0.05)，两组间IIEF-5评分［(19.29±1.85)分 vs (15.43±1.74)分］、SIS［(11.73±2.57)分 vs (6.55±2.71)分］、CDDU参数均有显著差异(P<0.05)。结论： 胰激肽原酶肠溶片联合西地那非治疗高海拔地区2型糖尿病合并ED患者具有一定临床疗效，且较单一西地那非治疗更为有效。.

Topics: Aged; Altitude; Coitus; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Erectile Dysfunction; Humans; Kallikreins; Male; Pancreas; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Treatment Outcome

Patient-reported outcomes are a valuable tool used to gauge treatment satisfaction in different conditions, including erectile dysfunction (ED).. To use person-item maps to quantify barriers to improvement of treatment satisfaction in men with ED.. Men 18 to 65 years old with documented ED received sildenafil 50 mg, sildenafil 100 mg, or placebo for 8 weeks in a double-blinded manner. Post hoc analyses were conducted on Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) data (11 items rating treatment satisfaction; each item score range = 0-4).. Person-item maps were developed based on Rasch models. To quantify barriers to improvement of treatment satisfaction, responses to the 11 items of the EDITS questionnaire were dichotomized to indicate improvement (responses of 3 or 4 were combined to a score of 1) vs no change or worsening (responses of 0, 1, or 2 were combined to a score of 0).. Analyses were conducted using data from 278 men who completed the EDITS questionnaire at the end of double-blinded treatment. The person-item map indicated that EDITS item 4 (ease of use of treatment) was the easiest barrier to overcome, whereas the most difficult barrier to improvement of treatment satisfaction was EDITS item 2 (degree to which treatment met expectations). Most men in the sildenafil 100-mg group endorsed most EDITS items, consistent with substantial improvement. The sildenafil 50-mg group was similar, but with smaller frequencies for endorsing improvement of the more difficult EDITS items. In contrast, men receiving placebo endorsed mainly the easiest EDITS items, with only a small number of men endorsing the difficult items.. A person-item map is a useful means for quantifying barriers to improvement of treatment satisfaction represented by EDITS items in patients with ED.

Topics: Adolescent; Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Sildenafil Citrate; Surveys and Questionnaires; Young Adult

Sildenafil citrate, a drug used to treat erectile dysfunction, is available in tablet form but has three major problems. First, the drug displays poor aqueous solubility, which delays its onset of action. Second, the drug undergoes extensive first-pass metabolism, resulting in a low (40%) bioavailability. Third, the gastrointestinal effects of sildenafil citrate include dyspepsia and a burning sensation. The objective of this study was to prepare sildenafil citrate using a fast orodissolvable film (ODF) containing the drug in a solid dispersion (SD) to mitigate the abovementioned problems. The solubility of sildenafil citrate in β-cyclodextrin derivatives was estimated, and SDs were prepared and characterized. To develop an ODF that disintegrates rapidly and releases the maximum amount of sildenafil citrate, a 3(3) Box-Behnken experimental design was used to estimate the effects of different concentrations of film forming polymer (X1), the film modifier (X2), and the plasticizer (X3) on the responses, i.e. the disintegration time (Y1) and the amount of drug released (Y2). Pharmacokinetic studies with the optimized (ODF) were conducted on human volunteers. SD prepared using hydroxybutyl-β-cyclodextrin enhanced the solubility of sildenafil citrate by more than eightfold. The Y1 for the optimized ODF was 89 seconds, and the Y2 was 86%; this formula also exhibited a rapid onset of action, and its bioavailability was enhanced by 2.25-fold compared with that of the marketed tablet. The ODF is a promising formulation for sildenafil citrate that results in higher solubility, a rapid onset of action, and enhanced systemic bioavailability.

Topics: Administration, Oral; Adult; beta-Cyclodextrins; Biological Availability; Chemistry, Pharmaceutical; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Excipients; Humans; Male; Middle Aged; Mouth Mucosa; Sildenafil Citrate; Solubility

Multiple studies have evaluated the use of PDE5 inhibitors in penile rehabilitation following nerve-sparing prostatectomy. These studies have evaluated the use of various pharmacologic agents as well as various approaches to treatment (on-demand vs. rehabilitative). Most of these studies relied on self-reported outcomes to determine efficacy of the therapy which could allow response bias to affect their results. The aim of this study was to evaluate the effects of nightly sildenafil citrate therapy during penile rehabilitation, using nocturnal penile rigidity (RigiScan(™), Gotop Medical, Inc., St. Paul, MN, USA) in addition to the IIEF-EF. Patients with localized prostate cancer and normal erectile function prior to nsRP were randomized to take either nightly 50 mg sildenafil citrate or placebo starting the night following surgery. Both groups were allowed on-demand sildenafil citrate. Erectile function was evaluated at 2 weeks, 3, 6, 9 and 12 months post-operatively, with a final assessment made at 13 months, following a 1 month drug washout. At all time points, self-reported (IIEF-EF) and objective (RigiScan(™)) measures were obtained and evaluated. About 74 of 97 randomized patients completed the study. On completion, 40% of patients in each group had normal erectile function based on RigiScan(™) (p = 1.0). Additionally, no statistical differences were seen using the IIEF-EF domain (32.4% of placebo, 29% of treatment; p = 0.79). Multivariable analysis showed no significant differences in erectile function based on treatment intervention. Results did show that African-American men in this cohort were at higher risk for lower RigiScan(™) scores over time (OR: 0.48, p = 0.0399). This study demonstrates that nightly sildenafil citrate does not provide a therapeutic benefit for recovery of erectile function post-prostatectomy when compared to on-demand dosing using both self-reported as well as objective measures. Differences in objective recovery parameters based on patients' race/ethnicity warrant further investigation.

Topics: Double-Blind Method; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Placebos; Prospective Studies; Prostate; Prostatectomy; Prostatic Neoplasms; Recovery of Function; Sildenafil Citrate

This report describes a post hoc analysis of data from a randomized, double-blinded, placebo-controlled, flexible-dose, sildenafil trial in men with erectile dysfunction.. To simplify interpretation of erectile function (EF) domain scores of the International Index of Erectile Function (IIEF).. Men at least 18 years old with erectile dysfunction were randomized to receive sildenafil or placebo for 12 weeks. Men taking nitrates or nitric oxide donors were excluded. Responses for each IIEF EF domain question (questions 1-5 and 15) were combined into two broad categories ("success" for responses of the two most favorable categories of a question and "no success" for other responses). Each question was expressed in a logistic regression model (sildenafil and placebo groups combined) as a function of overall EF domain score.. IIEF EF domain score and items.. A four-point increase in the IIEF EF domain score was associated with an odds ratio of success of 6.1 for getting an erection, 29.2 for having a firm erection, 10.0 for able to penetrate,12.8 for maintaining erection, 4.0 for maintaining erection to completion, and 3.7 for erection confidence. An EF domain score of 22 was associated with a probability of success of 81% for getting an erection, 86% for having a firm erection, 89% for able to penetrate, 67% for maintaining an erection, 70% for maintaining an erection to completion, and 32% for erection confidence. For an EF domain score of 16, the corresponding probabilities of success were 22%, 4%, 20%, 4%, 22%, and 6%, respectively.. These results provide stakeholders with a simplified and meaningful interpretation of IIEF EF domain scores based on six key aspects of EF.

Topics: Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Logistic Models; Male; Odds Ratio; Penile Erection; Phosphodiesterase 5 Inhibitors; Recovery of Function; Sildenafil Citrate; Surveys and Questionnaires; Treatment Outcome

This study aimed to evaluate the efficacy and safety of long-term and low-dose tadalafil combined with sildenafil as needed at the early stage of treatment for erectile dysfunction (ED). We enrolled 180 patients with ED 1 : 1 to tadalafil 5 mg once daily or once-a-day tadalafil 5 mg combined with sildenafil 50 mg as needed. The efficacy measures included the 5-item version of the International Index of Erectile Function (IIEF-5) and the Sexual Encounter Profile (SEP). The safety was assessed by observing drug tolerability and adverse events. Total IIEF-5 scores of patients with severe ED in combined medication group were significantly higher than in tadalafil alone group. Question 2 scores of IIEF-5 of patients with moderate and severe ED in combined medication group were significantly higher than in tadalafil alone group. The significant improvement in question 3 scores of IIEF-5 existed only in patients with severe ED receiving combined medication. The percentage of 'yes' responses to SEP4, SEP5 and partner's SEP3 were improved significantly in combined medication group. There was no difference between two groups in the incidence of adverse events. Our results suggest that combined medication can better improve erectile function, especially for patients with severe ED.

Topics: Adult; Carbolines; Drug Therapy, Combination; Early Medical Intervention; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Severity of Illness Index; Sildenafil Citrate; Sulfonamides; Tadalafil; Treatment Outcome; Young Adult

Phosphodiesterase type-5 inhibitors (PDE5Is) are first-line therapies for erectile dysfunction (ED). Sildenafil (SIL) and vardenafil (VAR) are approved for as-needed (PRN) dosing; tadalafil (TAD) is approved for both PRN and once-a-day (OaD) dosing for ED. Recent evidence suggests that TAD-OaD may be effective as therapy in men with an incomplete response to PRN-PDE5I therapy. This study evaluated whether TAD-OaD provides similar efficacy in men with ED who had previously demonstrated a partial response to PRN-PDE5I therapy.. In this randomized, double-blind, placebo-controlled trial, men with a ≥3 month ED history received SIL 100 mg, TAD 20 mg, or VAR 20 mg during a 4 week open-label lead-in period. Those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain scores <26 following lead-in treatment completed a 4 week washout period, then randomized to TAD 2.5 mg up-titrated to 5 mg, TAD 5 mg, or placebo (PBO) OaD for 12 weeks. MAIN OUTCOME MEASURES obtained from patients treated with TAD-OaD were compared to PBO-treated patients. Additionally, results of treatment with TAD-OaD were compared to results obtained from 4 week PRN-PDE5I therapy to determine whether OaD and PRN regimens provided comparable efficacy.. NCT01130532.. International Index of Erectile Function (IIEF) domain scores; Sexual Encounter Profile (SEP) questions 2-5.. Endpoint data was obtained from 590 men (391 TAD; 199 PBO). RESULTS for all IIEF and SEP measures were significantly better for TAD-OaD (p < 0.001 for all) compared to PBO and were comparable to those observed during PRN-PDE5I treatment. TAD 2.5 mg and TAD 5 mg OaD therapy were safe and generally well tolerated.. Tadalafil once daily is a viable alternative to as-needed PDE5I therapy in men with ED. Key limitations include the lack of a PRN PDE5I study group during the double-blind period, and that many more patients took tadalafil than sildenafil or vardenafil during the PRN period.

Topics: Adult; Carbolines; Dose-Response Relationship, Drug; Double-Blind Method; Drug Monitoring; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Patient Preference; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfonamides; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

To evaluate the correlation between the dosage frequency of sildenafil and its treatment outcomes in men with erectile dysfunction (ED).. Data were from a 4-week, multicenter, observational study of men (1699), between 18 and 60 years of age, with a clinical diagnosis of ED defined as the Sexual Health Inventory for Men (SHIM) score ≤21. The erectile function and quality of sexual life were evaluated at the baseline and the endpoint of sildenafil treatment (after 4 weeks) by using SHIM, Self-Esteem and Relationship Questionnaire, 36-Item Short Form Health Survey, Erection Hardness Score, and the global efficacy question.. Nine hundred thirty-five patients were enrolled in the ≤1 weekly, 573 in the 2-3 weekly, and 158 in the 4-7 weekly dosage frequency cohorts. After 4 weeks of treatment, a higher dosage frequency of sildenafil was associated with a better SHIM, Self-Esteem and Relationship Questionnaire, and 36-Item Short Form Health Survey score improvement (all P <.0001). Hyperlipidemia is a poor prognostic factor (odds ratio, 3.59; P = .04), whereas hypertension (odds ratio, 0.25; P <.01) and coronary heart disease (odds ratio, 0.56; P = .05) are sensitive to sildenafil treatment.. Higher dosage frequency of sildenafil is associated with a better improvement of sexual function and quality of life of men with ED, and the concomitant treatment of hyperlipidemia is recommended.

Topics: Adolescent; Adult; China; Dose-Response Relationship, Drug; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Quality of Life; Sexual Behavior; Sildenafil Citrate; Sulfonamides; Surveys and Questionnaires; Treatment Outcome; Young Adult

We evaluated the effect of lifestyle modifications and glycemic control on the efficiency of sildenafil citrate in patients with type-2 diabetes (T2DM) and erectile dysfunction (ED).. Eighty-three men with ED due to T2DM were included in the study. The Group 1 (n = 41) patients received lifestyle modifications (diet and exercise), and medical treatment for intensive glycemic control. In Group 2 (n = 42), in addition to the intensive glycemic control, the patients were given sildenafil citrate® 100 mg for 2-3 per weeks. The changes in ED were compared between the two groups after three months of treatment.. The mean age was 54.9 ± 9.1 (26-75) years. An increase in the IIEF-5 scores was observed in 23 of 41 patients in Group 1 (44.2%) and 29 of 42 in Group 2 (55.8%). When the changes of the IIEF-5 scores were evaluated, the mean increase was 2.5 in Group 1, and 5.0 in Group 2 (p = 0.012). The mean IIEF changes according to the duration of diabetes were 4.8 in <5 years, 3.6 in 5-10 years and 1.6 in >10 years (p = 0.021).. Glycemic control and lifestyle changes are not solely adequate for a better sexual function in ED due to diabetes, and sildenafil citrate should be used additionally.

Topics: Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Erectile Dysfunction; Glycemic Index; Humans; Male; Middle Aged; Risk Reduction Behavior; Sildenafil Citrate; Treatment Outcome; Vasodilator Agents

To apportion the direct effect and the indirect effect (through erections) that sildenafil (vs placebo) has on individual satisfaction and couple satisfaction over time, longitudinal mediation modeling was applied to outcomes on the Sexual Experience Questionnaire. The model included data from weeks 4 and 10 (double-blind phase) and week 16 (open-label phase) of a controlled study. Data from 167 patients with erectile dysfunction (ED) were available for analysis. Estimation of statistical significance was based on bootstrap simulations, which allowed inferences at and between time points. Percentages (and corresponding 95% confidence intervals) for direct and indirect effects of treatment were calculated using the model. For the individual satisfaction and couple satisfaction domains, direct treatment effects were negligible (not statistically significant) whereas indirect treatment effects via the erection domain represented >90% of the treatment effects (statistically significant). Week 4 vs week 10 percentages of direct and indirect effects were not statistically different, indicating that the mediation effects are longitudinally invariant. As there was no placebo arm in the open-label phase, mediation effects at week 16 were not estimable. In conclusion, erection has a crucial role as a mediator in restoring individual satisfaction and couple satisfaction in men with ED treated with sildenafil.

Topics: Double-Blind Method; Erectile Dysfunction; Humans; Male; Patient Satisfaction; Penile Erection; Personal Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Partners; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

An optimal outcome of an erectile dysfunction (ED) treatment is to enable a return to normal erectile function (as defined by an International Index of Erectile Function-Erectile Function [IIEF-EF] domain score ≥ 26). As-needed (PRN) phosphodiesterase type 5 (PDE5) inhibitor treatment does not always result in a return-to-normal erectile function.. The combined studies evaluated whether treatment with tadalafil once daily would allow men to return to normal erectile function who had less than normal IIEF-EF domain scores while using a maximum dose of a PRN PDE5 inhibitor treatment.. Men were ≥ 18 years of age, sexually active, reported a ≥ 3-month history of ED, and had been taking the maximum dose of sildenafil citrate, vardenafil, or tadalafil PRN. Randomization to once-daily therapy with tadalafil 2.5 mg to 5 mg (N = 207), tadalafil 5 mg (N = 207), or placebo (N = 209) for 12 weeks followed a 4-week maximum dose PRN PDE5 treatment and 4-week nondrug lead periods. Two identical double-blind, randomized, placebo-controlled studies were conducted; combined results are reported.. The main outcome measure was the percentage of subjects with a return-to-normal erectile function (IIEF-EF domain score ≥ 26) when treated with tadalafil once daily compared with placebo.. In subjects not achieving normal erectile function with the maximum dose of a PRN PDE5 inhibitor, a higher percentage of subjects treated with tadalafil had an IIEF-EF domain score ≥ 26 at end point (tadalafil 2.5- to 5-mg group [39%]; tadalafil 5-mg group [40%]) compared with the placebo group (12.1%; P < 0.001). Tadalafil was generally well tolerated and adverse events observed were consistent with previous reports of tadalafil once daily.. Treatment with tadalafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment.

Topics: Carbolines; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

It has been shown on experimental rat models that type 5-phosphodiesterase isoenzyme (PDE5) inhibitors have anti-fibrotic effects for Peyronie's disease (PD); however, this issue has not been addressed clinically. The aim of this study was to document the effects of PDE5 inhibitors used for erectile dysfunction (ED) seen in PD patients on the main course of the PD clinically.. A total of 39 PD patients with ED were divided into two groups. Patients in Group 1 (n = 18) served as controls and received 400 IU vitamin E per day. Those in Group 2 (n = 21) received 50 mg sildenafil per day for 12 weeks. Penile plaque volume was assessed by palpation and by duplex ultrasound. Erectile capacity, penile deformity and plaque characteristics were assessed by the International Index of Erectile Function questionnaire form (IIEF-5) and penile duplex ultrasound.. Statistically significant improvement in all parameters was observed within both groups except for IIEF score in Group 1 when compared with the initial values. Significant reduction in plaques and pain were observed in 7 (33.3 %) and 14 (66.6 %) patients in Group 2 and 6 (33.3 %) and 9 patients (42.8 %) in Group 1, respectively. At the end of the therapy, improvement in IIEF score and reduction in pain were statistically significant in Group 2 compared with Group 1 (p = 0.028 and p = 0.045, respectively).. We conclude that continuous administration of oral PDE5 inhibitors may be a candidate for medical treatment of PD; however, more controlled studies are needed.

Topics: Administration, Oral; Adult; Animals; Comorbidity; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Induration; Penis; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Rats; Sildenafil Citrate; Sulfones; Treatment Outcome; Ultrasonography, Doppler, Duplex

We studied adjuvant daily sildenafil citrate during and after radiotherapy for prostate cancer for erectile function preservation.. We performed a randomized, prospective trial of 279 patients with localized prostate cancer treated with radiotherapy who received sildenafil citrate (50 mg daily) or placebo (2:1 randomization). Medication/placebo was initiated 3 days before treatment and continued daily for 6 months. Before therapy and 3, 6, 9, 12, 18 and 24 months after radiotherapy patients completed the IIEF questionnaire, including the erectile function domain, the I-PSS questionnaire and the RAND SF-36®. All IIEF domains were scored.. At 12 months erectile function scores were better for sildenafil citrate than placebo (p = 0.018), 73% of patients on sildenafil citrate vs 50% on placebo had mild/no erectile dysfunction (p = 0.024) and the sildenafil citrate arm had superior overall satisfaction (p = 0.027) and IIEF total scores (p = 0.043). At 24 months erectile function and IIEF scores were no longer significantly better for sildenafil citrate (p = 0.172 and 0.09, respectively) and yet overall satisfaction scores were higher (p = 0.033). Sexual desire scores in patients who received sildenafil citrate were higher at 24 months although they had completed drug therapy 18 months previously (p = 0.049). At 24 months 81.6% of patients on sildenafil citrate and 56.0% of those on placebo achieved functional erection with or without erectile dysfunction medication (p = 0.045).. Daily sildenafil citrate during and after radiotherapy for prostate cancer was associated with improved overall sexual function compared with placebo for various sexual function domains. To our knowledge this is the largest randomized, prospective, controlled trial to show the usefulness of a phosphodiesterase-5 inhibitor as a rehabilitation strategy in patients with prostate cancer who received radiation therapy.

Topics: Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Prospective Studies; Prostatic Neoplasms; Purines; Radiotherapy; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Time Factors

A high incidence of erectile dysfunction (ED) among patients with obstructive sleep apnoea syndrome (OSAS) has been reported, with a strong correlation between obstructive sleep apnoea, ED, and quality of life (QOL), and it has been estimated that 10-60% of patients with OSAS suffer from ED. In this prospective randomised controlled trial, we investigated 82 men with ED consecutively who were referred to the outpatient clinic for sleep disorders and had severe OSAS (AHI> 30 events/h) without any other comorbidities as a possible cause of ED. The aim of this study was to evaluate and compare the efficacy of sildenafil vs. continuous positive airway pressure (CPAP) in men with ED and severe OSAS.. Eighty-two patients were randomised to two main treatment groups: group 1 patients (n = 41) were treated with 100-mg sildenafil 1 h before sexual intercourse without CPAP, and group 2 patients (n = 41 men) were treated with only nasal CPAP during night time sleep. Both groups were evaluated with the same questionnaires (International Index of Erectile Function-EF domain; Sex Encounter Profile; Erectile Dysfunction Inventory Treatment Satisfaction) 12 weeks after treatment.. In patients receiving sildenafil treatment, 58.2% of those who attempted sexual intercourses were successful compared to 30.4% in the CPAP group. The mean number of successful attempts per week was significantly higher in the sildenafil group compared with the CPAP group (2.9 vs. 1.7, respectively; p < 0.0001). The mean IIEF-EF domain scores were significantly higher in the sildenafil group compared with the CPAP group (p < 0.0001). The overall satisfaction rate was 68% with sildenafil treatment and 29% with CPAP treatment.. This study confirms that severe OSAS is strongly associated with erectile dysfunction. CPAP and sildenafil (100 mg) are safe and effective therapies for OSAS-related ED patients. In the present study sildenafil was more effective than CPAP in treating ED associated with OSAS, as indicated by a significantly higher rate of successful attempts at intercourse and higher IIEF-EF domain scores. Our study, to date, is the only that has investigated sildenafil in patients with severe OSAS.

Topics: Adult; Coitus; Combined Modality Therapy; Continuous Positive Airway Pressure; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prospective Studies; Quality of Life; Sildenafil Citrate; Sleep Apnea Syndromes; Surveys and Questionnaires; Vasodilator Agents

To evaluate the efficacy and safety of combination therapy of sildenafil plus vacuum erection devices in men with type 2 diabetes mellitus with moderate to severe erectile dysfunction who are dissatisfied with the results of using sildenafil alone.. The study included 66 diabetes mellitus patients presenting erectile dysfunction for at least 6 months and dissatisfied with the use of 100 mg sildenafil monotherapy. The patients were randomized in two groups. Those in group A (n = 33) were instructed to use a vacuum erection device only, whereas those in group B (n = 33) were treated with combination therapy, including sildenafil 100 mg and a vacuum erection device. Erectile function was evaluated subjectively using the International Index of Erectile Function, Sexual Encounter Profile questionnaire questions 2 and 3 at visit 1 (baseline; study entry), visit 2 (4 weeks after baseline), and visit 3 (12 weeks after baseline; study end).. There were no significant differences in average patient age, duration of diabetes, duration of erectile dysfunction, baseline International Index of Erectile Function scores, hypertension, blood testosterone, smoking and alcohol consumption between two groups. Mean International Index of Erectile Function scores were significantly higher for group B at the 1-month (14.86 ± 2.17 vs 12.41 ± 2.63; P < 0.0001) and 3-months (17.53 ± 2.95 vs 14.29 ± 2.81; P < 0.0001) visits. Men in group B had better successful penetration (73.3% vs 46.6%) and successful intercourse (70% vs 46.6%) at 3 months compared with group A.. Combined use of sildenafil and vacuum erection device therapy significantly enhances erectile function, and it is well tolerated by diabetes mellitus patients not responding to first-line sildenafil alone.

Topics: Adult; Diabetes Mellitus, Type 2; Double-Blind Method; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Penile Erection; Piperazines; Purines; Retrospective Studies; Sexual Behavior; Sildenafil Citrate; Sulfonamides; Surveys and Questionnaires; Treatment Failure; Vacuum; Vasodilator Agents

Phosphodiesterase type 5 (PDE-5) inhibitor treatment for erectile dysfunction (ED) is frequently discontinued; adherence may vary depending on the initial regimen.. To evaluate the effects of initiating treatment with tadalafil once a day (OaD), tadalafil on demand (pro re nata [PRN]), or sildenafil PRN on treatment adherence.. In this multicenter, open-label study, men (≥ 18 years) with ED, naïve to PDE-5 inhibitors, were randomized (1:1:1) to tadalafil 5 mg OaD, tadalafil 10 mg PRN, or sildenafil 50 mg PRN. An 8-week randomized treatment (RT) period (dose adjustment possible) was succeeded by 16 weeks of pragmatic treatment (switches between PDE-5 inhibitors allowed).. Treatment adherence was measured as time to discontinuation of RT (any cause), estimated by Kaplan-Meier product-limit method. Treatment-group differences were estimated as hazard ratio (HR; Cox proportional hazards).. Seven hundred seventy patients (mean age 53 years) were randomized to tadalafil OaD (N = 257), tadalafil PRN (N = 252), and sildenafil PRN (N = 261). Kaplan-Meier estimates for patients discontinuing RT were 52.2, 42.0, and 66.7%, respectively. Median time to discontinuation of RT was significantly longer for tadalafil OaD and PRN (130 and >168 days) compared with sildenafil (67 days) (HR [97.5% confidence interval]: 0.66 [0.51, 0.85] and 0.49 [0.37, 0.65]; P < 0.001). Reasons for discontinuation with significant differences between groups (P < 0.05) included "lack of efficacy (duration of erection)" (sildenafil 9.2% vs. tadalafil OaD 4.3%, PRN 2.8%), "time constraints due to short window of action" (sildenafil 4.2% vs. tadalafil OaD 0%, PRN 0.4%), and "feel medication controls my sexual life" (sildenafil 2.7% vs. tadalafil OaD 0%). No between-group differences were found in International Index of Erectile Function-Erectile Function domain change from baseline to end of RT (least squares mean: 9.4-10.0, P = 0.359) or discontinuations due to adverse events (1.2-1.6%). The most common adverse event (≥ 4%) was headache.. ED patients assigned to tadalafil OaD or PRN adhered significantly longer to initial treatment than patients assigned to sildenafil PRN. Improvement of erectile function and safety profiles were similar in all three treatment groups.

Topics: Adult; Aged; Carbolines; Drug Administration Schedule; Drug Substitution; Erectile Dysfunction; Europe; Humans; Kaplan-Meier Estimate; Male; Medication Adherence; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Proportional Hazards Models; Prospective Studies; Purines; Recovery of Function; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome

Erectile dysfunction (ED) is a multifactorial disease associated with vascular dysfunction, low nitric oxide (NO) bioavailability, and oxidative stress. However, it is not known whether low NO bioavailability and oxidative stress affect the responsiveness of ED patients to sildenafil. We tested this hypothesis by studying 28 healthy subjects (control group), 26 patients with ED without comorbidities (ED group), and 18 patients with ED and diabetes mellitus (ED/DM group). The International Index for Erectile Function (IIEF) questionnaire was used to assess the erectile function of all participants, and their responsiveness to sildenafil was assessed as the percentage of change in the five-item version of IIEF score before and after sildenafil treatment. Levels of whole blood nitrite, antioxidants markers (ferric reducing ability of plasma (FRAP) and reduced glutathione), and oxidative stress markers (thiobarbituric acid reactive substance and protein carbonyl) were determined. We found a negative correlation between whole blood nitrite levels and the responses to sildenafil in both ED groups (P<0.05). FRAP correlated negatively with the responses to sildenafil in the ED/DM group (P<0.05). No other significant associations were found. Our findings show evidence that low NO bioavailability is associated with better responses to sildenafil in patients with ED (with or without DM).

Topics: Adult; Aged; Biological Availability; Diabetes Mellitus, Type 2; Erectile Dysfunction; Glutathione; Humans; Male; Middle Aged; Nitric Oxide; Nitrites; Phosphodiesterase 5 Inhibitors; Piperazines; Protein Carbonylation; Purines; Sildenafil Citrate; Sulfones; Thiobarbituric Acid Reactive Substances; Treatment Outcome

The aim of the present study was to investigate serum homocysteine levels in patients with erectile dysfunction and to evaluate the relationship between serum homocysteine levels and response to the standard 50 mg phosphodiesterase 5 inhibitor treatment. Twenty-eight erectile dysfunction patients having normal vascular parameter according to Penile Doppler Ultrasonography and twenty healthy subjects were enrolled in the study. All subjects filled The International Index of Erectile Function (IIEF) questionnaire. A total of 4-6 doses of phosphodiesterase 5 inhibitor (sildenafil 50 mg) were given to patients. Later, they were divided into two groups as sildenafil responder and non-responder. Serum homocysteine levels were compared in groups based on sildenafil response. Compared with healthy subject, higher homocysteine levels were observed in patients with erectile dysfunction (p = 0.005), especially in sildenafil non-responder group (p = 0.005). There was significant negative correlation between homocysteine and IIEF scores in group responder to sildenafil treatment (r = -0.698, p = 0.008). Mean IIEF scores of patients with non-responder to sildenafil 50 mg were lower than those of controls (p = 0.0001), but mean IIEF scores of patients with responders approached values observed in control subjects (p = 0.002). The results indicated that measurement of serum homocysteine levels could be used as a marker for the evaluation of efficacy of phosphodiesterase 5 inhibitor and the selection of efficacious alternative therapies.

Topics: Adult; Biomarkers; Erectile Dysfunction; Homocysteine; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Reproducibility of Results; Sensitivity and Specificity; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

To clarify the role of phosphodiesterase type 5 (PDE5) inhibitors in post-prostatectomy penile rehabilitation (PPPR). To compare nightly and on-demand use of PDE5 inhibitors after nerve-sparing minimally invasive radical prostatectomy (RP).. We conducted a single-institution, double-blind, randomized controlled trial of nightly vs on-demand 50-mg sildenafil citrate after nerve-sparing minimally invasive RP. A total of 100 preoperatively potent men, aged <65 years, with scores on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) ≥26, underwent nerve-sparing surgery. The patients were randomized to either nightly sildenafil and on-demand placebo (nightly sildenafil group), or on-demand sildenafil and nightly placebo (on-demand sildenafil group; maximum on-demand dose six tablets/month) for 12 months. Patients then underwent a 1-month washout period. Validated measures of erectile function (IIEF-EF score and the Expanded Prostate Cancer Index Composite [EPIC]) were compared between treatment groups over the entire 13-month time course, using multivariable mixed linear regression models.. The treatment groups were well matched preoperatively (mean age 54.3 vs 54.6 years, baseline IIEF-EF score 29.4 vs 29.3, for the nightly vs the on-demand sildenafil groups, respectively). No significant differences were found in erectile function between treatments (nightly vs on-demand sildenafil) at any single timepoint after RP, after adjusting for potential confounding factors. When evaluated over all timepoints simultaneously, no significant effects of treatment group (nightly vs on-demand sildenafil) were found on recovery of potency, as assessed by absolute IIEF-EF scores (P = 0.765), on percentage of men returning to an IIEF-EF score >21 (P = 0.830), or on IIEF-EF score recovery to a percentage of baseline value (P = 0.778). When evaluated over all timepoints simultaneously, no significant effects of treatment group were found on secondary endpoints such as assessment of potency (including EPIC item 59 response 'erections firm enough for intercourse'), attempted intercourse frequency or confidence.. Erectile recovery up to 1 year after RP does not differ between previously potent men who use sildenafil nightly compared to on-demand. This trial does not support chronic nightly sildenafil as being any better than on-demand sildenafil for use in penile rehabilitation after nerve-sparing minimally invasive RP.

Topics: Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Minimally Invasive Surgical Procedures; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Prostate; Prostatectomy; Prostatic Neoplasms; Purines; Recovery of Function; Sildenafil Citrate; Sulfones; Treatment Outcome

To evaluate the efficacy and safety of Elonza (generic product of sildenafil) 100 mg, a phosphodiesterase type 5 (PDE5) inhibitor, in Thai men with erectile dysfunction (ED).. This prospective, Cohort study was conducted for eight weeks. Two hundred ten male patients, older than 20 years of age with ED were enrolled to receive generic product of sildenafil 100 mg taken as needed. Efficacy is evaluated through the International Index of Erectile Function (IIEF) scores for the five separate response domains, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domain.. After sildenafil administration, erectile function domain scores were significantly increased from baseline, 5.02 (p < 0.001) and 7.19 (p < 0.001) in one month and two months, respectively. Intercourse satisfaction domain scores and overall satisfaction domain scores were significantly increased from baseline, 3.17 (p < 0.001) and 1.74 (p < 0.001) in two months, respectively. Most treatment emergent adverse events were mild or moderate. The most frequent treatment-emergent adverse events were flushing (13.2%), nasal congestion (9.8%), abnormal vision (4.9%), headache (4.4%), dizziness (2.9%), and dyspepsia (0.5%).. Elonza, a generic product of sildenafil, was an effective and well-tolerated treatment for ED in Thai men.

Topics: Adult; Aged; Aged, 80 and over; Cohort Studies; Drugs, Generic; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

To compare efficacy and tolerability between 100-mg and 50-mg sildenafil doses in five double-blind, placebo-controlled (DBPC) fixed-dose studies.. Doses were compared for the change (baseline to end of 8-12 weeks of DBPC treatment) in score on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF; from five fixed-dose studies, > 1500 men); the per-patient estimated percentage of occasions that a specified Erection Hardness Score (EHS; from two of the five fixed-dose studies, > 500 men) was achieved, computed from logistic regression; the odds ratio (OR) of achieving EHS3 (hard enough for penetration, but not completely hard) and EHS4 (fully hard and completely rigid); and the adverse event incidence by treatment (from all five fixed-dose studies).. For the 100-mg vs. 50-mg dose, IIEF-EF score improvement was consistently greater across the five studies and was statistically significant when data from two studies with similar design were pooled (10.7 ± 0.64 vs. 8.9 ± 0.83, p = 0.0287); and during the first 2 weeks of treatment, the odds of achieving EHS4 erections were almost doubled in one study (OR = 1.77, p = 0.0398). Sildenafil was generally well tolerated at either dose.. Men with erectile dysfunction treated with 100-mg compared with 50-mg sildenafil may be more likely to achieve a greater improvement in erectile function and, within the first 2 weeks, completely hard and fully rigid erections, with little or no greater risk to tolerability.

Topics: Aged; Analysis of Variance; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Phosphodiesterase-5-inhibitors, such as sildenafil, increase intracavernosal cyclic guanosine monophosphate levels, which results in corporal smooth muscle relaxation and penile erection. Here, we determined the effects of sildenafil administration on the hypothalamic-pituitary-gonadal axis in men with erectile dysfunction and low testosterone levels. The Testosterone and Erectile Dysfunction trial (ClinicalTrials.gov # NCT00512707) initially administered an optimized dose of sildenafil to 140 men, aged 40-70 years with erectile dysfunction, low serum total testosterone (<11.4 nmol/L; 330 ng/dL) and/or free testosterone (<173 pmol/L; 50 pg/mL) over 3-7 weeks. Sex steroids and gonadotropins were measured at baseline and after sildenafil optimization in a longitudinal study without a separate control group. Serum testosterone, dihydrotestosterone (DHT) and oestrogens were measured using liquid chromatography-tandem mass spectrometry. Administration of an optimized dose of sildenafil was associated with mean increases of 3.6 nmol/L (103 ng/dL; p < 0.001) and 110 pmol/L (31.7 pg/mL; p < 0.001) in total and free testosterone levels respectively. This was accompanied by parallel increases in serum DHT (0.17 nmol/L; 4.9 ng/dL; p < 0.001) and oestradiol (14 pmol/L; 3.7 pg/mL; p < 0.001) and significant suppression of luteinizing hormone (change -1.3 units/L; p = 0.003) levels, suggesting a direct effect at the testicular level. Androstenedione and oestrone increased by 1.3 nmol/L (38 ng/dL; p = 0.011) and 10.7 pmol/L (2.9 pg/mL; p = 0.012), respectively, supporting a possible effect of sildenafil on adrenal steroidogenesis. In conclusion, sildenafil administration was associated with increased testosterone levels likely ascribable to a direct effect on the testis.

Topics: Adult; Aged; Androstenedione; Dihydrotestosterone; Erectile Dysfunction; Estradiol; Estrone; Humans; Luteinizing Hormone; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testis; Testosterone

Erectile dysfunction (ED) is a common adverse event associated with treatment for prostate cancer. This study aimed to identify whether early, regular use of sildenafil after radiation treatment for prostate cancer is effective at reducing the rate of ED at 2 years.. A randomised controlled trial with 27 men planned for radiation treatment for localised prostate cancer recruited from a single radiotherapy centre in Australia. Men were randomised to receive daily sildenafil, or a placebo tablet, for 6 months. The primary end-point was erectile function, as measured by the International Index of Erectile Function (IIEF) score, at 2-year follow-up. The abridged IIEF-5 survey was also used during the treatment period, and could be derived from the full IIEF at other time-points. Two-sided Student's t-tests and Mann-Whitney U-tests were used for the analysis of continuous outcomes, with Fisher's exact test for dichotomous outcomes.. No difference was seen at 2 years in the primary end-point, and IIEF scores did not differ significantly between groups during the study. Men in the sildenafil group exhibited significantly better IIEF-5 scores at 4 weeks (P = 0.02) and 6 months (P = 0.02). There was no difference in erectile function scores between the two groups throughout the treatment period. No significant difference in adverse events was identified between the two groups.. There was no evidence from this trial that sildenafil provides long-term erectile function for patients while on medication. Regular use of sildenafil may improve short-term sexual function for patients while on medication. Larger trials are required to examine the effectiveness of implementing sildenafil for prostate cancer patients undergoing radiation treatment.

Topics: Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Placebo Effect; Prostatic Neoplasms; Purines; Radiation Injuries; Radiotherapy, Conformal; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

To explore the clinical effects of Compound Xuanju Capsule (CXC) combined with sildenafil on erectile dysfunction (ED) that progressively fails to respond to sildenafil.. Totally, 36 ED patients who progressively failed to respond to sildenafil were randomly divided into a trial and a control group of equal number, the former treated with oral CXC at 3 g tid plus sildenafil at 50 mg an hour before sexual activity, while the latter with sildenafil alone at 100 mg an hour before sexual activity. After 2 months of treatment, we compared the patients' scores on IIEF-5 and their partners' scores on Treatment Satisfaction Scale (TSS) between the two groups.. The total rate of erectile function improvement was 94.44% in the trial and 88.89% in the control group (P > 0.05). The IIEF-5 score was 20.888 9 +/- 3.833 1 in the former and 18. 777 8 +/- 4.008 2 in the latter after treatment, significantly higher than 13. 166 7 +/- 3.601 5 and 13. 055 6 +/- 2.775 4 before treatment (P < 0.05). The post-treatment IIEF-5 scores of the patients and the TSS scores of their partners were markedly higher in the trial than in the control group (P < 0.05).. Compound Xuanju Capsule combined with sildenafil is effective for erectile dysfunction that progressively fails to respond to sildenafil.

Topics: Adult; Drug Therapy, Combination; Drugs, Chinese Herbal; Erectile Dysfunction; Humans; Male; Middle Aged; Phytotherapy; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day (OaD) vs. tadalafil 20 mg or sildenafil 100 mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED).. A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design.. The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. SECONDARY OUTCOMES INCLUDED: Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale.. Men naive to tadalafil OaD were enrolled (N = 378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P < 0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50 ± 0.78 following tadalafil OaD, 0.5 ± 0.72 for tadalafil PRN, and 0.39 ± 0.67 for sildenafil PRN. The difference in least-squares mean was 0.12 ± 0.04 (confidence interval [CI] = 0.04, 0.19; P = 0.001) between tadalafil OaD and sildenafil PRN and 0.01 ± 0.04 (CI = -0.06, 0.08; P = 0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P < 0.001). There were no differences in SEAR scores between treatments.. Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.

Topics: Administration, Oral; Carbolines; Cross-Over Studies; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome

To assess the efficacy of group psychotherapy (GTP) and/or sildenafil for psychogenic erectile dysfunction (ED).. A randomized controlled single-blind trial was performed at the Institute of Psychiatry of the Medical School of at Universidade de São Paulo, São Paulo, Brazil. In all, 30 men with mild and moderate psychogenic ED were randomized to receive for 6 months: GPT plus 50 mg sildenafil on-demand, or 50 mg sildenafil on-demand exclusively, or GPT exclusively. Changes in score from baseline for three questions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were evaluated at endpoint and after 3-months follow-up.. Satisfaction with the treatment, confidence and 'naturalness' increased in the GPT plus sildenafil and GPT exclusively groups (P= 0.001) from baseline to endpoint. The treatment-by-time comparison was not significant at endpoint vs the 3-month follow-up, in the three groups. There was no difference in the sildenafil group in the three study periods (P > 0.05). Men with mild and moderate psychogenic ED had higher treatment satisfaction, confidence and naturalness in engaging in sexual activity when receiving GPT plus sildenafil or GP exclusively, when compared with sildenafil exclusively, as assessed by these three EDITS questions after 6-months treatment.

Topics: Adult; Dose-Response Relationship, Drug; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase 5 Inhibitors; Piperazines; Psychotherapy, Group; Purines; Sexual Behavior; Sildenafil Citrate; Single-Blind Method; Sulfones; Surveys and Questionnaires; Treatment Outcome

Erectile dysfunction and low testosterone levels frequently occur together.. To determine whether addition of testosterone to sildenafil therapy improves erectile response in men with erectile dysfunction and low testosterone levels.. Randomized, double-blind, parallel, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00512707). Outpatient academic research center.. Men aged 40 to 70 years with scores of 25 or less for the erectile function domain (EFD) of the International Index of Erectile Function, total testosterone levels less than 11.45 nmol/L (<330 ng/dL), or free testosterone levels less than 173.35 pmol/L (<50 pg/mL).. Sildenafil dose was optimized, and 140 participants were then randomly assigned to 14 weeks of daily transdermal gel that contained 10-g testosterone for 70 participants and placebo for the remaining 70 participants. All participants were included in the primary analysis, although 10 in the testosterone group and 12 in the placebo group did not complete the study.. At baseline, the 2 groups had similar EFD scores. Administration of sildenafil alone was associated with a substantial increase in EFD score (mean, 7.7 [95% CI, 6.5 to 8.8]), but change in EFD score after randomization did not differ between the groups (difference, 2.2 [CI, -0.8 to 5.1]; P = 0.150). The findings were similar for other domains of sexual function in younger men, more obese men, and men with lower baseline testosterone levels or an inadequate response to sildenafil alone. Frequency of adverse events was similar for testosterone and placebo groups.. Whether testosterone could improve erectile function without sildenafil was not studied.. Sildenafil plus testosterone was not superior to sildenafil plus placebo in improving erectile function in men with erectile dysfunction and low testosterone levels.. National Institute of Child Health and Human Development.

Topics: Administration, Cutaneous; Adult; Aged; Androgens; Coitus; Double-Blind Method; Drug Therapy, Combination; Erectile Dysfunction; Gels; Hormone Replacement Therapy; Humans; Male; Middle Aged; Orgasm; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Testosterone

To investigate the effects of phosphodiesterase type 5 (PDE5) inhibitors on erectile variables during a period with no sexual stimulation in a laboratory setting double-blind study.. In all, 80 men without erectile dysfunction (ED) but with lifelong premature ejaculation (PE) were included in the study. The men were divided equally in to four groups and received either placebo, vardenafil (10 mg), sildenafil (50 mg) or tadalafil (20 mg) in a double-blind study design. The men attended the laboratory following 3 days of sexual abstinence and placebo or one of the PDE5 inhibitors was ingested after ≥ 2 h of fasting and non-smoking. The men were then immediately placed in a silent room and real-time penile rigidity and tumescence monitoring with Rigiscan Plus (Rigiscan Plus® System, Osbon Medical Systems, Augusta, GA, USA) began. The men read some magazines or newspapers that contained no sexually stimulating material for 1.5 h. There was no interaction between the men and observer during the test period. Times to first measured and total durations of base and tip rigidities, and also total and per minute rigidity were evaluated.. The recorded base and/or tip rigidity ratios were 40% (eight of 20), 71% (12/17), 47% (nine of 19) and 70% (14/20) in men who took placebo, sildenafil, tadalafil and vardenafil, respectively (P = 0.126). The ratio of men who could obtain ≥ 60% base and/or tip rigidities were 10% (two of 20), 41% (seven of 17), 26% (five of 19) and 55% (11/20) in placebo, sildenafil, tadalafil and vardenafil groups, respectively (P < 0.05). The median time to first measured base rigidity was 58.0, 21.5, 54.5 and 57 min with placebo, sildenafil, tadalafil and vardenafil, respectively (P = 0032). The median total duration of recorded base rigidity was 4.0, 27.5, 10.0 and 11.5 min in men who took placebo, sildenafil, tadalafil and vardenafil, respectively (P = 0.013). The median total base rigidity (area under the curve) was 72.8, 699.0, 360.5 and 553.0 with placebo, sildenafil, tadalafil and vardenafil, respectively (P = 0.016).. Significant penile rigidities were obtained with PDE5 inhibitors during the short test period, with no sexual stimulation, in laboratory conditions. This finding might support the use of PDE5 inhibitors in men who need penile rehabilitation.

Topics: Adolescent; Adult; Carbolines; Double-Blind Method; Ejaculation; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Photic Stimulation; Piperazines; Purines; Quality of Life; Sexual Behavior; Sildenafil Citrate; Sulfones; Tadalafil; Time Factors; Triazines; Vardenafil Dihydrochloride; Young Adult

Pharmacological rehabilitation of erectile function (EF) after nerve-sparing radical prostatectomy was repeatedly advocated.. To compare early vs. late penile rehabilitation in patients with nerve-sparing (NS) radical cystoprostatectomy based on a prospective randomized trial.. Eighteen patients without spontaneous erection 8 weeks after NS radical cystoprostatectomy were randomly divided into two groups; group I and II who started the erectogenic therapy at the 2nd and 6th month postoperatively, respectively. The pharmacological therapy constitutes of sildenafil citrate twice weekly to be shifted to intracavernosal injection (ICI) of prostaglandin E1 (PGE1) if not responding. The treatment continued for 6 months in both groups.. The EF status was evaluated before and at the end of the treatment by International Index of Erectile Function questionnaire and penile Doppler ultrasonography (PDU).. Six out of nine patients recovered unassisted erection after treatment in group I compared to three out of nine patients in group II. Two patients in group I and three patients in group II were maintained on sildenafil therapy on demand basis. The remaining four patients were dependent on ICI of PGE1. At final evaluation, a significant improvement was found in the EF, the intercourse satisfaction and overall satisfaction domains (P = 0.02, 0.03, and 0.02, respectively) in group I compared with group II. Regarding PDU findings, significant improvement in end-diastolic velocity was elicited in the early rehabilitation group compared with the pretreatment value (P = 0.03) with no significant difference between both groups.. Early compared with delayed erectile rehabilitation brings forward the natural healing time of potency and maintains nerve-assisted erection.

Topics: Adult; Alprostadil; Cystectomy; Erectile Dysfunction; Humans; Injections; Male; Middle Aged; Penis; Phosphodiesterase 5 Inhibitors; Piperazines; Prospective Studies; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Time Factors; Ultrasonography; Urinary Bladder Neoplasms; Vasodilator Agents

• To compare the underlying risk for diseases associated with erectile dysfunction (ED; i.e. cardiovascular disease and diabetes) in a population of men with mild ED relative to a general ED clinical trial population.. • Men enrolled in a randomized, double-blind placebo-controlled (DBPC) trial of sildenafil for the treatment of mild ED were compared with a database of men enrolled in 67 of the manufacturer's other DBPC sildenafil trials. • The main outcome measures were baseline demographics, comorbidities and concomitant medications.. • In both populations, most men were white, approximately one quarter were smokers, and most had an organic component to their ED etiology. • In the mild ED population (N = 176) versus the database population (N = 14,537), mean ± sd (range) age was 50 ± 12 (19-84) versus 55 ± 11 (18-89) years, body mass index was 29 ± 5 (20-48) versus 28 ± 5 (11-64) kg/m² and ED duration was 3.5 ± 3.2 (< 1-18) versus 4.6 ± 4.7 (< 1-45) years. • The prevalence of comorbidities associated with ED was similar (hypertension 26.1% (n = 46) vs 32.8%; diabetes mellitus 13.6% (n = 24) vs 22.1%; dyslipidemias 12.5% (n = 22) vs 11.7%; hypercholesterolemia 12.5% (n = 22) vs 9.5%; gastro-esophageal reflux disease 10.8% (n = 19) vs 6.0%; benign prostatic hyperplasia 9.7% (n = 17) vs 9.9%; depression 6.3% (n = 11) vs 5.6%; and anxiety 4.0% (n = 7) vs 1.6%), as was the rate of use of medications for those comorbidities.. • Men with mild ED have similar risk factors to a general ED clinical trial population. Thus, mild ED is an important indicator of risk for underlying disease associated with ED. • Inquiry into ED should be part of routine clinical evaluation to facilitate rapid identification and early intervention. • Men complaining of mild ED should be evaluated adequately for underlying cardiovascular risk.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Diseases; Comorbidity; Diabetes Mellitus; Epidemiologic Methods; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Young Adult

Depression and erectile dysfunction (ED) often co-occur. Phosphodiesterase type 5 inhibitors are effective in men with ED and untreated depression, or ED secondary to antidepressants. This study evaluated sildenafil treatment in Canadian men with clinically diagnosed ED (Sexual Health Inventory for Men score ≤ 21) and mild-to-moderate untreated depressive symptoms [Beck Depression Inventory II (BDI-II) score 14-28], but excluding major depressive disorder. Pretreatment screening using the Sexual Health Inventory for Men and BDI-II showed that men with ED were more likely to have depression than men without ED, and ED severity was a predictor of depression (P=0.0226). Two hundred and two men were randomized to 6 weeks of double-blind treatment with placebo (n=98) or sildenafil (n=104), initial dose of 50 mg, adjustable to 25 or 100 mg. The men were evaluated on all domains of the International Index of Erectile Function and the Sex Effects Questionnaire, Global Efficacy Questions, and Event-log data. Compared with placebo, patients treated with sildenafil had significantly greater changes from baseline in BDI-II scores (P<0.001). All International Index of Erectile Function domains and the Sex Effects Questionnaire components were also significantly improved in sildenafil group (P<0.01). The most common adverse events included headache, dyspepsia, vasodilatation, and respiratory tract infections and were generally mild in intensity.

Topics: Antidepressive Agents; Canada; Depression; Double-Blind Method; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Placebos; Psychiatric Status Rating Scales; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction (ED) and lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH/LUTS). The trial was conducted in hospitals in Beijing, Shanghai, Changsha, Wuhan and Guangzhou, five major cities in China. A total of 250 patients diagnosed with ED and BPH/LUTS aged 50-75 years, and who had International Index of Erection Function-5 (IIEF-5) scores ≤21 and International Prostate Symptom Score (IPSS) ≥10 points, were enrolled and randomly divided into Group A (168 cases; doxazosin GITS 4 mg once daily plus sildenafil 25-100 mg on demand) and Group B (82 cases; sildenafil 25-100 mg on demand). Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life (QoL) questionnaire, and adverse effects were evaluated during the treatment period. There were no statistically significant differences in mean age, and IIEF-5, IPSS and QoL scores pre-treatment between the two groups. After treatment, IIEF-5, IPSS and QoL scores were significantly improved in Group A, while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment. There were no significant differences in side effects between the two groups. The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy.

Topics: Aged; Asian People; China; Doxazosin; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prostatic Hyperplasia; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Treatment Outcome; Urination Disorders

The lack of phosphodiesterase type 5 inhibitor effects in patients with erectile dysfunction (ED) of arterial origin may be caused by an endothelial dysfunction that causes a series of biochemical alterations leading to a reduced nitric oxide (NO) bioavailability and increased oxidative stress.. The aim of this study was to evaluate the effects of the treatment with endothelial antioxidant compounds (EAC) on the erectile response to sildenafil in patients with arterial ED already treated with sildenafil (100 mg twice a week for 8 weeks).. A patient was considered responsive when the 5-item International Index of Erectile Function questionnaire score increased by >5 points.. Fifty-three patients with arterial ED, hypertension, and diabetes mellitus were randomly given, for 8 weeks, EAC (1 dose/day) and, after a wash out of 8 weeks, sildenafil (100 mg) plus EAC. The patients were divided into the following four groups: A (N = 12): patients with ED alone; B (N = 14): patients with ED plus atheromasic plaques and/or increased intima-media thickness of common carotid arteries; C (N = 14): patients with ED plus lower limb artery abnormalities; and D (N = 13): patients with ED plus carotid and lower limb artery abnormalities.. The administration of EAC plus sildenafil resulted in a significantly higher number of responsive patients (N = 36, 68%) compared with sildenafil alone (N = 24, 45%) or EAC alone (N = 17, 32%). The percentage of patients who successfully responded to the combined treatment increased in the various groups. It was 83%, 64%, 71%, and 54%, respectively, for groups A, B, C, and D. Furthermore, patients treated with EAC and sildenafil reached a successful response in a shorter length of time (3 weeks) compared with patients responsive to sildenafil (5.2 weeks) or EAC (5.7 weeks) alone.. EAC administration to patients with arterial ED improved the success rate to sildenafil. These data suggest that, in such patients, a combined treatment may be considered to increase bioavailable NO and to neutralize radical oxygen species, which in turn inactive NO.

Topics: Aged; Biological Availability; Coronary Artery Disease; Endothelium, Vascular; Erectile Dysfunction; Humans; Male; Middle Aged; Nitric Oxide; Oxidative Stress; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Purines; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

To evaluate the efficacy of sildenafil citrate only, 25 mg. Four times/week, tamsulosin only, 0.4 mg once daily, and the combination of both on lower urinary tract symptoms (LUTS) suggestive of benign prostate hyperplasia (BPH) and erectile dysfunction.. A total of 60 men with BPH-related LUTS were randomized to receive sildenafil citrate only (n = 20), tamsulosin only (n = 20), and the combination of both (n = 20) for 8 weeks. Changes from baseline in International Prostate Symptom Score (IPSS), maximum urinary flow rate (Q (max)), post voiding residual urine volume (PRV), Sexual Health Inventory for Male (SHIM) score, 3rd and 4th questions of International Index of Erectile Function (IIEF) were assessed at the end of the treatment.. The mean age was 58 years. IPSS, Q (max), PRV, SHIM scores, and 3rd and 4th questions in IIEF significantly improved in each group. Improvement of IPSS was more remarkable in combination (40.1%) and tamsulosin only (36.2%) groups in comparison with sildenafil citrate only group (28.2%; p < 0.001). Improvement of Q (max) and PRV were greater in tamsulosin only and combination than sildenafil citrate only group. SHIM scores significantly improved in sildenafil citrate only (65%) and combination (67.4%) than tamsulosin only (12.4%; p < 0.001). Increases in the 3rd and 4th questions of IIEF were greater in sildenafil only and combination than tamsulosin only (p < 0.001).. Treatment with the combination of tamsulosin only and sildenafil citrate only was not superior to tamsulosin only to enhance voiding symptoms. Also, sexual function improvement was similar for both the combination and sildenafil citrate only treatments.

Topics: Adrenergic alpha-Antagonists; Aged; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatism; Purines; Sildenafil Citrate; Sulfonamides; Sulfones; Tamsulosin

Sildenafil citrate is widely used for erectile dysfunction. The present study examined the short-term effects of sildenafil administration in individuals with cerebrovascular risk factors, including patients with a history of stroke.. Twenty-five consecutive male patients with erectile dysfunction and vascular risk factors were included in the study. A perfusion brain SPECT study was performed at baseline and 1 h after the oral administration of sildenafil.. Associations between any of the risk factors and the perfusion scores were not detected, with the exception of stroke. Stroke patients showed significantly more areas with diminished perfusion after sildenafil administration compared to baseline.. In patients with diabetes or hypertension, a dose of 50 mg sildenafil does not appear to produce detrimental effects on cerebral blood flow. However, patients with a history of stroke may be at increased risk of hemodynamic impairment after the use of sildenafil.

Topics: Adult; Aged; Brain Mapping; Cerebrovascular Circulation; Cerebrovascular Disorders; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Radiopharmaceuticals; Risk Factors; Sildenafil Citrate; Sulfones; Technetium Tc 99m Exametazime; Tomography, Emission-Computed, Single-Photon

To evaluate the efficacy of sildenafil in the treatment of neurogenic erectile dysfunction (ED) secondary to upper motor neuron (UMN) and lower motor neuron (LMN) spinal cord injury (SCI). After taking consents 105 patients suffering from ED were enrolled in this prospective study. Seventy-two patients had signs and symptoms of UMN and 33 patients had signs and symptoms of LMN or mixed (UMN and LMN) spinal cord injuries. The patients took 50-100 mg sildenafil or placebo tablet at least 45 min before sexual intercourse. Based on a IIEF questionnaire, success in achieving erection adequate for sexual intercourse was compared between sildenafil and placebo groups in UMN and non-UMN spinal cord injuries. In patients with UMN disease, sildenafil was effective in 82% of patients and its efficacy was statistically higher than placebo (82 vs. 25%, p < 0.05). Twenty-eight per cent of patients with non-UMN disease had a favourable response to sildenafil that was not statistically different from placebo. Sildenafil seems more effective in the treatment of neurogenic ED secondary to UMN spinal cord injury compared with that secondary to LMN injury. Actually, its efficacy on LMN injuries does not seem different from placebo and administration of this treatment may not be effective in spinal cord injury which has caused LMN symptoms.

Topics: Adult; Erectile Dysfunction; Humans; Male; Middle Aged; Paraplegia; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Monitoring of asthma control can be performed with different means including measurement of the concentration of nitric oxide (NO) in exhaled air. Due to its action on the NO-metabolism; we hypothesized that the intake of Sildenafil might augment and falsify the NO-values in exhaled air of subjects taking the drug to treat erectile dysfunction. This randomised, placebo-controlled cross-over study including 10 male non-asthmatic volunteers taking a single dose of 50 mg Sildenafil did not confirm this assumption in non-asthmatic subjects. We cannot think of any reason why asthmatics should behave differently. On the basis of these results, it does not seem necessary to ask asthma patients with elevated NO-values if they had taken any selective inhibitor of the cGMP-specific phosphodiesterase Type 5 as Sildenafil prior to the test.

Topics: Administration, Inhalation; Adult; Cross-Over Studies; Dose-Response Relationship, Drug; Erectile Dysfunction; Forced Expiratory Volume; Humans; Male; Middle Aged; Nitric Oxide; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents; Young Adult

To compare erectile function (EF) recovery of patients treated by early penile rehabilitation therapy (PRT) with sildenafil and with control group.. Forty men treated by bilateral nerve sparing radical prostatectomy (NSRP) and with a normal pre-operative EF were enrolled. Fourteen days after surgery, they were randomised to a flexible-dose sildenafil group and to a control group. The International Index of Erectile Function (IIEF) questionnaire was completed before surgery and at 3, 6, 12 and 24 weeks after NSRP.. In the group treated, the mean IIEF score before surgery was 26.2 and 14.1, 16.2, 22.5 and 25.2 at 3, 6, 12 and 24 weeks after NSRP, respectively. In the control group, the respective scores were 26.5 and 12.4, 15.8, 15.3 and 17.4. There was a significant difference in IIEF mean score (25+/-6 vs. 17+/-9, p<0.05) and in the potency rate (87% vs. 56%) between the groups at 24 weeks after NSRP. The percentage of patients who were capable of having medication-unassisted intercourse was 54% vs. 21%; 34% vs. 18% of patients had a normal EF with 72% vs. 32% of responders to sildenafil.. PRT with PDE-5 inhibitors should be offered early after RP to allow the recovery of EF.

Topics: Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones

The sex therapy is not yet popularized at present. This study aimed to evaluate the effect of the combination of the improved sex therapy and oral sildenafil on erectile dysfunction (ED).. A total of 3130 Uigur cases of ED received in Xinjiang Bogda Hospital were divided into a control group (n=625) and a trial group (n=2505), the former treated with oral sildenafil alone, and the latter by the combination of the improved genital therapy and sildenafil, both for 3 months and followed up at 6 and 12 months after the treatment. The therapeutic effects were evaluated and compared using IIEF-5.. The IIEF-5 scores of the control group were 12.80 +/- 3.76 and 18.10 +/- 2.61 before and after the treatment, and 17.35 +/- 2.73 and 16.64 +/- 2.63 at 6 and 12 months, respectively, while those of the trial group were 12.73 +/- 3.52 and 19.06 +/- 4.07 before and af- ter the treatment, and 19.86 +/- 2.42 and 20.47 +/- 2.38 at 6 and 12 months, respectively, with statistically significant differences either between pre- and post-treatment (P < 0.05) or between the control and trial groups at 6 and 12 months (P < 0.05).. The combination of the improved sex therapy and oral sildenafil is superior to sildenafil alone in the treatment of ED, and its efficacy is relatively stable at 12 months.

Topics: Adult; Aged; Asian People; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Retrospective Studies; Sildenafil Citrate; Sulfones; Treatment Outcome; Young Adult

To our knowledge we report the first large, randomized, prospective penile rehabilitation clinical trial to compare the effectiveness of nightly intraurethral alprostadil vs sildenafil citrate after nerve sparing prostatectomy.. We performed a prospective, randomized, open label, multicenter American study in men with normal erectile function who underwent bilateral nerve sparing radical prostatectomy. The International Index of Erectile Function erectile function domain was the primary end point. Subjects initiated nightly treatment within 1 month of surgery with intraurethral alprostadil or oral sildenafil citrate (50 mg) for 9 months. After 1-month washout and before sexual activity subjects self-administered sildenafil citrate (100 mg) for a total of 6 attempts in 1 month. Secondary end points were the global assessment question, sexual encounter profile, Erectile Dysfunction Inventory of Treatment Satisfaction and measured stretched penile length.. Of 139 men who started intraurethral alprostadil and 73 who started sildenafil citrate, 97 and 59, respectively, completed the trial. There were no statistically significant differences in International Index of Erectile Function erectile function domain and intercourse success rates to intraurethral alprostadil. The global assessment question was significantly better only at 6 months for intraurethral alprostadil (p <0.028). At completion there were no differences between treatments for any of the end points.. This is the first study to directly compare the ability of alprostadil and a phosphodiesterase-5 inhibitor to enhance penile recovery subsequent to bilateral nerve sparing radical prostatectomy. The use of nightly subtherapeutic intraurethral alprostadil is well tolerated after radical prostatectomy. The benefit to return of erectile function of nightly sildenafil citrate and subtherapeutic intraurethral alprostadil appears to be comparable within the first year of surgery.

Topics: Administration, Topical; Alprostadil; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Prostatectomy; Purines; Recovery of Function; Sildenafil Citrate; Sulfones; Urethra; Vasodilator Agents

Erectile dysfunction (ED) is prevalent in end-stage renal disease (ESRD) and has been associated with impaired health-related quality of life (HRQoL). HRQoL, in turn, is related to morbidity and mortality in ESRD patients. Previous studies have shown improved HRQoL with ED treatment using sildenafil and vardenafil. However, no study has examined the effects of sildenafil or vardenafil on HRQoL in impotent ESRD patients. Furthermore, vardenafil has never been tested and its safety profile has not been determined in ESRD patients. The aim of this randomized crossover study was to compare the effects of sildenafil and vardenafil on measures of HRQoL and on ED scores as well as to determine the safety profile of vardenafil in ESRD patients.. In 32 haemodialysis patients with impotence, ED and HRQoL were evaluated by the International Index of Erectile Function (IIEF-5) and the 36-item Short-Form Health (SF-36) surveys, respectively. Patients were randomized into sildenafil and vardenafil groups. After a 4-week treatment and 2-week washout periods, crossover was performed and an additional 4-week treatment was administered. IIEF-5 and SF-36 surveys were given before and after each treatment period. Adverse effects were evaluated by interview. Friedman tests and Bonferroni-adjusted Wilcoxon signed-rank tests were used to compare groups and for post hoc analysis, respectively.. IIEF-5 and SF-36 scores were significantly improved by both sildenafil and vardenafil compared to pretreatment values. There were no differences between sildenafil and vardenafil with respect to the studied parameters. Adverse effect profiles were also similar. No patient dropped out because of side effects.. Sildenafil and vardenafil caused similar improvements in ED and HRQoL in haemodialysis patients. Vardenafil was well tolerated in our patient population.

Topics: Adult; Aged; Cross-Over Studies; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Prospective Studies; Purines; Quality of Life; Renal Dialysis; Sildenafil Citrate; Sulfones; Triazines; Vardenafil Dihydrochloride; Young Adult

Erectile dysfunction (ED) may be present but unrecognized in men with other comorbidities, such as cardiovascular disease (CVD), diabetes, or lower urinary tract symptoms (LUTS). The efficacy of sildenafil citrate treatment for ED in men who did not self-identify with or were unsure about whether they had ED, but had ED based on International Index of Erectile Function Erectile Function domain (IIEF-EF) scores, was evaluated.. Men with an ED-associated comorbidity were asked, "Do you have ED?" Those who answered "no" or "unsure" and were diagnosed with ED (score of or=30 kg/m(2)), and waist circumference >or=40 inches were the most frequently reported risk factors. Sildenafil-treated men had improved scores on both functional and psychosocial measures. Most adverse events were mild to moderate.. Many men do not recognize that they have ED; sildenafil treatment improved sexual function and satisfaction in these men. Because ED affects quality of life, it should be suspected and assessed in men with risk factors for ED.

Topics: Adolescent; Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Young Adult

Erectile dysfunction (ED) commonly affects the quality of life of men after treatment of prostate cancer. We conducted a placebo-controlled, crossover randomised trial to assess the efficacy and tolerability of sildenafil citrate in the treatment of ED developing after external beam radiation treatment (EBRT) of localized prostate cancer. Sixty-six patients who had developed ED following radiation treatment agreed to participate and were allocated to sildenafil or placebo to be taken prior to four sexual attempts. In the crossover period, subjects received the alternative tablet for a further four attempts. Allocation was centrally randomized, and researchers and patients were both blinded to the trial arm. Efficacy was assessed using the International Index of Erectile Function (IIEF) questionnaire and with a separate global efficacy question. Forty-three subjects completed the study. There was a significant increase in mean scores from baseline for all domains of the IIEF with sildenafil compared with placebo (P < 0.001). Affirmative response to the global efficacy question was more common after taking sildenafil compared with placebo. In approximately half of the patients, the improvement in the erectile function domain score corresponded to a moderate improvement in ED (e.g. success 'sometimes' to 'most times'). Sildenafil was associated with mild flushing, nasal stuffiness or indigestion in 8-10% patients and moderate flushing in 10%. The current study adds to the evidence that phosphodiesterase inhibitors are an effective and well-tolerated treatment for ED after EBRT for prostate cancer.

Topics: Aged; Combined Modality Therapy; Cross-Over Studies; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Placebo Effect; Prostatic Neoplasms; Purines; Radiotherapy, Conformal; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

In a previous paper using mediation modeling, the direct and indirect effects of sildenafil on erection maintenance were demonstrated.. In an extension of this previous work, the historical psychosocial paradigm of ED, which focuses on performance anxiety, is tested by using mediation modeling to define the relationship of the physiological aspects (hardness and maintenance) and the associated psychosocial aspects (confidence, sexual relationship satisfaction, and performance anxiety) of ED.. Statistical mediation analysis using the following outcomes from a double-blind placebo-controlled trial of fixed-dose sildenafil 100 mg or 50 mg: Erection Hardness Score; the 15-item International Index of Erectile Function (IIEF), including item 4 (frequency of erection maintenance after penetration) and item 5 (difficulty of erection maintenance to intercourse completion); the Self-Esteem And Relationship questionnaire; and the question, "Do you feel anxious about your next attempt at sexual intercourse?". Estimated percentages of direct and indirect effects of sildenafil on psychosocial aspects of ED (95% confidence intervals).. The model estimated that erection hardness mediated 43.7% (29.3%, 62.4%) of the effect of treatment onto confidence and 45.9% (32.2%, 61.8%) of the effect of treatment onto sexual relationship satisfaction, and that erection maintenance (using IIEF item 4 as a proxy) mediated 23.0% (10.1%, 39.1%) and 22.4% (10.1%, 36.5%), respectively. Similar results were obtained when IIEF item 5 was used as the proxy for measurement of maintenance. Of all possible paths to performance anxiety, only that from treatment via confidence was statistically significant, mediating an estimated 88.6% (55.5%, 146.2%; item 4 model) or 74.9% (47.0%, 121.0%; item 5 model) of the effect of treatment onto anxiety. The direct path to anxiety from treatment was not statistically significant.. In men treated with sildenafil for ED, performance anxiety might be ameliorated by improved confidence. Improved confidence might be mainly mediated via increased erection hardness.

Topics: Adult; Aged; Anxiety; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Self Efficacy; Sildenafil Citrate; Sulfones

Men with erectile dysfunction often have concurrent medical conditions. Conversely, men with these conditions may also have underlying erectile dysfunction. The prevalence of unrecognized erectile dysfunction in men with comorbidities commonly associated with erectile dysfunction was determined in men invited to participate in a double-blind, randomized, placebo-controlled trial of sildenafil citrate.. Men ≥30 years old presenting with ≥1 erectile dysfunction risk factor (controlled hypertension, hypercholesterolemia, smoking, metabolic syndrome, stable coronary artery disease, diabetes, depression, lower urinary tract symptoms, obesity [body mass index ≥30 kg/m2] or waist circumference ≥40 inches), and not previously diagnosed with erectile dysfunction were evaluated. The screening question, "Do you have erectile dysfunction?," with responses of "no," "yes," and "unsure," and the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) were administered.. Of 1084 men screened, 1053 answered the screening question and also had IIEF-EF scores. IIEF-EF scores indicating erectile dysfunction occurred in 71% (744/1053), of whom 54% (399/744) had moderate or severe erectile dysfunction. Of 139 answering "yes," 526 answering "unsure," and 388 answering "no," 96%, 90%, and 36%, respectively, had some degree of erectile dysfunction. The mean±SD (range) number of risk factors was 2.9 ± 1.7 (3-8) in the "yes" group, 3.2 ± 1.7 (3-9) in the "unsure" group, and 2.6 ± 1.5 (2-8) in the "no" group.. Although awareness of having erectile dysfunction was low, most men with risk factors had IIEF-EF scores indicating erectile dysfunction. Erectile dysfunction should be suspected and assessed in men with risk factors, regardless of their apparent level of awareness of erectile dysfunction.. ClinicalTrials.gov Identifier NCT00343200.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Diseases; Comorbidity; Diabetes Mellitus; Double-Blind Method; Erectile Dysfunction; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Obesity; Phosphodiesterase 5 Inhibitors; Piperazines; Placebos; Purines; Risk Factors; Set, Psychology; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Urologic Diseases

The purpose of this study was to evaluate the effect of low-dose sildenafil (25 mg) for rehabilitation of erectile function after nerve-sparing radical prostatectomy.. In a prospective study, 43 sexually active patients underwent nerve-sparing retropubic radical prostatectomy. Rigiscan® measurement of nocturnal penile tumescence and rigidity (NPTR) was carried out 7-14 days after surgery. A group of 23 patients with preserved nocturnal erections received sildenafil 25 mg/day at night to support recovery of erectile function. A control group of 18 patients underwent follow-up without PDE-5 inhibitors. Evaluation using the IIEF-5 questionnaire was performed 6, 12, 24, 36, 52 and 78 weeks after the operation.. Of 43 patients, 41 (95%) showed 1-5 erections during the first night after catheter removal. In the group receiving daily sildenafil, the mean IIEF-5 score decreased or increased from 20.8 preoperatively to 3.6 at 6 weeks, 3.8 at 12 weeks, 5.9 at 24 weeks, 9.6 at 36 weeks, 14.1 at 52 weeks and 19.3 at 78 weeks after prostatectomy. In the control group, the mean preoperative IIEF-5 score of 21.2 decreased or increased to 2.4 at 6 weeks, 3.8 at 12 weeks, 5.3 at 24 weeks, 6.4 at 36 weeks, 9.3 at 52 weeks and 13.2 at 78 weeks. Statistical evaluation showed significant differences regarding the IIEF-5 score and recovery period of erectile function between the groups (p<0.001), with potency rates of 92 vs 68%.. The measurement of NPTR after nerve-sparing radical prostatectomy showed erectile function as early as the first night after catheter removal. In cases of early penile erections, daily low-dose PDE-5 inhibitors lead to a significant improvement/acceleration of erectile function recovery.

Topics: Aged; Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

To evaluate the acute effects of sildenafil (50 mg) on the micturation of men with erectile dysfunction (ED) and concomitant benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS) using uroflowmetric parameters.. A total of 68 male patients randomized into two groups (36 treatment, 32 control groups) with International Prostate Symptom Score (IPSS) greater than 7 and International Index of Erectile Dysfunction-erectile function domain score lower than 26 were enrolled in the study. Patients in the treatment group received a single dose of 50 mg of oral sildenafil. Patients in the control group received no treatment. Prevoiding urine volumes determined ultrasonographically and voided urine volumes were also recorded. Statistical comparisons were made with the use of analysis of variance (ANOVA).. Mean ages were similar between treatment and control groups (60.4 +/- 9.8 and 58.6 +/- 8.3 years, respectively, P = 0.430). In the treatment group the maximum and average flow rates increased significantly (Q (max) from 15.6 +/- 6.8 cc/s to 19.3 +/- 7.2 cc/s, P < 0.0001; Q (avg) from 7.3 +/- 3.0 cc/s to 9.1 +/- 3.0 cc/s, P < 0.0001) with sildenafil administration, while other parameters studied remained unchanged.. Despite the limitations of variations of uroflowmetry, this study showed that sildenafil improves Q (max) and Q (avg) in patients suffering from ED with concomitant BPH-LUTS. Long-term studies are needed to evaluate the effects on IPSS, side effects, and drug interactions.

Topics: Administration, Oral; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatic Hyperplasia; Purines; Sildenafil Citrate; Sulfones; Time Factors; Urination; Urodynamics

We evaluated the safety and efficacy of sildenafil citrate for treating erectile dysfunction in patients with multiple sclerosis.. A total of 203 patients with multiple sclerosis (age range 18 to 50 years old) with erectile dysfunction were randomly assigned to receive 50 to 100 mg sildenafil (102 patients in group 1) or a similar regimen of placebo (101 patients in group 2) 45 minutes to 2 hours before sexual stimulation. Patients were asked to use at least 24 doses/attempts at home. Primary outcome measures consisted of responses to questions 3 and 4 from the International Index of Erectile Function questionnaires well as responses to Sexual Encounter Profile diary questions 2 and 3. We also assessed the number of attempts at sexual intercourse, the number of attempts that were successful and adverse drug effects.. Improved erections (positive response to the Global Assessment Questionnaire) were reported by 32.8% of patients receiving sildenafil and 17.6% of those receiving placebo (p = 0.04). For Sexual Encounter Profile question 2 (successful penetration) the increase from baseline in mean per patient percentage of yes responses was 29.4% after sildenafil vs 18.8% after placebo (p = 0.04). The proportion of successful sexual attempts ranged from 12% to 26% for sildenafil and from 9% to 21% for placebo, respectively (p = 0.044). Of patients taking sildenafil and placebo 24 (23.5%) and 9 (8.9%) experienced 81 and 31 adverse events, respectively (p = 0.01).. Compared with placebo, sildenafil has little effect on multiple sclerosis emergent erectile dysfunction and, therefore, cannot be recommended for the routine treatment of erectile dysfunction in patients with multiple sclerosis. This finding implies that there must be other mechanisms that are not affected by sildenafil or are resistant to the effects of sildenafil.

Topics: Adult; Double-Blind Method; Erectile Dysfunction; Evoked Potentials, Somatosensory; Humans; Male; Middle Aged; Multiple Sclerosis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

We investigated changes in serum biomarkers of vascular function after short-term, continuous sildenafil dosing in men with type 2 diabetes with erectile dysfunction.. Men with erectile dysfunction associated with type 2 diabetes mellitus were randomized to receive continuous, daily sildenafil (50 mg for 1 week run-in and 100 mg for 3 weeks) (148), or placebo (144) for 4 weeks (phase I) and then sildenafil (25, 50 or 100 mg) on demand for 12 weeks (phase II). Blood draws at baseline and after phases I and II were analyzed for cyclic guanosine monophosphate (endothelial function marker), 8-isoprostane (oxidative stress marker), and interleukin-6 and interleukin-8 (inflammatory cytokines). Primary and secondary erectile function outcome variables were affirmative responses on Sexual Encounter Profile question 3 (ability to maintain erection sufficient for sexual intercourse) and Erection Hardness Score, respectively.. Serum cyclic guanosine monophosphate levels were increased in the sildenafil group relative to the placebo group at 4 (p <0.01) and 16 (p <0.05) weeks, correlating with affirmative responses to Sexual Encounter Profile question 3 at the 4-week interval only (p <0.05). Serum 8-isoprostane levels were decreased to a nonsignificant degree in the sildenafil group at 4 weeks with no further change at 16 weeks, whereas interleukin-6 and interleukin-8 levels were unchanged at either interval, and these levels were unassociated with erectile function outcomes.. These data suggest that short-term, continuous sildenafil treatment causes systemic endothelial function to be enhanced and remain so for a duration after its discontinuation. However, they do not indicate any influence of this treatment on systemic oxidative stress or inflammation, or an effect on long-term erectile function improvement.

Topics: Adult; Aged; Biomarkers; Cyclic GMP; Diabetes Complications; Diabetes Mellitus, Type 2; Dinoprost; Endothelium, Vascular; Erectile Dysfunction; Humans; Interleukin-6; Interleukin-8; Male; Middle Aged; Oxidative Stress; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Sildenafil, frequently used as on demand medication for the treatment of erectile dysfunction (ED), has been suggested to improve endothelial function but also to alter blood pressure (BP) and induce sympathetic activation. In people with type 2 diabetes mellitus (T2DM), a high-risk population, the safety profile and the effects on endothelial function of a maximal sildenafil dose (100 mg) have not been investigated and therefore constituted the aim of our study.. A double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo has been conducted in 40 subjects with T2DM without known CVD. Haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests and spontaneous baroreflex sensitivity (BRS) were measured.. Sixty minutes after administration of sildenafil but not placebo, a fall of supine systolic blood pressure (SBP) (-5.41 +/- 1.87 vs. + 0.54 +/- 1.71 mmHg) and diastolic blood pressure (DBP) (-4.46 +/- 1.13 vs. + 0.89 +/- 0.94 mmHg), as well as orthostatic SBP (-7.41 +/- 2.35 vs. + 0.94 +/- 2.06 mmHg) and DBP (-5.65 +/- 1.45 vs. + 1.76 +/- 1.00 mmHg) during standing occurred, accompanied by an increase in heart rate (+1.98 +/- 0.69 vs. - 2.42 +/- 0.59 beats/min) (all p < 0.01 vs. placebo). Changes in BP to standing up, FMD, time domain and frequency domain indices of heart rate variability (HRV) and BRS were comparable between sildenafil and placebo.. Sildenafil administered at a maximum single dose to T2DM men results in a mild increase in heart rate and decrease in BP, but it induces neither an acute improvement of FMD nor any adverse effects on orthostatic BP regulation, HRV and BRS.

Topics: Autonomic Nervous System; Baroreflex; Blood Pressure; Brachial Artery; Cardiovascular System; Cross-Over Studies; Diabetes Mellitus, Type 2; Erectile Dysfunction; Heart Rate; Humans; Male; Patient Selection; Phosphodiesterase Inhibitors; Piperazines; Placebos; Posture; Pulse; Purines; Sildenafil Citrate; Sulfones; Vasodilation; Vasodilator Agents

Phosphodiesterase 5 inhibitors (PDE5) such as sildenafil are first-line treatment for erectile dysfunction (ED). Alpha1 (alpha1)-adrenoceptor antagonists such as doxazosin are indicated for the treatment of patients with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH). ED and LUTS/BPH are conditions that are often associated. Accordingly, alpha1-adrenoceptor antagonists and PDE5 inhibitors will be often prescribed in real life setting together.. To evaluate the effects of the combination of sildenafil and doxazosin on human cavernosal and prostatic tissue.. Prostatic and erectile tissues were obtained from nine to 12 patients, respectively. Patients underwent cystoprostatectomy for infiltrating bladder cancer or penile surgery for penile implant, congenital curvature or Peyronie's disease.. In organ baths, prostatic and cavernosal strips were submitted to either concentration-response curves (CRC) to phenylephrine (Phe) or norepinephrine (NE), respectively, in presence of vehicle, sildenafil (10(-6) M, 10(-5) M), doxazosin (10(-8) M, 3.10(-8) M, or 10(-7) M), or a combination of both. Continuous electrical field stimulation (EFS; 32 Hz, 5 ms, 5 seconds, 300 mA) was performed on prostatic strips which were incubated with sildenafil 10(-6) M or vehicle before the successive addition of doxazosin (10(-7) M, 10(-6) M) or vehicle. Cavernosal strips were pre-incubated with doxazosin (10(-9) M, 10(-8) M) or vehicle, then CRC to sildenafil were constructed on NE (3.10(-6) M) precontracted cavernosal strips.. Combination of sildenafil and doxazosin exerted a greater relaxing effect on CRC to Phe or NE compared with each compound alone in both tissues. Sildenafil significantly enhanced the relaxing effect of doxazosin on EFS-induced contractions in prostatic strips. Doxazosin significantly increased the ability of sildenafil to inhibit NE-induced contractions in cavernosal strips.. Sildenafil and doxazosin reduced adrenergic tone of prostatic and cavernosal smooth muscle and their combination provided a significant benefit when targeting relaxation of both tissues. These experiments provide support for further clinical evaluation of the sildenafil and doxazosin combination in ED patients with LUTS/BPH.

Topics: Adrenergic alpha-Antagonists; Adult; Doxazosin; Drug Combinations; Erectile Dysfunction; Humans; Male; Muscle Relaxation; Muscle, Smooth; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Prostate; Purines; Sildenafil Citrate; Sulfones

The validated Quality of Erection Questionnaire (QEQ) evaluates satisfaction with erection quality.. To collate QEQ data, including correlations between QEQ outcomes and outcomes assessing emotional well-being, treatment satisfaction, and erection hardness after sildenafil citrate treatment.. In four trials, men older than 18 years and with erectile dysfunction, a stable sexual partner, and no recent phosphodiesterase type 5 inhibitor use were randomized to double-blind flexible-dose sildenafil or placebo (1:1 ratio) for 6 or 10 weeks (two trials), fixed-dose 50 mg, 100 mg, and placebo (1:1:1 ratio) for 8 weeks (one trial), and 50 mg and 100 mg (1:1 ratio) for 4 weeks after 4 weeks of single-blind sildenafil 50 mg. Exclusion criteria included recent significant cardiovascular disease, use of nitrates, nitric oxide donors, cytochrome P450 3A4 inhibitors, or other erectile dysfunction treatment, and sildenafil hypersensitivity or previous severe or serious treatment-related adverse event.. Scores on the QEQ, QEQ Question 5 (satisfaction with erection hardness), the Self-Esteem and Relationship Questionnaire, and the Erectile Dysfunction Inventory of Treatment Satisfaction; the percentage of occasions with Erection Hardness Score 3 (EHS 3, hard enough for penetration but not completely hard) and/or EHS 4 (completely hard and fully rigid); and Pearson correlation coefficients.. 1,296 men (18-80 years) were randomized. Except for the percentage of occasions with EHS 3, all outcomes improved in men treated with sildenafil and correlated positively with the change in QEQ scores in all trials.. Satisfaction with the quality of erections, which is easily monitored with the QEQ, correlated positively with measures of emotional well-being and treatment satisfaction and with the change in percentage of erections that were completely hard and fully rigid, but not with the change in percentage of erections that were hard enough for penetration but not completely hard.

Topics: Adolescent; Adult; Affect; Aged; Aged, 80 and over; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Personal Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Severity of Illness Index; Sexual Behavior; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Young Adult

The Erection Hardness Score (EHS), a validated single-item patient-reported outcome (PRO), may provide a simple method to capture erectile dysfunction (ED) symptoms and to monitor treatment outcome.. To map the relationship between the EHS, which was used as the anchor, and other validated PROs: International Index of Erectile Function (IIEF), Quality of Erection Questionnaire (QEQ), Sexual Experience Questionnaire (SEX-Q), and Self-Esteem and Relationship questionnaire (SEAR). Methods. Data were from a trial of flexible-dose sildenafil (50 or 100 mg) in 209 men with ED.. A mixed-effects repeated-measures model with EHS as a categorical explanatory variable and each of the other PROs, as a separate dependent variable, was applied to analyze the longitudinal data from randomization to the end of the 10-week, double-blind, placebo-controlled phase and the 6-week open-label phase. EHS data, which were generated at each sexual encounter (event), were averaged per patient over the same recall period that preceded administration of the other PRO questionnaires.. Scores on all domains of the IIEF and SEX-Q, as well as the SEAR total score and SEAR Sexual Relationship domain, discriminated on all EHS categories. The QEQ total score discriminated on all EHS categories except EHS 1 and EHS 2. Although the model did not impose any functional relationship between PRO score and EHS, an approximately linear relationship existed between the EHS and all other PROs, which was especially pronounced for those PROs that were more directly related to erectile quality or function.. The relationship between discrete EHS categories and PRO scores demonstrates the close correspondence of erectile hardness with erectile function (IIEF), erection quality (QEQ), overall sexual experience (SEX-Q), and ED-related psychosocial factors (SEAR) in men with ED.

Topics: Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Personal Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Self Concept; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Women's quality of sexual life is strongly impaired by erectile dysfunction (ED). Women's involvement in ED treatment is important for compliance and long-term efficacy but remains difficult. The Index of Sexual Life (ISL), specific of the quality of sexual life of women with ED partners, is used here to assess the impact of ED treatment on female partners.. The study explored in a context close to routine clinical practice the effect of sildenafil citrate (Viagra(R); Pfizer, New York, NY, USA) treatment on women's quality of sexual life, in parallel with men's ED evaluations.. This prospective, open-labeled clinical trial was performed in France in 2006. Sexologists and andrologists recruited 67 volunteer couples for a 14-week sildenafil citrate treatment of male partners, without sex therapy in parallel.. Women's quality of sexual life using ISL, and men's ED using International Index of Erectile Function (IIEF) and Self-Esteem And Relationship (SEAR) were assessed at baseline and at the end of the study. Satisfaction for treatment was measured using Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and EDITS Partner.. The ISL sexual life satisfaction score was low at baseline (12.3), and increased by 8.3 during the study (P < 0.0001). Women were 79.0% to be responders according to ISL assessment. The other ISL dimensions also improved. The final ISL sexual life satisfaction score was dependant on women's age and final IIEF scores. The observed correlations between the ISL sexual life satisfaction dimension and the IIEF erectile function dimension, and the SEAR confidence dimension confirmed our assumptions. Both partners were highly satisfied with the treatment.. Women satisfaction with their sex life was improved by ED treatment (sildenafil citrate). Couple global caring seemed to amplify the well-known effect of ED treatment for men. The ISL could be a useful tool to help women in their partner's treatment and to integrate ED treatment in a couple approach.

Topics: Adult; Aged; Coitus; Erectile Dysfunction; Family Characteristics; Female; Humans; Male; Middle Aged; Personal Satisfaction; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Quality of Life; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

Psychosocial manifestations of erectile dysfunction (ED) differ across cultures. Understanding the treatment response to ED medications within cultural groups can aid in resource allocation and in developing treatment strategies.. Evaluate the effect of sildenafil treatment on self-esteem, confidence, and sexual relationship satisfaction in Brazilian men with ED.. The Self-Esteem and Relationship (SEAR) questionnaire, a validated, 14-question instrument developed to specifically address self-esteem and relationship issues within the context of ED.. Men aged 18 years or older with a clinical diagnosis of ED (< or = 21 on the Sexual Health Inventory for Men) and in a stable relationship with a partner during the study were eligible. The primary end point was a change from baseline in the self-esteem subscale of the SEAR questionnaire. Thirteen Brazilian sites participated in a randomized, double-blind, placebo-controlled trial of sildenafil treatment for ED. Patients were randomized to receive either 50 mg of sildenafil (adjustable to 25 mg or 100 mg based on patient response) or matching placebo approximately 1 hour before anticipated sexual activity but not more than once a day.. At the end of double-blind treatment, 63 and 66 patients in the placebo and sildenafil groups, respectively, from 13 Brazilian sites were assessed for efficacy. Brazilian patients receiving sildenafil had significantly greater improvements in their scores on the SEAR self-esteem subscale (42.9 [95% confidence interval 35.7-50.0]) compared with placebo (21.1 [95% confidence interval 13.7-28.6]; P < 0.0001). Effect sizes ranged from 0.91 to 1.25 for individual SEAR components.. The psychosocial parameters in Brazilian men with ED assessed by the SEAR questionnaire showed significant improvements in self-esteem, confidence, and relationships after treatment with sildenafil.

Topics: Adolescent; Adult; Aged; Brazil; Double-Blind Method; Erectile Dysfunction; Female; Humans; Interpersonal Relations; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Psychology; Purines; Self Concept; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Young Adult

The efficacy and safety of two types of phoshodiestrase type 5 ( PDE 5) inhibitors (sildenafil (sil) and vardenafil (var)) were investigated for multi-centric study.. One hundred and twenty five patients (55.9 +/- 10.9 years old) with erectile dysfunction (ED) were treated by both of sil and var. The patients were administered a pair of 25 mg of sil and 5 mg of var, or 50 mg of sil and 10 mg of var. The efficacy for ED and safety of these 2 drugs were evaluated after administration of each drugs at least 2 times.. The results showed that the score of international index of erectile function 5 (IIEF5) were elevated from 8.87 +/- 4.10 to 17.24 +/- 6.17 after treatments (p< 0.0001, Student' s t test). The efficacy rates for ED were 81.6% in sil and 81.6% in var, respectively. The adverse reactions rates such as headache, burning, palpitation, etc. were 13.6% in sil and 5.6% in var, which is significantly higher in sil (p = 0.032; chi2 test). These side effects were not serious at all, and there were no cases that gave up to use PDE5 inhibitors because of adverse reactions. According to individual patients experiences, 40.7% of patients preferred sil, 45.4% choose var. In addition, associated effects for quality of life (QOL) of ED patients treated by PDE5 inhibitors were analyzed. The results revealed that encouraging in life 46.5%, rejuvenation feeling 45.1%, self care for their health 28.2%, improvement of depression 12.7%, improvement of voiding dysfunction 5.6%, intimacy with partner 38.0%, good conversation with partner 18.3%, and so on.. The treatments of ED by sil and var were very effective and safety. Furthermore, associated effects for QOL of ED patients were also improved with these treatments.

Topics: Adult; Aged; Erectile Dysfunction; Humans; Imidazoles; Japan; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Treatment options for managing erectile dysfunction (ED) include medical and psychological interventions. The present study examined the effectiveness of a drug-only vs. combined treatment approach on erectile function as well as other domains of sexual function and cognition, couple intimacy and adaptation, and treatment satisfaction. Couples with ED were randomly assigned to either Viagra-only (VO) or Viagra plus sex therapy (VST). Sexual and relationship variables were measured at specific time points. Despite limitations, study findings extend previous conclusions and provide empirical support for the effectiveness and satisfaction with the combined treatment approach for treating men with ED of mixed etiology.

Topics: Adult; Aged; Coitus; Combined Modality Therapy; Erectile Dysfunction; Female; Humans; Male; Marital Therapy; Middle Aged; Patient Satisfaction; Piperazines; Purines; Quality of Life; Sexual Partners; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

To evaluate the safety and efficacy of sildenafil citrate for treating erectile dysfunction (ED) in patients with combat-related post-traumatic stress disorder (PTSD).. In all, 266 combat-exposed war veterans with ED (aged 37-59 years) were recruited. They met the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for PTSD according to the Structured Clinical Interview for Patients, Investigator Version. The patients were also evaluated with the Clinician-Administered PTSD Scale, both to establish the diagnosis of PTSD and to measure symptom severity. Only patients with psychogenic ED were included in the study. Patients with comorbid conditions (diabetes mellitus, hypercholesterolaemia, hypertension, Peyronie's disease) and smokers of more than five cigarettes daily were excluded. The patients were randomly divided into a group of 133 who received 100 mg of on-demand sildenafil 0.75-2 h before sexual stimulation, and 133 who received placebo. Patients were asked to use > or =16 doses or attempts at home. The efficacy of the treatments was assessed every four attempts during treatment, and at the end of the study, using responses to the 15-question International Index of Erectile Function (IIEF), Sexual Encounter Profile diary questions 2 and 3, Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, patients' event logs of sexual activity, and a Global Assessment Question about erections.. Sildenafil did not produce significantly and substantially greater improvement than placebo in each of the primary and secondary outcome measures (P = 0.08). A normal EF domain score (> or =26) at endpoint was reported by 13 (9.8%), and 11 (8.3%) of patients on the sildenafil and placebo regimens, respectively (P = 0.09). Patients treated with sildenafil had no statistically significantly greater improvement in the five sexual function domains of the IIEF questionnaire than those treated with placebo (P = 0.08). The incidences of treatment-emergent adverse events were significantly greater in the sildenafil arm than in the placebo group (P = 0.01).. Sildenafil is no better than placebo in treating PTSD-emergent ED. Further randomized clinical trials are warranted in combat veterans and other populations with PTSD to better elucidate the role of phosphodiesterase type 5 inhibitors in treating PTSD-emergent ED.

Topics: Adult; Analysis of Variance; Combat Disorders; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Stress Disorders, Post-Traumatic; Sulfones; Treatment Outcome

Erectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self-esteem.. In men with ED, to use the validated Self-Esteem and Relationship (SEAR) questionnaire to evaluate changes in self-esteem associated with sildenafil treatment of ED and to assess changes dependent on concomitant comorbid conditions.. This was a 14-week, international, randomized, parallel-group, double-blind, flexible-dose (25, 50, or 100 mg), placebo-controlled study of sildenafil in men aged >or=18 years with a clinical diagnosis of ED (score

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Depressive Disorder; Double-Blind Method; Erectile Dysfunction; Expressed Emotion; Humans; Hyperlipidemias; Hypertension; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Prostatic Hyperplasia; Purines; Quality of Life; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Young Adult

To examine the effect of sildenafil on erectile dysfunction (ED) and psychosocial outcomes in alcohol-dependent (AD) men, 108 men with these diagnoses were randomly assigned to either take sildenafil (50 mg) as add-on to standard treatment for AD, or the same treatment without sildenafil, for 12 weeks. Only 50 patients in sildenafil group and 51 in control group twice completed the International Index of Erectile Function (IIEF) and a battery of self-report questionnaires. IIEF scores and psychosocial functioning, self-esteem and support from friends improved only for sildenafil-treated patients (P < 0.001). The high effect sizes suggest that the observed benefits are unlikely to be a placebo effect, although their unspecific nature could not be ruled out. In men with ED associated with AD, sildenafil improves both ED and psychosocial outcomes. Further placebo-controlled clinical trial is warranted.

Topics: Adolescent; Adult; Erectile Dysfunction; Ethanol; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Young Adult

Although the effect of phosphodiesterase type 5 inhibitors on endothelial function in the systemic circulation has been extensively studied, its effect on penile endothelial function remains unexplored. Therefore, we evaluated the effect of daily sildenafil on penile endothelial function.. A total of 60 patients with erectile dysfunction were randomized blindly to daily placebo or 50 mg sildenafil for 4 weeks. Penile and forearm blood flow as well as endothelial function indices were measured at baseline and after 4 weeks using venoocclusive strain gauge plethysmography for both organs. Sequential changes in flow, maximal blood flow and area under the curve induced by reactive hyperemia after 5 minutes of transient ischemia were considered indices of endothelial function.. There were 34 patients treated with sildenafil and 19 on placebo who completed the study. The general characteristics of both groups were comparable. Mean +/- SEM baseline penile blood flow was 6.2 +/- 1.4 and 7.0 +/- 0.6 ml/dl per minute for the placebo and sildenafil groups, respectively (p = 0.54). Baseline forearm blood flow was similar in both groups. At baseline penile AUC was 420 +/- 50 and 520 +/- 50 (p = 0.18), and in the forearm it was 445 +/- 40 and 410 +/- 40 (p = 0.45) for the placebo and sildenafil groups, respectively. After 4 weeks on the assigned drug penile blood flow increased to 11.2 +/- 2 ml/dl per minute in the sildenafil group (p = 0.02) and remained unchanged in the placebo group. After 4 weeks penile AUC increased to 720 +/- 65 in the sildenafil group (0.04) and remained unchanged in the placebo group. Placebo and sildenafil did not affect the indices of forearm endothelial function.. Daily sildenafil significantly improves penile blood flow and penile endothelial function indices without causing any relevant systemic effects.

Topics: Adult; Aged; Double-Blind Method; Endothelium, Vascular; Erectile Dysfunction; Humans; Male; Middle Aged; Penis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

To compare the effectiveness, safety and tolerability of sildenafil and apomorphine in Brazilian patients with erectile dysfunction (ED) of various causes.. In all, 108 patients (mean age 55 years, sd 11) and documented ED for > or =6 months were included in 12 centres in Brazil. The patients were initially followed for 2 weeks and then randomized to initial treatment with apomorphine or sildenafil, taken before sexual intercourse, no more than once a day. The initial dose (2 mg apomorphine and 50 mg sildenafil) could be adjusted (to 3 mg apomorphine, or to 25 or 100 mg for sildenafil) depending on the effectiveness and tolerability during the first 4 weeks of treatment. The patients were re-evaluated after 8 weeks on treatment and, after a wash-out period of 2 weeks (no treatment), received the other study drug (other than that received in the first phase), and then had the same procedures as in the first phase.. In all, 97 patients were evaluated for therapeutic effectiveness, the overall effectiveness being assessed using two questions; sildenafil had a significantly higher proportion of affirmative answers for both (P < 0.001). Likewise, the estimates for the mean (sd) proportion of successful sexual intercourse, of 83.3 (4.7)% vs 40.3 (4.7)% and the total ED Inventory of Treatment Satisfaction score, of 86.7 (2.9) vs 56.9 (2.9) (P < 0.001) were higher for sildenafil. At the end of the study, 93.8% of the patients randomized to initial therapy with apomorphine declared a preference for sildenafil, and 81.3% of those initially treated with sildenafil declared a preference for that drug. The two drugs were well tolerated, and the main adverse events for apomorphine were nausea, vomiting, headache, taste perversion and dizziness; for sildenafil they were headache, flushing or vasodilatation, abdominal pain or dyspepsia and nasal congestion.. Sildenafil is more effective than apomorphine for treating ED, in the domains of erectile function, satisfaction with sexual intercourse and overall satisfaction, and was the drug preferred by most of the patients.

Topics: Adult; Aged; Apomorphine; Coitus; Cross-Over Studies; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Topics: Adult; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Receptor, Melanocortin, Type 4; Sildenafil Citrate; Sulfones; Vasodilator Agents

The Sexual Experience Questionnaire (SEX-Q) enables quick and easy assessment of functional, emotional, and satisfaction-related aspects of the sexual experience in men with erectile dysfunction (ED).. To assess correlations between improvement on the SEX-Q and outcomes on other validated questionnaires. METHODS. Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function [IIEF]) who had used less than or equal to six doses of any phosphodiesterase 5 inhibitor (none within 6 months) were randomized to 10 weeks of double-blind, placebo-controlled (DBPC) flexible-dose sildenafil citrate (50 or 100 mg, as needed), followed by 6 weeks of open-label (OL) sildenafil.. SEX-Q, IIEF, Quality of Erection Questionnaire (QEQ), Self-Esteem and Relationship (SEAR) Questionnaire, Erection Hardness Score (EHS), successful intercourse attempts (SIAs), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and global efficacy questions (GEQs).. Compared with the placebo group (N = 105), the sildenafil group (N = 104) at DBPC end of treatment (EOT) had significantly more improvement (P < 0.05) on all SEX-Q, IIEF (except the Sexual Desire domain), QEQ, and SEAR outcomes, more frequent SIAs and EHS 3 (hard enough for penetration but not completely hard) or EHS 4 (completely hard) erections (odds ratio [OR], 2.52 and 3.46, respectively), EHS 4 erections four times as often (OR, 6.41), more men satisfied with treatment (EDITS; OR, 2.6), approximately twice as many men with improved erections (GEQ1; OR, 5.8) and ability to have sexual intercourse (GEQ2; OR, 5.4), and GEQ3 scores that indicated better sex (P < 0.0001). SEX-Q score improvements correlated positively with all other outcomes. At OL EOT, most outcomes were >60% (and approximately half were > or =80%) of the maximum positive result.. SEX-Q change scores correlate with several other functional, emotional, and satisfaction-related outcomes in men treated with sildenafil for ED, allowing a simple and focused evaluation of the sexual experience.

Topics: Adult; Double-Blind Method; Erectile Dysfunction; Humans; Libido; Male; Middle Aged; Orgasm; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Psychometrics; Purines; Quality of Life; Reproducibility of Results; Sexual Behavior; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Vasodilator Agents

To evaluate the body mass index (BMI) and lower urinary tract symptom (LUTS) severity on treatment response to sildenafil in men with erectile dysfunction (ED) and moderate to severe LUTS associated with benign prostatic hyperplasia.. A post hoc analysis of data from a 12-week, double-blind, placebo-controlled study of sildenafil (50 mg once daily titrated to 100 mg once daily) was conducted. The BMI categories were obese (> or = 30 kg/m(2)), overweight (> or = 25 to < 30 kg/m(2)), and normal weight (< 25 kg/m(2)). ED was defined as a score of < or = 25 on the erectile function domain of the International Index of Erectile Function, and LUTS was defined by an International Prostate Symptom Score of > or = 12. The maximal urinary flow rate was determined by uroflowmetry.. Patients receiving sildenafil (n = 189) had a significant improvement in the erectile function domain scores of the International Index of Erectile Function (P < .0001 vs placebo, n = 180), which did not vary across BMI groups. A greater improvement in LUTS score was observed with sildenafil compared with placebo for men with severe LUTS (-8.6 vs -2.4, P < .0001) than in men with moderate LUTS (-3.6 vs -1.7, P = .06). Also, the improvement in LUTS scores was significant (P < or = .02) for men taking sildenafil independent of BMI (obese, -8.9 vs -5.4; overweight, -7.3 vs -3.2; normal weight, -7.1 vs -0.84). No difference was found among the treatment groups in the change from baseline maximal urinary flow rate across all LUTS and BMI categories (range 4.5 to -4.2 mL/s).. The results of our study have shown that daily dosing with sildenafil improved ED and LUTS independent of baseline LUTS severity or BMI.

Topics: Aged; Body Mass Index; Body Weight; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Obesity; Overweight; Penile Erection; Piperazines; Placebos; Purines; Sildenafil Citrate; Sulfones; Urologic Diseases; Vasodilator Agents

Satisfaction with the sexual experience is considered important when evaluating the impact of treatments for erectile dysfunction, yet enhanced satisfaction has been infrequently assessed in the sexual trials. We evaluated the efficacy of sildenafil vs. tadalafil, in Saudi men with erectile dysfunction and determined the self-based rating of medicinal preference. Sildenafil citrate (Viagra) is a potent inhibitor of the electrolytic enzyme type V phosphodiesterase (PDE5), in the corpus cavernosum and therefore increases the penile response to sexual stimulation. Tadalafil (Cialis) is also a PDE5 inhibitor that increases the level of cyclic guanosine monophosphate (cGMP) in cavernous smooth muscle cells. Whereas cGMP is a second messenger for the vasodilator effects of nitric oxide causing smooth muscle relaxation, which in turn leads to penile erection; however the mechanism by which cGMP stimulates relaxation of the smooth muscles remains to be elucidated. Both sildenafil and tadalafil have a rapid onset with the effectiveness up to 4 hours and 36 hours respectively. In this study subjects treated with 100 mg oral dose of sildenafil / 20 mg tadalafil were found to be associated with higher mean scores for the questions of the International Index of Erectile Function (IIEF). Frequency of penetration and maintenance of erection after sexual penetration and/or during masturbation were found to be enhanced significantly (p<0.001) in both sildenafil/tadalafil treated men. Similarly mean domain of erectile function, orgasmic function, and intercourse satisfaction also showed a significantly positive improvement (p/0.001) in both the treated groups in comparison with their age matched untreated controls. Interestingly in all the cases, tadalafil group showed considerably greater positive responses than the sildenafil group but within the same significant levels. Strikingly the sexual-desire domain in sildenafil treated men with respect to their aged matched controls showed a non-significant difference, where as this difference was found to be highly significant in tadalafil treated group. Similarly mean scores for the overall satisfaction domains of the IIEF in comparison with the untreated subjects showed a significant positive response in the sildenafil treated group (p<0.001), where as tadalafil treated group showed a highly significant positive response (p<0.005). These findings suggest that both sildenafil and tadalafil may assist an individual in extending

Topics: Administration, Oral; Adult; Carbolines; Coitus; Erectile Dysfunction; Humans; Male; Middle Aged; Orgasm; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Saudi Arabia; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Tadalafil; Treatment Outcome

The Erection Hardness Score (EHS), recently validated, was developed in 1998 as a simple (one-item) method to quantify erection outcome data. Although it is intuitive that erection hardness and successful sexual intercourse (SSI) are related, the link has not been directly established.. To evaluate the relationship between erection hardness (assessed by EHS) and SSI, establishing the EHS as a clinically useful tool.. The data set (N = 307) was from a multinational, double-blind, placebo-controlled trial (with open-label extension) of sildenafil citrate in men with erectile dysfunction.. Event-based modeling used every intercourse attempt and the EHS to estimate the odds ratio of SSI between adjacent EHS categories. Mean-based modeling used mean EHS per patient to determine its relationship to percentage of SSI. Mediation-based modeling used mean EHS and mean percentage of SSI over the double-blind phase to estimate the direct effect of sildenafil treatment on SSI and the indirect effect of sildenafil treatment on SSI via erection hardness.. The odds of SSI for EHS 3 (hard enough for penetration but not completely hard) were 41.9 times (95% confidence interval [CI], 33.0-53.2; P < 0.0001) that for EHS 2 (hard but not hard enough for penetration), and the odds of SSI for EHS 4 (completely hard and fully rigid) were 23.7 times (95% CI, 19.5-28.9; P < 0.0001) that for EHS 3. The percentage of SSI increased approximately curvilinearly with the increase in mean EHS, from almost 60% at EHS 3 to 78.5% at EHS 3.5 and to 93.1% at EHS 4. The indirect effect of sildenafil treatment on SSI via erection hardness accounted for almost 90% of the total effect on SSI (P < 0.0001).. The close and direct relationship between erection hardness and SSI supports the broader use of the EHS-a simple, valid, reliable, and responsive measure-in clinical practice.

Topics: Adolescent; Adult; Coitus; Confidence Intervals; Double-Blind Method; Erectile Dysfunction; Health Status Indicators; Humans; Logistic Models; Male; Middle Aged; Models, Statistical; Odds Ratio; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Behavior; Sildenafil Citrate; Sulfones; Young Adult

To evaluate the efficacy, tolerability, and treatment satisfaction after initiating treatment with sildenafil 50 mg and later titrating to 100 mg, compared with continuing treatment with sildenafil 50 mg, in men with erectile dysfunction (ED).. A multicentre, parallel-group trial was conducted in two 4-week periods. In period 1, patients received 50-mg doses of sildenafil single-blinded for 4 weeks. In period 2, patients were randomized to double-blind, placebo-controlled treatment with sildenafil 50 mg or sildenafil 100 mg for 4 weeks. All patients were aged >or=18 years with a documented clinical diagnosis of ED (score of

Topics: Adult; Aged; Aged, 80 and over; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Young Adult

We report the methodology and results of a study that compared a dopaminergic agonist, apomorphine, with a phosphodiesterase type-5 inhibitor, sildenafil, in terms of efficacy, tolerability, satisfaction and patient preference.. This was a 20-week open- label, randomized, flexible-dose, crossover study to assess the comparative efficacy and safety of sildenafil and apomorphine. One sequence group received treatment with sildenafil followed by apomorphine and the other sequence group received treatment with apomorphine followed by sildenafil. The primary efficacy variable was the measurement of the score of the erectile function domain (the sum of questions 1-5 and 15) of the International Index of Erectile Function (IIEF) questionnaire. The secondary efficacy variables were: the responses to the Global Efficacy Assessment Questions; the score of the responses to all the questions of the IIEF questionnaire; the index score of the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, and the event log variables.. A marked increase in the mean IIEF score was observed after treatment with sildenafil, compared with a small increase following treatment with apomorphine. The mean baseline and final scores before and after treatment with sildenafil were 13.9 +/- 5.2 and 24.1 +/- 5.2, while the corresponding mean scores before and after treatment with apomorphine were 14.2 +/- 5.1 and 16.8 +/- 6.2. The comparison between treatments showed a statistically significant difference in favor of sildenafil. Furthermore, sildenafil was found to be significantly superior to apomorphine in all the other secondary variables, produced a high level of patient satisfaction, and a significantly larger number of patients indicated their preference for sildenafil compared to apomorphine.

Topics: Adult; Apomorphine; Cross-Over Studies; Dopamine; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Research Design; Safety; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Time Factors; Vasodilator Agents

To show the efficacy, safety, and tolerability of sildenafil in men with erectile dysfunction (ED) associated with complete or incomplete spinal cord injury (SCI) and to assess its effects on quality of life (QoL) using the Life-Satisfaction Check List.. This was a placebo-controlled, multicenter, randomized, double-blind, flexible-dose, 2-way crossover study with a 2-week washout period between each phase. Patients with ED attributable to SCI (Sexual Health Inventory-Male score < or =21) received 50 to 100 mg sildenafil (n = 24) or placebo (n = 26).. Compared with placebo, sildenafil produced higher levels of successful sexual stimulation, intercourse success, satisfaction with sexual life and sexual relationship, erectile function, overall sexual satisfaction, and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score, with no clinically relevant effects on vital signs. Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI, producing significant improvements, compared with placebo, in a number of measures only in patients with incomplete SCI. All patients who expressed a preference selected sildenafil over placebo, although the drug had no effect on patient QoL. Sildenafil was well tolerated, with a profile comparable to that of placebo.. Compared with placebo, treatment with oral sildenafil safely and effectively improved erectile function in patients with ED attributable to SCI, especially in those with incomplete injury, and was the agent of choice in those who expressed a preference.

Topics: Adult; Analysis of Variance; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Evaluation Studies as Topic; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Severity of Illness Index; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Time Factors

To assess the efficacy and safety of sildenafil citrate in the management of erectile dysfunction (ED) following radical cystectomy (RC) and to define the different prognostic factors predicting the response to sildenafil in such a challenging group of patients.. One hundred patients with ED following RC participated in an open-label, non-randomized, prospective, dose-escalation study. The median age of the patients was 53 years and the mean period after RC was 80.7 +/- 54.8 months. The study duration was 12 weeks, comprising a 4-week run-in period followed by two active treatment periods of 4 weeks each with 50 and 100 mg of sildenafil. Patients were assessed by means of the International Index of Erectile Function (IIEF) questionnaire at baseline and after each treatment period. At the end of the study, the Global Efficacy Assessment Question was used to evaluate treatment satisfaction. Factors affecting the patient's response to sildenafil were assessed by means of uni- and multivariate analysis.. The entire study group was suffering from severe ED at baseline, with a mean erectile function (EF) domain score of 6.5 +/- 0.93. EF scores improved to 12.2 +/- 7.76 and 18 +/- 10.3 with 50 and 100 mg of sildenafil, respectively. Sildenafil therapy significantly improved the ability of many patients to achieve and maintain an erection. The mean scores for question 3 of the IIEF were 1 +/- 0.14, 2.1 +/- 1.4 and 3 +/- 1.8 at baseline and with 50 and 100 mg of sildenafil, respectively, while the corresponding scores for question 4 were 1 +/- 0.10, 1.9 +/- 1.35 and 3 +/- 1.85. The satisfaction rate was 54%. The response was dose-dependent but the incidence of adverse effects increased from 6% with 50 mg of sildenafil to 34% with 100 mg. In univariate analysis, tumor histology and grade and postoperative partial tumescence were found to significantly impact the patient's response to sildenafil. In multivariate analysis, postoperative partial tumescence was the only independent predictive variable. CONCLUSIONS. Sildenafil was found to be a safe and satisfactory treatment for post-RC ED. The effect was dose-related. Patients with postoperative partial tumescence were the best responders.

Topics: Adult; Aged; Cystectomy; Dose-Response Relationship, Drug; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Multivariate Analysis; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prognosis; Prospective Studies; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Time Factors; Urinary Bladder Neoplasms

Erectile dysfunction (ED) impacts erection hardness and compromises quality of life.. Assess erection hardness and its correlation with sexual function, emotional well-being, and satisfaction (erection quality, intercourse, sex life, sexual relationship, and treatment).. Men with ED were randomized to double-blind, flexible-dose sildenafil (25, 50, or 100 mg) or placebo (6 weeks) with open-label extension (6 weeks).. Erection Hardness Score (EHS), Quality of Erection Questionnaire (QEQ), International Index of Erectile Function (IIEF), Self-Esteem And Relationship (SEAR) questionnaire, and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS).. A total of 307 men (mean [range] age, 45 [18-55] years) were randomized to sildenafil (N = 154) or placebo (N = 153). At the end of double-blind treatment, occasions with EHS 3 (hard enough for penetration but not completely hard) or 4 (completely hard) had increased by 40% +/- 3% for sildenafil vs. 11% +/- 3% for placebo (least squares mean +/- standard error; P < 0.0001); the estimated percentage of occasions with EHS 4 was 58% (95% CI, 52-65%) vs. 14% (95% CI, 10-19%) (odds ratio, 8.5; P < 0.0001). There was greater improvement in mean QEQ, IIEF, and SEAR scores (P < 0.0001), and more men were satisfied with sildenafil treatment (EDITS Index score >50: 90% vs. 49%). QEQ, IIEF, SEAR, and EDITS outcomes correlated positively with EHS 3 or 4, and with EHS 4 alone and were highest (no overlap of 95% CI vs. other EHS subgroups) in the subgroup with most frequent EHS of 4.. In the group of men with ED treated with sildenafil, it was estimated that completely hard erections were achieved on 58% (95% CI, 52-65%) of occasions. Improvement in function, emotional well-being, and satisfaction was greatest in men with completely hard erections and correlated positively with other measures of hardness.

Topics: Adult; Confidence Intervals; Double-Blind Method; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Odds Ratio; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Reproducibility of Results; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

After bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP), nocturnal and sexually mediated erections may help to preserve normal erectile function (EF).. To investigate nocturnal penile tumescence and rigidity (NPTR) in a subset (N = 54 men) from a randomized, double-blind trial (N = 76) of nightly sildenafil after BNSRRP.. Inclusion required preoperative "normal" EF (defined as a combined score of >/=8 for International Index of Erectile Function questions 3 (penetration) and 4 (maintained erection after penetration) and NPTR testing (>/=10 continuous minutes of >/=55% rigidity [R >/= 55%] at the base). Postoperative assessments were at weeks 4 (pretreatment), 16, 28, 40 (during 36 weeks of nightly prophylaxis: sildenafil 50 mg [N = 17], 100 mg [N = 18] or placebo [N = 19]), and 48 (after 8 weeks of no erectile dysfunction therapy, when "responders" were delineated by the defined normal EF and a "yes" response to "Over the past 4 weeks, have your erections been good enough for satisfactory sexual activity?"). Base and tip rigidity and tumescence were measured using penile plethysmography.. Duration of R >/= 55% and area under the curves for rigidity and tumescence.. Postoperatively, rapid profound reduction in nocturnal EF was noted in all groups. There was a gradual dose-dependent improvement in base and tip rigidity in the sildenafil groups but little improvement in the placebo group. Eight weeks after treatment termination (48 weeks postoperatively), 24% (4/17) of 50-mg sildenafil recipients, 33% (6/18) of 100-mg sildenafil recipients, and 5% (1/19) of placebo recipients were responders. Tip R >/= 55% was the most discriminating NPTR measure between nonresponders and responders to sildenafil, in whom it regained baseline (preoperative) levels (whereas base R >/= 55% did not). It was most prolonged in responders to sildenafil 100 mg.. In our subset analysis, nightly sildenafil for 9 months post-BNSRRP objectively improved nocturnal erections and pharmaceutically unassisted EF.

Topics: Adult; Aged; Area Under Curve; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Longitudinal Studies; Male; Middle Aged; Minimally Invasive Surgical Procedures; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Prostatic Neoplasms; Purines; Sildenafil Citrate; Sulfones; Time Factors; Treatment Outcome

Erectile dysfunction (ED) treatment studies do not measure treatment response and treatment satisfaction (both patient and partner satisfaction) where dissatisfaction reflects an aspirations/achievement gap.. To test the subjective implications of satisfaction to various therapeutic modalities for pure or mixed organic ED, and to address changes in the health-oriented quality of life (QoL) and the relation of psychiatric status of these patients to treatment satisfaction.. A prospective study included of 354 couples classified according to their line of therapy into five treated groups: testosterone, sildenafil citrate, intracavernosal injection, external negative vacuum device, and penile prosthesis.. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and the International Index of Erectile Function (IIEF). Satisfied patients were compared to unsatisfied cases using the PCASEE scale for QoL and Middlesex Hospital Questionnaire (MHQ) for psychiatric status.. Sildenafil citrate-treated group represented the highest mean value of satisfaction score on EDITS, erectile function, orgasmic function, and overall satisfaction domains of IIEF. Penile implants-treated group was the second for satisfaction score on EDITS. The testosterone-treated group represented the highest mean value for sexual desire domain score of IIEF. Low scores in various domains of QoL were significantly improved among satisfied cases more than unsatisfied subjects after therapy. High association was found between dissatisfaction and scores for anxiety, obsession, and phobia, followed by scores of depression and somatic concomitant of anxiety.. ED is best conceived as intermingle of somatic, lifestyle, psychological, and partner relationship determinants. This should be taken into account to increase sexual satisfaction with improved QoL, and not only to produce rigid erection.

Topics: Adaptation, Psychological; Adult; Aged; Double-Blind Method; Erectile Dysfunction; Female; Health Status Indicators; Humans; Male; Mental Health; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Psychometrics; Purines; Quality of Life; Risk Factors; Sexual Partners; Sildenafil Citrate; Stress, Psychological; Sulfones; Surveys and Questionnaires

We evaluated the safety and efficacy of intranasal bremelanotide in men with erectile dysfunction who did not respond to sildenafil.. A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg bremelanotide as an intranasal spray (group 1, 172) 45 minutes to 2 hours prior to sexual stimulation, or a similar regimen of placebo (group 2, 170). Patients were asked to use at least 16 doses/attempts at home. They underwent preliminary assessment, including medical and sexual history, and self-administered International Index of Erectile Function. The efficacy of 2 treatments was assessed every 4 attempts during treatment and at the end of study, using responses to International Index of Erectile Function, and evaluation of mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects.. Positive clinical results were seen in 51 (33.5%) patients in the bremelanotide group compared with 13 (8.5%) patients in the placebo group (p = 0.03). Patients in the bremelanotide group reported significantly greater intercourse satisfaction than those in placebo group (p = 0.03). More drug related adverse effects occurred in the bremelanotide group (p = 0.01).. Bremelanotide can be an alternative treatment for erectile dysfunction with a potentially broad patient base. Further studies with different dosages and treatment regimens are necessary to draw final conclusions on the efficacy of this drug in erectile dysfunction.

Topics: Administration, Intranasal; Adult; alpha-MSH; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Peptides; Peptides, Cyclic; Phosphodiesterase Inhibitors; Piperazines; Purines; Receptors, Melanocortin; Sildenafil Citrate; Sulfones; Treatment Failure; Treatment Outcome

Phosphodiesterase type 5 inhibitors are the first choice therapy in the treatment of erectile dysfunction. Many men in their reproductive years are now using phosphodiesterase type 5 inhibitors. The purpose of this study was to determine the effects of 6 months of treatment with 20 mg vardenafil, compared with 100 mg sildenafil and placebo, on semen characteristics and reproductive hormones in men with and without erectile dysfunction.. This was a randomized, double-blind, placebo controlled, parallel group, multicenter study. A total of 200 men with or without erectile dysfunction, able to produce semen samples without erectile dysfunction therapy, 25 to 64 years old, were randomized to daily treatment with vardenafil, sildenafil or placebo for 6 months. The primary variable was the percentage of vardenafil treated individuals with a 50% or greater decrease in mean sperm concentration from baseline to 6-month last observation carried forward, compared with placebo treated individuals.. The between group difference (vardenafil minus placebo) in the percentage of patients with 50% or greater decrease in sperm concentration (baseline to 6 months last observation carried forward) was 0.07% (95% CI, -8.53% to 8.39%). Vardenafil also had no clinically significant effects on any other semen parameters, or on levels of reproductive hormones, when compared with placebo. Similar data were observed with sildenafil.. This study demonstrated that vardenafil had no adverse effects on sperm concentration, compared with sildenafil and placebo, when administered daily at the maximum recommended dose for 6 months. Specifically, use of vardenafil for 6 months does not impair sperm concentration, total sperm count per ejaculate, or sperm morphology and motility. Levels of reproductive hormones were also unaffected.

Topics: Adult; Double-Blind Method; Erectile Dysfunction; Gonadal Hormones; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Semen; Sildenafil Citrate; Sperm Count; Sulfones; Triazines; Vardenafil Dihydrochloride

To evaluate the effect of low-dose sildenafil for rehabilitating erectile function after nerve-sparing radical prostatectomy (NSRP), as the delay to recovery of erectile function after NSRP remains under debate.. Forty-three sexually active patients had a NSRP; at 7-14 days after surgery they had a Rigiscan (Dacomed Corporation, Minneapolis, MN, USA) measurement of nocturnal penile tumescence and rigidity (NPTR). To support the recovery of spontaneous erectile function, 23 patients with preserved nocturnal erections received sildenafil 25 mg/day at night. A control group of 18 patients were then followed but had no phosphodiesterase-5 inhibitors. The International Index of Erectile Function (IIEF)-5 questionnaire was completed 6, 12, 24, 36 and 52 weeks after NSRP.. Of the 43 patients, 41 (95%) had one to five erections during the first night after catheter removal. In the group using daily sildenafil the mean IIEF-5 score decreased from 20.8 before NSRP to 3.6, 3.8, 5.9, 9.6 and 14.1 at 6, 12, 24, 36 and 52 weeks after NSRP, respectively. In the control group the respective scores were 21.2, decreasing to 2.4, 3.8, 5.3, 6.4 and 9.3. There was a significant difference in IIEF-5 score and time to recovery of erectile function between the groups (P < 0.001), with potency rates of 86% vs 66%.. The measurement of NPTR after NSRP showed erectile function even the 'first' night after catheter removal. In cases of early penile erection, daily low-dose sildenafil leads to a significant improvement in the recovery of erectile function.

Topics: Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Penis; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Prostatic Neoplasms; Purines; Recovery of Function; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Several preference studies comparing a short-acting with a longer-acting phosphodiesterase type 5 inhibitor have been conducted in men. Most men in those studies preferred tadalafil rather than sildenafil, and recent post hoc analysis of one study described several factors associated with men's treatment preference. No prospective studies have investigated the woman partners' preferences.. To investigate the treatment preference of women who were partners of men using oral medications for erectile dysfunction (ED) in a single-center open-label crossover study.. One hundred heterosexual couples in stable relationships, with male partners having ED based on the erectile function subscale of the International Index of Erectile Function, were randomly assigned to receive sildenafil or tadalafil for a 12-week phase, followed by another 12-week period using the alternate drug. Male and female participants completed sexual event diaries during both study phases, and the female participants were interviewed at baseline, midpoint, and end of study.. Primary outcome data were the women's final interviews during which they were asked which drug they preferred and their reasons for that preference.. A total of 79.2% of the women preferred their partners' use of tadalafil, while 15.6% preferred sildenafil. Preference was not affected by age or treatment order randomization. Women preferring tadalafil reported feeling more relaxed, experiencing less pressure, and enjoying a more natural or spontaneous sexual experience as reasons for their choice. Mean number of tablets used, events recorded, events per week, and days between events were not significantly different during each study phase.. Women's preferences were similar to men when using these two drugs. While the women's reasons for preferring tadalafil emphasized relaxed, satisfying, longer-lasting sexual experiences, those preferring sildenafil focused on satisfaction and drug effectiveness for their partner.

Topics: Carbolines; Cross-Over Studies; Erectile Dysfunction; Female; Humans; Male; Middle Aged; Personal Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sexual Partners; Sildenafil Citrate; Sulfones; Tadalafil

To clarify the period of responsiveness to sildenafil.. Under a double-blind protocol, men with mild to moderate erectile dysfunction (International Index of Erectile Function [IIEF] Erectile Function domain score, 11 to 25) were randomized to sildenafil (100 mg) or placebo and attempted intercourse 8 hours (range, 7 to 9 hours) postdose (first 4-week phase) and 12 hours (11 to 13 hours) postdose (second 4-week phase after treatment crossover). The primary outcome was the per-patient proportion (PPP; least squares means [95% confidence interval]) of affirmative responses to the Sexual Encounter Profile question 3 (SEP3: "Did your erection last long enough for you to have successful intercourse?").. For sildenafil (n = 174) versus placebo (n = 177), baseline values were similar but the PPP of successful intercourse attempts increased to 76% (69% to 82%) versus 50% (43% to 57%) in phase 1 (odds ratio [OR] = 3.2) and 79% (72% to 85%) versus 52% (44% to 60%) in phase 2 (OR = 3.5), and the PPP of Erection Hardness Score 4 erections (completely hard and fully rigid) was 41% (34% to 48%) versus 10% (7% to 15%) in phase 1 (OR = 6.2) and 44% (37% to 51%) versus 17% (12% to 23%) in phase 2 (OR = 4.0). Thus, at 12 hours, the odds of successful intercourse tripled and of a completely hard erection quadrupled. The sildenafil group achieved greater (P <0.001) PPP of successful penetration (SEP2), satisfaction with erection hardness (SEP4), and satisfaction with the sexual experience (SEP5); improvement in IIEF domain scores; and treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction.. In men with mild to moderate ED, responsiveness to sildenafil may persist much longer than 4 hours.

Topics: Adult; Aged; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Half-Life; Humans; Male; Middle Aged; Orgasm; Patient Satisfaction; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Sexual satisfaction is linked to life satisfaction, and erectile dysfunction (ED) may lead to an impaired quality of life (QOL).. Our goal was to evaluate the QOL among Brazilian patients with ED, before and after three kinds of treatment.. Men aged 25-55 years, with a diagnosis of psychogenic or mixed ED, according to the Classification of Mental and Behavioral Disorders of the International Classification of Diseases, 10th edition, and the Standard Practice in Sexual Medicine, were randomly assigned to three treatment groups: counseling, sildenafil, and sildenafil plus counseling. At baseline each group had 40 patients. Sildenafil was provided in 50 mg that could be adjusted to 100 mg. The patients could initially take one to two tablets per week and the entire treatment lasted for 3 months. Counseling was provided in group sessions that took place once a week. They were evaluated at baseline and after 3 months of treatment with the Male Sexual Quotient (MSQ) and the Sexual Health Inventory for Men (SHIM).. The correlation between the patients' MSQ score and scores on the SHIM.. One hundred seventeen patients were enrolled. The three groups were similar according to age, marital status, mean time of ED, and ED severity and etiology. At baseline, MSQ and SHIM total scores were not different among the three groups. MSQ scores increased from 41.2 +/- 15.3, 38.7 +/- 18.0, and 46.8 +/- 17.0 to 48.5 +/- 15.3, 63.8 +/- 21.6, and 70.0 +/- 17.3 after counseling, sildenafil, and sildenafil plus counseling, respectively (P < 0.05). SHIM scores also increased significantly (9.6 +/- 4.1, 9.7 +/- 4.1, and 10.2 +/- 3.9 to 12.1 +/- 3.9, 16.7 +/- 5.6, and 17.7 +/- 4.5 after counseling, sildenafil, and sildenafil plus counseling, respectively) (P < 0.05). There were no serious adverse events related to sildenafil, and no patient was withdrawn from the study because of an adverse event.. The three treatments were significantly efficient, and the best treatment was sildenafil associated with counseling.

Topics: Adult; Erectile Dysfunction; Health Status Indicators; Humans; Male; Middle Aged; Personal Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Psychological Tests; Psychometrics; Purines; Quality of Life; Sex Counseling; Sildenafil Citrate; Sulfones; Treatment Outcome

Erectile and endothelial dysfunction are common pathologies of multiple cardiovascular risk factors and are considered longitudinal predictors of cardiovascular events. Oxidative stress and decreases in testosterone levels play an important role in the pathogenesis of endothelial dysfunction.. We sought to determine whether the severity of erectile dysfunction (ED) was associated with individual levels of testosterone and oxidative stress, and whether treatment with a phosphodiesterase type 5 inhibitor could reduce oxidative stress and increase testosterone availability.. We evaluated the association of salivary 8-hydroxy-2'-deoxyguanosine (8-OHdG), salivary testosterone, International Index of Erectile Function-erectile function domain (IIEF-EF) scores, and Medical Outcome Study (MOS) 36-item Short-Form Healthy Survey (SF-36) questionnaires in 128 middle-aged male volunteers. We investigated the changes in testosterone levels, salivary 8-OHdG levels, IIEF-EF scores, and SF-36 scores in 20 ED patients (according to the IIEF-EF) who took 50 mg of sildenafil once a week for 6 months.. IIEF-EF scores were used to assess ED severity. Antioxidant status was defined by salivary 8-OHdG. Salivary testosterone was used to evaluate serum bioavailable testosterone availability.. Salivary 8-OHdG (OR = 9.88, 95% CI: 1.52-64.10), salivary testosterone (Odds ratio [OR] = 0.96, 95% CI: 0.93-0.98), and vitality on the SF-36, version 2 (SF-36 v2) (OR = 0.92, 95%CI: 0.84-0.98) were significantly associated with the severity of ED in healthy volunteers. Treatment with sildenafil for 6 months significantly increased the total serum testosterone (426.4 +/- 174.8 vs. 569.6 +/- 146.1 ng/dL, P = 0.021) and salivary testosterone levels (56.1 +/- 22.3 vs. 110.0 +/- 48.4 pg/mL, P < 0.001), whereas it decreased salivary 8-OHdG levels (2.30 +/- 0.23 vs. 0.90 +/- 0.05 ng/mL, P = 0.0046).. Salivary 8-OHdG is a useful biomarker for predicting severe ED and hypogonadism in middle-aged men. Once-a-week treatment with sildenafil can have beneficial effects on men's health by decreasing oxidative stress and increasing testosterone levels.

Topics: 8-Hydroxy-2'-Deoxyguanosine; Adult; Biomarkers; Cross-Sectional Studies; Deoxyguanosine; Erectile Dysfunction; Humans; Hypogonadism; Male; Middle Aged; Oxidative Stress; Phosphodiesterase Inhibitors; Piperazines; Purines; Saliva; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Testosterone

The effects of pioglitazone on sildenafil responsiveness in men with erectile dysfunction(ED) and a history of poor response to sildenafil were assessed.. In a double-blinded study,38 men aged 47 +/- 1.5 years with moderate-to severe ED and poor response to sildenafil were randomly assigned to take a premedication of pioglitazone 30 mg (n=19) or placebo (n=19) once daily for 9 weeks along with on-demand use of sildenafil during the last month of pioglitazone treatment.Erectile function (EF) scores, assessed by EF domain of International Index of Erectile Function (IIEF), along with responses to Global Assessment Questions (GAQs) were major outcome measures. Serum levels of total testosterone (T),dehydroepiandrosterone sulfate (DHEAS), glucose,lipid profile and liver function test were minor outcome measures.. Pioglitazone significantly improved major outcome measures compared with placebo. The decrease from baseline of total cholesterol level was more in pioglitazone than in placebo-treated groups. In 84% (32 out of 38) of the sildenafil poor-responders, at least one of the associated risk factors of ED was found. There was undiagnosed hypercholesterolemia in 34% of the subjects. Serum levels of T, DHEAS, glucose and other parameters remained unchanged in both groups. The intervention was well tolerated.. Pioglitazone increased sildenafil response to improve ED of men with prior sildenafil failure and seems to be safe based on the present preliminary study. This improvement is likely regardless of fasting glucose and sex hormones levels.

Topics: Adult; Aged; Double-Blind Method; Drug Synergism; Erectile Dysfunction; Humans; Male; Middle Aged; Pioglitazone; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Thiazolidinediones; Treatment Outcome

Erectile dysfunction (ED) is common among men taking antihypertensive agents to control blood pressure.. We evaluated the efficacy and safety of sildenafil citrate in men with ED taking antihypertensive agents.. A total of 198 male subjects, aged 20 years and older were enrolled. This study was conducted for 10 weeks as an open-label, multicenter and flexible dose trial with a 2-week screening period and an 8-week treatment phase.. Subjects were asked to complete Event Log Worksheets, as well as the International Index of Erectile Function (IIEF) and the Global Efficacy Assessment Questions (GEAQ) questionnaires during the study period.. The average age among the 167 subjects who completed the study was 55.8 (31.7 to 77.1). The scores for questions 3 and 4 of IIEF improved from 2.3 and 1.8 at baseline to 3.7 and 3.4 at week 4 and 3.8 and 3.4 at week 8, respectively. There were 86.3% of the patients reported improved erectile function at week 8; 88.3% of the patients reported improved ability to achieve sexual intercourse at week 8. There were no significant differences observed in the responses to questions 3 and 4 of IIEF and GEAQ by the number of antihypertensive agents taken. The adverse events were facial flushing (20.1%), headache (11.7%), palpitation (5.0%), rhinitis (2.8%), URI (2.8%), dizziness (2.2%), dyspnea (2.2%), and nausea (1.7%).. Sildenafil citrate is an effective treatment for ED; it is safe and well tolerated by patients with ED taking multiple antihypertensive agents for arterial hypertension.

Topics: Adult; Aged; Analysis of Variance; Antihypertensive Agents; Erectile Dysfunction; Humans; Hypertension; Korea; Male; Middle Aged; Penis; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

Open, before-after study.. To assess the efficacy and safety of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction (ED) in spinal cord-injured (SCI) patients.. Home- and clinic-based assessments in the outpatient department at the Centre Bouffard Vercelli, Cerbère France.. Clinic trials with Sildenafil (Viagra) on 120 patients, Tadalafil (Cialis) on 54 patients and Vardenafil (Levitra) on 66 patients were performed. Flexible doses of PDE5 inhibitors were given depending on efficacy and tolerability, from 50 to 100 mg for Sildenafil, and from 10 to 20 mg for Vardenafil and Tadalafil. Each trial was performed after a week's interval. The efficacy was self-assessed by the patients on a six-point quantitative scale assessment. The response to treatment was assessed at home in 90 patients (57 patients on Sildenafil, 12 patients on Vardenafil and 21 patients on Tadalafil) using the International Index of Erectile Function (IIEF).. In clinic trials, PDE5 inhibitors were effective (rigidity enough for penetration) in 85% of the patients on Sildenafil, 74% of the patients on Vardenafil and 72% of the patients on Tadalafil. The mean duration of erection was 34, 28 and 26 min, respectively. Adverse effects were mild, usually attenuated with continued dosing. More than 70% of the patients on Vardenafil and Tadalafil required higher doses of 20 mg, whereas 50 mg of Sildenafil was effective in 55% of the patients. Two-thirds of our patients on Tadalafil reported a duration of action longer than 24 h. The presence of an upper motor neuron lesion was significantly associated with therapeutic success, lower motor neuron lesions and cauda equina patients were poor responders. Other variables such as completeness of lesion had no impact. In the follow-up visits, the IIEF global scores and three IIEF domains (erectile function, intercourse satisfaction and overall satisfaction) were significantly improved in all patients. Patients on Sildenafil showed a significant improvement of orgasmic function, ejaculation (Question 9) and orgasm (Question 10).. Sildenafil, Vardenafil and Tadalafil are all effective and well-tolerated treatments for ED in SCI patients. Although no statistical analysis could be applied on these data, these results might indicate that Sildenafil is more effective in treating ED. Clinic trials are important for proper dose titration and appropriate education of the patients.

Topics: Adult; Analysis of Variance; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Reaction Time; Retrospective Studies; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Tadalafil; Triazines; Vardenafil Dihydrochloride

This observational study was conducted across Europe to assess health outcomes in men with erectile dysfunction (ED) who took tadalafil, sildenafil citrate (sildenafil), or vardenafil HCl (vardenafil) for 6 mo.. Therapy effectiveness and patient satisfaction were evaluated using established and new questions on erectile function. Behavioural, psychological, and relationship outcomes were assessed using the short form of the Psychological and Interpersonal Relationship Scales (SF-PAIRS).. In nine European countries at 904 sites, 8047 patients were enrolled and 94% (7560) selected either tadalafil (5315), sildenafil (1252), or vardenafil (993) for treatment at baseline. Of the 7560, 3998 (52.9%) took the same drug for 6 mo. Baseline characteristics across the three treatment groups were comparable: mean age approximately 56 yr, moderate or severe ED, and mean International Index of Erectile Function-Erectile Function domain score about 13. Tadalafil, sildenafil, and vardenafil were therapeutically effective and improved patient satisfaction in the 40-58% of men who completed 6 mo of a single therapy. Patients taking tadalafil consistently had numerically higher levels of therapeutic effectiveness and satisfaction compared with patients who took sildenafil or vardenafil. The three cohorts had statistically significant changes from baseline in response to SF-PAIRS and there were significant differences, in favour of tadalafil, among cohorts in the Time Concerns domain.. In a large observational study that mimics a routine clinical setting, most patients selected an inhibitor of phosphodiesterase 5 to treat ED, which resulted in a high level of therapeutic effectiveness and patient satisfaction.

Topics: Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Remission Induction; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Tadalafil; Time Factors; Triazines; Vardenafil Dihydrochloride

To test the hypothesis that sildenafil (50 mg nightly for one year) can improve spontaneous erectile function (EF) in men with mild-to-moderate arteriogenic erectile dysfunction (ED) responsive to erectogenic treatment.. In a prospective open-label trial, 112 men with ED were randomized to sildenafil 50 mg nightly or sildenafil 50 or 100 mg as needed for 12 months, followed by one-month and 6-month non-medicated periods. Non-randomized, non-medicated men with ED were also assessed. The EF domain of the International Index of Erectile Function (IIEF EF) and the peak systolic velocity (PSV) of penile cavernous arteries were used to measure the efficacy.. After sildenafil treatment and a subsequent non-medicated month, IIEF EF was normal in 29 of 48 (60.4%, 95% confidence interval [CI]: 45.3-74.2%) of the nightly group vs. 4 of 49 (8.2%, 95% CI: 2.3-19.6%) of the as-needed group. PSV improved by 11.2 cm/s (95% CI: 4.7-21.4; P=0.012) in the nightly group but only by 3.4 cm/s (-5.1-14.7; P=0.435) in the as-needed group. IIEF EF normalized in 1 of 18 (5.6%, 95% CI: 0.1-27.3%) non-medicated men and the PSV declined slightly. Six months after treatment, the IIEF EF remained normal and PSV was stabilized in most (28/29, 97%) nightly group men who had initially normalized.. Sildenafil nightly for one year resulted in ED regression that persisted well beyond the end of treatment, so that spontaneous EF was characterized as normal on the IIEF in most men. The results from this open-label, randomized trial warrant verification under double-blind, placebo-controlled conditions.

Topics: Adult; Dose-Response Relationship, Drug; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones; Time Factors; Treatment Outcome; Vasodilator Agents

The validated Quality of Erection Questionnaire (QEQ) is a six-question, patient-reported outcome measure for comprehensively evaluating satisfaction with the quality of erections in terms of hardness, onset, and duration, which can be used to develop and monitor individualized treatment goals.. To further validate the QEQ by determining responsiveness/sensitivity to change in erectile function, erection hardness grade, and psychosocial outcomes in men treated with sildenafil for erectile dysfunction (ED).. This open-label, noncomparative, multicenter trial of sildenafil (50 or 100 mg as needed for 10 weeks) enrolled men with ED who were in a stable, sexual relationship for at least 6 months. Previous phosphodiesterase type 5 inhibitor use must have been no more than 6 doses ever and no doses more recently than the previous 4 weeks.. The baseline to week 10 change in the QEQ total score and its correlations with the end-of-treatment Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) score and with changes in: (i) International Index of Erectile Function (IIEF) domain scores; (ii) Self-Esteem And Relationship (SEAR) questionnaire component scores; and (iii) the frequency of erections graded hard enough for penetration (grade 3) or completely hard (grade 4) on the event log Erectile Hardness Grading Scale.. The mean +/- standard deviation transformed QEQ total score tripled from 22.0 +/- 21.1 to 69.9 +/- 35.9 (P < 0.0001), and correlated positively with the end-of-treatment EDITS index score (r = 0.71) and with changes in IIEF domain scores (r = 0.29-0.86), SEAR component scores (r = 0.37-0.78), and the percentage of occasions that grade 3 or 4 erections were achieved (r = 0.66).. The brief, easy-to-administer QEQ is responsive to the benefits of sildenafil treatment of men for ED and has convergent validity with measures of clinical and psychosocial outcomes.

Topics: Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Reproducibility of Results; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Sildenafil citrate has been used worldwide by men with erectile dysfunction. The prescribing information for sildenafil suggests ingestion 1 hour before sexual activity and also notes reduced maximum plasma concentration and delayed time to maximum concentration following ingestion with a high-fat meal. The clinical impact of coingestion of food and these factors has never been evaluated.. To determine, using a naturalistic study design, whether sildenafil taken 1 hour before or during a meal compared with usual ingestion 30-60 minutes before sexual activity affects efficacy or patient satisfaction.. After a 1-2-week washout, 48 men (29-79 years old), currently satisfied with sildenafil, followed each of four regimens: (A) sildenafil 1 hour before a meal and placebo 30-60 minutes before planned coitus vs. (B) placebo 1 hour before a meal and sildenafil 30-60 minutes before coitus; and (C) sildenafil during a meal and placebo 30-60 minutes before coitus vs. (D) placebo during a meal and sildenafil 30-60 minutes before coitus. Subjects were not instructed to change their regular dietary habits during the course of the study.. Change from baseline in the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score, responses to Sexual Encounter Profile (SEP) questions 2 (erection sufficient for penetration) and 3 (erection sufficient to complete intercourse), and measures of patient preference and satisfaction.. Mean changes in IIEF-EF domain scores were 11.4 for regimens A and B and 11.2 for C and D. Positive SEP2 responses were recorded for 93.9% and 91.8% of intercourse attempts in A and B and 91.4% and 92.6% in C and D. Corresponding results for SEP3 were 84.7% and 85.9%, and 83.4% and 87.5%, respectively. There were no significant differences between pairs of treatments on satisfaction. The time between sildenafil ingestion and intercourse attempt (0-0.5 to >10 hours) had no significant effect on responses to SEP2, but decreased responses to SEP3 from a maximum of 92.8% at 1.5-2 hours to 81.6% at more than 10 hours (P = 0.003).. No significant loss of efficacy occurs when sildenafil is taken shortly before or with a meal. The duration of action for sildenafil may exceed 10 hours.

Topics: Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Food-Drug Interactions; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

This pilot study was undertaken to assess the efficacy and safety of the alpha(1)-blocker alfuzosin 10mg once daily (OD), the PDE-5 inhibitor sildenafil 25mg OD, and the combination of both on lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and erectile dysfunction (ED).. Men aged 50-76 yr with previously untreated LUTS and ED were randomized to receive alfuzosin (n=20), sildenafil (n=21), or the combination of both (n=21) for 12 wk. Changes from baseline in International Prostate Symptom Score (IPSS), voiding diary, maximum urinary flow rate (Qmax), postvoid residual urine (PVRU) volume, and erectile function domain of the International Index of Erectile Function (IIEF) were assessed at week 12.. Improvement of IPSS was significant with the three treatments but greatest with the combination (-24.1%) compared with alfuzosin (-15.6%) and sildenafil (-11.8%) [corrected] alone (p<0.03). Frequency, nocturia, PVR, and Qmax were significantly improved with alfuzosin only and the combination. Improvement in IIEF was slight with alfuzosin (16.7%), marked with sildenafil (49.7%), and greatest with the combination (58.6%). Likewise, increases in the frequency of penetration (Q3) and of maintained erection (Q4) were greater with the combination therapy (65.2% and 68.2%, respectively) than with sildenafil (41.7% and 59.1%, respectively) and alfuzosin (27.3% and 33.3%, respectively) alone. All three treatments were well tolerated.. In this pilot study, the combination of alfuzosin 10 mg OD and sildenafil 25 mg OD is safe and more effective than monotherapy with either agent to improve both voiding and sexual dysfunction in men with LUTS suggestive of BPH.

Topics: Adrenergic alpha-Antagonists; Aged; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Prostatic Hyperplasia; Purines; Quinazolines; Sildenafil Citrate; Sulfones; Treatment Outcome; Urination Disorders

To investigate the effect of improvement in erectile dysfunction (ED) on sexual function and satisfaction measures in heterosexual couples in which the woman reports that sexual intercourse is unsatisfactory at least half of the time.. Multicentre, double-blind, placebo-controlled study.. Outpatient medical clinics.. Hundred and eighty men with ED and their female partners in whom sexual intercourse was satisfactory about half the time or less (score of < or =3 on the Female Partner of ED Subject Questionnaire question 3 [FePEDS Q3]).. Men were randomised to flexible-dose sildenafil (25, 50, and 100 mg) or placebo as needed for 12 weeks.. Primary: FePEDS Q3 ('Over the past four weeks, when you had sexual intercourse, how often was it satisfactory for you?') scored as 0 (no sexual activity) and 1 (almost never or never) to 5 (almost always or always). Secondary, partners: Sexual Function Questionnaire, Female Sexual Function Index (FSFI), and ED Inventory of Treatment Satisfaction (EDITS) partner version (EDITS-Partner). Secondary, men: International Index of Erectile Function (IIEF), General Efficacy Questions, event log data, Self-Esteem And Relationship questionnaire, and EDITS. Secondary, partners and men: Dyadic Adjustment Scale.. The intention-to-treat population included 85 sildenafil recipients (mean age 59 +/- 12 years) and 91 placebo recipients (mean age 57 +/- 11 years). Most partners (aged 20-79 years; mean, 54 years) were postmenopausal. Sildenafil compared with placebo couples had greater improvement in the primary outcome (FePEDS Q3 [P < 0.0001]) and in sexual function, intercourse success rates, and secondary sexual satisfaction measures (FSFI satisfaction domain [P < 0.0001] and IIEF satisfaction domains [P < 0.001]) and had higher treatment satisfaction (EDITS and EDITS-Partner; P < 0.0001). Several predictors of improvement were identified, and improvement in one member of the couple correlated positively with improvement in the other member.. The interdependence of sexual function and sexual satisfaction measures between members of couples consisting of men with ED and sexually healthy women reporting infrequent satisfactory sexual intercourse underscores the importance of including partners in ED treatment discussions.

Topics: Adult; Aged; Coitus; Double-Blind Method; Erectile Dysfunction; Female; Heterosexuality; Humans; Male; Middle Aged; Personal Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Dysfunctions, Psychological; Sexual Partners; Sildenafil Citrate; Sulfones

We evaluated sildenafil for erectile dysfunction and lower urinary tract symptoms in men with the 2 conditions.. This was a 12-week, double-blind, placebo controlled study of sildenafil in men 45 years or older who scored 25 or less on the erectile function domain of the International Index of Erectile Function and 12 or greater on the International Prostate Symptom Score. Men with confirmed or suspected prostate malignancy, or prostate specific antigen 10 ng/ml or more were excluded. End points were changes in International Index of Erectile Function domain scores, International Prostate Symptom Score (irritative, obstructive and quality of life), the Benign Prostatic Hyperplasia Impact Index, the Self-Esteem And Relationship questionnaire and Erectile Dysfunction Inventory of Treatment Satisfaction Index Score.. The 189 men receiving sildenafil had significant improvements in erectile function domain score vs the 180 on placebo (9.17 vs 1.86, p<0.0001) and on all other International Index of Erectile Function domains. In men on sildenafil vs placebo significant improvements were observed in International Prostate Symptom Score (-6.32 vs -1.93, p<0.0001), Benign Prostatic Hyperplasia Impact Index (-2.0 vs -0.9, p<0.0001), mean International Prostate Symptom Score quality of life score (-0.97 vs -0.29, p<0.0001) and total Self-Esteem And Relationship questionnaire scores (24.6 vs 4.3, p<0.0001). There was no difference in urinary flow between the groups (p=0.08). Significantly more sildenafil vs placebo treated patients were satisfied with treatment (71.2 vs 41.7, p<0.0001). Sildenafil was well tolerated.. Improved erectile dysfunction and lower urinary tract symptoms with sildenafil in men with the 2 conditions were associated with improved quality of life and treatment satisfaction. Daily dosing with sildenafil may improve lower urinary tract symptoms. However, the lack of effect on urinary flow rates may mean that a new basic pathophysiology paradigm is needed to explain the etiology of lower urinary tract symptoms.

Topics: Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatic Hyperplasia; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Treatment Outcome; United States; Urination Disorders

To assess efficacy and safety of the combination of sildenafil and continuous positive airway pressure (CPAP), and satisfaction with treatment for erectile dysfunction (ED) in men with obstructive sleep apnea (OSA).. Forty men suffering from OSA and concurrent ED were treated with CPAP after a thorough investigation. After a 4-week run-in period, the patients were randomly allocated to treatment for 6 weeks; 20 men to the combination group, receiving additionally 100 mg sildenafil on demand for intercourse, and 20 men to CPAP alone. After a 1-week washout phase, the two groups switched to the other treatment arm for an additional 6 weeks period. End points for efficacy evaluation were the percentage of successful attempts for intercourse based on an event log and the overall satisfaction with sildenafil in the treatment of ED.. The patients recorded a total of 149 attempts for intercourse during the run-in phase with a success rate of 19.5%. During the 12 weeks of treatment, the success rate of intercourse attempts was 24.8% when only on CPAP and 61.1% when in combination with sildenafil (P < 0.001). Of the studied men, 70% were satisfied with the use of sildenafil while 30% remained unhappy with this additional treatment.. Sildenafil in combination with CPAP appears clearly superior to CPAP alone. The efficacy of this combination is superior to that of sildenafil alone, as reported in previous studies. Both treatment modalities are safe and well tolerated. However, approximately one-third of the patients remain unsatisfied even from the combination treatment. Further treatment options are needed.

Topics: Combined Modality Therapy; Continuous Positive Airway Pressure; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sleep Apnea, Obstructive; Sulfones

To assess the efficacy of sildenafil and continuous positive airway pressure (CPAP) in the treatment of concurrent erectile dysfunction (ED) with obstructive sleep apnea (OSA), and to gauge the level of treatment satisfaction in patients and their partners.. Forty men were treated for 12 weeks with sildenafil 100 mg (20 men) or CPAP during nighttime sleep (20 men). Treatment efficacy was assessed by the rate of successful intercourse attempts, and satisfaction with treatment was assessed by patients' and partners' answers to question 1 of the Erectile Dysfunction Inventory of Treatment Satisfaction.. Under sildenafil, 128 of 249 (51.4%) intercourse attempts were successful; under CPAP, 51 of 193 (26.9%) attempts were successful ((c)P < 0.001). Erectile function was improved in both groups. After sildenafil and CPAP treatment, the mean International Index for Erectile Function domain scores were 14.3 and 10.8, respectively ((b)P = 0.025), compared to 7.8 and 7 at baseline, respectively. CPAP and sildenafil were well tolerated. Sporadic episodes of nasal dryness under CPAP and transient headache and flushing under sildenafil were not significant. Fifty percent of patients treated with sildenafil and 25% with CPAP were satisfied with the treatment, and their partners were equally satisfied. The satisfaction scores for both patients and partners under sildenafil were superior to those under CPAP ((c)P < 0.002).. Both sildenafil 100 mg and CPAP, used separately, had positive therapeutic impact but sildenafil was superior. Patients and their partners were more satisfied with sildenafil for the treatment of ED. However, because of the high proportion of dissatisfied men and partners, new therapeutic agents or a combination of the two methods must be studied further.

Topics: Adult; Continuous Positive Airway Pressure; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Piperazines; Purines; Sildenafil Citrate; Sleep Apnea, Obstructive; Sulfones; Treatment Outcome

Sildenafil citrate is a specific inhibitor of phosphodiesterase (PDE) type-5 and represents a powerful therapy for male erectile and fertility dysfunctions of different etiologies. Present study demonstrates whether sildenafil administration modifies seminal parameters in diabetic neuropathic patients. In this investigation 50 insulin dependent (IDDM) and 50 non insulin dependent (NIDDM) diabetic male patients with and without an objective evidence of neuropathy and 50 age matched non diabetic male controls were selected. Every male had age between 20 to 65 years with duration of diabetes distributed over 1 to 20 years. Treatment with 100 mg of oral sildenafil citrate on seminal parameters was evaluated by semen analysis in these patients. In both IDDM and NIDDM diabetic neuropathic patients, chronic sildenafil treatment exhibited a significant decrease in total sperm output and sperm concentration (p<0.001). On the other hand, sperm motility and semen volume were found to be increased by about 40% and 48% respectively in these patients, where as sperm morphology and quality of sperm motility remained unaffected. However both types of non neuropathic diabetics showed a non significant difference in all the above mentioned parameters when compared with the untreated groups and their respective control subjects. A comparison between IDDM and NIDDM neuropathic and non neuropathic diabetic groups further indicated a non significant difference in all the parameters of semen analysis. These findings suggest a chronic neuro physiological effect of sildenafil treatment on male fertility profile exclusively in diabetic neuropathic condition with an improvement in testicular function which was probably arrested due to some kind of testicular hyperplasia resulted by testicular necrosis and promoted spermatogenesis. Sildenafil seems to be associated with an improvement in the entire smooth musculature of reproductive tract and testicular morphology which was altered due to neuropathy like a reduction in excess accumulation of interstitial collagen and calcification in the smooth muscles of seminiferous tubules which made them rigid leading to atonia of bladder and urethra which resulted in partial or retrograde ejaculation associated with a decreased sperm motility. Sildenafil treatment returned back the spermatogenesis to normal with a positive influence on sperm motility and ejaculate volume in these neuropathic patients irrespective of the type of diabetes.

Topics: Administration, Oral; Adult; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Erectile Dysfunction; Fertility; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sperm Count; Sperm Motility; Spermatogenesis; Spermatozoa; Sulfones; Treatment Outcome

Sildenafil and apomorphine are oral agents for the improvement of erection hardness. The aim of the study was a direct comparison of the two compounds under clinical routine conditions.. 131 previously untreated men with erectile dysfunction (ED) were enrolled in a cross-over trial and randomly allocated to 50 mg sildenafil or 2 mg apomorphine. Dose-adaptation was allowed as required.. Improvements in rigidity, the capacity to get and maintain an erection, and sexual confidence were statistically significantly larger with sildenafil (p <0.0001). 90% of the men were satisfied with sildenafil as compared to 46% with apomorphine. At study end, 95% of the patients preferred sildenafil. Both agents were well tolerated.. In this cross-over comparison under clinical routine conditions men reported superior efficacy of sildenafil vs apomorphine together with a statistically significantly higher treatment satisfaction.

Topics: Adolescent; Adult; Aged; Apomorphine; Coitus; Cross-Over Studies; Erectile Dysfunction; Humans; Male; Middle Aged; Orgasm; Patient Satisfaction; Penile Erection; Piperazines; Purines; Sexual Partners; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

To investigate the synergic effect of propionyl L-carnitine (PLC) plus sildenafil in reducing monocyte oxidative activity and endothelial dysfunction markers in diabetic patients with erectile dysfunction (ED).. Thirty-two type 2 diabetic patients with ED (according to the International Index of Erectile Function-5 [IIEF-5]) were randomized to receive PLC (2 g/d) alone (n=8) or combined with sildenafil (50 mg/d twice weekly) (n=8), sildenafil alone (50 mg/d twice weekly) (n=8), or placebo (n=8) in a double-blind, fixed-dose study. Monocyte oxidative activity (stimulation index [SI]), intercellular adhesion molecule-1 [ICAM-1], P-selectin, advanced glycation end product (AGE) levels, Doppler sonography (recording peak systolic velocity [PSV]; end diastolic velocity [EDV]; systolic wave time [SWT]; resistive index [RI]), and IIEF score were evaluated before and after 12 wk of treatment; IIEF-5 was evaluated again 4 wk posttreatment.. SI was reduced by treatment with PLC alone or combined with sildenafil (p<0.05). In patients treated with PLC plus sildenafil, a decrease in ICAM-1, P-selectin, and EDV values was observed compared with patients treated with sildenafil alone (p<0.05, p<0.01, p<0.001, respectively). IIEF-5 improved in all patients treated with PLC plus sildenafil or sildenafil alone (p<0.03, p<0.05, respectively). Four weeks posttreatment, patients treated with PLC plus sildenafil maintained the improvement of the IIEF-5 compared with patients on sildenafil alone (p=0.05). In patients on PLC treatment (with or without sildenafil), SI was correlated with IIEF-5 (p<0.001), glycemia with STW (p<0.03), and AGEs with IIEF-5 (p<0.01).. PLC plus sildenafil was more effective in reducing SI and endothelial dysfunction markers in patients with type 2 diabetes and ED.

Topics: Aged; Antioxidants; Biomarkers; Carnitine; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Endothelium, Vascular; Erectile Dysfunction; Glycated Hemoglobin; Humans; Male; Middle Aged; Monocytes; Phosphodiesterase Inhibitors; Piperazines; Purines; Reactive Oxygen Species; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) is a complex condition wherein men with minimal organic ED may develop a variable degree of psychogenic component sufficient to reduce the efficacy of medical management. A combination of trazodone with sildenafil has been used to overcome both organic as well as psychogenic components, thus improving the results of medical management.. To evaluate the efficacy of combination of trazodone with sildenafil citrate in treatment of ED in men with initial failure to sildenafil citrate alone.. The symptoms of ED were evaluated using the Erectile Dysfunction Intensity Scale (EDIS) before and after the treatment.. Eighteen men with ED who initially failed to respond to sildenafil citrate alone were enrolled in the study between February 2004 and December 2004. All these men were given a priming dose of trazodone for a 2-week period before giving them sildenafil citrate.. Of the 18 men, 12 responded favorably to the above treatment and continued to enjoy good sexual activity while on trazodone and sildenafil. The score on EDIS improved considerably in 12 (66.7%) men, marginally in two (11.1%) men, and did not improve at all in four (22.2%) men.. Priming the patients with trazodone appears to be a reasonably good alternative in patients who have initial failure to oral sildenafil citrate and have been found to have no organic cause of ED. However, large double-blind studies are required to potentiate this hypothesis.

Topics: Adult; Aged; Antidepressive Agents, Second-Generation; Coitus; Combined Modality Therapy; Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Partners; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Trazodone; Treatment Outcome; Vasodilator Agents

We examined whether treatment of erectile dysfunction with sildenafil citrate is associated with amelioration of the symptomatology of androgen decline in the aging male, and whether this alters the endocrine pattern.. A double-blind, randomized, placebo controlled, crossover study with sildenafil citrate was conducted in 60 men (age range 47 to 75 years old) who presented with erectile dysfunction and screened positively for androgen decline in the aging male by the questionnaire of the same name. The patients were randomized to receive sildenafil citrate or placebo in a 1:1 ratio and were crossed over after 3 months of treatment for an additional 3 months. The evaluation included International Index Erectile Function and Aging Male Symptoms questionnaires, hormonal profiles, total testosterone, and bioavailable testosterone.. A total of 40 patients completed the study. Compared to placebo, sildenafil citrate improved erectile function (52.7 +/- 2 vs 39 +/- 1.9, p <0.001) and Aging Male Symptoms score (33.5 +/- 1.3 vs 28.6 +/- 1.3, p <0.001) in the total group. Breakdown into hypogonadal and normal men showed that the International Index of Erectile Function score improved more in normal (Delta 18.5 +/- 3.6) than in hypogonadal men (Delta 6.7 +/- 2.7). There were no differences in improvement on the Aging Male Symptoms questionnaire between hypogonadal and normal men. No treatment changes were observed in total testosterone and bioavailable testosterone.. In the total group of patients sildenafil citrate was associated with expected improvement in erectile function and in the Aging Male Symptoms questionnaire without any alteration in hormonal pattern. The available questionnaires for androgen decline in the aging male are not specific for the diagnosis of biochemical androgen decline in the aging male, although the suboptimal response to sildenafil citrate suggests the presence of hypogonadism.

Topics: Aged; Aging; Andropause; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Testosterone

To determine if baseline characteristics, treatment efficacy, psychosocial outcomes or tolerability were associated with patient preference for sildenafil citrate (sildenafil) or tadalafil for treating erectile dysfunction (ED) in men naive to phosphodiesterase 5 inhibitor therapy.. In an open-label, crossover study of sildenafil (25, 50 or 100 mg) and tadalafil (10 or 20 mg), dosed as needed, after a 4-week baseline assessment, 367 men with ED were randomly assigned to sildenafil followed by tadalafil or vice versa (8-week dose optimization and 4-week assessment phase for each treatment period). Patients completing both periods chose which treatment they preferred for an 8-week extension phase. Bivariate logistic regression and stepwise logistic regression were used to determine if any baseline characteristics or post-baseline measurements were associated with the patients' treatment preference. Baseline variables examined were age, race, ED aetiology/duration, body mass index, smoking status, alcohol consumption, vital signs, comorbid medical conditions, and baseline scores for the International Index of Erectile Function (IIEF) domains, Psychological and Interpersonal Relationship Scales (PAIRS) domains, and Sexual Encounter Profile (SEP) diary questions. Post-baseline variables examined were therapy sequence, dosage, and differences in IIEF and PAIRS domains, SEP scores, in number/timing of sexual attempts and in the severity of side-effects (overall patient perception).. Of 291 patients completing both treatments and indicating a preference, 85 (29%) preferred sildenafil and 206 (71%) preferred tadalafil. Variables were individually analysed using bivariate analysis; one baseline characteristic (presence/absence of hyperlipidaemia) and 13 post-baseline measurements were significantly associated with the patients' treatment preference. Variables were analysed as a group using stepwise logistic regression; a set of six post-baseline factors was identified as significantly associated with patient preference. Dosage choice, reductions in the PAIRS time concerns domain, IIEF intercourse satisfaction domain improvements, smaller side-effect severity scores, more sexual attempts, and increased SEP4 scores (satisfaction with erection hardness) during the tadalafil or sildenafil treatment periods were all significantly associated with preference for tadalafil or sildenafil.. We identified no baseline characteristics that prospectively distinguish patients who will prefer tadalafil or sildenafil. Patient differences in time concerns, dosage choice, intercourse satisfaction, treatment tolerability, number of sexual attempts and satisfaction with erection hardness were the set of factors most significantly associated with treatment preference, and the preference observed for tadalafil (71%) or sildenafil (29%) might be substantially accounted for by differences in these factors during the tadalafil and sildenafil treatment periods.

Topics: Adolescent; Adult; Aged; Carbolines; Cross-Over Studies; Erectile Dysfunction; Humans; Logistic Models; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Tadalafil; Treatment Outcome

We prospectively investigated whether postoperative statin use would contribute to earlier recovery of erectile function in men who underwent bilateral nerve sparing radical retropubic prostatectomy for clinically localized prostate cancer.. A total of 50 potent men without hypercholesterolemia undergoing bilateral nerve sparing radical retropubic prostatectomy for clinically localized prostate cancer were prospectively randomized into 2 equal groups. Group 1 patients were instructed to ingest only 50 mg sildenafil per day if needed following hospital discharge after radical retropubic prostatectomy. Group 2 patients were prescribed atorvastatin at a dose of 10 mg daily from postoperative days 1 to 90 and they were also instructed to ingest sildenafil, as in group 1. Patient status regarding potency and adverse events were assessed 6 months after surgery.. The 2 groups demonstrated no significant differences regarding various baseline factors, including International Index of Erectile Function-5 scores. Group 2 had a significantly higher postoperative International Index of Erectile Function-5 score than group 1 at 6 months postoperatively (p = 0.003). Meanwhile, as judged by a preset definition, the incidence of potent patients 6 months after prostatectomy was 26.1% in group 1 and 55% in group 2 (p = 0.068). Also, 17.4% and 40% of the men reported achieving intercourse by vaginal penetration without a phosphodiesterase 5 inhibitor in groups 1 and 2, respectively (p = 0.172). No serious adverse events associated with medication were reported.. Postoperative treatment with atorvastatin in men who report normal erectile function preoperatively may contribute to earlier recovery of erectile function after nerve sparing radical retropubic prostatectomy.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Aged; Atorvastatin; Cyclic Nucleotide Phosphodiesterases, Type 5; Denervation; Drug Therapy, Combination; Erectile Dysfunction; Follow-Up Studies; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Microsurgery; Middle Aged; Penile Erection; Peripheral Nerves; Piperazines; Postoperative Complications; Prospective Studies; Prostate; Prostatectomy; Prostatic Neoplasms; Purines; Pyrroles; Sildenafil Citrate; Sulfones; Vasodilator Agents

Assess the effectiveness of sildenafil in Asian males with erectile dysfunction (ED) and one or more of the co-morbidities, mild-to-moderate hypertension, dyslipidemia, and diabetes.. A six-week, double-blind, randomized, placebo-controlled, multicenter study was carried out in Thailand, Malaysia and Singapore. One hundred and fifty five male subjects were randomized (2:1) to sildenafil (n = 104) or placebo (n = 51). Sildenafil was started at 50 mg and increased (100 mg) or decreased (25 mg) at week 2 if necessary.. On the primary efficacy endpoint, sildenafil-treated subjects had significantly better scores on the International Index of Erectile Function (IIEF) questions 3 and 4 than placebo (p < 0.001, both questions). When accumulated into IIEF domains, all five domains were significant in favor of sildenafil. In addition, sildenafil-treated subjects were more satisfied with treatment and had a higher intercourse success rate. The majority of adverse events were mild in severity; the most commonly reported treatment-related events were dizziness (7.7%) and tinnitus (2.9%).. Sildenafil (25, 50, and 100 mg) was found to be an effective, safe, and well-tolerated treatment for ED in the present study population of Thai, Malaysian, and Singaporean males who also had increased cardiovascular risk

Topics: Asian People; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Dyslipidemias; Erectile Dysfunction; Humans; Hypertension; Malaysia; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Assessment; Risk Factors; Sildenafil Citrate; Singapore; Sulfones; Thailand; Treatment Outcome

Men with psychogenic erectile dysfunction (ED) present a challenge to physicians. Treatment with pharmacological agents alone does not address the complexities of the causative or resulting psychological issues.. To evaluate the effectiveness of an integrative treatment protocol (ITP) with sildenafil and cognitive-behavior sex therapy (CBST) compared with sildenafil alone for men with psychogenic ED.. Change from baseline on the International Index of Erectile Function (IIEF) in the domains of erectile function and sexual satisfaction to demonstrate improved sexual functioning and confidence.. Men with psychogenic ED and female partners were randomized to receive either sildenafil alone or an ITP with sildenafil and CBST for the first 4 weeks. In the last 4 weeks, couples in the sildenafil group added CBST sessions to their regimen; patients in the ITP group continued the combined therapy. The IIEF questionnaire was used to compare erectile function and overall satisfaction serially at pretreatment, 4, and 8 weeks. Couples who met the success criteria in both domains after the first 4 weeks received no further treatment.. Fifty-three couples constituted the study population. After the first 4 weeks of sildenafil and ITP, 48% of men met criteria for success on erectile function and 65.5% for satisfaction compared to men on sildenafil alone with 29% and 37.5% success rates, respectively. After the last 4 weeks, integration of CBST with sildenafil resulted in a 58% success rate for erectile function which was comparable to the 66% rate for the initial drug/ITP group; satisfaction rates for men were 45% and 75%, respectively.. CBST was shown to have a positive influence when used throughout the entire 8 weeks of the ITP or added to the sildenafil in the last 4 weeks. Although patients in both treatment regimens had significant improvements in the IIEF domain scores confirming efficacy of sildenafil, those in the CBST and drug regimen achieved higher rates of clinical success within the first 4 weeks of therapy.

Topics: Adult; Aged; Coitus; Combined Modality Therapy; Dose-Response Relationship, Drug; Erectile Dysfunction; Female; Humans; Male; Marital Therapy; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Purines; Sexual Partners; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

The South Australian Couples Sildenafil (SACS) study sought to look more closely at the role of sexual functioning in couples by exploring the impact of treatment for erectile dysfunction (ED) with sildenafil.. The SACS study investigated the individual and dyadic impact of the drug sildenafil (Viagra) on couples over a 6-month period.. A range of outcome measures were utilized including the Dyadic Adjustment Scale (DAS), the International Index of Erectile Function (IIEF), and the Erectile Dysfunction Inventory of Treatment Satisfaction.. Couples were recruited through the use of local media and general practitioners. Couples were randomly allocated to placebo or active drug with the option of using up to one study tablet per day for 6 months. Couples were reviewed at 2 weeks, 4 weeks, 8 weeks, 3 months, and 6 months.. There were 108 couples who were eligible for the study with the eventual analysis including 49 couples in the active treatment group and 47 in the placebo group with similar demographic and background profiles found in both groups. A large number of psychosocial, quality-of-life, and sexual measures were recorded at the end of the trial for both male subjects and their female partners. Predictably, the erectile response in the active treatment group showed a significant improvement as measured by the IIEF although no change was found between the active and placebo groups in relationship functioning as measured by the DAS scores.. The SACS study found no difference between treatment arms with regard to relationship functioning after the use of sildenafil for ED. Potential contributing factors to a "no change" result are discussed. The SACS study adds to the available literature on psychological and interpersonal factors in the treatment of ED which have not been sufficiently investigated until recently.

Topics: Adult; Aged; Coitus; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Female; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Purines; Sexual Partners; Sildenafil Citrate; South Australia; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

The importance of patient instructions, designed to optimize therapy with phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction (ED), has recently been demonstrated.. To evaluate the impact of an educational program for new sildenafil users against usual ED management in Canadian primary care practices.. This multicenter, 6-month cluster randomized prospective study was conducted across Canada in general practitioners' offices where sites were randomized to receive a treatment optimization program (TOP) tool at visit 1 (TOP sites) or not to receive the TOP tool (non-TOP sites) while continuing with usual practice. Study participants were men seeking medical attention for ED and who were sildenafil naïve. The TOP tool consisted of a tear-off sheet, a brochure, and a video. Study drug was not provided to the patients. Sildenafil samples and prescriptions were dispensed as per usual care practices.. The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used to determine treatment satisfaction at visit 2 (month 3) and visit 3 (month 6). Patient and physician satisfaction with the TOP tool was assessed using self-reported questionnaires.. The intent-to-treat (ITT) population consisted of 2,573 patients from 231 primary care sites. At visits 2 and 3, treatment satisfaction with sildenafil was high with almost 9 patients out of 10 satisfied with treatment. No significant statistical differences were observed in the EDITS scores between the TOP and the non-TOP groups at visits 2 and 3. More than 80% of the participants were satisfied or very satisfied with the video and the brochure. More than 8 out of 10 participating physicians (84%) would use the TOP tool in their current practice if available.. TOP is a valuable and time-efficient ED management tool providing benefits to newly diagnosed ED patients and to their physicians.

Topics: Adult; Aged; Aged, 80 and over; Canada; Combined Modality Therapy; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Education as Topic; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Primary Health Care; Professional-Patient Relations; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

To evaluate once-daily 100-mg sildenafil for the treatment of erectile dysfunction (ED) in men with ED and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).. This was a 12-week, randomised, double-blind, placebo-controlled (DBPC) trial, with an 8-week open-label (OL) extension, in men > or = 45 years of age who scored < or = 25 on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and > or = 12 on the International Prostate Symptom Score.. At DBPC end of treatment (EOT), the sildenafil group (n = 189, vs. placebo, n = 180) had improved EF (IIEF), improved emotional well-being [Self-Esteem And Relationship questionnaire (SEAR)], and greater treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction) (p < 0.0001). At OL EOT, IIEF and SEAR scores improved slightly in the group previously randomised to sildenafil (n = 168), but much more in the group previously randomised to placebo (N = 155), such that total improvement over the 20-week trial was comparable between the groups. Erections at baseline were hard enough for penetration on approximately half of occasions and lasted long enough for successful intercourse on less than one quarter of occasions, increasing at sildenafil DBPC and OL EOT to approximately 90% (penetration) and 80% (intercourse success) vs. 61% (penetration) and 39% (intercourse success) for DBPC placebo. At sildenafil DBPC and OL EOT, > or = 90% of men were taking sildenafil 100 mg. Sildenafil was generally well tolerated.. In this trial of men with ED and BPH-associated LUTS, sildenafil treatment for ED was efficacious, effective and generally well tolerated.

Topics: Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prostatic Hyperplasia; Prostatism; Purines; Quality of Life; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

To assess the impact of a sexual therapy module on male patients participating in phase 2 cardiac rehabilitation after a cardiac event.. We randomly assigned 92 consecutive male patients (age < or =70 years, mean age 58 years), on their admission to phase 2 cardiac rehabilitation after myocardial infarction/acute coronary syndromes and/or coronary artery bypass graft, into a 'sexual therapy group' (n=47) and a 'control group' (n=45). Two co-therapists met with the patient and spouse for 5 h in three sessions, in addition to cardiac rehabilitation. Sexual therapy included patient education, cognitive restructuring, emotional support, guided imagery, and medication (Viagra). Controls participated in cardiac rehabilitation without sexual therapy. Self-report questionnaires were used three times: before, 1, and 4 months after sexual therapy. Baseline characteristics of both groups were similar. More sexual therapy patients resumed sexual activity within 1 month (87% vs. 50% in control). Sexual therapy patients improved more than controls in quality of sexual function in terms of libido, confidence to attain erection, satisfaction with sexual relationship, frequency of erection, and enjoyment of sex. Sexual therapy patients were highly satisfied with cardiac rehabilitation and sexual therapy.. Sexual therapy is significantly effective in improving the frequency and quality of sexual activity in a patient's postcardiac event beyond the usual cardiac rehabilitation. Sexual therapy should be an integral part of cardiac rehabilitation.

Topics: Adult; Aged; Coronary Artery Bypass; Counseling; Erectile Dysfunction; Humans; Male; Middle Aged; Myocardial Infarction; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

To evaluate patient preferences for sildenafil citrate or tadalafil (PDE-5 inhibitors available for the treatment of erectile dysfunction [ED]) and assess potential reasons for these preferences.. This open-label study was conducted on Korean men taking sildenafil, at least 6 weeks prior to study entry, for ED. Following screening, patients continued sildenafil treatment for 4 weeks, then after a 1-week washout period, switched to tadalafil for 8 weeks. Patients then continued with their treatment of choice during an extension phase. Psychosocial factors (time concern, spontaneity, sexual self-confidence) were evaluated using Psychological and Interpersonal Relationship Scales (PAIRS), while timing of dose to sexual attempt patterns were assessed from patient diaries.. The present study enrolled 160 Korean men (mean age 55 years) with prior median sildenafil use of 585 days. During the extension phase, 73.7% of patients elected to take tadalafil, whereas 26.3% chose sildenafil (P < 0.001). After switching from sildenafil to tadalafil, mean PAIRS time concern scores decreased from 2.54 to 2.42 (P = 0.002), with no statistically significant differences observed between the sildenafil and tadalafil assessment phases in sexual spontaneity and self-confidence scores. Sexual attempts made > 4 h to =/< 36 h post-dose occurred in 4.5% of patients during the sildenafil assessment phase compared with 17.5% during the tadalafil assessment phase.. After experiencing both sildenafil and tadalafil, the majority of patients exhibited a preference for tadalafil. This preference might be influenced by psychosocial factors, such as decreased time concerns, and a broader window of opportunity available for sexual activity.

Topics: Adult; Aged; Carbolines; Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Korea; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Psychology; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome

Prospective, open-label, comparative study, to assess the effects of sildenafil on blood pressure in a population of patients with spinal cord injury (SCI).. To determine the effect of sildenafil on blood pressure in patients with erectile dysfunction secondary to SCI by comparing changes in blood pressure in SCI patients with a neurologic level below T5 versus higher levels. To establish a relationship between the potential hypotensive effect and protective muscle spasm against blood pressure reduction. To assess the effects of age, complexity and duration of SCI on changes in blood pressure. To record any adverse effects occurring during the study.. Spinal Cord Injury Unit, Insular University Hospital of Gran Canaria, Canary Islands, Spain.. In total, 22 male SCI patients aged 18 years or older with a history of SCI greater than 3 months in duration.. Patients with erectile dysfunction secondary to SCI were included in the study, without excluding patients with a neurologic level above 75 or asymptomatic low blood pressure. Patients with specific contraindications for use of the drug were excluded. A personal history was obtained, and the level of injury (ASIA/IMSOP scales of international standards), impairment grade (ASIA impairment scale), spasticity grade (modified Ashworth scale) and baseline sitting and supine blood pressure values were determined. A single dose of 50 mg of sildenafil was administered, and patients remained sitting at 45 degrees . Blood pressure was monitored every 10 min for 4 h and whenever the patient reported symptoms. Any relevant signs and symptoms manifested during the study period were also recorded. Analysis of the changes in blood pressure values was performed using a paired t-test in each group of patients according to neurologic level and spasticity grade.. A decrease in blood pressure was observed in all patients, although patients with a level of injury at T5 or above and those with a complete SCI showed a less intense decrease (P<0.05). The spasticity grade of the patients was protective against the fall in blood pressure, as it was less significant in patients with grade 3 (P>0.1) than in those with grade 0. Adverse effects were few and transient. None were related to hypotension.. Sildenafil caused a decrease in blood pressure in SCI patients with a neurologic level of injury above T5 and complete injuries (grade A), but did not have clinical implications in the patients studied. A higher spasticity grade tends to protect the patient from the fall in blood pressure. Age and duration of injury do not appear to influence this decrease.

Topics: Adult; Blood Pressure; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Severity of Illness Index; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Time Factors; Treatment Outcome

We assessed the change in confidence, relationships and self-esteem, and its correlation with erectile function in men with ED treated with sildenafil citrate in the first United States based, double-blind, placebo controlled, randomized trial assessed by the validated SEAR.. This 12-week flexible dose (25, 50 or 100 mg) trial determined change scores from baseline to end of treatment for the 5 SEAR components (Sexual Relationship domain, Confidence domain, Self-Esteem subscale [prespecified as the primary end point], Overall Relationship subscale and Overall score), and their correlations with the IIEF and event log data, as well as correlations between SEAR components and a general efficacy question at the end of treatment.. Compared with the placebo group (125 patients, mean age +/- SD 55 +/- 13 years, mean years ED 3.8 +/- 4.2), the sildenafil group (128 patients, mean age +/- SD 56 +/- 12, mean years ED 4.6 +/- 4.3) had significantly greater improvements in all 5 SEAR components (p < 0.0001) and all sexual function measures. SEAR component scores showed significant correlations with IIEF Erectile Function domain scores (r range 0.34 to 0.69, p < 0.0001), other IIEF domain scores (p < 0.0001), percentage of successful intercourse attempts (p < 0.0001) and frequency of erection that allowed satisfactory intercourse (p < 0.0001).. In this study of men with ED, sildenafil produced substantial improvements in self-esteem, confidence and relationship satisfaction as measured by SEAR scores, which showed moderate to high positive correlations with IIEF scores.

Topics: Adult; Aged; Aged, 80 and over; Coitus; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Psychological Tests; Purines; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; United States

Erectile dysfunction (ED) can negatively impact psychosocial measures of a patient's sexual life.. To evaluate self-esteem, confidence, and relationships in men with ED, before and after treatment with sildenafil citrate (Viagra), with reference to controls without ED.. Sildenafil-naïve patients with ED were enrolled in a 10-week, open-label, flexible-dose (25 mg, 50 mg, or 100 mg) trial of sildenafil. In a separate study, men without ED who did not take sildenafil also completed the Self-Esteem And Relationship (SEAR) questionnaire. In addition to traditional statistical testing, equivalency testing was applied to compare the ED group, before and after treatment, with the control group and to examine whether the ED group improved to normative ranges on the SEAR questionnaire after treatment (within half a standard deviation of the normative or control group mean).. Baseline and end-of-treatment responses on psychosocial aspects of ED were measured with the validated SEAR.. Mean SEAR scores between subjects with ED (N = 93, mean age 55.0 years) at baseline and control subjects without ED (N = 94, mean age 52.5 years) were statistically different from zero and not statistically equivalent. Conversely, mean SEAR scores between ED subjects after treatment and control subjects were statistically equivalent and not statistically different from zero.. The results indicate that sildenafil is associated with normalization of relationships, confidence, and self-esteem in men with ED.

Topics: Aged; Confidence Intervals; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Piperazines; Purines; Quality of Life; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Vasodilator Agents

The efficacy of prostaglandin E1 (PGE1)-intracavernous injection (ICI) therapy for erectile dysfunction (ED) after non-nerve-sparing (NNS) radical pelvic surgery depends on patient compliance. The purpose of this study was to verify the utility of sexual counseling in ICI in terms of treatment efficacy, compliance, and dropout rate.. In this prospective randomized study, 57 patients with ED after NNS radical prostatectomy or cystectomy were divided: 29 patients (group SC+) were treated with sexual counseling and PGE1-ICI therapy; the others 28 (group SC-) were treated with only ICI. At the start of the study all patients were administered the International Index of Erectile Function (IIEF) questionnaire and ICI training test; follow-up (at 3, 6, 9, 12, 18 months) was achieved by home Sildenafil test and ambulatory IIEF test; sexual counseling was provided only to group SC+.. The mean IIEF score at the end of study was 26.5 (SC+) vs. 24.3 (SC-) (P < 0.05); eight patients (SC+, 27.5%) became responders to home Sildenafil vs. five (SC-, 17.8%) (P < 0.05); no dropout cases occurred (SC+) vs. eight (SC-, 28.5%) (P < 0.05). Moreover, we recorded best IIEF scores in group SC+ in sexual satisfaction (P < 0.05), sexual desire (P < 0.05), orgasmic function, and general satisfaction. Mean PGE1 doses were better in group SC+ (P < 0.05). ICI-oriented sexual counseling was utilized to motivate couples, to improve sexual intercourses, to correct mistakes in ICI administration. At the end of follow-up 21 patients (SC+) declared themselves satisfied vs. 12 (SC-).. ICI-oriented sexual counseling in ICI increased the efficacy of treatment, the compliance, and Sildenafil responders rate, decreased the dropout rate.

Topics: Aged; Alprostadil; Cystectomy; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Piperazines; Prospective Studies; Prostatectomy; Purines; Sex Counseling; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

Tadalafil, a phosphodiesterase type 5 inhibitor, has an extended period of effectiveness, up to 36 hours, for the treatment of erectile dysfunction (ED). Changes in behavior of long-term sildenafil users were evaluated by assessing time of dose relative to sexual intercourse attempts during treatment with sildenafil and tadalafil.. This open-label study was conducted in men with ED and a history of >or=6-week prior sildenafil use in Australia, New Zealand, Asia, Central and Eastern Europe, the Middle East, and Latin America. Patients continued sildenafil treatment for 4 weeks, then switched to tadalafil for 8 weeks. Timing of sexual intercourse attempt relative to dose was assessed through patient diaries for the final 4 weeks of each treatment period. Patients continued their treatment of choice in an extension period.. A total of 2,760 men (mean age 54.4 years) with a median duration of prior sildenafil use of 474 days were enrolled. Significant increases in median time from dose to intercourse attempt were observed when changing treatment from sildenafil citrate (1.21 hours) to tadalafil (3.25 hours; P < 0.001). Fifty-nine percent of intercourse attempts were within 4 hours of dosing when patients were treated with tadalafil (88% with sildenafil). The proportion of intercourse attempts per patient made >4 hours after dose was considerably higher during the tadalafil than during the sildenafil assessment period. Similar daily cycles of frequency of dosing and intercourse attempts were observed in all study periods and were characterized by a small peak in the morning and a large peak in the evening. When changing treatment to tadalafil, patients administered the drug earlier in the day and over a broader period of time.. Following the dosing instructions reflecting tadalafil's extended period of effectiveness, men with a history of established sildenafil use changed their dose-attempt behavior when treated with tadalafil.

Topics: Adult; Aged; Aged, 80 and over; Carbolines; Coitus; Cross-Over Studies; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Vasodilator Agents

Erectile dysfunction (ED) may be one manifestation of a generalized vascular disorder characterized by endothelial dysfunction. Statin drugs may improve endothelial function, even before altering the lipid profile.. We sought to determine whether the addition of a statin with sildenafil would improve ED in men who initially responded poorly to sildenafil.. Men with moderate-to-severe ED despite an adequate sildenafil trial were enrolled in this randomized, double-blind, placebo-controlled pilot study. ED was defined using a validated self-administered questionnaire as a score of

Topics: Adult; Aged; Anticholesteremic Agents; Atorvastatin; Cholesterol, LDL; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Erectile Dysfunction; Heptanoic Acids; Humans; Male; Middle Aged; Penile Erection; Pilot Projects; Piperazines; Purines; Pyrroles; Sildenafil Citrate; Sulfones; Treatment Outcome

Antipsychotic-induced erectile dysfunction is a significant clinical problem and is a common reason for poor medication compliance. This report studied the efficacy and tolerability of sildenafil citrate in patients with antipsychotic-induced erectile dysfunction.. The study design was a randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover trial carried out at a tertiary referral center. Thirty-two married male outpatients with schizophrenia or delusional disorder and antipsychotic-induced erectile dysfunction were recruited for the trial. Sexual function was assessed from patient logs of sexual activity.. Thirty-two subjects and their spouses, who agreed to take part in the study, were included in the crossover trial. Thirty-one (96.9%) completed the trial. There was no significant period effect or treatment-period interaction. Patients reported significant improvement while taking sildenafil in the number of adequate erections, satisfaction with sexual intercourse, and the duration of erections over 2 weeks. The odds ratios for adequate erections and for satisfactory sexual intercourse with sildenafil were 4.07 and 3.77, respectively. The effect of sildenafil remained significant even after adjustment for period and week effects and treatment-period interaction with Poisson regression analysis. There were no major side effects or adverse drug interactions.. Sildenafil citrate is safe and effective in the treatment of antipsychotic-induced erectile dysfunction. It is also well tolerated.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Antipsychotic Agents; Comorbidity; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Piperazines; Placebos; Prolactin; Purines; Regression Analysis; Schizophrenia; Schizophrenia, Paranoid; Sexual Behavior; Sildenafil Citrate; Sulfones; Treatment Outcome

To evaluate whether combination therapy with testosterone gel (T-gel) and sildenafil citrate is effective in achieving adequate potency in subjects with low-normal serum testosterone levels in whom sildenafil alone has failed.. From July 2000 to June 2001, we evaluated 90 men (aged 32 to 72 years) in whom 3 months of sildenafil therapy at the maximal recommended dose (100 mg) with at least three attempts at intercourse during the 3-month period had failed. Of these, 24 men had testosterone levels less than 400 ng/dL (range 92 to 365, mean 231.4) and were subsequently started on 1% T-gel monotherapy (AndroGel, 5 g daily). After 4 weeks of T-gel alone (week 4), sildenafil citrate (Viagra, 100 mg) was added to the treatment regimen for an additional 12 weeks (through week 16). Potency was defined as the ability to have at least one episode of satisfactory intercourse during the treatment period.. All the men had normalized serum testosterone levels after 4 weeks of T-gel monotherapy (range 424 to 596 ng/dL, mean 525). However, none of the men regained potency. At week 16, almost all (22 of 24, 92%) of the men reported improved potency with combination therapy. Improvement in erection quality was also observed.. The results of this study support the use of T-gel with sildenafil citrate in men with low-normal serum testosterone levels in whom sildenafil alone fails. It also underscores the numbers of men with low to low-normal testosterone levels who would benefit from testosterone screening when evaluated for erectile dysfunction.

Topics: Administration, Cutaneous; Administration, Oral; Adult; Aged; Androgens; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Syndrome; Testosterone; Treatment Failure

To evaluate the efficacy of short-term treatment with sildenafil citrate in men with serotonin reuptake inhibitor (SRI)-associated erectile dysfunction (ED).. Men (aged>or=18 years) with major depressive disorder (MDD; DSM-IV criteria) in remission and taking SRIs who experienced SRI-associated ED were enrolled in this multicenter, 6-week, randomized, flexible-dose, double-blind, placebo-controlled trial. The primary study measures were questions 3 (Q3: frequency of penetration) and 4 (Q4: frequency of maintained erections after penetration) of the International Index of Erectile Function (IIEF) questionnaire. Secondary study measures were all other questions and domains of the IIEF, the Erectile Dysfunction Index of Treatment Satisfaction (EDITS), a global efficacy questionnaire (GEQ), and a patient-maintained event log of sexual activity.. Patients receiving sildenafil (N=71) versus placebo (N=71) reported significantly higher mean+/-SE scores on Q3 (3.9+/-0.2 vs. 3.1+/-0.2, p=.003) and Q4 (3.7+/-0.2 vs. 2.8+/-0.2, p<.001) of the IIEF and significantly higher scores on all domains of the IIEF. Patients receiving sildenafil also reported significantly improved scores on all questions of the EDITS questionnaire (p<.02) and the GEQ (p<.0001) and an increased number of successful sexual intercourse attempts per week (p<.0001) compared with patients receiving placebo. All patients remained in MDD remission (score

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Aged; Antidepressive Agents; Depressive Disorder, Major; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Erectile Dysfunction; Humans; International Cooperation; Male; Medical Records; Middle Aged; Patient Satisfaction; Piperazines; Placebos; Prospective Studies; Purines; Selective Serotonin Reuptake Inhibitors; Sexual Behavior; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Erectile dysfunction (ED) can significantly impact a man's relationships and well-being.. We assessed changes in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction in men with ED using the validated Self-Esteem And Relationship questionnaire (SEAR).. This was a 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, 100 mg, as needed) international study of sildenafil in men > or =18 years of age in Mexico, Brazil, Australia, and Japan.. The primary study outcome was change in self-esteem from baseline to the end of treatment. Secondary study measures were changes in other SEAR components, International Index of Erectile Function (IIEF) domains, percentage of intercourse attempts that were successful, and the response to a global efficacy question at the end of treatment.. Patients were well balanced for age and duration of ED (placebo = 149 and sildenafil = 151). Compared with placebo, sildenafil significantly improved self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction (P < 0.0001). The psychosocial measures of well-being assessed with the SEAR were positively correlated (range 0.60-0.86, P < 0.0001) with erectile function, the frequency of achieving erections that allowed satisfactory sexual intercourse, the percentage of successful sexual intercourse attempts, and global treatment efficacy.. Significant improvements in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction after treatment of ED with sildenafil were consistent among countries. These data suggest a substantial cross-cultural improvement in well-being after successful treatment of ED with sildenafil.

Topics: Adult; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Humans; Interpersonal Relations; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Self Concept; Sexual Behavior; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

To compare patient preference for sildenafil citrate (sildenafil) vs. tadalafil and for their respective dosing instructions in a cohort of Spanish patients with erectile dysfunction (ED).. Sixty four Spanish patients from a multicenter, two period, cross-over, double-blind study (265 patients enrolled in total) were randomized to receive on-demand sildenafil 50 mg or tadalafil 20 mg for 12 weeks and afterwards were crossed over to the alternate regimen for another 12 weeks to assess drug preference in an extension period of the study. Similarly, to evaluate preference for their respective dosing instructions, 30 patients were randomized to one of the 2 arms treated with tadalafil: one with sildenafil (S) dosing instructions and the other with tadalafil (T) dosing instructions.. Seventy percent of 56 patients completing the study chose to receive tadalafil treatment versus sildenafil treatment (30%) in the extension period (p<0.01). Correspondingly, 73% of 13 evaluating each drug dosing instructions preferred T dosing instructions (p>0.05). Preference did not vary with age, concomitant diseases and previous use of sildenafil.. In this study, 7 out of 10 patients preferred tadalafil and its dosing instructions to sildenafil, for the treatment of their ED.

Topics: Adult; Aged; Carbolines; Double-Blind Method; Erectile Dysfunction; Europe; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; United States

The quality of life consequences of erectile dysfunction (ED) include depression, anxiety, and loss of self-esteem. The Self-Esteem And Relationship (SEAR) questionnaire is a validated, patient-administered, psychometric instrument specific to ED.. To determine correlations between erectile function (EF), intercourse success, and emotional well-being measured with the SEAR questionnaire in men treated with sildenafil citrate for ED and stratified by age (< 50 years, 50-65 years, and > 65 years).. This was an open-label, flexible-dose trial of sildenafil (25, 50 and 100 mg) administered for 10 weeks to 382 men with ED (mean +/- SD age, 55 +/- 13 years; mean ED duration, 4 years), which was conducted at 62 centers in the United States.. Analysis (by intent-to-treat, n = 368) of the change from baseline to the week-10 endpoint in the SEAR questionnaire Self-Esteem subscale, the intercourse success rate (percent of occasions at which an erection that lasted long enough for successful intercourse was achieved), and their correlation.. For the overall population, there was mean +/- SD improvement (p < 0.0001, paired t-tests) in the Self-Esteem subscale (56 +/- 25 to 79 +/- 22) and intercourse success rate (21 +/- 30% to 70 +/- 36%), which showed positive correlation (p < 0.0001). Secondary outcomes (i.e., EF domain of the International Index of Erectile Function; event log frequency of erection hard enough for sexual intercourse and of ejaculation/orgasm) also improved (p < 0.0001) and correlated positively with the SEAR Self-Esteem subscale and Sexual Relationship domain (p < 0.05 for all correlations). All 10 correlations were positive (p < 0.05) in men aged 50 to 65 years, eight were positive in men aged > 65 years, and six were positive in men aged < 50 years. The most common treatment-related adverse events were mild-to-moderate headache (12% of patients), vasodilatation (7%), and rhinitis (4%).. Men treated with sildenafil for ED demonstrated improved erectile function and an increased intercourse success rate, which correlated positively with improvement in SEAR measures of self-esteem and sexual relationship.

Topics: Adult; Age Factors; Aged; Coitus; Emotions; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Psychometrics; Purines; Quality of Life; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

Erectile dysfunction (ED) is very common in patients with renal failure, probably as a side effect of long-term treatments and dialysis, among other etiologic factors. Over the last few years, new highly effective oral treatments for ED have been introduced in the market. We designed a prospective trial in 42 dialytic patients with ED, focusing on the therapeutic effect of syldenafil and apomorphine.. Forty-two patients aged 57 years (range 34-71), [40 on hemodialysis (HD) and 2 on peritoneal dialysis (PD)] were enrolled in a prospective study comparing sildenafil with apomorphine. After a careful nephrologic anamnesis and uroandrological examination, all patients underwent, before and after each treatment, the International Index Erectile Function (IIEF) test, and the Life Satisfaction test. Expert opinion was based on grading of evidence based medical literature, widespread internal committee discussion, public presentations and debates.. The 2 patients on PD were the only responders to 25 mg sildenafil; 25 patients on HD had a clear improvement of the IIEF score after 50 mg sildenafil administration; finally, 11 patients on HD would benefit only from 100 mg sildenafil; the nonresponders to sildenafil were only 4 patients, having to switch to PgE1. When apomorphine was tested on the same patients, a mild response was seen only in 6 patients at the 3 mg dose. No response was seen in the 2 patients on PD.. There was a statistically significant difference in the therapeutic role of sildenafil versus apomorphine, the first producing an overall improvement of the IIEF in 90.5% of patients, compared to 14% of the same patients receiving apomorphine (P<0.001).

Topics: Adult; Aged; Apomorphine; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Renal Dialysis; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) is observed frequently in patients with end-stage renal disease, hemodialysis patients, and renal allograft recipients. There are few studies of sildenafil use in renal allograft recipients.. The study is designed as a randomized, double-blind, placebo-controlled, crossover trial. Efficacy was assessed by using the self-administered International Index of Erectile Function (IIEF), a 15-question validated measure of ED, and a global efficacy question (Did the treatment improve your erection?).. Thirty-two eligible renal transplant recipients were included in this study. After treatment with sildenafil citrate, patients had significantly better scores in 13 of 15 questions, except for questions 11 (desire frequency; P = 0.39) and 12 (desire level; P = 0.61). Treatment efficacy assessed through questions 3 (penetration ability; P < 0.001) and 4 (maintenance frequency; P < 0.001) was significantly better after sildenafil therapy. There were no significant differences between baseline and post-placebo treatment scores, except for question 13 (relationship satisfaction). Patients treated with sildenafil had significantly better scores in 4 domains compared with baseline, but a difference was not observed in the sexual desire domain (P = 0.32). There were no significant differences in scores between placebo and baseline in any domain. On the global efficacy question, 81.3% of patients showed improvement compared with 18.7% with placebo. There were no differences in areas under the curve and maximum cyclosporine concentrations before and after sildenafil therapy. No patient discontinued the drug because of side effects except for 1 patient with visual hallucination.. Treatment with sildenafil in renal transplant recipients is a valid option with an effective response.

Topics: Adult; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Kidney Failure, Chronic; Kidney Transplantation; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Men with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction.. We evaluated the impact of sildenafil citrate and its generalizability across cultures on self-esteem, confidence, and sexual relationship satisfaction in men with ED using the Self-Esteem And Relationship (SEAR) questionnaire.. Pooled analysis of 2 double-blind, placebo-controlled, flexible-dose trials of sildenafil with identical protocols: 1 was conducted in the United States and the other in Mexico, Brazil, Australia, and Japan.. Men > or = 18 years old with ED.. The impact of treatment on psychosocial factors associated with ED was determined by patient responses to the SEAR questionnaire. Erectile function was determined using the International Index of Erectile Function (IIEF) and a global efficacy question. Successful sexual intercourse attempts were derived from event logs of sexual activity. Treatment effect sizes were calculated for all study outcomes.. Compared with patients who received placebo (n = 274), patients who received sildenafil (n = 279) reported significantly greater improvements (P < .0001) in self-esteem, confidence, sexual relationship satisfaction, and in all sexual function domains of the IIEF. Treatment effect sizes were large (range, 0.7 to 1.2) for all SEAR components, and improvement in psychosocial measures showed moderate to high correlations (range, 0.50 to 0.83, P < .0001) with improvement in erectile function, percentage of successful intercourse attempts, and global efficacy.. In men with ED from 5 different nations, sildenafil produced substantial improvements in self-esteem, confidence, and sexual relationship satisfaction. Improvements in these psychosocial factors were observed crossculturally and correlated significantly and tangibly with improvements in erectile function.

Topics: Adult; Aged; Aged, 80 and over; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Self Concept; Sexual Behavior; Sildenafil Citrate; Sulfones

Although sildenafil citrate (sildenafil) and tadalafil are efficacious and well-tolerated treatments for erectile dysfunction (ED), preference studies have shown that patients may favor one medication over the other.. To determine whether psychosocial outcomes differed when men with ED received tadalafil compared with sildenafil.. Measures included a treatment preference question, Psychological and Interpersonal Relationship Scales (PAIRS), and Drug Attribute Questionnaire.. Randomized, open-label, crossover study. After a 4-week baseline, men with ED (N = 367; mean age = 54 years; naïve to type 5 phosphodiesterase inhibitor therapy) were randomized: tadalafil for 12 weeks then sildenafil for 12 weeks or vice versa (8-week dose optimization/4-week assessment phases). During dose optimization, patients started with 10 mg tadalafil, or 25 or 50 mg sildenafil and could titrate to their optimal dose (10 or 20 mg tadalafil; 25, 50, or 100 mg sildenafil). Medications were taken as needed. Patients completing both 12-week periods chose which medication to continue during an 8-week extension.. Of 291 men completing both treatment periods, 71% (N = 206) chose tadalafil and 29% (N = 85) chose sildenafil (P < 0.001) for the 8-week extension. When taking tadalafil compared with sildenafil men had higher mean endpoint scores on PAIRS Sexual Self-Confidence (tadalafil = 2.91 vs. sildenafil = 2.75; P < 0.001) and Spontaneity (tadalafil = 3.32 vs. sildenafil = 3.17; P < 0.001) Domains and a lower mean endpoint score on Time Concerns Domain (tadalafil = 2.2 vs. sildenafil = 2.59; P < 0.001). The two most frequently chosen drug attributes to explain treatment preference were ability to get an erection long after taking the medication and firmness of erections. Tadalafil and sildenafil were well tolerated with 12 (3.3%) patients discontinuing for an adverse event.. As measured with PAIRS, men with ED had higher sexual self-confidence and spontaneity and less time concerns related to sexual encounters when treated with tadalafil compared with sildenafil. These psychosocial outcomes may help explain why more men (71%) preferred tadalafil for the treatment of ED in this clinical trial.

Topics: Adult; Aged; Analysis of Variance; Carbolines; Cross-Over Studies; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Self Concept; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Vasodilator Agents

Sildenafil citrate is an effective and well-tolerated oral erectogenic medication. Through phosphodiesterase type 5 (PDE5) inhibition, it induces relaxation in penile smooth muscle, resulting in erection. Due to its mild affinity for other PDE enzymes, it may cause smooth muscle relaxation in a number of other organs. Recent data suggest an association between erectile dysfunction (ED) and lower urinary tract symptoms (LUTS). Anecdotally some patients cite improvement in LUTS while using sildenafil.. This study was conducted to assess the impact of Viagra on LUTS, using the International Prostate Symptom Score (IPSS) questionnaire.. International Index of Erectile Function (IIEF) and IPSS inventories.. Men presenting to a sexual dysfunction clinic who were candidates and opted for treatment with sildenafil completed the IIEF and IPSS. Men with the IPSS scores greater than 10 were enrolled and completed the IPSS and IIEF questionnaires at least 3 months after the commencement of sildenafil. Comparisons were made between pre- and posttreatment scores in the IPSS and erectile function (EF) domain of the IIEF.. Forty-eight men were enrolled, with a mean age of 62 +/- 11 years. The mean improvement in the EF domain score was 7 points (P = 0.01). The mean improvement in the IPSS score was 4.6 points (P = 0.013) and in quality of life (QOL) score was 1.4 points (P = 0.025). In total, 60% of men improved their IPSS score, and 35% had at least a 4-point improvement in their score. The mean number of uses of sildenafil per week was 2.0 +/- 0.6. No significant correlation was seen between the degree of the IPSS improvement and baseline IPSS, baseline EF domain score, or magnitude of improvement in EF domain score.. These data indicate a positive impact of Viagra on men with mild to moderate LUTS. It is presumed, although unproven, that the medication's effect is mediated through bladder neck/prostatic smooth muscle relaxation.

Topics: Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Urination Disorders; Vasodilator Agents

Post Traumatic Stress Disorder (PTSD) is known to be associated with Erectile Dysfunction (ED). Sildenafil citrate was shown to be effective treatment for ED among different clinical populations. However, to date, no placebo-controlled trial has assessed sildenafil's effectiveness for treating ED in PTSD patients. The goal of the present study was to address this question using a double-blind placebo controlled crossover design.. A four-week double-blind crossover trial of sildenafil (50 mg up to 100 mg per usage) versus placebo was conducted on 21 outpatients diagnosed with chronic PTSD accompanied by ED. Erectile function was assessed biweekly using the International Inventory of Erectile Function (IIEF). Depressive symptoms, PTSD symptoms and subjective well-being scores were assessed as well.. Analysis of IIEF scores revealed a main effect of treatment phase (E = 33.361, df =2, P < 0.000). Pairwise comparisons showed that sildenafil IIEF scores (mean = 45.19 +/- 15.05) were significantly higher compared to baseline scores (mean = 20.00 +/- 12.32, P = 0.000) and placebo scores (mean = 33.04 +/- 12.99). Compared to placebo, a significant improvement was also observed during the sildenafil phase in erectile function, orgasmic function and sexual desire. There was no significant change in depression, PTSD symptoms or subjective well-being.. The results of this study suggest that sildenafil citrate treatment for ED in PTSD patients was accompanied with improvement of ED symptoms and was found to be significantly better than placebo. Nevertheless, this effect should be considered marginal since patients still meet the criteria of ED after treatment. Larger, parallel group studies are warranted.

Topics: Adolescent; Adult; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Piperazines; Purines; Sexuality; Sildenafil Citrate; Stress Disorders, Post-Traumatic; Sulfones; Surveys and Questionnaires; Treatment Outcome

To prospectively investigate whether vardenafil can effectively treat patients for whom sildenafil (100 mg) has failed. The introduction of two new oral phosphodiesterase type 5 inhibitors (tadalafil and vardenafil) raises the question of whether the new agents will permit us to treat sildenafil nonresponders with another oral agent.. Patients were seen at one institution during a 5-year period. A total of 327 patients complaining of sildenafil-refractory erectile dysfunction underwent intracavernous pharmacologic injection and color duplex Doppler ultrasonography. Subsequently 59 of these men tried vardenafil home dosing.. Of the 327 men in whom sildenafil failed, 16% were younger than 50, 21% were 51 to 60, 34% were 61 to 70, and 28% were older than 70 years. The Doppler diagnoses were arterial insufficiency in 154 (47%), mixed vascular insufficiency in 73 (22%), and cavernous venous occlusive disease in 57 (17%). Forty-three men (13%) had normal erectile responses to prostaglandin E1 (10 to 20 microg). Of the 59 men who tried vardenafil, 19% were younger than 50, 17% were 51 to 60, 40% were 61 to 70, and 23% were older than 70 years. The Doppler diagnoses were arterial insufficiency in 28 (42%), mixed vascular insufficiency in 10 (19%), and cavernous venous occlusive disease in 15 (29%). Six men (8%) had normal erectile responses to prostaglandin E1. Only 7 (12%) of the 59 men reported that home vardenafil dosing resulted in successful intercourse.. An appropriate diagnostic evaluation and subsequent treatment algorithm have yet to be established for those for whom phosphodiesterase type 5 inhibitors fail. We found that most sildenafil nonresponders had severe arterial insufficiency and were older, with 62% older than 60 years. Our preliminary experience suggests that only a small percentage (12%) of sildenafil nonresponders can be salvaged with vardenafil.

Topics: Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Treatment Failure; Triazines; Vardenafil Dihydrochloride

We conducted a prospective, randomized, open-label, fixed-dose preference study, with a crossover design, using sildenafil, vardenafil, and tadalafil.. To assess patient preference for sildenafil (100 mg), vardenafil (20 mg), and tadalafil (20 mg) for the treatment of erectile dysfunction. Secondary objectives included finding out whether patients would follow treatment with a second or third option, in the event that the preferred drug was not available, and to assess side effects.. Patient preference for any treatment, and evaluation of the elements that patients would assess when choosing one of these drugs.. Sildenafil (100 mg), vardenafil (20 mg), and tadalafil (20 mg) were taken at least six times over a period of 45-60 days with a washout period of 7 days. A total of 132 patients were enrolled to achieve a valid sample of 90 cases (15 per randomized group, total of six groups). Enrolled patients had mild to moderate erectile function.. The International Index of Erectile Function (IIEF) score improved from baseline and was statistically significant in all cases (P < 0.0001). When we compared the IIEF scores, we found a statistically significant difference between tadalafil and vardenafil (P = 0.0002) favoring the former; similar results were obtained with the Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) Questionnaire (P = 0.000075). We also found a significant difference (P = 0.012) between tadalafil and sildenafil, again in favor of the former. In assessing drug preference, 25 patients (27.77%) chose sildenafil, 18 (20%) vardenafil, and 47 (52.22%) tadalafil. A total of 94% of patients would be willing to take another drug if the preferred choice was not available. All drugs were well tolerated.. Although this is a preference study based on subjective elements, statistically significant differences comparing the IIEF score and the EDITS Questionnaire lead us to believe that beyond patients' subjective preference per se, said preference is probably also based on a genuinely superior response to one drug over another.

Topics: Aged; Carbolines; Coitus; Cross-Over Studies; Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Quality of Life; Severity of Illness Index; Sexual Behavior; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

To assess the effect of premature ejaculation (PE) and low desire on the efficacy and satisfaction rate of sildenafil in the treatment of erectile dysfunction (ED).. A total of 586 male patients with ED in association with and without PE or low desire were enrolled in this study. Patients were screened for ED using the International Index for Erectile Function. All patients were also screened for PE and low desire. We compared the responses to the erectile function domain, questions 3 and 4, before and after sildenafil in patients with and without PE or low desire. Overall satisfaction and global efficacy question responses were also assessed in all patients.. The mean age +/- SD was 58 +/- 6.4 years. Significant associations were found between the increased duration and severity of ED and the decreased rate of overall satisfaction. Before sildenafil administration, significant differences were found in the erectile function domain, Q3 and Q4 between patients with and without PE or low desire. After sildenafil administration, no significant differences were found in those assessment variables and the presence or absence of PE and low desire. No significant differences were found between the global efficacy question response and the overall satisfaction rate between patients with and without PE or low desire.. The efficacy of sildenafil was negatively affected by an increased duration and severity of ED; however, global efficacy and overall patient satisfaction were not attenuated by PE or low desire.

Topics: Ejaculation; Erectile Dysfunction; Humans; Libido; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sulfones; Time Factors

Erectile dysfunction (ED) is a complex condition, which is variously influenced by physical, emotional, societal, and relationship factors. ED has serious implications for the quality of life (QoL) enjoyed by an affected male and his partner. It is very important, therefore, to understand the impact of ED on the QoL of those affected by it. Our objective was to determine if the eight-question Patient Reported Erectile Function Assessment (PREFA) could act as an independent, comprehensive disease-specific instrument in the assessment of QoL as it is impacted by ED.. During the development and validation of the Erectile Function-Visual Analog Scale (EF-VAS) (14), a new ED-specific preference-based instrument, a series of questions were included at the beginning of the assessment that would act as a way to encourage respondents to focus on their own experience with ED. Upon analysis of the EF-VAS data, it became apparent that the eight-question "warm up" section might act as a stand-alone assessment. Accordingly, the eight questions were named PREFA, and a validation analysis was undertaken to determine their consistency, feasibility, reliability, validity, and responsiveness.. The PREFA questionnaire was found to be feasible and simple to complete, reliable, and valid, with excellent responsiveness. Overall, the PREFA has demonstrated that it can perform as a stand alone, validated assessment of the impact of ED on QoL, assessing areas of QoL not previously captured in existing instruments.. The PREFA is suitable for use in clinical and research settings as a disease-specific QoL assessment tool.

Topics: Erectile Dysfunction; Humans; Male; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Vasodilator Agents

Our objective was to assess the effects of customized instructions and dose optimization on treatment satisfaction and improvement in erectile function (EF) with sildenafil citrate in men with erectile dysfunction (ED) who had not been previously treated with a phosphodiesterase-5 inhibitor. This 8-week, multicenter, open-label, flexible-dose (25, 50, or 100 mg sildenafil) study included 2 phases. During phase 1, patients took 50 mg sildenafil and followed the sildenafil sample package instructions. In phase 2, sildenafil dose could be adjusted on the basis of efficacy and tolerability, and investigators provided additional customized instructions. The primary efficacy variable was the satisfaction rate (defined as patients responding "very" or "somewhat" satisfied to the Erectile Dysfunction Inventory of Treatment Satisfaction [EDITS] Question 1). Other efficacy assessments included the International Index of Erectile Function (IIEF) and the percentage of successful sexual intercourse attempts. Of 1109 men (mean age, 54+/-13 years) treated, 867 completed the study. In phase 1, 75% of patients were very or somewhat satisfied with treatment. Mean EF domain score on the IIEF increased from 14.3 at baseline to 23.5, and 79% of sexual intercourse attempts were successful. In phase 2, 53% of patients increased their sildenafil dose to 100 mg and 2% decreased to 25 mg. Satisfaction with sildenafil increased to 86%, 91% of sexual intercourse attempts were successful, and mean IIEF EF domain score increased to 25.7. Of the 196 men who were not initially satisfied at the end of phase 1, 64% became very or somewhat satisfied with treatment by the end of phase 2. Initially high levels of efficacy and satisfaction with sildenafil were achieved when patients were provided with only the sample package instructions and the recommended 50-mg starting dose. These results were enhanced with dose optimization, individual patient counseling, and customized instructions.

Topics: Adult; Aged; Aged, 80 and over; Clinical Protocols; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones

The first double-blind, placebo controlled trial in the United States of the Self-Esteem And Relationship questionnaire revealed that treatment with sildenafil citrate improves erectile function and measures of quality of life in men with erectile dysfunction. We investigated long-term improvement, and correlations between improved erectile function and confidence, self-esteem and sexual relationship satisfaction in men with erectile dysfunction.. This was a 36-week open label extension of the double-blind, placebo controlled trial. The blind was not broken. Patients were 18 years or older with clinically diagnosed erectile dysfunction. Erectile function was assessed using the International Index of Erectile Function. Self-esteem, confidence and relationship satisfaction were assessed using the Self-Esteem And Relationship questionnaire. Correlations were determined using Pearson's product moment coefficients.. A total of 204 participants were enrolled in the open label extension, including 108 on placebo and 96 on sildenafil. In men who received placebo in the double-blind, placebo controlled phase mean erectile function scores and self-esteem, confidence and relationship satisfaction scores were increased significantly at week 36 of the open label extension (p < 0.0001). Men who received sildenafil in the double-blind, placebo controlled phase maintained high scores in the open label extension. Correlations between improved erectile function, and self-esteem, confidence and relationship satisfaction were strong and positive (p < 0.0001).. Open label extension sildenafil after double-blind, placebo controlled placebo significantly improved erectile function, self-esteem, confidence and relationship satisfaction. Following an initial 12 weeks of double-blind, placebo controlled sildenafil therapy for erectile dysfunction improvements were sustained an additional 9 months. Positive correlations between erectile function, and self-esteem, confidence and relationship satisfaction suggest that improved erectile quality can improve long-term psychosocial quality of life.

Topics: Adult; Aged; Aged, 80 and over; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Self Concept; Sildenafil Citrate; Sulfones; Time Factors

Data from head-to-head clinical trials of phosphodiesterase type 5 (PDE5) inhibitors are scarce, making it difficult for clinicians to differentiate among these agents to select the most appropriate treatment for their patients with erectile dysfunction (ED).. This randomized, double-blind, crossover head-to-head clinical trial compared patient preference, efficacy, and safety of vardenafil and sildenafil in men with ED and diabetes, hypertension, and/or hyperlipidemia.. Prospective analysis was performed on two studies in which 1,057 men were randomized to vardenafil 20 mg (N = 530) or sildenafil 100 mg (2 x 50 mg encapsulated tablets) (N = 527) for 4 weeks. Following a 1-week washout, patients switched treatment for 4 weeks.. Patients were asked about overall preference: "Overall, which medication do you prefer?", plus 11 other preference questions relating to their ED treatment. Efficacy assessments after each treatment period included the erectile function (EF) domain score of the International Index of Erectile Function (IIEF); Sexual Encounter Profile (SEP) diary questions SEP2 and SEP3; Global Assessment Question (GAQ); and Treatment Satisfaction Scale (TSS). Data regarding adverse events were collected throughout the study.. A total of 931 men (mean age 57.9 years) were included in the intent-to-treat (ITT) population. Non-inferiority of vardenafil over sildenafil was achieved for overall preference (vardenafil 38.9%; sildenafil 34.5%; and no preference 26.6%). Additionally, the change from baseline in the EF domain score of the IIEF achieved nominal significance for vardenafil over sildenafil (10.00 vs. 9.40; P = 0.0052). Patients also had a higher percentage of positive responses for vardenafil for SEP2, SEP3, GAQ, and 12 of 19 questions on the TSS. Both drugs were well tolerated.. This randomized, double-blind, head-to-head trial in ED patients with cardiovascular risk factors demonstrated noninferiority of vardenafil for overall preference. Vardenafil achieved nominal statistical superiority over sildenafil for several frequently used efficacy measures. Both drugs were well tolerated.

Topics: Adult; Aged; Cardiovascular Diseases; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Chronic heart failure (CHF) is an increasingly common cardiovascular disorder. Many patients who have CHF report moderate to marked decreases in the frequency of sexual activity, and up to 75% of patients report erectile dysfunction (ED). There are few controlled clinical data on the efficacy and safety of sildenafil citrate in men who have ED and CHF; thus, we evaluated these parameters in patients who had stable CHF. This was a double-blind, placebo-controlled, flexible-dose study. Men who had ED and stable CHF were randomized to receive sildenafil or placebo for 12 weeks. Primary outcomes were questions 3 and 4 of the International Index of Erectile Function. Secondary outcomes included the 5 functional domains of the International Index of Erectile Function, 2 global efficacy assessment questions, intercourse success rate, the Erectile Dysfunction Inventory of Treatment Satisfaction, and the Life Satisfaction Checklist. By week 12, patients who received sildenafil (n = 60) showed significant improvements on questions 3 and 4 compared with patients who received placebo (n = 72; p <0.002). Larger percentages of patients who received sildenafil reported improved erections (74%) and improved intercourse (68%) compared with patients who received placebo (18% and 16%, respectively). Intercourse success rates were 53% among patients who received sildenafil and 20% among those who received placebo. Patients who received sildenafil were highly satisfied with treatment and their sexual life compared with patients who received placebo. Sixty percent of patients who received sildenafil and 48% of patients who received placebo developed adverse events, including transient headache, facial flushing, respiratory tract infection, and asthenia. The incidence of events related to cardiovascular effects was low. Sildenafil is an effective and well-tolerated management of ED in men who have mild to moderate CHF.

Topics: Adult; Aged; Aged, 80 and over; Double-Blind Method; Erectile Dysfunction; Heart Failure; Humans; Male; Middle Aged; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

We evaluated the efficacy of testosterone gel (T-gel) alone and in combination with sildenafil in hypogonadal patients with erectile dysfunction (ED).. A total of 49 hypogonadal men (mean age 60.7 years) with ED participated for a mean of 20.2 months. Blood was tested for total and bioavailable testosterone, and prostate specific antigen. Sexual function was assessed using the International Index of Erectile Function questionnaire and a global assessment question (GAQ). Men received 1% 5 gm T-gel for 6 months, and 100 mg sildenafil was added to those with a "no" response to the GAQ after 3 months on testosterone supplement.. A total of 31 patients reported significant improvement in the sexual desire domain (from a mean +/- SD of 4.2 +/- 0.8 to 8.6 +/- 0.4) and erectile function (EF) domain (from 13.6 +/- 1.9 to 27 +/- 0.8) following treatment with testosterone supplement alone. One patient was excluded from study after urinary retention developed and 9 reported irritation at the gel application site. In spite of normalization of total and bioavailable testosterone values, and significant improvement of sexual desire domain scores, the EF of 17 men remained less than 26 or they responded "no" to the GAQ. These men received combined T-gel and sildenafil, after which all graded EF greater than 26 and responded positively to the GAQ.. Combined treatment with sildenafil and T-gel has a beneficial effect on ED in hypogonadal patients in whom treatment with testosterone supplement alone failed.

Topics: Adult; Aged; Androgens; Drug Therapy, Combination; Erectile Dysfunction; Gels; Humans; Hypogonadism; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Testosterone; Treatment Failure

A large proportion of patients who have erectile dysfunction also have coronary artery disease (CAD). In these patients, nitrate therapy is a contraindication to the use of sildenafil. To assess whether the metabolic anti-ischemic agent, trimetazidine, is effective in controlling episodes of myocardial ischemia during sexual activity in patients who have CAD and use long-term nitrate therapy, we studied 38 men (57 +/- 6 years of age) who had proved CAD. Patients underwent 24-hour ambulatory electrocardiographic monitoring at baseline, after 1 week of oral nitrate therapy (20 mg 3 times a day), and after 1 week of trimetazidine (20 mg 3 times a day). Patients were asked to engage in >/=1 session of sexual intercourse during each session of ambulatory electrocardiographic monitoring. They were instructed to take sildenafil (100 mg) 1 hour before sexual intercourse performed at baseline and during therapy with trimetazidine and sildenafil or placebo (blinded) during therapy with nitrates. A decrease in total ischemic burden was observed with nitrates and trimetazidine compared with baseline (-3 +/- 1.2 episodes/patient/24 hours vs -5 +/- 1.3 episodes/patient/24 hours and -6 +/- 5 min/patient/24 hours vs -8 +/- 3 min/patient/24 hours, p <0.01 for nitrates and trimetazidine vs baseline). Trimetazidine plus sildenafil was more effective in controlling episodes of myocardial ischemia during sexual activity than nitrates alone (-45 +/- 11% vs -18 +/- 7%, p <0.04). In conclusion, in patients who have CAD, combination therapy with sildenafil and trimetazidine is more effective than nitrate therapy in the control of ischemic episodes during sexual activity, suggesting that long-term nitrate therapy may be safely switched to trimetazidine therapy when therapy for erectile dysfunction is required.

Topics: Adult; Aged; Analysis of Variance; Coitus; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Electrocardiography, Ambulatory; Erectile Dysfunction; Humans; Male; Middle Aged; Myocardial Ischemia; Nitrates; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Trimetazidine; Vasodilator Agents

The aim of this study was to evaluate the safety and effectiveness of sildenafil in male peritoneal dialysis patients with erectile dysfunction.. Sixteen peritoneal dialysis patients were recruited to this prospective, randomized, double-blind, placebo-controlled, crossover study of sildenafil during a period of 8 weeks. Efficacy was assessed by using the International Index of Erectile Function and a Global Assessment Question. Penile arterial supply was assessed by means of Doppler ultrasound in all patients, and adverse events were recorded.. Three patients failed to complete the study (1 patient received a renal transplant, 1 patient died unrelated to the study, and 1 patient withdrew for personal reasons). In the remainder, there was a significant improvement in erectile function with sildenafil compared with placebo (P = 0.01) and the baseline assessment (P = 0.002). There were also significant improvements in intercourse satisfaction (P = 0.002) and overall satisfaction (P = 0.005) compared with baseline. In response to the Global Assessment Question, 75% of patients reported improvement in erections. Only 1 adverse event was reported: a headache, which resolved after the third dose of sildenafil.. Sildenafil caused a significant improvement in erectile function in peritoneal dialysis patients, with a success rate at least as high as that reported in other patient groups. The drug was well tolerated, with few adverse events.

Topics: Adult; Aged; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Penis; Peritoneal Dialysis; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Ultrasonography

To assess the effectiveness of combining sildenafil citrate with a vacuum constriction device (VCD) in men (after radical prostatectomy) unsatisfied with the results of the VCD alone.. A total of 31 patients unsatisfied with the early use of VCD alone after radical prostatectomy (mean follow-up of 4.5 months) were instructed to take 100 mg of sildenafil 1 to 2 hours before VCD use for sexual intercourse. Patients used combination therapy for a minimum of five attempts before assessment with the abridged International Index of Erectile Function (IIEF) questionnaire and a visual analogue scale to gauge rigidity. The effect of combination therapy on the total IIEF-5 score and penile rigidity score were assessed.. Of the 31 patients, 7 (22%) had no improvement with the addition of sildenafil with VCD and discontinued the drug, and 24 (77%) reported improved penile rigidity and sexual satisfaction. The IIEF-5 score revealed statistically significant improvement in each domain, and patients reported that sildenafil enhanced their erections 100% of the time. The penile rigidity scores on a scale of 0 to 100 with the VCD alone averaged 55% (range 23% to 85%) for the men and 59% (range 26% to 90%) for their partners. With the addition of sildenafil, it increased to 76% for the men and 82% for their partners. Of the 24 men, 7 (30%) reported a return of natural erections at 18 months using combination therapy, with 5 of 7 reporting erections sufficient for vaginal penetration.. In this study, the addition of sildenafil with VCD improved sexual satisfaction and penile rigidity in patients unsatisfied with VCD alone after radical prostatectomy.

Topics: Coitus; Combined Modality Therapy; Constriction; Erectile Dysfunction; Humans; Male; Middle Aged; Penis; Personal Satisfaction; Piperazines; Postoperative Complications; Prostatectomy; Purines; Sexual Partners; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vacuum

To evaluate the safety and pharmacodynamic effect of co-administration of subtherapeutic doses of PT-141, a cyclic heptapeptide melanocortin analogue, and sildenafil to patients with erectile dysfunction.. Nineteen patients with erectile dysfunction who were responders to either Viagra or Levitra by self-report were given 25 mg sildenafil and 7.5 mg intranasal PT-141, 25 mg sildenafil and an intranasal placebo spray, and a placebo tablet and an intranasal placebo spray in a randomized cross-over design. Erectile activity in response to two 30-minute episodes of visual sexual stimulation was assessed by RigiScan during a 6-hour postdose period.. The erectile response induced by co-administration of PT-141 and sildenafil was significantly greater than the response elicited by administration of sildenafil alone. Co-administration of PT-141 and sildenafil was safe and well-tolerated and did not result in new adverse events or adverse events that were increased in frequency or severity compared with monotherapy.. Co-administration of intranasal PT-141 and a phosphodiesterase type 5 inhibitor may constitute a treatment alternative for patients in whom higher doses of a single therapy are not effective or well tolerated.

Topics: Administration, Intranasal; Adult; Aged; alpha-MSH; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Peptides, Cyclic; Pilot Projects; Piperazines; Purines; Remission Induction; Sildenafil Citrate; Sulfones

Identifying and effectively treating erectile dysfunction (ED) can result in an improvement of the quality of life (QoL) in men with multiple sclerosis (MS).. This randomised, double blind (DB), placebo controlled, flexible dose study with an open label extension (OLE) assessed efficacy, QoL, and safety of sildenafil citrate in men with MS and ED. Overall, 217 men received sildenafil (25-100 mg; n = 104) or placebo (n = 113) for 12 weeks. Efficacy was assessed by the International Index of Erectile Function (IIEF) questionnaire that includes questions on achieving (Q3) and maintaining (Q4) an erection as well as a global efficacy question (GEQ). QoL was also assessed.. After 12 weeks, patients receiving sildenafil had higher mean scores for IIEF Q3 and Q4 compared with those receiving placebo (p<0.0001), and 89% (92/103) reported improved erections compared with 24% (27/112) of patients receiving placebo (p<0.0001). At the end of the OLE phase, 95% of men reported improved erections. Patients receiving placebo during the DB phase showed a nearly fourfold increase in improved erections (97% v 26%). Men receiving sildenafil also showed improvements in five of the eight general QoL questions compared with men receiving placebo (p<0.05). The total mean score for the QoL questionnaire improved by 43% for the sildenafil group versus 13% for the placebo group (p<0.0001). Treatment related AEs were predominantly mild in nature, and no patient discontinued due to an AE.. Sildenafil treatment for ED in men with MS was effective and well tolerated, and resulted in significant improvements in both general and disease specific QoL variables.

Topics: Adult; Aged; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Multiple Sclerosis; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction is a recognized complication of radiation therapy for prostate cancer. Sildenafil citrate is a well-known management strategy for erectile dysfunction that has been found to be efficacious across a wide spectrum of comorbidities, including post-radiation erectile dysfunction. We defined the efficacy of sildenafil citrate in patients with erectile dysfunction following radiation therapy for prostate cancer and assessed the impact of the interval after radiation on the success of this therapy.. Baseline and followup data on 110 patients presenting with erectile dysfunction secondary to radiation for prostate cancer was obtained. A total of 68 patients underwent 3-dimensional conformal external beam irradiation (CRT), while 42 underwent brachytherapy (BT) without androgen deprivation. All patients were considered to have erectile dysfunction after radiotherapy, as assessed by the International Index of Erectile Function (IIEF), and they were prescribed sildenafil citrate. Mean time +/- SD between the completion of radiation therapy and the initiation of sildenafil was 8 +/- 4 months. The response to sildenafil was assessed using the IIEF questionnaire. Within and between group comparisons were done for 3 time points, that is less than 12, 13 to 24 and 25 to 36 months following the completion of radiation therapy.. The respective response rates in men who underwent BT/CRT at the 3 time points of less than 12, 13 to 24 and 25 to 36 months was 76%/68%, 54%/46% and 44%/38%, respectively. Mean IIEF erectile function domain scores for these 3 time points after BT/CRT was 26/23, 22/19 and 17/15, respectively. The percent of patients who achieved normalization of the IIEF erectile function domain at the 3 time points in the BT/CRT groups was 60%/50%, 48%/42% and 26%/19%, respectively.. Sildenafil citrate improves erectile function in men in whom erectile dysfunction develops following radiation therapy for prostate cancer. There is a clear time dependence for the response to this therapy with a stepwise decrease in all end points examined serially in a 3-year period.

Topics: Aged; Brachytherapy; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Prostatic Neoplasms; Purines; Radiotherapy, Conformal; Sildenafil Citrate; Sulfones; Time Factors

To investigate the effects of sildenafil, a popular new drug in the treatment of erectile dysfunction, on ocular blood flow.. This study was designed as a prospective, double-blind, placebo-controlled study. Twenty participants with erectile dysfunction were given a single oral dose of 100 mg sildenafil, while 10 participants with erectile dysfunction were given placebo. All the participants underwent routine systemic and ophthalmological examinations. Intraocular pressure, systolic and diastolic blood pressure and ocular blood flow (ophthalmic, central retinal, short posterior ciliary arteries) were measured in both eyes before and 1 hour after the dose of sildenafil or placebo. Ocular blood flow measurements were performed using colour Doppler ultrasonography.. None of the parameters were significantly different between the groups before study drug intake. Although central retinal artery velocities were not changed, ophthalmic artery and short posterior ciliary artery peak systolic velocity, end-diastolic velocity, and mean velocity values were significantly increased 1 hour after drug intake in the sildenafil group compared to the placebo group (p < 0.05).. Sildenafil causes a significant increase in blood flow in these arteries. A possible role of inhibition of phosphodiesterase-5 in vascular smooth muscles by sildenafil is implicated. Further studies are needed to investigate the effects of sildenafil on ocular blood flow in patients with senile macular degeneration, diabetic retinopathy and glaucoma.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Aged; Blood Flow Velocity; Blood Pressure; Ciliary Arteries; Double-Blind Method; Erectile Dysfunction; Eye; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmic Artery; Piperazines; Prospective Studies; Purines; Retinal Artery; Sildenafil Citrate; Sulfones; Ultrasonography, Doppler, Color; Vasodilator Agents

Our goal was to analyze the morbidity of organic erectile dysfunction (ED) in kidney-transplant patients and to evaluate the efficacy and reliability of sildenafil citrate treatment.. Sixty-five ED patients with normal graft function for 3 to 12 months after kidney transplantation were involved in our study. Erectile dysfunction was diagnosed in all the patients by the International Index of Erectile Dysfunction (IIEF). Among them, 10 patients were in light degree; 32 patients in moderate degree, and 23 patients in severe degree according to IIEF score. All of the patients underwent medical history, physical and chemical examinations. In each patient, the IIEF score, blood urea nitrogen, creatinine, and trough concentrations of cyclosporine were compared before and after taking sildenafil citrate at an initial dose of 50 mg every night.. Twenty-six patients without ED before transplantation suffered ED after the operation, and 32 patients with ED before transplantation noticed worsening. Taking sildenafil citrate was effective in 53 patients (81.54%). There were no statistical differences in blood urea nitrogen, creatinine, or trough concentrations of cyclosporine in patients before and after sildenafil treatment.. The morbidity of organic erectile dysfunction increased after transplantation. Sildenafil citrate treatment for ED in kidney-transplant patients was effective and safe. Graft function and trough concentrations of cyclosporine were not affected by sildenafil citrate.

Topics: Blood Urea Nitrogen; Creatinine; Cyclosporine; Erectile Dysfunction; Humans; Kidney Transplantation; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

To determine whether propionyl-L-carnitine (PLC) plus acetyl-L-carnitine (ALC) improves the effectiveness of sildenafil in restoring sexual potency after bilateral nerve-sparing radical retropubic prostatectomy.. We analyzed the data from 96 patients who had undergone bilateral nerve-sparing radical retropubic prostatectomy: 33 were given placebo (group 1), 32 used PLC 2 g/day plus ALC 2 g/day plus sildenafil 100 mg when needed (group 2), and 35 used sildenafil alone (group 3). The studied variables were sexual function (assessed through sexual behavior interviews and the International Index of Erectile Function), peak systolic velocity and end-diastolic velocity of cavernosal arteries (assayed by dynamic echo-color Doppler), the percentage of patients able to achieve a positive intracavernous injection test, and side effects.. Placebo proved ineffective and sildenafil and sildenafil plus ALC and PLC proved effective. The International Index of Erectile Function-15 scores of the group 2 patients were significantly greater than those of group 3 in the following domains: erectile function, sexual intercourse satisfaction, orgasm, and general sexual well-being. The drugs did not significantly modify the score in the sexual desire domain or in the peak systolic velocity or end-diastolic velocity of the cavernosal arteries. Sexual behavior interviews revealed that 2 of 29 in group 1, 28 of 32 in group 2, and 20 of 39 in group 3 attained satisfactory sexual intercourse (P <0.01). Only group 2 had a significantly increased percentage of patients with a positive intracavernous injection test after therapy (36.4% versus 63.6%; P <0.01). ALC plus PLC did not significantly improve the side effects of sildenafil.. PLC and ALC proved to be safe and reliable in improving the efficacy of sildenafil in restoring sexual potency after bilateral nerve-sparing radical retropubic prostatectomy.

Topics: Acetylcarnitine; Carnitine; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prospective Studies; Prostate; Prostatectomy; Purines; Sildenafil Citrate; Sulfones

To compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in men naïve to phosphodiesterase 5 (PDE5) inhibitor therapy.. This was an open-label, crossover study of sildenafil and tadalafil (taken as needed). After a 4-week baseline assessment, 367 men with ED (mean age 54 years) were randomized to receive sildenafil for 12 weeks followed by tadalafil for 12 weeks or vice versa (8-week dose optimization and 4-week assessment phases). During dose optimization, patients started taking 25- or 50-mg sildenafil or 10-mg tadalafil and could titrate to find their optimum dose (25-, 50- or 100-mg sildenafil; 10- or 20-mg tadalafil). After completing both 12-week periods, patients chose which treatment to continue during an 8-week extension. Efficacy was measured with the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) diary.. Of the 291 men who completed both treatments, 85 (29%) chose sildenafil and 206 (71%) chose tadalafil (P < 0.001) for the 8-week extension. The IIEF erectile function domain scores were 14.2 at baseline, 23.9 at endpoint on sildenafil, and 24.3 at endpoint on tadalafil (P = 0.08, sildenafil vs tadalafil). The mean per patient percentage success scores for SEP2 (penetration) were: baseline (46%), sildenafil (post-baseline 82%) and tadalafil (post-baseline 85%; P = 0.06, sildenafil vs tadalafil), and for SEP3 (successful intercourse) were: baseline (19%), sildenafil (post-baseline 72%), and tadalafil (post-baseline 77%; P = 0.003, sildenafil vs tadalafil). The only treatment-emergent adverse events that were reported by >5% of men were headache and flushing.. In men with ED who were naïve to PDE5 inhibitor therapy, sildenafil and tadalafil were both effective and well tolerated. After treatment with sildenafil and tadalafil, 29% of men chose sildenafil and 71% chose tadalafil for ED therapy during an 8-week extension.

Topics: Adolescent; Adult; Aged; Carbolines; Cross-Over Studies; Erectile Dysfunction; Humans; Italy; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; United Kingdom

It has been suggested that postradical prostatectomy (RP) erectile function outcomes are improved by early use of erectogenic medications. This analysis was designed to assess the ability of a post-RP vasoactive drug program to improve long-term spontaneous erectile function.. Men with functional preoperative erections who underwent RP were challenged early postoperatively with oral sildenafil. Nonresponders were switched to intracavernosal injection therapy (ICI). Patients were instructed to inject three times a week. Only patients who presented within 6 months post RP, who completed the International Index of Erectile Function (IIEF) questionnaire on at least three separate occasions after surgery, and who had been followed for at least 18 months were included. Data from men who were committed to rehabilitation were compared with those of men who did not follow the protocol but continued to be followed serially following RP.. There were 58 patients in the rehabilitation (R) group and 74 in the nonrehabilitation (NR) group. No differences existed in mean patient age, comorbidity profile, intraoperative nerve sparing status, or postoperative erectile hemodynamics between the two groups. At 18 months post RP, there were statistically significant differences between the two groups in the percentage of patients who were capable of having medication-unassisted intercourse (R=52% vs. NR=19%, P<0.001); mean erectile rigidity (R=53+/-21% vs. NR=26+/-43%, P<0.01); mean IIEF erectile function (EF) domain scores (R=22+/-6 vs. NR=12+/-14, P<0.01); the percentage of patients with normal EF domain scores (R=22% vs. NR=6%, P<0.01); the percentage of patients responding to sildenafil (R=64% vs. NR=24%, P<0.001); the time to become a sildenafil responder (R=9+/-4 vs. NR=13+/-3 months, P=0.02); and the percentage of patients responding to ICI (R=95% vs. NR=76%, P<0.01).. The data generated from this nonrandomized study indicate that a pharmacologic penile rehabilitation protocol results in higher rates of spontaneous functional erections and erectogenic drug response after RP.

Topics: Clinical Protocols; Coitus; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Prostatic Neoplasms; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Time Factors

Recent studies suggest a direct relationship between free testosterone and cavernous vasodilatation. Some men with erectile dysfunction (ED) associated with PADAM (partial androgen deficiency in aging men) might possibly benefit from testosterone undecanoate therapy (TRT).. To determine the efficacy of testosterone undecanoate in facilitating the erectile response and patient satisfaction with sildenafil in men 40-70 years old with PADAM symptoms.. Prospective study including 40 patients recruited after a sildenafil therapeutic trial. Total testosterone and sex hormone binding globulin (SHBG) were measured to calculate the free androgen index. Prostate specific antigen (PSA) was measured and repeated 2 months after treatment. A rating score was used for PADAM symptoms, and the 5-point abbreviated version of the International Index of Erectile Function (IIEF-5) to assess erectile function. Men failing to respond to sildenafil were randomized into two groups receiving sildenafil plus continuous TRT (group 1ST), and TRT (group 1T) alone. Men partially responding to sildenafil were randomized into two groups receiving sildenafil plus continuous TRT for 2 months (group 2ST), or sildenafil alone (group 2S). Treatment efficacy was assessed by analysis of between-group differences.. Groups 1T, 2S, and 2ST showed significant improvement in PADAM scores (P<0.05, Wilcoxon matched pairs test). Patients receiving both sildenafil plus continuous TRT (groups 1ST and 2ST) showed significant improvement in IIEF-5 scores (P<0.5, paired t-test). No significant changes in serum levels of PSA were detected (paired t-test).. We conclude that TRT appears to be beneficial and safe in facilitating the erectile response and patient satisfaction with sildenafil in men with PADAM symptoms. Androgen supplementation should be carried out cautiously with careful monitoring to avoid possible adverse effects.

Topics: Adult; Aged; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Testosterone; Treatment Outcome

Premature ejaculation (PE) is the most common ejaculatory dysfunction. We assessed the efficacy of sildenafil to increase the time to ejaculation, improve ejaculatory control, and decrease the postejaculatory erectile refractory time in men with PE.. The main study was an 8-week, double-blind, placebo-controlled, parallel group study in men between 18 and 65 years of age with diagnosed PE. A substudy was also conducted using a subset of patients (two-way crossover, one center) before entry to the main study. The primary study measured intravaginal ejaculatory latency (IELT) and responses to the Index of Premature Ejaculation (IPE) questionnaire. The substudy measured vibrotactile stimulation ejaculatory latency time (VTS-ELT) and postejaculatory erectile refractory time. Differences between treatment groups were determined by ancova at the 5% level of significance.. The change in IELT (1.6 +/- 6.08 vs. 0.6 +/- 2.07 minutes) and VTS-ELT (2.9 +/- 0.4 vs. 2.4 +/- 0.4 minutes) were higher after taking sildenafil, compared with placebo, but did not reach statistical significance. However, patients who took sildenafil (vs. placebo) reported significantly (P < 0.05) increased ejaculatory control (1.8 +/- 0.3 vs. 1.5 +/- 0.3), increased ejaculatory confidence (2.2 +/- 0.2 vs. 1.9 +/- 0.2), and improved overall sexual satisfaction scores (3.1 +/- 0.2 vs. 2.8 +/- 02) on the IPE, and had a decreased postejaculatory erectile refractory time (3.2 +/- 0.7 vs. 6.4 +/- 0.7 minutes). The most common adverse events for sildenafil (vs. placebo) were headache (15% vs. 1%), flushing (15% vs. 0%), dyspepsia (5% vs. 1%), abnormal vision (5% vs. 0%), and rhinitis (5% vs. 0%).. Although IELT and VTS-ELT were not significantly improved, sildenafil increased confidence, the perception of ejaculatory control, and overall sexual satisfaction, and decreased the refractory time to achieve a second erection after ejaculation in men with PE.

Topics: Adolescent; Adult; Aged; Cross-Over Studies; Double-Blind Method; Ejaculation; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Mild hemodynamic effects have been reported with sildenafil citrate therapy.. To compare the hemodynamic effects of sildenafil and isosorbide mononitrate (ISMN) in men with coronary artery disease and erectile dysfunction.. A total of 31 men aged 35 years or older with coronary artery disease (at least 50% narrowing of the left main stem or at least 70% narrowing of any other coronary artery) and erectile dysfunction (receiving medication for erectile dysfunction or scoring less than 26 out of a maximum score of 30 on the erectile function domain questions of International Index of Erectile Function) were randomized to sildenafil 100 mg (n = 10), ISMN 40 mg (n = 11), or placebo (n = 10) in this single-dose multicenter study.. Hemodynamic parameters were measured at baseline, 1, 2, 4, and 6 hours post dose.. Compared with baseline, cardiac index increased slightly with sildenafil (0.29 L/min/m2 at 1 hour) and decreased slightly with placebo (-0.12 L/min/m2 at 4 hours) and ISMN (-0.14 L/min/m2 at 1 hour). The stroke volume index increased from baseline at each time point post dose with sildenafil (4.4 mL/m2 at 2 hours), but decreased with ISMN (-5.8 mL/m2 at 1 hour) and placebo (-2.8 mL/m2 at 4 hours). ISMN reduced mean arterial pressure more than sildenafil did (-22 vs. -10 mm Hg at 2 hours, respectively). Both sildenafil and ISMN increased heart rate (4 vs. 7 beats/minute at 1 hour, respectively) and decreased systemic vascular resistance, but sildenafil produced greater reductions in pulmonary vascular resistance. There were no serious adverse events in the sildenafil group.. Sildenafil 100 mg was well tolerated and induced smaller changes in central and peripheral hemodynamic pressures compared with ISMN 40 mg. Moreover, sildenafil selectively reduced pulmonary resistance, which may have clinical importance in pulmonary hypertension.

Topics: Adult; Coronary Artery Disease; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Hemodynamics; Humans; Isosorbide Dinitrate; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Sildenafil citrate is a highly effective erectogenic agent. However, predicting which patients will respond to this agent is often difficult. While the patient response to this agent is dependent on the nitric oxide-guanylate cyclase-cyclic guanosine monophosphate cascade, the integrity of penile arterial flow and venocclusive mechanism is also important. Duplex Doppler penile ultrasonography can reliably document penile hemodynamics. This study aimed at defining response rates based on degree of penile vascular sufficiency.. This study enrolled patients who met strict criteria for sildenafil citrate response who had also undergone penile ultrasound. Correlation was drawn between the nature and the severity of the vascular insufficiency and the response rate to sildenafil citrate.. The distribution of vascular diagnoses was arteriogenic 64%, venogenic 6%, mixed vascular insufficiency 18%, and normal 12%. The best response was seen in those men with normal vascular studies, 80% responding. Fifty-three percent of all men with any abnormality on penile ultrasound responded; 65% of men with arteriogenic erectile dysfunction (ED), 25% of patients with venogenic ED, and 6% of men with a mixed vascular insufficiency were responders. There was a correlation between the degree of vascular impairment and the response rate. All men with venogenic ED who responded had mild leak.. These data demonstrate a correlation between the nature and severity of penile vascular disease and the ability to respond to sildenafil citrate. These data may be useful to the sexual medicine practitioner when counseling patients regarding oral erectogenic therapy.

Topics: Erectile Dysfunction; Hemodynamics; Humans; Male; Middle Aged; Penis; Peripheral Vascular Diseases; Piperazines; Purines; Regional Blood Flow; Sildenafil Citrate; Sulfones; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vasodilator Agents

Men not entirely satisfied with erectile function after separate use of sildenafil or a vacuum entrapment device (VED) are usually given more invasive alternatives. This prospective study was designed to evaluate the efficacy of concomitant use of sildenafil and a vacuum entrapment device in men not satisfied with erectile function while using each of these treatment modalities separately.. A total of 161 patients suffering from erectile dysfunction for at least 6 months were evaluated and treated with 100 mg sildenafil and a VED each as monotherapy. The 41 patients not satisfied with erectile function while using either modality alone were treated with concomitant use of sildenafil and a VED. The International Index of Erectile Function and global assessment question about satisfaction from treatment were used to evaluate satisfaction before and after each treatment.. All 41 patients stated on the global assessment question that they had a greater level of satisfaction with the results of combined treatment than with each treatment alone (p <0.0001). Older (age greater than 60 years) participants reported better overall satisfaction. There was no correlation between treatment outcome and erectile dysfunction etiology or between satisfaction from treatments and the order in which they were given and the pretreatment scores for the International Index of Erectile Function domains.. Combined use of sildenafil and a VED may be offered to patients not satisfied when either treatment is used alone.

Topics: Adult; Aged; Aged, 80 and over; Combined Modality Therapy; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Urology; Vacuum

To assess the efficacy of sildenafil in increasing penile glans tumescence and improving patient satisfaction in men with a penile prosthesis, as this remains a major treatment for erectile dysfunction but a common complaint is the lack of glans engorgement.. To determine whether sildenafil combined with a penile prosthesis improves satisfaction, patients used an implant alone for at least 1 month, after which they completed the International Index of Erectile Function (IIEF) questionnaire. The same patients were then given sildenafil citrate and completed the IIEF questionnaire after using the sildenafil/implant combination.. Patients who responded to sildenafil with glans engorgement reported significantly greater satisfaction scores than with an implant alone.. We currently offer sildenafil citrate after implantation to all men who have a penile prosthesis placed.

Topics: Adult; Aged; Combined Modality Therapy; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

This was a double-blind, placebo-controlled, flexible-dose study of the efficacy and safety of sildenafil in men with erectile dysfunction (ED) and clinically stable coronary artery disease (CAD). Patients were randomized to receive sildenafil or placebo for 12 weeks. Primary outcomes were questions 3 and 4 of the International Index of Erectile Function (IIEF). Secondary outcomes included the other IIEF questions and functional domains, the Life Satisfaction Checklist, the Erectile Dysfunction Inventory of Treatment Satisfaction, 2 global efficacy assessment questions, and intercourse success rate. By week 12, sildenafil-treated patients (n = 70) showed significant improvements on questions 3 and 4 compared with placebo-treated patients (n = 72; p <0.01). Larger percentages of sildenafil-treated patients reported improved erections (64%) and improved intercourse (65%) compared with placebo-treated patients (21% and 19%, respectively). Sildenafil-treated patients were highly satisfied with treatment and their sexual life compared with placebo-treated patients. Forty-seven percent of sildenafil- and 32% of placebo-treated patients experienced adverse events, including transient headache, hypertension, flushing, and dyspepsia. There were no serious drug-related cardiovascular effects. Thus, sildenafil is an effective and well-tolerated treatment for ED in men with CAD. Sildenafil was not associated with additional safety risks in this patient population.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Coronary Disease; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Patient Satisfaction; Penile Erection; Piperazines; Prospective Studies; Purines; Safety; Sildenafil Citrate; Sulfones; Time Factors; Vasodilator Agents

Sexual dysfunction frequently occurs in treated and untreated patients with schizophrenia. Sildenafil is used for treatment of erectile dysfunction caused by diverse factors. The aim of our study was to evaluate its potential value, safety, and effect on compliance with anti-psychotic medications in risperidone-treated male schizophrenia patients suffering from erectile dysfunction.. In a 6-week open-label trial, sildenafil was administered to 12 male schizophrenia (DSM-IV) patients, treated with risperidone and reporting erectile dysfunction. The starting dose was 25 mg with the possibility to increase the dose to 75 mg. Three patients who did not respond stopped sildenafil treatment after 3 weeks. The effect on sexual function was assessed by the International Index of Erectile Function and the Valevski-Weizman Male Sexual Function scale.. Nine (75%) of the 12 patients completed the 6-week trial, and 3 patients (25%) stopped taking sildenafil after 3 weeks due to lack of response. We observed statistically significant improvements in all sexual function domains (desire, erectile function, orgasmic function, intercourse satisfaction, and overall satisfaction) in the 9 patients who completed the trial and in most of the domains for all 12 study participants. More than half (8/12; 67%) of the patients exhibited partial or much improvement.. Sildenafil is a useful agent for the treatment of erectile dysfunction in risperidone-treated male schizophrenia patients.

Topics: Administration, Oral; Adult; Antipsychotic Agents; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Patient Compliance; Patient Satisfaction; Piperazines; Purines; Risperidone; Schizophrenia; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

The aim of this study was to establish the prevalence of erectile dysfunction (ED) in hypertensive patients in specialized care hypertension units (SCHUs) and to assess the effectiveness and tolerability of sildenafil treatment.. This was a multicenter, prospective, open, observational pharmacoepidemiology study conducted in 25 Spanish SCHUs. A total of 2130 men with essential hypertension under treatment were recruited. In a second phase, 291 subjects with a score < or = 21 in the Sexual Health Inventory for Men (SHIM) received sildenafil (50 mg/day) as required 30 to 60 minutes before sexual activity, and were evaluated by the International Index of Erectile Function (IIEF).. A total of 975 subjects (45.8%) had a score < or = 21 in the SHIM. In the second phase, sildenafil improved the score in the erectile function domain in 232 patients (83.2%). Severity of ED significantly improved (P <.001); severe (22.3% to 7.7%), moderate (23% to 5.6%), and mild impairment (36.3% to 44.8%). The IIEF was normalized in 39.1% of patients who completed post-treatment IIEF. In all, 33 subjects (11.8%) failed to complete the study: two (0.7%) because of lack of efficacy, two (0.7%) intercurrent disease, 10 (3.6%) failure to return to the visits, three (1.1%) fear of therapy, four (1.4%) adverse effects requiring treatment discontinuation, and 12 (4.3%) protocol violations. No statistically significant association was found between the prevalence of adverse effects and antihypertensive treatment with single drug or combination therapy.. A high incidence of ED was found in hypertensive patients from Spanish SCHUs. Sildenafil showed an excellent response and safety profile.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Aged; Antihypertensive Agents; Body Mass Index; Erectile Dysfunction; Headache; Humans; Hypertension; Male; Middle Aged; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Erectile dysfunction (ED) is commonly associated with depressed mood and diminished quality of life (QoL), but few studies have investigated the causal associations involved. Therefore, we evaluated the correlation between several measures of mood, QoL, and sexual function in a retrospective analysis of a sample of depressed men (n=152), with ED enrolled in a clinical trial of sildenafil citrate (VIAGRA). Strong correlations were observed at baseline among measures of erectile function (EF), mood, and overall QoL. Significant treatment effects were observed on all three domains, with significant interactions between changes in mood and QoL. Based on multiple regression and path analysis, a model was developed in which EF changes were associated with improved mood and quality of sexual life, which resulted in improved partner satisfaction, family life, and overall life satisfaction. These data suggest that QoL changes associated with ED therapy may be mediated by changes in sexual function, mood, and family relationships.

Topics: Adolescent; Adult; Affect; Depressive Disorder; Double-Blind Method; Erectile Dysfunction; Humans; Male; Models, Psychological; Phosphodiesterase Inhibitors; Piperazines; Psychiatric Status Rating Scales; Purines; Quality of Life; Regression Analysis; Sexual Behavior; Sildenafil Citrate; Sulfones; Treatment Outcome

The aim of the study was to establish and compare the efficacy and safety of sildenafil and apomorphine in men with arteriogenic erectile dysfunction (ED). In all, 43 men with ED and postinjection max penile systolic velocity <25 cm/s in repeated Doppler ultrasonography were included. Of these, 24 men started on apomorphine 2 mg and 19 on sildenafil 50 mg, the doses titrated up to 3 and 100 mg according to effectiveness and tolerability. Safety was evaluated according to adverse events (AEs) and patient withdrawal. Efficacy was the percentage of attempts resulting in erections firm enough for intercourse, based on event log data. The incidence of AEs with apomorphine 3 mg was higher than with sildenafil 100 mg. Two men on apomorphine 3 mg discontinued treatment due to AEs. The overall success rate of sildenafil was 63.7% compared to 32.1% of apomorphine (Pearson chi(2), P<0.01). Of all men, 25 (58.1%) responded to sildenafil 50 mg without the need for dose increase, while only one responded to apomorphine 2 mg. The response to sildenafil 50 mg was age related (analysis of variance, p=0.04). Satisfaction was reported by 76.75 and 13.95% of patients for sildenafil and apomorphine, respectively, but 20.9% were not satisfied with any of the two drugs. In conclusion, this study provides clear evidence that sildenafil, even at 50 mg dose, is more effective than apomorphine 3 mg in men with arteriogenic ED. The fact that one out of five patients is not satisfied with the above-studied drugs shows that new oral agents need to be evaluated for the treatment of this disorder.

Topics: Apomorphine; Arteries; Cross-Over Studies; Dopamine Agonists; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vascular Diseases; Vasodilator Agents

We compared the effectiveness of sildenafil citrate and alprostadil in improving arterial penile inflow (peak systolic velocity (PSV)) and penile rigidity in 55 patients with erectile dysfunction caused by atherosclerosis. A total of 35 patients with pure vasculogenic impotency were randomly assigned to alprostadil (Av group; n=11), sildenafil (Sv group; n=12), or placebo (P group; n=12), and 20 patients with nonvasculogenic impotency were randomly assigned to alprostadil (A group; n=10) or Sildenafil (S group; n=10): Av and A used alprostadil injection (capable of giving a full erection) once a week for 1 month, Sv and S took daily oral sildenafil (25 mg) for 1 month, and P took daily oral placebo for one month. The PSV was measured with Duplex sonography and penile rigidity was assessed using the IIEF-15 questionnaire, both of which were administered before and after treatment. Although both treatments improved penile rigidity, they increased PSV only in the Av and Sv groups. Our results suggest that alprostadil and oral therapy should be the starting therapy in men with vasculogenic impotency, whereas alprostadil should be avoided as the first-line approach in men with nonvasculogenic impotency.

Topics: Adult; Aged; Alprostadil; Arteries; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Placebos; Purines; Regional Blood Flow; Sildenafil Citrate; Sulfones; Treatment Outcome; Ultrasonography; Vascular Diseases; Vasodilator Agents

To assess inappropriate use as a cause of sildenafil (Viagra ) failure and the feasibility of successfully rechallenging nonresponding patients, a total of 60 consecutive erectile dysfunction (ED) patients who first presented to our hospital and claimed poor response to sildenafil were enrolled into the study. The International Index of Erectile Function-5 (IIEF-5) was used to evaluate their baseline ED status and a self-administered sildenafil-use questionnaire composed of nine questions (SUQ-9) to assess how they had used sildenafil. A total of 44 subjects consent to rechallenge with sildenafil and were given thorough instruction based on individual answers to SUQ-9 and four doses of sildenafil 100 mg. After a 4-week follow-up, end point efficacy of rechallenge was evaluated using the IIEF-5 and the global assessment question (GAQ), 'After the treatment, did you have successful sexual intercourse?' Of the 60 subjects, 44 (77.3%) had one or more areas of major suboptimal use of sildenafil: 18 (30.0%) did not know that sexual stimulation was necessary for sildenafil to work, 36 (60.0%) attempted to use sildenafil less than four times, and 27 (45.0%) took a maximal dose less than 100 mg. Of the 44 patients undergoing sildenafil rechallenge, 34 (77.3%) completed the follow-up, while seven (15.9%) received only GAQ assessment by telephone interview and three (6.8%) were lost to follow-up. The total follow-up rate was 93.2% (41/44). Based on answers to the GAQ, the response rate to rechallenge was 58.5% (24/41). The mean improvement in the IIEF-5 score was 8.4+/-5.5 in responders (P <0.05). With individualized thorough instruction based on answers to SUQ-9 and scheduled follow-up, a high success rate was achieved by rechallenge with sildenafil in prior failures. The efficacy of sildenafil could be improved to a great extent by adequate education of patients and continuing medical education given to primary-care physicians.

Topics: Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Feasibility Studies; Follow-Up Studies; Humans; Male; Middle Aged; Outpatients; Patient Education as Topic; Piperazines; Purines; Salvage Therapy; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Failure; Vasodilator Agents

PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following subcutaneous administration to healthy male subjects and to patients with erectile dysfunction (ED) who report an inadequate response to Viagra. An inadequate response was defined for this study by patient report indicating that achievement of an erection suitable for vaginal penetration occurred < or =50% of the time while taking 100 mg Viagra. Erectile responses were assessed by RigiScan in healthy subjects in the absence of visual sexual stimulation (VSS) and in ED patients in the presence of VSS. Doses ranging from 0.3 to 10 mg were administered to healthy male subjects, resulting in a statistically significant erectile response at doses greater than 1.0 mg. ED patients were treated with placebo, 4 or 6 mg PT-141 in a crossover design in the presence of VSS. The erectile response induced by PT-141 was statistically significant at both doses. PT-141 was safe and well tolerated in both studies. The erectogenic potential of PT-141, its tolerability profile and its ability to cause significant erections in patients who do not have an adequate response to a PDE5 inhibitor suggest that PT-141 may provide an alternative treatment for ED with a potentially broad patient base.

Topics: Adult; alpha-MSH; Cross-Over Studies; Dose-Response Relationship, Drug; Erectile Dysfunction; Headache; Humans; Injections, Subcutaneous; Male; Middle Aged; Nausea; Penile Erection; Peptides, Cyclic; Piperazines; Purines; Receptors, Melanocortin; Reference Values; Sildenafil Citrate; Sulfones; Time Factors; Vomiting

Sildenafil citrate was introduced as a treatment for erectile dysfunction in April 1998 in the United States and has been available since March 1999 in Japan. In this article, we assess the efficacy of sildenafil in the treatment of erectile dysfunction in Japanese men after radical retropubic prostatectomy for localized prostate cancer.. Of 106 men who underwent radical retropubic prostatectomy between January 1994 and March 2000, 43 were prescribed sildenafil at their request after radical retropubic prostatectomy. Medication was initiated at 25 mg, and if this was ineffective, the dose was increased to 50 mg. Of the patients, 18 underwent bilateral and 21 unilateral nerve sparing (NS) procedures, while in 4 patients, a non-NS procedure was performed. These patients were interviewed using a questionnaire about their response to sildenafil and using the 5-item International Index of Erectile Function (IIEF-5) questionnaire.. Thirty-three of the 43 patients were eligible for evaluation of the efficacy of sildenafil and 27 completed the IIEF-5 questionnaires. Sildenafil at 50 mg had a better effect on sexual function than 25 mg in most Japanese patients. Of the 16 patients who underwent bilateral NS procedures, 10 (62.5%) had improved ability for intercourse and 3 (18.8%) had improved erections. Of the 13 patients who underwent unilateral NS procedures, 7 (53.8%) had improved ability for intercourse and 4 (30.8%) had improved erections. None of the 4 patients who underwent non-NS procedures had a positive response. Of 24 patients with positive response to sildenafil, 3 (12.5%) did not have to take sildenafil after receiving it because they did not require it for intercourse. Mean IIEF-5 score increased from 4.3 to 11.4 (P < 0.0001). Patient age, time since surgery, PSA and pathological stage did not have statistically significant effects on outcome. The most commonly cited adverse effect was headache (21%).. Sildenafil is equally effective for erectile dysfunction in Japanese patients who have undergone bilateral and unilateral NS procedures, and aids recovery of natural erectile function after radical retropubic prostatectomy. However, non-NS procedure patients had no response to sildenafil. This study suggested that sildenafil is well tolerated and should be initially used for treatment of Japanese men with erectile dysfunction after radical retropubic prostatectomy.

Topics: Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

To assess patient preference for erectile dysfunction treatment between either sildenafil or tadalafil, each administered with their respective dosing instructions, and to evaluate preference for either sildenafil or tadalafil dosing instructions during tadalafil therapy.. We conducted a randomized, double-blind, crossover study consisting of four treatment arms. Because the dosing instructions for sildenafil and tadalafil are different, a unique methodology using sham placebo arms was employed to maintain the blind. To assess drug preference, 219 patients were randomized to either sildenafil 50 mg or tadalafil 20 mg, with dosing instructions reflecting their respective product profiles. To assess dosing instruction preference during tadalafil therapy, 46 patients were randomized to tadalafil 20 mg with either tadalafil or sildenafil dosing instructions. After 12 weeks, patients were crossed-over. After 4 weeks of each treatment, all patients following sildenafil dosing instructions were offered the opportunity for an upward dose titration. In a double-blind fashion, all patients who requested an upward titration received additional capsules. To mimic the pattern of dose usage observed in clinical practice, the number of patients who received additional double-blind active medication was limited to 35% of patients taking sildenafil in each treatment period in each country. Following the crossover treatment period, patients chose their preferred double-blind treatment with dosing instructions to receive in the 12-week extension period.. In the drug preference assessment, 132 of 181 (73%) evaluable patients chose to receive tadalafil (p < 0.001) during the extension period. In the dosing instruction preference assessment, 24 of 36 (67%) evaluable patients preferred tadalafil with tadalafil dosing instructions (p = 0.046). Sildenafil and tadalafil were well tolerated.. In the doses utilized in this study, 73% of patients preferred tadalafil with tadalafil dosing instructions for the treatment of their erectile dysfunction over sildenafil with sildenafil dosing instructions. During tadalafil therapy, 67% of patients preferred tadalafil dosing instructions over sildenafil dosing instructions.

Topics: Adult; Aged; Carbolines; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil

Sildenafil may provide an effective treatment for erectile dysfunction, frequently observed in uremic patients and after kidney transplantation. Pharmacokinetic interactions between sildenafil and tacrolimus are to be expected due to a common elimination pathway via cytochrome P450 3A4. Therefore, the pharmacokinetics during combined use of these agents were studied over 9 days.. Nine male patients (age 29-52 years) were included, who had previously participated in a recent interaction study with sildenafil given as a single dose. Comedication remained unchanged in order to avoid introducing confounding factors. In the previous study in the patients, tacrolimus blood levels with and without sildenafil were measured for pharmacokinetic analysis. In the present study, 25 mg sildenafil were coadministered daily over 9 days and tacrolimus levels were assessed at sampling times optimized using simulation. In addition, laboratory parameters and blood pressure changes were measured and adverse effects monitored.. Terminal half-lives of tacrolimus did not differ significantly and trough levels did not change when sildenafil was coadministered daily over 9 days. Mean arterial blood pressure was lower after sildenafil intake. Two patients had to reduce their antihypertensive treatment, 6 patients reported mild side effects. In 1 case, there was an asymptomatic, temporary increase in the serum concentration of gamma-GT.. There was no evidence obtained for a change in elimination half-life or average concentration of tacrolimus during repeated coadministration of sildenafil. Since blood pressure decreased, a starting dose of 25 mg sildenafil and, if necessary, adjustment of the dose of antihypertensive drugs on days when sildenafil is given has to be considered. With respect to the observed blood pressure changes, pharmacokinetic/pharmacodynamic interaction studies with other antihypertensive drugs are of critical importance in these patients.

Topics: Adult; Blood Pressure; Drug Interactions; Erectile Dysfunction; Half-Life; Humans; Immunosuppressive Agents; Kidney Transplantation; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tacrolimus; Vasodilator Agents

The aim of this study was to compare the efficacy of sildenafil and continuous positive airway pressure (CPAP) in men with erectile dysfunction (ED) and obstructive sleep apnea syndrome (OSAS). In all, 30 men were randomly treated for 12 weeks either with sildenafil 100 mg before intercourse (15 men) or CPAP during night time sleep (15 men). Under sildenafil, 97/180 (53.9%) of attempted intercourses were successful compared to 33/138 (23.9%) under CPAP. The mean IIEF (erectile function domain score) was 12.9 and 9.3 after sildenafil and CPAP treatment, respectively (P=0.007), compared to 7.9 and 7 at baseline. In all, 53.3% of patients were satisfied with sildenafil and 20% with CPAP for ED treatment (P=0.058). Although sildenafil was superior to CPAP, comorbidities and OSAS per se possibly resulted in a lower effectiveness of sildenafil compared to that in the general population of ED men. While about half of the patients were not satisfied even with the more effective treatment, we conclude that a combination of the two therapeutic tools or a different therapeutic mode should be studied further.

Topics: Coitus; Combined Modality Therapy; Continuous Positive Airway Pressure; Erectile Dysfunction; Humans; Male; Patient Satisfaction; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sleep Apnea, Obstructive; Sulfones; Vasodilator Agents

To evaluate in a pooled analysis of multiple studies the perceptions of effectiveness and overall treatment satisfaction in the partners of patients who received sildenafil citrate for treatment of erectile dysfunction. Partner satisfaction with treatment of erectile dysfunction can have a substantial impact on the continuation of therapy.. Each partner rated the man's erectile function and her own intercourse satisfaction by responding to three appropriately modified questions from the International Index of Erectile Function, assessing frequency of erections, ability to maintain erections, and satisfaction of intercourse in 14 double-blind placebo-controlled trials of sildenafil. Partner satisfaction with sildenafil treatment was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction partner questionnaire in six of these trials.. Of 3634 patients enrolled in these 14 trials, the partners of 930 patients agreed to participate. The partners reported that men receiving sildenafil had significantly greater erection frequency and ability to maintain erections than men receiving placebo, irrespective of patient age. Partners of sildenafil-treated men also had more frequent intercourse satisfaction compared with partners of placebo-treated men (P <0.0001). In both treatment groups, the partner and patient responses correlated highly (P <0.0001). The correlation between patient and partner Erectile Dysfunction Inventory of Treatment Satisfaction index scores was 0.80 for placebo and 0.86 for sildenafil (P <0.0001).. Partner evaluations corroborated the patient assessments, with both indicating that treatment with sildenafil resulted in statistically significant improvement in erectile function and suggesting that partners were satisfied with sildenafil treatment for erectile dysfunction.

Topics: Adult; Age Distribution; Aged; Attitude to Health; Erectile Dysfunction; Female; Humans; Male; Middle Aged; Penile Erection; Personal Satisfaction; Piperazines; Placebos; Purines; Sexual Behavior; Sexual Partners; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Effects of sildenafil citrate on nocturnal penile tumescence and rigidity (NPTR) were evaluated among sildenafil non-responding patients with psychogenic erectile dysfunction. All patients (n=30), equally divided into groups I and II, completed four consecutive nights using the RigiScan Plus device. Sildenafil citrate (50 mg) was given in the third night in group I and in the fourth in group II, whereas a placebo was given in the remaining nights. Additional patients (n=12) receiving only a placebo served as a control group. Results of NPTR recordings revealed neither significant differences between the control and non-sildenafil nights of both test groups, nor between the corresponding values of both groups (P>0.05). On the other hand, when sildenafil citrate nights of groups I and II taken together were compared with placebo nights, a significant increase of total events duration (P<0.001), average rigidity of the tip (P<0.05) and base (P<0.01), and rigidity activity unit (RAU) and tumescence activity unit (TAU) of tip and base (P<0.001) was observed. These results suggest that performance anxiety may be responsible for failure of response during awakening.

Topics: Adult; Anxiety; Circadian Rhythm; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Piperazines; Placebos; Purines; Sildenafil Citrate; Sulfones; Treatment Failure; Wakefulness

To compare the efficacy and safety of sildenafil and apomorphine in the treatment of men with erectile dysfunction (ED).. In all, 139 men with ED who were naïve to treatment were entered into an open-label crossover trial with two treatment periods, each of 8 weeks, separated by a 2-week washout period. Men were randomized to receive either sildenafil then apomorphine or apomorphine then sildenafil, and were allowed to titrate the dose on both drugs. The primary endpoint was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), and other endpoints included diary data, the other domains of the IIEF, overall assessment questions and the Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire.. The EF domain score after treatment was 25.2 for sildenafil and 15.9 for apomorphine. The treatment difference of the adjusted means was 9.3 points (95% confidence interval 7.6-11.1; P < 0.001). After sildenafil the successful intercourse rate was 75%, vs 35% for apomorphine (P < 0.001), and the EDITS scores were 82.5 for sildenafil and 46.8 for apomorphine (P < 0.001). Of the men, 96% expressed a preference for sildenafil as a treatment for their ED. The side-effect profiles for both drugs were in keeping with published data.. By all measurable endpoints sildenafil was superior to apomorphine in this open-label crossover study of men with ED who were naïve to therapy

Topics: Adult; Aged; Aged, 80 and over; Apomorphine; Cross-Over Studies; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Erectile dysfunction (ED) is highly prevalent in men with renal disease. The clearance of sildenafil citrate, a highly effective oral treatment for ED, is decreased in men with severe renal insufficiency, but the pharmacokinetic and hemodynamic profiles during maintenance hemodialysis in men with end-stage renal disease have not been studied.. Fifteen men undergoing chronic outpatient maintenance hemodialysis received a single 50-mg oral dose of sildenafil on 2 occasions, once 2 hours before, and once 2 hours after hemodialysis, with randomized assignment to sequence. Blood and dialysate samples were collected, and hemodynamic measurements were made.. Hemodialysis did not significantly clear either sildenafil or its primary metabolite, UK-103,320. Administration after hemodialysis was associated with a 17% higher peak plasma concentration and earlier time to peak, which were not clinically meaningful, whereas the overall extent of absorption and the elimination half-life were not affected. The average extent of drug bound to plasma protein was approximately 96% in hemodialysis patients. Intradialytic hypotension was not observed more frequently when sildenafil was administered before hemodialysis. Systolic blood pressure tended to decrease less during hemodialysis when subjects were treated with sildenafil before dialysis.. The present study demonstrates that sildenafil is not cleared by hemodialysis, and the pharmacokinetic profile resembles more closely that observed in normal volunteers than that observed in patients with severe renal insufficiency. In addition, we found that sildenafil does not promote intradialytic hypotension.

Topics: Adult; Cross-Over Studies; Drug Administration Schedule; Erectile Dysfunction; Hemodynamics; Humans; Kidney Failure, Chronic; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Renal Dialysis; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) and depression are highly prevalent and frequently comorbid. Sildenafil effectively treats ED in men with depression and in men taking antidepressants. We evaluated the efficacy of sildenafil in men with depression in remission and ED. Patients with a history of ED when major depressive disorder (MDD) was diagnosed, which persisted after MDD was treated to remission, were randomized to 12 weeks of treatment with sildenafil (50 mg, flexible) or placebo. Efficacy was assessed using intercourse success rates, a global efficacy question (Has treatment improved your erections?), the International Index of Erectile Function (IIEF) and Life Satisfaction Checklist (LSC). By week 12, intercourse success rates were significantly higher among sildenafil- (74%) compared to placebo-treated patients (29%; P=0.0001). About 83% and 34% of sildenafil- and placebo-treated patients, respectively, reported improved erections (odds ratio=9.4, P=0.0001). IIEF scores in the sildenafil group (n=83) were significantly improved compared to those in the placebo group (n=85; P <0.0001). LSC sexual life item improved significantly among sildenafil- versus placebo-treated patients. The most frequently reported adverse events were transient and mild-to-moderate. Sildenafil is an effective and well-tolerated treatment for ED in patients with a history of ED at the time of MDD diagnosis, and which persisted after the MDD was treated to remission.

Topics: Adult; Aged; Ambulatory Care Facilities; Antidepressive Agents; Depressive Disorder, Major; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prospective Studies; Purines; Quality of Life; Remission Induction; Sildenafil Citrate; Sulfones; Vasodilator Agents

To compare the efficacy of apomorphine and sildenafil in men with nonarteriogenic erectile dysfunction (ED), 40 men were studied. Post-injection penile peak systolic velocity was greater than 25 cm s(-1). Twenty men started on apomorphine 2 mg and 20 on sildenafil 50 mg, the doses titrated up to 3 and 100 mg, respectively, if necessary. After a 1-week washout period each group switched to the other treatment mode. Efficacy was the percentage of attempts resulting in erections firm enough for intercourse, based on an event log data. The majority (85%) of the men had concomitant diseases, risk factors for ED and 95% were heavy smokers. The overall success rate of apomorphine was 62.7%, compared with 73.1% of sildenafil (Yates-corrected chi-square, P < 0.0004). The response to apomorphine 2 mg and sildenafil 50 mg was age related. Sildenafil was statistically more effective than apomorphine in impotent men with normal penile Doppler. Given the contraindication of sildenafil in men taking nitrates and the quick time of action of apomorphine, the two drugs are satisfactory first line therapeutic tools in such individuals and the choice should be based on patient's needs and preferences.

Topics: Apomorphine; Cross-Over Studies; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

We compare the efficacy of testosterone gel (T-gel) versus placebo as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone.. A randomized, placebo controlled, double-blind, parallel group, multicenter study was performed. A total of 75 hypogonadal men (18 to 80 years old, morning serum total testosterone 400 ng/dl or less) with confirmed lack of response to sildenafil monotherapy were randomized (1:1) to receive a daily dose of 1% T-gel or 5 gm placebo gel as adjunctive therapy to 100 mg sildenafil during a 12-week period. Subjects were evaluated for sexual function, primarily based on the International Index of Erectile Function (IIEF), quality of life and serum testosterone levels at baseline and weeks 4, 8 and 12.. Testosterone treated subjects had greater improvement in erectile function compared to those who received placebo, reaching statistical significance at week 4 (4.4 vs 2.1, p = 0.029, 95.1% CI 0.3, 4.7). Similar trends were observed for improvements in orgasmic function, overall satisfaction, total IIEF score and percentage of IIEF responders. T-gel significantly (p < or =0.004) increased total and free testosterone levels throughout the study, although no significant correlations were made between testosterone levels and the IIEF at end point.. T-gel taken with sildenafil may be beneficial in improving erectile function in hypogonadal men with erectile dysfunction who are unresponsive to sildenafil alone.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Double-Blind Method; Drug Therapy, Combination; Erectile Dysfunction; Gels; Humans; Hypogonadism; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Testosterone; Treatment Failure

To evaluate the efficacy and safety of sildenafil citrate in man kidney transplant recipients with erectile dysfunction.. One hundred and seventy married males, aged 26 approximately 50 years, who had received kidney transplantations at least half a year before and whose serum creatinine was under 133 umol/l, were selected randomly in the study. Their sexual function was investigated according to the International Index of Erectile Function-5 (IIEF-5), and those with erectile dysfunction (ED) were treated with oral sildenafil citrate for 6 months. The efficacy was assessed by IIEF-5.. Fifty-three men with ED received oral sildenafil citrate for 6 months. At the end of the treatment, each index in IIEF-5 increased significantly. There were no interactions between sildenafil and cyclosporine and there was no significant adverse effect of sildenafil on the graft function.. Sildenafil is an effective and safe agent for the treatment of ED in kidney transplant recipients.

Topics: Adult; Erectile Dysfunction; Humans; Kidney Transplantation; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones

A randomized, blinded, crossover clinical trial comparing sildenafil versus tadalafil for erectile dysfunction (ED) in male spinal cord-injured (SCI) patients.. To compare the safety, time/duration effectiveness, and the impact on the quality of life (QoL) of tadalafil 10 mg versus sildenafil 50 mg.. Neurourology Section, Careggi Hospital, Florence, Italy.. During a screening (visit 1), a diary card was distributed, in which the subjects assessed, after each attempt at intercourse the quality of their erection, responding (Yes/No) to both Sexual Encounter Profile Questions 2 (SEP2) and 3 (SEP3). The subjects made at least four attempts at intercourse. At visit 2, 15 patients (group 1) were assigned sildenafil and 15 (group 2) started with tadalafil. Responses to baseline International Index of Erectile Function 5 items (IIEF-5), Questions 13-14 (IIEF 15 items) and SEP diary were recorded. Patients attempted intercourse on four separate occasions: within 4 h of taking the first tablet, within 12 h for the second tablet, 24 h for the third, and the fourth from 24 to 36 h. At visit 3, the investigators evaluated the effectiveness with the same measures used at baseline. After a wash-out period, at visit 4, Group 1 was given tadalafil, and Group 2 was given sildenafil. Patients were required to observe the same criteria in taking the four tablets as in visit 2. After 4 weeks (visit 5), we evaluated the patients as we did in visit 3.. Overall, 28 patients completed the study. No subjects discontinued the drugs due to drawbacks. Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 h postdosing compared to sildenafil (P<0.01) and improved overall sex life satisfaction as well as sexual relations with partner.. Based on these data, tadalafil may have the potential to become an important treatment option for ED in SCI patients.. This study was not sponsored.

Topics: Carbolines; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Tadalafil; Time Factors; Vasodilator Agents

This open-label study investigated the efficacy of sildenafil citrate at 12 hours postdose among prior treatment responders.. Eight 100-mg doses of sildenafil were provided to 40 eligible patients with erectile dysfunction (ED), who were to record the results of each sexual attempt in a patient diary. Each patient was instructed to make a sexual attempt at 1 and 12 hours postdose on 4 occasions (part 1) and only at 12 hours postdose on 4 subsequent occasions (part 2).. Of 40 enrolled patients, 34 (85%) completed the study. In these evaluable patients, 97% and 74% of patients achieved erections that resulted in successful intercourse at 1 hour and 12 hours postdose, respectively. There was a nonsignificant reduction in the percentage of responders at 12 hours during part 1 versus part 2 of this study (71% versus 78%).. This study demonstrates that, in the majority of these patients with ED, sildenafil remains clinically active 12 hours after administration. Larger studies may be necessary to confirm and clarify the therapeutic window of sildenafil.

Topics: Adult; Dose-Response Relationship, Drug; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Medical Records; Middle Aged; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Time Factors; Treatment Outcome; Vasodilator Agents

Lack of sexual activity due to erectile dysfunction (ED) decreases testosterone (T) levels through a central effect on the hypothalamic-pituitary axis. In this paper we studied the effect of different type V phosphodiesterase (PDE5) inhibitor treatments for ED on the reversibility of this endocrine pattern.. Open-label, retrospective study.. Seventy-four consecutive patients were treated on demand with sildenafil (Sild) (50 mg) and tadalafil (Tad) 20 mg.. The success in sexual intercourse was recorded and total (tT) and free testosterone (fT) levels were studied before and after 3 months of treatment.. Basal level of tT and fT were at the bottom of the normal range and LH levels were at the top of the high normal range. After treatments, this endocrine pattern was reversed in both groups. However, the T increase in Sild-treated patients was significantly lower than in those treated with Tad (4.7 +/- 2.7 vs. 5.1 +/- 0.9, P < 0.001). fT levels followed a directly proportional pattern, while the inverse was found when LH production was studied. The intercourse rate reflected this effect: in fact, the Sild group showed a 4.9 +/- 2.9/month full sexual intercourse rate while in the Tad group a significantly higher rate of sexual intercourse was found (6.9 +/- 4.6/month, P = 0.04). However, drug consumption was comparable between the groups (Sild 4.9 +/- 2.9 vs. Tad 4.4 +/- 2.8 pills/month, P = 0.72).. As it is unlikely that the two drugs have a different direct effect on the pituitary-testis axis, this effect is probably due to the higher frequency of full sexual intercourse in the Tad-treated group, because of the drug's longer half-life.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Aged; Carbolines; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Luteinizing Hormone; Male; Middle Aged; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Retrospective Studies; Sildenafil Citrate; Sulfones; Tadalafil; Testosterone

To assess efficacy of sildenafil citrate in treatment of erectile dysfunction: effect of type 2 diabetes.. A total of 466 male patients with erectile dysfunction (ED) were enrolled in this study. Of them 382 were diabetic and 84 were non-diabetic. Patients were screened for ED using the erectile function domain of the International Index for Erectile Function (IIEF). Patients underwent routine laboratory investigations, in addition to total testosterone and prolactin assessment. To assess the effect of diabetes on efficacy of sildenafil, we compared the pre and post sildenafil responses to erectile function domain, Q3, Q4. Overall satisfaction and global efficacy question (GEQ) were also assessed.. Mean age +/- S.D. was 53 +/- 8.4 and 49.7 +/- 10.6 years for patients with and without diabetes respectively. There were significant associations between increased severity of ED and longer duration, poor metabolic control and presence of more than one diabetes-related complication (p < 0.05 for each). Differences were significant between pre and post sildenafil administration regarding erectile function domain, Q3, Q4 (p < 0.05 for each). In the non-diabetic patients the GEQ and the overall satisfaction were significantly higher than in diabetics (p < 0.05 for each). Global efficacy question was significantly low in patients with fair and poor metabolic control, longer duration of diabetes, and patients with diabetic complications (p < 0.05 for each).. Sildenafil is an effective treatment for diabetic patients with ED. Although the efficacy of sildenafil was negatively affected by factors as poor control and longer duration of diabetes and presence of more than one diabetes-related complication, however, the global efficacy and the overall patients' satisfaction were high.

Topics: Analysis of Variance; Diabetes Mellitus, Type 2; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

To investigate the efficacy and tolerability of oral propionyl-L-carnitine (PLC) plus sildenafil in men with erectile dysfunction (ED) and diabetes unresponsive to sildenafil monotherapy.. Patients with medically documented ED of organic or mixed aetiology and diabetes (type 1 and 2) were randomised to receive oral PLC (2 g/day) plus sildenafil (50 mg twice weekly) (20 patients, Group 1) or sildenafil alone (20 patients, Group 2), in a double-blind, fixed-dose study. All patients had been previously treated unsuccessfully with a minimum of eight administrations of sildenafil. Efficacy was evaluated using the International Index of Erectile Function (IIEF) questionnaire: total score, subscores for questions 3 (Q3; achieving an erection) and 4 (Q4; maintaining an erection) and global efficacy question (GEQ: 'Has treatment improved your erections?'). Patients Event Logs were also used.. After 24 weeks of treatment, mean scores for IIEF Q3 and Q4 had improved significantly in patients of Group 1 (4.25 +/- 0.63 and 3.95 +/- 1.0) compared with Group 2 (2.9 +/- 0.71 and 2.7 +/- 0.96) (p < 0.01). Moreover, the percentage of patients with improved erections (GEQ 68% vs. 23%) and successful intercourse attempts (76% vs. 34%) was significantly increased in Group 1 compared with Group 2 (p < 0.01). Fourteen (70%) patients in Group 1 and four (20%) in Group 2 reported an increase in mean IIEF EF domain score of > or = 4 (p < 0.01). Treatments were well tolerated and no patient discontinued study medication. Two patients in Group 1 reported mild gastric pain.. Salvage therapy with PLC plus sildenafil was more effective than sildenafil in the treatment of ED in patients with diabetes refractory to sildenafil monotherapy.

Topics: Carnitine; Diabetes Complications; Double-Blind Method; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

To explore the possible relationship between erectile dysfunction (ED) and benign prostate hyperplasia (BPH) in men, and to assess the positive effect of Sildenafil on the lower urinary tract symptoms (LUTS) from BPH while treating ED.. Thirty-two patients with ED and BPH were offered oral Sildenafil and reviewed before and six months after the administration of Sildenafil by the International Index of Erectile Function-5 (IIEF-5) and the International Prostate Symptom Score (IPSS) questionnaires. Scores were tested by chi-square.. IIEF-5 scores were increased by 42.36% and IPSS scores declined by 20.14%, with statistical significance (P < 0.01).. Treatment of ED with Sildenafil appears to improve urinary symptom scores. A lower IPSS at baseline seems to predict a better response to Sildenafil therapy for ED.

Topics: Aged; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatic Hyperplasia; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Urination Disorders

The aim of the present study was to show the efficacy and safety of sublingual sildenafil and to determine whether lower doses cause the same effect with a faster onset of action in this mode of application.. Forty consecutive patients with erectile dysfunction for more than three months were included in the study. The mean age was 55 years (range, 25-65). Serum glucose and testosterone levels, lipid profile and erectile function scores were obtained in all patients. Twenty patients received placebos and the other 20 patients received 20 mg sublingual sildenafil in a double blind randomized design.. The effect of sildenafil on erection was significantly higher than that of placebo. Sixty-five percent of patients (13/20) who received sublingual sildenafil achieved satisfying erections and coitus, whereas the rate was 15% in the placebo group (3/20). The mean onset of action with sublingual sildenafil was 15.5 min and lasted for an average of 40 min. Minimal headaches, sweating and flushing were noted as the side-effects.. 20 mg sublingual sildenafil is safe and effective in the treatment of erectile dysfunction. Sublingual administration has some advantages as it is not effected by food ingestion and quickly appears in the circulation. These advantages provide a faster onset of action with a lower dose when compared to oral sildenafil. Sublingual use of sildenafil may be more cost-effective and possibly provides a more predictable onset of action.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Sublingual; Adult; Aged; Dose-Response Relationship, Drug; Erectile Dysfunction; Flushing; Headache; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Sweating; Treatment Outcome

The pelvic floor muscles are active in normal erectile function. Therefore, it was hypothesised that weak pelvic floor muscles could be a cause of erectile dysfunction.. To compare the efficacy of pelvic floor muscle exercises and manometric biofeedback with lifestyle changes for men with erectile dysfunction.. Randomised controlled trial.. The Somerset Nuffield Hospital, Taunton, United Kingdom.. Fifty-five men with erectile dysfunction (median age 59.2 years; range 22-78 years) were enrolled from a local urology clinic. Of these, 28 participants were randomised to an intervention group and engaged in pelvic floor exercises, as well as receiving biofeedback and suggestions for lifestyle changes. Twenty-seven controls were solely advised on lifestyle changes. Baseline, 3- and 6-month assessments were: erectile function domain of International Index of Erectile Function (IIEF), Partner's International Index of Erectile Function (PIIEF), Erectile Dysfunction-Effect on Quality of Life (ED-EQoL), anal manometry, digital anal measurements, and clinical assessment by an assessor blind to treatment allocation. After 3 months, the control group were transferred to the active arm.. At 3 months, compared with controls, men in the intervention group showed significant mean increases in the erectile function domain of the IIEF (6.74 points, P = 0.004); anal pressure (44.16 cmH(2)O, P <0.001); and digital anal grades (1.5 grades, P <0.001). All showed further improvement in these outcomes at 6 months. Similar benefits were seen in men of the control arm after transfer to active treatment. A total of 22 (40.0%) participants attained normal function, 19 (34.5%) participants had improved erectile function, and 14 (25.5%) participants failed to improve.. Pelvic floor muscle exercises and biofeedback are an effective treatment for men with erectile dysfunction.

Topics: Adult; Aged; Biofeedback, Psychology; Erectile Dysfunction; Exercise Therapy; Humans; Male; Manometry; Middle Aged; Pelvic Floor; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

We established the efficacy and safety of sublingual apomorphine compared with oral sildenafil in comparable groups of patients with erectile dysfunction (ED).. This prospective, randomized, crossover study included 77 heterosexual men with ED of various etiologies and severities. A total of 62 men were randomized but only 34 were evaluable for efficacy and tolerability. The study started with a run-in period of 2 to 4 weeks. The first 4 weeks of treatment were followed by a washout period of 4 weeks, after which patients changed to the alternate treatment for an additional 4-week period. The sequence of the 2 treatments was established by a randomization list in blocks in closed packets. The primary efficacy end point was the percent of attempts resulting in erection firm enough for intercourse. Additional variables were the percent of attempts resulting in intercourse and improvement in ED, as evaluated by the erectile function domain score of the International Index of Erectile Function questionnaire.. Sildenafil was significantly more effective than apomorphine in regard to the percent of attempts resulting in erection firm enough for intercourse (85% vs 44%, p <0.0001) and actually resulting in intercourse (81% vs 43%, p <0.0001) as well as erectile function evaluated by the erectile function domain score of the International Index of Erectile Function (p <0.001). The incidence of adverse events was not significantly different for the 2 drugs. Although the number of patients was small, this study had strong statistical power due to the striking difference in results.. Sildenafil was significantly more effective than apomorphine for ED. No statistical difference in adverse events was noted.

Topics: Administration, Oral; Administration, Sublingual; Adult; Aged; Apomorphine; Cross-Over Studies; Dopamine Agonists; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) is a common sequel of pelvic fracture urethral disruption (PFUD). After repair of the urethral injury ED may be the most devastating long-term effect for the patient. Some patients with ED may regain normal erectile function. We prospectively studied the response to sildenafil and the erectile function of patients with ED due to PFUD.. The erectile function of patients referred to us with PFUD for urethroplasty were prospectively evaluated before surgery. Patients underwent nocturnal penile tumescence testing and, if results were abnormal, penile duplex ultrasonography with intracavernous injection and arteriography were performed to diagnose the etiology of ED. Patients were questioned about erectile function every 3 months after surgery and if they complained of ED they were offered 100 mg sildenafil. Patients were followed for at least 18 months after surgery.. A total of 29 consecutive patients were evaluated and 22 (76%) of them had ED before surgery. Sufficient followup was available for 15 of the patients. Overall 47% of these patients responded favorably to sildenafil. Of the patients 60% with neurogenic ED and 20% of those with arterial ED responded to this treatment. In 33% of the patients ED resolved within the followup period. All patients with spontaneous resolution of ED previously responded to sildenafil (71% of sildenafil responders).. In patients with ED due to PFUD, those with neurogenic ED are more likely to respond to sildenafil than those with arterial damage. Favorable response to sildenafil may predict spontaneous resumption of normal erectile function over time.

Topics: Adolescent; Adult; Algorithms; Erectile Dysfunction; Fractures, Bone; Humans; Male; Middle Aged; Pelvic Bones; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Urethra

Erectile dysfunction (ED) is common among men taking antihypertensive drugs to control blood pressure. We evaluated the safety and efficacy of sildenafil citrate for treating ED in men taking multiple antihypertensive medications in a randomized, double-blind, placebo-controlled trial.. A total of 568 men (> or =18 years) with ED and hypertension who were taking two or more antihypertensives were randomized to sildenafil (n = 281) or matching placebo (n = 287) for a 6-week double-blind trial followed by a 6-week open-label phase during which all patients received sildenafil. Primary efficacy variables were questions (Q) 3 and 4 (frequency of erections and penetration) of the International Index of Erectile Function (IIEF), and secondary efficacy variables were two global efficacy assessment (GEA) questions regarding improvement in erections and intercourse.. A total of 562 men (mean age, 59 years) took > or =1 dose of study drug. At week 6, mean scores on both Q3 and Q4 improved significantly among sildenafil-treated compared with placebo-treated patients. In regard to Q3 and Q4 there were no differences between patients taking two and those taking three or more antihypertensive agents. In all, 71% and 69% of sildenafil-treated patients reported improved erections (GEA1) and intercourse (GEA2) compared with 18% and 20% of placebo-treated patients, respectively. By week 12, >80% of all patients (regardless of initial treatment group) had improved erections and intercourse. During double-blind treatment, 40% of sildenafil-treated and 25% of placebo-treated patients experienced adverse events; fewer than 2% in each group discontinued because of adverse events.. Sildenafil was an effective and well tolerated treatment for ED in men receiving multiple antihypertensives. The results suggest that there were no additional safety risks associated with the use of sildenafil in these patients.

Topics: Adolescent; Adult; Aged; Antihypertensive Agents; Australia; Canada; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Europe; Humans; Hypertension; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; United States

To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil.. A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged > or = 18 years with moderate-to-severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4-week treatment-free run-in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ).. There was significantly better EF with vardenafil than with placebo throughout the study. The least-square mean EF domain scores increased from 9.3 at baseline to 17.6 at the 'last' observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least-square mean per-patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score > or = 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase-5 inhibitor profile.. Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Double-Blind Method; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

We undertook to determine if any significant differences in the efficacy of sildenafil citrate for erectile dysfunction (ED) exists between patients who have received external beam radiation or brachytherapy for prostate cancer.. Thirty-one patients who had received external beam radiation and nineteen patients who had received brachytherapy for prostate cancer and were subsequently treated with sildenafil citrate for post-irradiation ED comprised the patient population. A chart analysis was performed to determine either the presence or absence of concomitant risk factors for ED (coronary artery disease, diabetes, hypertension and smoking history) as well as age at radiation and time lapse between radiation completion and sildenafil citrate administration. Patients were then contacted to ascertain sildenafil citrate efficacy (defined as the continued use of sildenafil citrate), dosage used and medication tolerance.. Continued use of sildenafil citrate was reported by 12/19 (63%) of the brachytherapy patients and 7/31 (22%) of the external beam radiation patients, a significant difference (P<0.007). Of those with continued use of sildenafil citrate, the patients who had undergone external beam radiation had a longer mean period of use (33.7 months) than those who had been treated with brachytherapy (14.3 months) (P=0.006). The mean elapsed time between completion of radiation and administration of sildenafil citrate was 7.6 months and 21.6 months for the brachytherapy and external beam radiation patients respectively (P=0.002). A significant difference in mean age existed between the patient groups, with the external beam radiation group being significantly older (69.8 years and 65.1 years respectively, P=0.007) at the time of sildenafil citrate administration. Of the risk factors for ED examined in each patient group, none were found to predict treatment failure with sildenafil citrate. Of the patients who did not experience success with sildenafil citrate, both groups used the medication for comparable periods of time.. Sildenafil citrate improved ED in a significantly greater number of patients who had undergone brachytherapy over those who had received external beam radiation. However, the patients who had received external beam radiation were both older and experienced a longer lapse of time between completion of radiotherapy and administration of sildenafil citrate than the brachytherapy patient group. This may explain the poorer success in the external beam radiation patients. The success of sildenafil in both groups of patients was lower than has previously been reported.

Topics: Age Factors; Aged; Brachytherapy; Erectile Dysfunction; Humans; Male; Piperazines; Prostatic Neoplasms; Purines; Radiation Injuries; Risk Factors; Sildenafil Citrate; Sulfones; Vasodilator Agents

There are still no clinical predictive factors to determine the response rate of erectile dysfunction (ED) patients to sildenefil citrate. The aim of the present study is to evaluate and stratify the risk factors and attempted to determine the prognostic factors in clinical practice to predict the response rate. This is important in improving cost effectiveness and avoiding side-effects.. This is an open label prospective study including patients attending the andrology clinic in Tan Tock Seng Hospital, Singapore, over 2 years. The patients were evaluated and investigated for possible underlying causes and ED severity was assessed by five-items of the International Index of Erectile Function questionnaire (IIEF-5), together with the duration, degree and rigidity of erection. Psychogenic causes were excluded with a minimal follow up of 6 months. All patients were placed on 100 mg of sildenafil citrate and were reassessed at the end of 6 months. Logistic regression with univariate and multivariate was used as the method of statistical analysis.. A total of 232 patients were in the cohort. The overall response rate was 43%, with the best response rate in veno-occlusive cases and the worst responses from neurogenic causes. Age, smoking, diabetes mellitus, hypertension, hyperlipidemia, pretreatment IIEF-5 score, interval to achieve erection and duration of erection were significant in univariate analysis, but only age, smoking and IIEF-5 score were significant in multivariate analysis. With a combination of these factors, a table was formed to determine the possible response rate in clinical practice. This will assist physicians in selecting patients with potentially favorable responses and avoid side-effects and an unnecessary wastage of time and cost.. Possible factors could be determined and used clinically to predict the response rate to sildenafil citrate.

Topics: Age Factors; Aged; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Risk Factors; Severity of Illness Index; Sildenafil Citrate; Smoking; Sulfones; Treatment Outcome

Viagra (sildenafil citrate) has a rapid onset of action for the treatment of erectile dysfunction (ED). However, its duration of action has not been thoroughly investigated. Practical knowledge of the time window available for sexual intercourse would be valuable for couples planning sexual activity.. We investigated the duration of action of sildenafil in men with ED.. This was a double-blind, randomized, placebo-controlled, four-way crossover study of 16 men, mean age of 55 years (range, 36-68 years) with ED of no known organic cause. Participants received oral sildenafil (100 mg) or placebo 1, 8, or 12 hours before visual sexual stimulation (VSS). Measurements included the duration of erections of >or= 60% rigidity, assessed by penile plethysmography (RigiScan), and the proportion of sildenafil responders, defined as patients with erections of >or= 60% rigidity for >or= 4 minutes and >or= 50% improvement over erections achieved in their placebo arm. Self-assessed duration of grade 3 (hard enough for penetration) or grade 4 (fully hard) erections was also recorded.. At 1, 8, and 12 hours after dosing with sildenafil, the mean duration of erections with >or= 60% rigidity was 26, 11, and 8 minutes, respectively, compared with only 3 minutes after placebo dosing (P < 0.05). However, the mean duration of self-assessed erections was 33, 23, and 16 minutes, respectively, compared with 7 minutes after placebo dosing (P < 0.05), and was greater than that assessed by RigiScan. Of the 69% sildenafil responders at 1 hour, 82% responded at 8 hours and 45% responded at 12 hours after sildenafil administration.. Sildenafil improved objective and self-assessed erectile function in men with ED, and the duration of action of sildenafil was longer than that previously reported. These data suggest that sildenafil may be effective in a significant proportion of men with ED up to 12 hours after being taken.

Topics: Adult; Aged; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Flushing; Headache; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Placebos; Plethysmography; Purines; Sexual Behavior; Sildenafil Citrate; Sulfones; Time Factors; Treatment Outcome

Sexual dysfunction is a common adverse effect of antidepressants that frequently results in treatment noncompliance.. To assess the efficacy of sildenafil citrate in men with sexual dysfunction associated with the use of selective and nonselective serotonin reuptake inhibitor (SRI) antidepressants.. Prospective, parallel-group, randomized, double-blind, placebo-controlled trial conducted between November 1, 2000, and January 1, 2001, at 3 US university medical centers among 90 male outpatients (mean [SD] age, 45 [8] years) with major depression in remission and sexual dysfunction associated with SRI antidepressant treatment.. Patients were randomly assigned to take sildenafil (n = 45) or placebo (n = 45) at a flexible dose starting at 50 mg and adjustable to 100 mg before sexual activity for 6 weeks.. The primary outcome measure was score on the Clinical Global Impression-Sexual Function (CGI-SF); secondary measures were scores on the International Index of Erectile Function, Arizona Sexual Experience Scale, Massachusetts General Hospital-Sexual Functioning Questionnaire, and Hamilton Rating Scale for Depression (HAM-D).. Among the 90 randomized patients, 93% (83/89) of patients treated per protocol took at least 1 dose of study drug and 85% (76/89) completed week 6 end-point assessments with last observation carried forward analyses. At a CGI-SF score of 2 or lower, 54.5% (24/44) of sildenafil compared with 4.4% (2/45) of placebo patients were much or very much improved (P<.001). Erectile function, arousal, ejaculation, orgasm, and overall satisfaction domain measures improved significantly in sildenafil compared with placebo patients. Mean depression scores remained consistent with remission (HAM-D score < or =10) in both groups for the study duration.. In our study, sildenafil effectively improved erectile function and other aspects of sexual function in men with sexual dysfunction associated with the use of SRI antidepressants. These improvements may allow patients to maintain adherence with effective antidepressant treatment.

Topics: Adult; Antidepressive Agents; Depressive Disorder, Major; Double-Blind Method; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Selective Serotonin Reuptake Inhibitors; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction (ED) is common in men with renal failure, but is not always alleviated following kidney transplant. The objective of the present study was to assess the feasibility in renal transplant patients of sildenafil citrate treatment, an agent with proven efficacy in the management of ED.. This was a phase IV, open, multicentre, 3 month, dose-escalation study. All patients meeting the inclusion criteria were prescribed a dose of 50 mg sildenafil at the first visit. Thereafter the dose could be increased to 100 mg or reduced to 25 mg based on efficacy or tolerability. The primary efficacy parameter assessed the ability of patients to achieve erections sufficient for intercourse and to maintain erections after penetration. Secondary endpoints assessed patient satisfaction with sildenafil and the effect of sildenafil on their quality of life. Patients were carefully monitored throughout the study for adverse events, interactions with immunosuppressive therapy and effect on graft function.. The study included 50 patients in the intent-to-treat population. Sildenafil significantly improved patient's erection ability and the frequency of their erection maintenance. Analysis of the secondary efficacy parameters revealed that 66% of patients believed treatment had improved their erections. Patients reported improvements in their sexual life and partner relationships and a high level of satisfaction with treatment. There were no interactions between sildenafil and the immunosuppressive drugs and there was no significant adverse effect of sildenafil on graft function.. Sildenafil is an effective and well-tolerated agent for the treatment of ED in renal transplant recipients.

Topics: Dose-Response Relationship, Drug; Erectile Dysfunction; Feasibility Studies; Humans; Kidney Failure, Chronic; Kidney Transplantation; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Safety; Sildenafil Citrate; Sulfones; Treatment Outcome

In the 5-10% of diabetic men with type 1 diabetes, erectile dysfunction (ED) may be a particularly common and unwanted complication. This is the first study focusing exclusively on the effects of sildenafil in men with type 1 diabetes and ED.. A total of 188 patients were entered into a double-blind, placebo-controlled, parallel-group, flexible-dose study and were randomized to receive sildenafil (25-100 mg; n = 95) or placebo (n = 93) for 12 weeks. Efficacy was evaluated using questions three (Q3; achieving an erection) and four (Q4; maintaining an erection) from the International Index of Erectile Function (IIEF), a global efficacy question (GEQ; "Did treatment improve your erections?"), and a patient event log of sexual activity.. Improvements in mean scores from baseline to end-of-treatment for IIEF Q3 (35.7 vs. 19.9%) and Q4 (68.4 vs. 26.5%) were significant in patients receiving sildenafil compared with those receiving placebo (P = 0.0001). Moreover, the percent of improved erections (GEQ, 66.6 vs. 28.6%) and successful intercourse attempts (63 vs. 33%) was significantly increased with sildenafil compared with placebo. Improvements in sexual function were seen irrespective of the degree of ED severity. Adverse events were generally mild to moderate in severity, with headache (20 vs. 8%), flushing (18 vs. 3%), and dyspepsia (8 vs. 1%) reported more often in the sildenafil than in placebo-treated patients.. Treatment with sildenafil for ED was effective, resulting in an increased percentage of successful attempts at intercourse, and was well tolerated among men with type 1 diabetes.

Topics: Adult; Aged; Diabetes Mellitus, Type 1; Diabetic Angiopathies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

The objective of this study was to investigate if sildenafil influences the pharmacokinetics of nelfinavir. Five HIV-infected patients on steady-state nelfinavir-containing therapy were subject to pharmacokinetic sampling for nelfinavir concentration twice: without sildenafil and with sildenafil 25 mg as a single dose. There were no differences in the AUC, T(max), or C(max) of nelfinavir. In a similar design, two patients on indinavir and two patients on ritonavir combined with saquinavir were studied. In accordance with the literature, neither of these two treatments was affected. It is concluded that nelfinavir pharmacokinetics were unaffected by concomitant intake of a single dose of sildenafil.

Topics: Adult; Area Under Curve; Chromatography, High Pressure Liquid; Drug Interactions; Drug Therapy, Combination; Erectile Dysfunction; Half-Life; HIV Infections; HIV Protease Inhibitors; Humans; Indinavir; Male; Middle Aged; Nelfinavir; Piperazines; Purines; Ritonavir; Saquinavir; Sildenafil Citrate; Sulfones; Vasodilator Agents

To determine the treatment responsiveness of the disease-specific Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction.. The SEAR questionnaire was administered at baseline and at the end of the study in 93 patients with erectile dysfunction enrolled in a 10-week, open-label, flexible-dose (50-mg sildenafil, adjustable to 25 mg or 100 mg) trial. Changes from the baseline score were analyzed using the paired t test. The correlation between the changes from baseline on the SEAR questionnaire and the Erectile Function domain of the International Index of Erectile Function was examined.. Significant and meaningful differences (P = 0.0001) from baseline were observed in the two primary domains (Sexual Relationship and Confidence) and the two Confidence domain subscales (Self-Esteem and Overall Relationship). The magnitude of the change was quite high for most aspects (Sexual Relationship, effect size [ES] = 1.6; Confidence, ES = 1.0; Self-Esteem, ES = 1.1) and moderate for one (Overall Relationship, ES = 0.6). Changes in Erectile Function domain score correlated moderately with changes in the SEAR domain and subscale scores (Sexual Relationship, r = 0.69; Confidence, r = 0.48; Self-Esteem, r = 0.47; and Overall Relationship, r = 0.35; P

Topics: Adult; Aged; Comorbidity; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Quality of Life; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Vasodilator Agents

Sildnenafil citrate is a powerful phosphodiesterase type 5 isoenzyme; it is the first oral treatment to have had a significant success in treatment of erectile dysfunction (ED). After oral dosing on an empty stomach the pharmacological activity starts within 30 to 120 minutes (average 60 minutes) whereas the effect of this medication after a meal could be notably delayed. We evaluated the start of pharmacological activity in 30 patients affected by non-psychogenic ED after sublingual administration of Sildenafil citrate.. Patients participating in our study were all affected by ED whose etiology was assessed as vasculogenetic or diabetic. The study lasted 6 months. For the first 3 months patients were asked to take Sildenafil (50-100 mg) for oral administration, under normal everyday conditions, 30 minutes before planned sexual relations. During the second 3 months the patients were asked to take Sildenafil for sublingual administration (crushing the pill in the mouth and dissolving the drug under the tongue) 15 minutes before planned sexual relations. The patients did not know the purpose of the study.. An appreciable reduction in the start of pharmacological activity was reported during the time of sublingual administration. In fact, while throughout the first 3 months the average pharmacological onset was 62.8 minutes (DS +/- 16.8), during the second 3 months it was 29.3 minutes (DS +/- 8.1), the mean difference in the start of pharmacological activity was 35.3 (DS +/- 12.4). The results of T-student test for paired observation were T (29) = 15.629; p-value 0.00001. During the two modalities of administration no differences were noted in the efficacy or in the frequency of adverse events. All the patients declared they preferred the sublingual way because of faster onset.. Even though ours is a limited study, our clinical data points out that the sublingual administration of Sildenafil is useful because of the rapid onset unrelated to meals. All the patients were reported to appreciate this method of administration, particularly in the case of unplanned sexual relations.

Topics: Administration, Oral; Administration, Sublingual; Aged; Diabetes Complications; Eating; Erectile Dysfunction; Fasting; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Time Factors; Treatment Outcome; Vascular Diseases

To evaluate the efficacy and safety of sildenafil citrate (Viagra) in a randomized, double-blind, placebo-controlled, flexible-dose study in Thai men with erectile dysfunction of broad-spectrum etiology and more than 6 months' duration.. 125 patients aged 26 to 77 years were randomized at 4 centers in Thailand to receive either sildenafil citrate (50 mg initially, increased if necessary up to 100 mg or decreased to 25 mg depending on efficacy and/or tolerability) (n = 63) or a matching placebo (n = 62) taken on an 'as needed' basis approximately 1 hour prior to anticipated sexual activity for a period of 12 weeks. Efficacy was assessed by the patients' responses to the 15-question International Index of Erectile Function (IIEF), to questions on the event log of sexual activity, and to the global efficacy assessment question concerning improvement in erections.. At the conclusion of the study, both the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse and the secondary efficacy variables, which included the 5 separate domains of sexual functioning of the IIEF, the percentage of successful attempts at sexual intercourse, and the global efficacy assessment question concerning improvement in erections, were all significantly improved statistically by sildenafil in comparison with placebo except in the sexual desire domain which showed no difference. The percentage of successful attempts at sexual intercourse in the sildenafil group was 66.16 per cent while in the placebo group it was 33.05 per cent. The percentage of global efficacy assessment was improved in the sildenafil group by 82.5 per cent compared to 36.1 per cent in the placebo group. Adverse events considered treatment-related occurred in 19 patients (30.2%) receiving sildenafil and 7 (11.3%) receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache, and dizziness, which occurred in 14.3 per cent, 6.3 per cent, and 6.3 per cent of patients respectively. All events were mild in nature.. Sildenafil is a safe and effective treatment for erectile dysfunction of broad-spectrum etiology in Thai men. Its efficacy appears similar to that reported in other studies in Western populations.

Topics: Administration, Oral; Adult; Aged; Analysis of Variance; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Piperazines; Probability; Purines; Reference Values; Sildenafil Citrate; Sulfones; Thailand; Treatment Outcome

The efficacy and safety of sildenafil was evaluated in a randomiSed, double-blind, placebo-controlled, flexible-dose study in Korean men aged 28-78 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months duration. A total of 133 patients were randomised at six centres in Korea to receive either sildenafil (50 mg initially, increased if necessary to l00 mg or decreased to 25 mg depending on efficacy and tolerance) (n=66) or matching placebo (n=67) taken on an 'as needed' basis l h prior to anticipated sexual activity for a period of 8 weeks. At the end of this time, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the International Index of Erectile Function (IIEF) scale, (2) the percentage of successful intercourse attempts, and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P&<0.0001). Treatment-related adverse events occurred in 56.1% of patients receiving sildenafil and 20.9% receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache and abnormalities in colour vision (31.8, 22.7 and 6.1% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western populations.

Topics: Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Korea; Male; Middle Aged; Outpatients; Piperazines; Placebos; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Selective serotonin reuptake inhibitor (SSRI)-induced ejaculatory delay is a common problem that has no treatment with established efficacy. Sildenafil citrate is effective for erectile dysfunction and appears to be safe at doses up to 200 mg.. We enrolled men who were in remission from depression according to DSM-IV criteria and who reported that they had developed new-onset ejaculatory delay in the setting of SSRI treatment. Enrolled patients were instructed to use 25 mg of sildenafil 1 hour prior to sexual activity on at least 2 occasions. If this was not effective for the ejaculatory delay, they were instructed to increase the dose progressively up to a maximum of 200 mg. We compared baseline sexual functioning to 2 phases of open treatment: low-dose phase (sildenafil 25-100 mg) and high-dose phase (sildenafil 150-200 mg). The primary outcome measure was a modified, self-report Clinical Global Impressions (CGI) scale that was specific for erectile (CGI-EF) and ejaculatory (CGI-EJF) aspects of sexual function.. Twenty-one men (mean age = 56 years) with major depressive disorder (MDD) in remission and SSRI-associated ejaculatory delay enrolled in the study and received sildenafil. At baseline, 14 of 21(67%) had comorbid erectile dysfunction. At the low-dose phase follow-up assessment, 12 of 14 achieved full erectile dysfunction remission, and 4 of 21 achieved ejaculatory delay remission. Sixteen patients with persistent ejaculatory delay were eligible for the high-dose phase: 5 withdrew from the study, 4 increased to a maximum dose of 150 mg, and 6 increased to a maximum dose of 200 mg. The 1 patient who had clinically significant erectile dysfunction and ejaculatory delay reported improvement of both conditions after the high-dose phase. Of the 10 patients who had ejaculatory delay without significant erectile dysfunction and who chose to take high-dose sildenafil, 9 reported a significant clinical improvement in ejaculatory delay (CGI-EJF improvement score of 1 or 2) and 7 achieved full remission (CGI-EJF severity score of 1 or 2 and CGI-EJF improvement score of 1 or 2).. In this open clinical trial with men who had SSRI-induced ejaculatory delay, high-dose sildenafil appeared to be effective in reducing ejaculatory latency.

Topics: Adult; Aged; Depressive Disorder; Dose-Response Relationship, Drug; Drug Administration Schedule; Ejaculation; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Psychiatric Status Rating Scales; Purines; Selective Serotonin Reuptake Inhibitors; Sexual Dysfunctions, Psychological; Sildenafil Citrate; Sulfones; Treatment Outcome

Fifty-eight Nigerian outpatients with documented erectile dysfunction (ED) received open-label sildenafil citrate (Viagra) for 8 weeks. The 50-mg starting dose could be adjusted to 100 or 25 mg based on response and tolerability. The International Index of Erectile Function (IIEF) Questionnaire, a global efficacy question, and intercourse data recorded in a patient event log were used to assess efficacy. Frequency of penetration and maintained erection were both significantly enhanced (P<0.0001); 95% of patients reported improved erections and 81% of all attempts at intercourse were successful. Orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction also improved significantly (P&<0.0001). The most frequent adverse events (all-cause) were headache (17%) and myalgia (3%); only one patient discontinued treatment because of headache, which was considered unrelated to sildenafil. Oral sildenafil significantly improved erectile function and was well tolerated in this trial of Nigerian men suffering from ED. Our results are consistent with reports from other countries.

Topics: Adult; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Nigeria; Outpatients; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Although sildenafil citrate (Viagra) has demonstrated effectiveness in the treatment of erectile dysfunction (ED), the dosing regimens often used in clinical trials may not always match those employed in clinical practice. This study was undertaken to further assess the efficacy and safety of sildenafil taken as required in male outpatients 18 years of age and older with ED (n=71). It was conducted as a placebo-baseline-controlled, open-label, flexible dose-escalation study, with sildenafil (25,50, or 100 mg) administered for 8 weeks following a 4-week placebo run-in. Efficacy variables included questions 3 and 4 of the International Index of Erectile Function (IIEF), other IIEF domains, patient event logs, and quality-of-life (QOL) assessments. Treatment with sildenafil resulted in improvements from baseline in all IIEF domains analyzed (all P<0.0001), as well as overall QOL and amelioration of specific sexual and social relationships (all P&<0.0001). Sildenafil was well tolerated. One participant discontinued treatment because of adverse events. Results suggest that flexible dosing with oral sildenafil is safe and has beneficial effects on all indices of erectile function and QOL.

Topics: Adult; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Morocco; Outpatients; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

The efficacy of sildenafil citrate (Viagra), an oral agent for the treatment of erectile dysfunction (ED), has been demonstrated in global studies. This 12-week randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study assessed the efficacy and safety of sildenafil to treat ED in men in Egypt and South Africa. Men with ED of varied etiology were randomized to receive sildenafil 50 mg (n=128) or placebo (n=126); doses could be adjusted to 100 or 25 mg. Questions from the International Index of Erectile Function (IIEF) assessing the ability to achieve (Q3) and maintain (Q4) erections demonstrated a significant improvement with sildenafil compared with placebo (P<0.0001). Improved erections were reported by 74% of patients receiving sildenafil and 27% of those receiving placebo (P<0.0001). Headache, dyspepsia, and flushing were the most common adverse events in sildenafil-treated patients. These results are consistent with clinical trials in other countries. We conclude that sildenafil is an efficacious and well-tolerated treatment for men with ED in Egypt and South Africa.

Topics: Adult; Aged; Egypt; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; South Africa; Sulfones; Treatment Outcome; Vasodilator Agents

To determine the efficacy of sildenafil citrate (Viagra) in patients with erectile dysfunction after three-dimensional conformal external beam radiotherapy for prostate cancer.. Sixty patients treated with radiotherapy for prostate cancer at least 6 months previously, complaining of erectile dysfunction, and not using nitrates were entered into a double-blind, placebo-controlled, crossover study lasting 12 weeks. They received 50 mg of sildenafil or placebo for 2 weeks; at week 2, the dose was increased to 100 mg in the case of an unsatisfactory erectile response. At week 6, patients crossed over to the alternative treatment. Patients were then allowed to enter a 6-week open-label phase using 50 mg of sildenafil in the first 2 weeks, increasing the dose to 100 mg in the case of an insufficient erectile response in the following 4 weeks. Data were collected before trial entry (baseline evaluation) and every 2 or 4 weeks using the International Index of Erectile Function questionnaire. Any side effects were recorded. Two years later, all patients were approached by mail to evaluate their current sexual functioning and possible use of sildenafil.. All patients completed the double-blind, crossover study. For nearly all the International Index of Erectile Function questions, sildenafil caused a significant increase in mean scores from baseline. Placebo had no effect. Seventy-seven percent entered the open-label phase; they were the better responders in the double-blind phase. Sildenafil was as equally effective as in the double-blind phase. The side effects were mild or moderate and significantly decreased in the open-label period. Two years after trial entry, 24% still used sildenafil.. Sildenafil is relatively effective in patients with erectile dysfunction after three-dimensional conformal external beam radiotherapy for prostate cancer. New drugs and combination therapies are needed to improve outcome.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adenocarcinoma; Aged; Cross-Over Studies; Cyclic Nucleotide Phosphodiesterases, Type 5; Double-Blind Method; Drug Evaluation; Erectile Dysfunction; Follow-Up Studies; Health Surveys; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Prostatic Neoplasms; Purines; Radiation Injuries; Radiotherapy, Conformal; Safety; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

To further discuss the method of evaluating curative effect on erectile dysfunction(ED).. Clinical trials(Phase II) of sildenafil and phentolamine were both 8-week-long, randomized, double-blind and placebo-controlled. Not only the curative effect between each treatment group and placebo group but also between the treatment groups were compared. The dosage of sildenafil and phentolamine was respectively 50-100 mg and 40 mg.. Efficiency, success rate of sexual intercourse and general curative effect in sildenafil and phentolamine groups were respectively 79.17%, 75.00%, 83.33% and 52.38%, 85.71%, 52.38%. The result revealed a statistically significant (P < 0.05) improvement over placebo. But no obvious differences were shown between the two treatment groups(P > 0.05).. Most assessments of curative effect of ED drugs come from questionnaires answered subjectively by patients. The Lack of objective assessment criteria way lead to the non-conformity between trial results and clinical practices. So the curative effect of drugs shall be assessed more accurately and from more perspectives.

Topics: Adrenergic alpha-Antagonists; Double-Blind Method; Erectile Dysfunction; Humans; Male; Phentolamine; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

To determine the minimal time to successful intercourse after taking sildenafil citrate for erectile dysfunction (ED).. Male patients with ED (mean age 60 years; mean ED duration 7.0 years) who were successfully treated with sildenafil (100 mg) for 2 months or longer were randomized to sildenafil (n = 115) or placebo (n = 113) for 4 weeks of double-blind treatment. Using a stopwatch, patients recorded the time needed to obtain an erection hard enough for sexual intercourse after taking the study drug at least 2 hours after eating.. Within 14 and 20 minutes of sildenafil dosing, 35% and 51% of sildenafil-treated patients, respectively, versus 22% and 30% of placebo-treated patients, respectively, had an erection that led to successful intercourse (P <0.05 for both). The median time to erection leading to successful intercourse after sildenafil dosing was 36 minutes compared with 141 minutes for placebo.. In this study, slightly more than one half of a population of prior sildenafil responders achieved an erection that led to successful sexual intercourse within 20 minutes of sildenafil administration, suggesting that the onset of action of sildenafil can be less than 30 minutes in men with ED.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Coitus; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Piperazines; Purines; Reaction Time; Sildenafil Citrate; Sulfones

A blind, placebo-controlled, randomized trial showed clinical effectiveness of the preparation Impaza containing antibodies to endothelial NO synthase in ultralow doses. Impaza surpassed placebo, but was less potent than sildenafil in the ability to improve erectile function and other parameters characterizing sexual activity of men. Safety of Impaza was greater than that of other test preparations.

Topics: Adult; Aged; Antibodies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Young Adult

To determine the efficacy of sildenafil in patients with erectile dysfunction after external beam radiotherapy for prostate cancer.. Randomised, double-blind, placebo-controlled, crossover study.. A total of 406 patients with erectile dysfunction reported in their medical records who had completed external beam radiotherapy at least 6 months prior to the study, were approached by letter. Sixty patients were included in a study which lasted 12 weeks. They received 50 mg of sildenafil citrate or placebo for two weeks; during week 2 the dose could be increased to 100 mg in the case of unsatisfactory erectile response. At week 6 patients crossed over to the alternative treatment. Data were collected using the validated 'International index of erectile function' (IIEF) questionnaire, and side-effects were recorded. Patients were given the possibility of continuing to a 6-week open-label phase.. The mean age of those participating was 68 years. All patients completed the double-blind phase. For the majority f questions in the IIEF questionnaire, there was a significant increase in mean scores from baseline with sildenafil, but of the patients with sildenafil, versus 18% with placebo. Ninety percent of the patients required a dose adjustment to 100 mg sildenafil, and 100% of the patients in the placebo group increased the dose. Side-effects were mild or moderate. Patients who proceeded to the open-label phase reported the same results as in the double-blind phase.. Sildenafil improved erectile function in about half of the patients with erectile dysfunction after external beam radiotherapy for prostate cancer, and it was well tolerated.

Topics: Aged; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prostatic Neoplasms; Purines; Radiation Injuries; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Vasodilator Agents

To evaluate the efficacy and safety of sildenafil in the treatment of erectile dysfunction in hypertensive patients taking antihypertensive drugs, and to investigate factors associated to treatment failure.. Observational prospective study comparing two groups of patients suffering from erectile dysfunction with or without hypertension. Patients were evaluated by anamnesis, physical examination, blood tests, and the International Index of Erectile Function (IIEF). Blood pressure was measured before and after treatment with an automatic digital oscillometric device.. Erections improved in 88.2% and 91.7% of the patients with an without hypertension respectively. On the initial visit 55.2% of all patients had severe dysfunction, which was reduced after sildenafil treatment to 4.7%. Diastolic arterial blood pressure, evaluated in random measures, was slightly reduced after starting treatment with Viagra. No significant adverse events were registered.. Oral treatment with sildenafil in patients with erectile dysfunction and hypertension is effective, well-tolerated and does not produce pharmacologic interactions with antihypertensive drugs.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Erectile Dysfunction; Humans; Hypertension; Male; Middle Aged; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

The aim of this study was to evaluate whether sildenafil, used for treatment of erectile dysfunction (ED), affects the exercise tolerance and ischaemic threshold in men with exercise-induced angina not taking nitrates.. This was a double-blind placebo-controlled study in men with ED and chronic stable angina, assessing the effect of sildenafil on time to limiting angina during incremental treadmill exercise. Patients remained on their antianginal therapy and received a 100-mg dose of sildenafil or placebo 1h prior to treadmill exercise. Other measurements included times to onset of angina, 1-mm ST-segment depression, and total exercise time.. Adjusted treatment differences for the time to limiting angina, time to onset of angina, total exercise time, and time to 1-mm ST-segment depression were (mean+/-SE) 20+/-10s (95% CI, 1-39; P=0.040), 32+/-11s (95% CI, 11-53; P=0.004), 20+/-10s (95% CI, 0-39; P=0.049), and 12+/-17s (95% CI, -21 to 45, P=0.48), respectively, in favour of sildenafil. There were no serious treatment-related adverse events.. Sildenafil was well tolerated and did not adversely affect any exercise parameter in men with coronary artery disease and ED. Favourable trends in total exercise duration and times to onset of angina and limiting angina were recorded with sildenafil use.

Topics: Adolescent; Adult; Aged; Angina Pectoris; Chronic Disease; Double-Blind Method; Erectile Dysfunction; Exercise Test; Exercise Tolerance; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

To assess the long-term sexual potency and attrition in sexual function after iodine-125 ((125)I) seed radiotherapy and the effect of sildenafil on radiation-induced erectile dysfunction (ED).. This prospective study consisted of 86 sexually active patients (mean age 63.5 +/- 7.7 years) who underwent (125)I seed implantation from 1997 to 1999 to treat low-volume prostate cancer (prostate-specific antigen less than 10 ng/mL, Gleason score 6 or less, stage T1-T2). All patients were followed up every 6 to 8 months for 4 years. Patients prescribed sildenafil citrate for ED completed the abridged five-item version of the International Index of Erectile Function (IIEF) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaires.. The median follow-up was 49.7 months (range 36 to 66). Of 86 patients, 43 (50%) did not initiate drug therapy; and only 36 (83.7%) of the 43 were interviewed at 4 years. Twenty-three (63.8%) of the 36 patients had erections sufficient for vaginal penetration, with a total mean +/- SD IIEF-5 score of 15.76 +/- 1.13. The other 50% (43 of 86) initiated sildenafil citrate for treatment of ED after seed implantation, with a minimal follow-up of 6 months. At 4 years, 32 (74%) of the 43 were responding positively to sildenafil citrate, with a total IIEF-5 score of 18.3 +/- 1.2. The mean EDITS +/- SD score was 76.5 +/- 3.2, and the spousal satisfaction rate was 72% (31 of 43). The dropout rate was 37% (16 of 43); 10 (63%) of the 16 discontinued because of a lack of efficacy, 3 (19%) because of a return of natural erections sufficient for vaginal penetration, and 3 (19%) discontinued because of side effects (headaches).. ED is a major long-term issue after (125)I seed radiotherapy, with a long-term potency rate of 29%. Sildenafil citrate improves erections in most patients after (125)I seed implantation.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Brachytherapy; Erectile Dysfunction; Follow-Up Studies; Headache; Humans; Iodine Radioisotopes; Male; Middle Aged; Patient Satisfaction; Piperazines; Prospective Studies; Prostatic Neoplasms; Purines; Severity of Illness Index; Sexual Partners; Sildenafil Citrate; Sulfones; Vasodilator Agents

Treatment satisfaction, subanalysed by demographic variables, was evaluated in patients switching from successful intracavernosal prostaglandin E(1) (PGE(1)) therapy to oral sildenafil citrate. The validated Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire was administered at the end of PGE(1) therapy and after 12 weeks of sildenafil treatment in a multicentre, open-label study. Men with erectile dysfunction (n=176) who were switched from stable PGE(1) therapy to sildenafil (25-100 mg) were equally satisfied with onset of action, duration of action, and confidence in ability to engage in sexual activity, but expressed greater overall treatment satisfaction with sildenafil (P<0.01), better ease of use (P<0.001), naturalness of erectile process (P<0.001), and intention to continue treatment (P<0.001). Partners (n=32) were overall more satisfied with sildenafil (P<0.05), and their responses correlated with patient satisfaction (r=0.68). Compared with PGE(1) injection, these data suggest that patients may be less likely to discontinue taking sildenafil treatment for their erectile dysfunction.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Alprostadil; Erectile Dysfunction; Humans; Injections; Male; Middle Aged; Patient Satisfaction; Piperazines; Prognosis; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor approved in >30 countries for the treatment of erectile dysfunction (ED). It has been shown to improve erectile function compared with placebo in Phase III studies, but clinical experience comparing tadalafil with the PDE5 inhibitor sildenafil citrate is lacking.. This study compared patient preference for tadalafil 20 mg or sildenafil 50 mg during initial treatment for ED. It also compared the tolerability of the 2 agents at these doses.. This randomized, double-blind, fixed-dose, 2-period crossover trial took place at 13 sites in the United States and Germany. Patients were randomized 1:1 to receive 4 weeks of treatment with tadalafil 20 mg or sildenafil 50 mg, followed by the alternative treatment, to be taken as needed up to once daily before sexual activity.. The study enrolled 215 men with ED, 109 randomized to the tadalafil-sildenafil sequence and 106 to the sildenafil-tadalafil sequence. Their mean age was 49.8 years; 84.7% were sildenafil naive and 15.3% had undergone a previous inadequate trial of sildenafil. Most patients had moderate ED (60.5%) of >or=1 year's duration (74.9%). Of 190 evaluable patients, 126 (66.3%) preferred to initiate treatment with tadalafil, compared with 64 (33.7%) with sildenafil (P < 0.001). Patients' preference did not differ by age, duration of ED, treatment sequence, or previous sildenafil exposure. Both medications were well tolerated, with no significant differences in the incidence of treatment-emergent adverse events. Headache (11.2% tadalafil, 8.8% sildenafil), dyspepsia (6.0% and 4.2%, respectively), nasopharyngitis (4.7% and 2.8%), and flushing (2.8% and 4.7%) were the most common adverse events. The rate of ocular disturbances was low: 1 patient experienced intermittent bilateral reduction in visual acuity with tadalafil, and 2 exhibited conjunctival hyperemia or eyelid edema with sildenafil.. Tadalafil 20 mg was preferred to sildenafil 50 mg for the initiation of ED therapy in this study population. Both medications were well tolerated.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Carbolines; Cross-Over Studies; Cyclic Nucleotide Phosphodiesterases, Type 5; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil

Three inhibitors of phosphodiesterase 5 (PDE5) are now available for the treatment of erectile dysfunction (ED): sildenafil citrate, vardenafil, and tadalafil. Pharmacologic differences between these compounds may result in patient preferences for one over another and may influence treatment decisions made by the physician and patient. Therefore, clinical research is needed to investigate whether individual properties of the PDE5 inhibitors play a role in shaping patient preference.. The goal of this study was to determine what proportion of ED patients currently taking sildenafil would, after a period of treatment with tadalafil, elect to resume treatment with sildenafil at the customary dose and what proportion would elect a switch to tadalafil 20 mg for a longer period. The tolerability of both treatments was also investigated.. This was a short-term, multicenter, open-label, 1-way crossover trial conducted in Sweden and Italy. Eligible patients included men aged >or=18 years with a minimum 3-month history of ED who had been taking sildenafil at stable fixed doses of 25, 50, or 100 mg as needed for at least 6 weeks and up to 24 weeks. The study consisted of 6 phases: a 1-week screening phase, a 3-week sildenafil assessment phase, a 1-week washout phase, a 6-week tadalafil initiation phase, a 3-week tadalafil assessment phase, and a 6-month extension phase, during which patients received their treatment of choice free of charge. The primary outcome measure was the proportion of patients electing to take sildenafil or tadalafil during the extension phase.. Of 155 men enrolled, 147 (97.8%) completed the assessment phases of the trial. Of these 147 men, 133 (90.5%) elected to receive tadalafil in the 6-month extension phase and 14 (9.5%) elected to receive sildenafil (P < 0.001). The proportions preferring tadalafil to sildenafil were similar irrespective of age group (>or=50 years, 92%; <50 years, 90%), severity of ED (mild, 95%; moderate, 88%; severe, 96%), etiology of ED (psychogenic, 94%; organic, 91%; mixed, 87%), and sildenafil dose at study entry (50 mg, 90%; 100 mg, 89%). Both medications were well tolerated. The most common treatment-emergent adverse events occurring in >or=2% of patients during the tadalafil assessment phase included headache (4.8%), nasal congestion (4.1%), dyspepsia (3.4%), flushing (2.7%), back pain (2.0%), diarrhea (2.0%), and nausea (2.0%); the most common treatment-emergent adverse events during the sildenafil assessment phase were flusing (7.1%), nasal congestion (6.5%), headache (4.5%), and nasopharyngitis (3.2%).. In this short-term, open-label study, patients who were currently taking sildenafil for ED and then received tadalafil preferred to continue oral therapy with tadalafil over sildenafil by a ratio of approximately 9:1. Although the study sought to mimic the experience of actual patients receiving treatment for ED, the results are subject to potential limitations due to the design of the study, which included differences in dosing instructions and dosages for sildenafil and tadalafil. Both sildenafil and tadalafil were well tolerated.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Aged; Carbolines; Cross-Over Studies; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Italy; Male; Middle Aged; Patient Satisfaction; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Sweden; Tadalafil

Flow-mediated dilatation (FMD), induced by occlusion of the brachial artery, is an index of nitric oxide-dependent endothelial function that is impaired in patients with type 2 diabetes. Sildenafil (Viagra) is an inhibitor of phosphodiesterase 5 (PDE-5), which is used for management of erectile dysfunction in a broad range of patients, including those with type 2 diabetes. Its effects on endothelial function in these patients have not been previously assessed.. We assessed the acute and prolonged effects of a low dose of sildenafil (25 mg) on FMD in patients with type 2 diabetes. We performed a double-blind, placebo-controlled cross-over trial in 16 patients (14 of whom completed the study) with type 2 diabetes who had erectile dysfunction without overt clinical heart disease.. In these patients, the mean +/- SD brachial artery diameter (BAD) measured by ultrasound was 4.33 +/- 0.6 mm. After inducing FMD, the BAD increased 8% to 4.66 +/- 0.6 mm (P = 0.2). One hour after oral administration of sildenafil 25 mg, FMD increased the BAD significantly by 15% to 4.99 +/- 0.5 mm (P < or = 0.01), whereas it did not change with placebo (4.6 +/- 0.6 mm, P = 0.1). After treatment with sildenafil 25 mg daily for 2 weeks and testing 24 h after the last dose, the mean FMD was 14% (P = 0.01). In contrast, the mean FMD with placebo was 9% (P = 0.45).. We conclude that acute and prolonged sildenafil treatment has a favorable effect on brachial artery flow-mediated dilatation that persists for at least 24 h after the last dose. Further investigation is needed to determine whether this prolonged effect has clinical implications in patients with type 2 diabetes.

Topics: Adult; Brachial Artery; Cross-Over Studies; Diabetes Mellitus, Type 2; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prospective Studies; Purines; Regional Blood Flow; Sildenafil Citrate; Sulfones; Vasodilation; Vasodilator Agents

Our objectives were: (1) to determine the efficacy, safety, and tolerability of sildenafil citrate (Viagra) administered to men with broad-spectrum erectile dysfunction (ED) in southern Latin America; and (2) to correlate Rigiscan measurements assessing ED etiology with the investigator's assessment. A total of 141 men with broad-spectrum ED (mean age 57) were enrolled in a randomized, 12-week, double-blind, placebo-controlled, flexible-dose escalation study of sildenafil. After the 12-week treatment period, the mean score for the primary efficacy variables had risen significantly: for the sildenafil group, 66.2% from baseline for question 3 of the International Index of Erectile Function and 77.6% for question 4, vs 15.1% and 21.2% for the placebo group, respectively (P<0.0001). Rigiscan data confirmed investigator assessments of etiology. Headache and flushing, usually mild and transient, were the most common adverse events. Sildenafil was an effective, well-tolerated treatment for men in southern Latin America with broad-spectrum ED.

Topics: Aged; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Humans; Latin America; Male; Middle Aged; Piperazines; Placebos; Purines; Safety; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

A 12-week, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of flexible-dose sildenafil citrate (Viagra) treatment (25, 50 or 100 mg) in Brazilian and Mexican men with erectile dysfunction (ED) of broad-spectrum etiology. Efficacy was assessed on the basis of responses to the 15-item International Index of Erectile Function (IIEF) questionnaire, completed at baseline and after 12 weeks of treatment. At end point, mean scores for all IIEF domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) were significantly (P<0.0001) higher in the sildenafil group (n=109) than in the placebo group (n=105). These findings confirm the significant increases in frequency of penetration and frequency of maintained erections reported previously. Sildenafil treatment was well tolerated. The most common adverse events were headache and flushing. In conclusion, sildenafil is a well-tolerated and effective treatment for ED of broad-spectrum etiology in Latin American men.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Brazil; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Libido; Male; Mexico; Middle Aged; Orgasm; Patient Satisfaction; Piperazines; Purines; Safety; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

The objective of this work was to assess the efficacy and safety of sildenafil in patients with erectile dysfunction (ED) from Colombia, Ecuador, and Venezuela. One hundred and fifty-eight outpatients with ED participated in a double-blind, flexible-dose, randomized-controlled trial. Efficacy measures included question 3 (achieving an erection) and question 4 (maintaining an erection) from the International Index of Erectile Function (IIEF), the five functional domains of the IIEF, a global efficacy question, and patient event log. Sildenafil increased patients' ability to achieve/maintain erections (P<0.01). Seventy-seven per cent of sildenafil- vs 46% of placebo-treated patients reported improved erections (P<0.001). Sixty-five percent and 35% of intercourse attempts were successful among sildenafil and placebo patients, respectively (P<0.05). Sildenafil patients showed significant improvements in three of the five IIEF functional domains (P<0.05). Adverse events were reported for 51% and 33% of sildenafil and placebo patients, respectively. It can be concluded that sildenafil is an effective, well-tolerated treatment for ED in patients from Latin America.

Topics: Administration, Oral; Adult; Aged; Colombia; Dose-Response Relationship, Drug; Double-Blind Method; Ecuador; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Placebos; Purines; Safety; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents; Venezuela

This open-label, multi-center study from Mexico compared the efficacy and safety of oral sildenafil and phentolamine in men with erectile dysfunction. Patients received sildenafil (25-100 mg; n=123) or phentolamine (40 mg; n=119) for 8 weeks, and efficacy was assessed using the International Index of Erectile Function (IIEF) as well as two global efficacy questions. Mean scores for the erectile function domain of the IIEF were significantly higher for sildenafil (27.23 +/- 0.62; P=0.0001) than for phentolamine (19.35 +/- 0.66). Approximately twice as many men receiving sildenafil had successful attempts at sexual intercourse (88% vs 42%), improved erections (95% vs 51.1%), and improved ability to have sexual intercourse (94.4% vs 46.4%) compared with phentolamine. The most common adverse events included rhinitis, headache, tachycardia, and nausea, with a higher frequency reported in patients receiving phentolamine than sildenafil (41% vs 33%), with the exception of headache, which was reported more frequently in sildenafil users. Overall, sildenafil was more effective and appeared to be better tolerated than phentolamine for the treatment of erectile dysfunction.

Topics: Administration, Oral; Adolescent; Adrenergic alpha-Antagonists; Adult; Aged; Aged, 80 and over; Coitus; Erectile Dysfunction; Humans; Male; Mexico; Middle Aged; Phentolamine; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Erectile dysfunction (ED) is common in patients with congestive heart failure (CHF). ED reduces quality of life, and it may affect compliance, thereby impairing the success of CHF treatment.. In the first phase (fixed-dose double-blind, randomized, placebo-controlled, two-way crossover study), we studied in 23 men with CHF the effects of 50 mg sildenafil on exercise and neurohormonal activation. Patients underwent a treadmill 6-minute cardiopulmonary walking (6'WT) test followed by a maximal cardiopulmonary exercise test (ET). In the second phase, patients received sildenafil, taken as required for ED. Sildenafil reduced the heart rate (HR) (bpm) before the 6'WT (from 75+/-15 to 71+/-14, P=0.02) and ET (from 75+/-15 to 71+/-15, P=0.02); the systolic blood pressure (mm Hg) before the 6'WT (from 116+/-18 to 108+/-18, P=0.004) and ET (from 116+/-15 to 108+/-17, P=0.001); the diastolic blood pressure before the 6'WT (from 69+/-9 to 63+/-11, P=0.01) and ET (from 70+/-8 to 65+/-10, P=0.004); and the Ve/VCO2 slope during the 6'WT (from 32+/-7 to 31+/-6, P=0.04) and ET (from 33+/-8 to 31+/-5, P=0.03). Sildenafil attenuated the HR increment during the 6'WT (P=0.003) and ET (P=0.000). Sildenafil increased the peak *O2 from 16.6+/-3.4 to 17.7+/-3.4 mL/kg per min (P=0.025) and the exercise time from 12.3+/-3.4 to 13.7+/-3.2 minutes (P=0.003). Sildenafil improved most scores of International Index of Erectile Function.. Sildenafil was tolerated and effective for ED treatment in CHF, and improved the exercise capacity. The reduction of HR during exercise with sildenafil could theoretically decrease the myocardial oxygen consumption during sexual activity.

Topics: Administration, Oral; Blood Pressure; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Exercise Test; Exercise Tolerance; Heart Failure; Heart Rate; Humans; Male; Middle Aged; Norepinephrine; Oxygen Consumption; Patient Satisfaction; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Our purpose was to assess the efficacy and safety of sildenafil as a treatment for erectile dysfunction in hypertensive patients, and to investigate those factors associated with a treatment failure.. Open, prospective study including 114 patients suffering from erectile dysfunction plus arterial hypertension who were evaluated by anamnesis, physical examination, blood tests including glycemia and lipidic and hormonal profiles, penile colour Doppler ultrasonography after intracavernosal prostaglandin E1 (PGE1) injection, and the Sexual Health Inventory for Men (SHIM). Efficacy of sildenafil was assessed by administering again the SHIM and by means of a global assessment questionnaire. Side effects were also recorded. Factors influencing treatment outcome were evaluated by univariate and multivariate statistical analysis.. Overall, sildenafil was effective in 59.2% of 103 eligible patients. Efficacy in patients with psychogenic erectile dysfunction was 75%, whereas in those with an organic etiology, the efficacy was 50.7%. Age, diabetes mellitus, nocturnal penile tumescence, response to intracavernosal PGE1 injection and erectile dysfunction severity (defined by the SHIM basal score) significantly influenced treatment response (p < 0.05) after an univariate analysis. The multivariate analysis, however, selected only diabetes mellitus and severity of erectile dysfunction as the prognostic factors. No severe side effects were noticed.. Sildenafil is a rather effective and well-tolerated treatment for erectile dysfunction in hypertensive patients. Baseline severity of erectile dysfunction and diabetes mellitus represent the prognostic factors most significantly associated with treatment outcome.

Topics: Erectile Dysfunction; Humans; Hypertension; Male; Middle Aged; Multivariate Analysis; Piperazines; Prognosis; Prospective Studies; Purines; Regression Analysis; Sildenafil Citrate; Sulfones; Vasodilator Agents

The aim of this study was to evaluate the efficacy and safety of oral sildenafil to treat erectile dysfunction (ED) in chronic renal failure in patients on hemodialysis (HD). A double-blind, randomized, placebo-controlled study of oral sildenafil (50 mg) administered as required in HD patients with ED was designed. Patients on HD for at least 6 mo and who had a stable relationship with a female sexual partner were included. Patients older than 70 yr with penile anatomic abnormalities, cirrhosis, diabetes, angina, severe anemia, and those who were on nitrate treatment or with a recent history of stroke or myocardial infarction were not included. The International Index of Erectile Dysfunction (IIEF) was employed to evaluate ED and treatment response. Forty-one patients were evaluated (21 received placebo, and 20 sildenafil). Baseline clinical and demographic parameters were similar in both groups. Sildenafil was associated with improvement in the score of all questions and domains of the IIEF, except those related to sexual desire. Using the erectile function domain to evaluate primary efficacy, improvement was observed in 85% of the sildenafil patients compared with 9.5% of placebo patients. Sildenafil use resulted in normal EF scores in 35% of sildenafil patients. Sildenafil was well tolerated. Headaches and flushing occurred in both groups. Dyspepsia was reported by two patients in the sildenafil group. In conclusion, oral sildenafil seems to be an effective and safe treatment for ED in selected patients with chronic renal failure on hemodialysis.

Topics: Administration, Oral; Adult; Double-Blind Method; Erectile Dysfunction; Humans; Kidney Failure, Chronic; Male; Middle Aged; Piperazines; Purines; Renal Dialysis; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

The objective of this study was to assess the efficacy and safety of sildenafil citrate (Viagra) in black American and Hispanic American men with erectile dysfunction (ED) of broad-spectrum etiology. A total of 246 black American and 197 Hispanic American men were randomized to sildenafil (50 mg, adjustable to 25 mg or 100 mg, depending on efficacy and tolerability; n = 124 and n = 99, respectively) or matching placebo (n = 122 and n = 98, respectively). After 6 weeks, patients were given the option of switching to the other blinded treatment for the following 6 weeks. The 12 weeks of double-blind treatment were followed by 12 weeks of open-label extension. Despite differences in prevalence of hypertension, diabetes mellitus, hyperlipidemia, and use of concomitant antihypertensive agents between the 2 study groups, sildenafil was efficacious and well tolerated. After 6 weeks, scores for questions 3 and 4 from the International Index of Erectile Function (IIEF) were significantly higher among sildenafil-treated black and Hispanic patients than in placebo-treated patients. In addition, compared with placebo, a significantly larger proportion of sildenafil patients reported improved erections and improved ability to have sexual intercourse. When efficacy results were stratified by ED severity or number of risk factors, scores for IIEF questions 3 and 4 were lower in men with severe ED versus mild-to-moderate ED. Similarly, the percentage of patients reporting improved erections decreased with ED severity and number of risk factors. The proportion of patients switching to the other treatment after 6 weeks was significantly higher in the placebo group (71% to 85%) than in the sildenafil group (27% to 28%). The most common adverse events included headache and vasodilation, which were mild to moderate in nature and were comparable between groups. These data demonstrate that despite differences in prevalence rates of comorbidities, efficacy and safety of sildenafil is maintained across different ethnic groups.

Topics: Adult; Black or African American; Coitus; Double-Blind Method; Erectile Dysfunction; Hispanic or Latino; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

To evaluate the outcome of treatment in patients with erectile dysfunction (ED) using sildenafil or intracavernosal injection of prostaglandin E1(PGE1).. 54 patients with ED were randomly classified into two groups and received either oral sildenafil (group A) or intracavernosal injection of PGE1(group B) for 4-9 months with an average of 6 months.. The percentages of efficacy in the two groups were 80.0% and 83.3%, respectively. There was no statistical difference between group A and B (P > 0.05). Two of six patients who did not respond to sildenafal in group A achieved erections sufficient for sexual intercourse when the six patients received intracavernous injection of PGE1. None of the four patients who did not respond to intracavernous injection of PEG1 in group B achieved erection sufficient for sexual intercourse when they received oral sildenafil.. Both oral sildenafil and intracavernous injection of PGE1 are effective for patients with ED of various etiologies. The patients who do not respond to sildenafil can receive intracavernous injection therapy. The satisfactory results can probably achieved.

Topics: Administration, Oral; Adult; Aged; Alprostadil; Drug Administration Routes; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

To discuss the therapeutic choices of erectile dysfunction (ED) and to improve the therapeutic efficacy for different ED cases.. Two hundred and twenty-seven patients with ED were treated repectively with psychological treatment(31 cases), oral testosterone(30 cases), Viagra(121 cases), psychological treatment + Viagra (16 cases), intraurethral PGE1 (8 cases) and intracavemous injection(21 cases).. Among those ED patients, 142 (62.6%) cases reported improved erections after they had undergone above-mentioned therapies. The improved patients include 12 cases(38.7%) with psychological treatment, 9 cases (30.0%) with oral testosterone, 91 cases (75.2%) with Viagra, 13 cases (81.3%) with psychological and Viagar, 2 cases (25.0%) with intraurethral PGE1 and 21 cases (71.4%) with intracavemous injection.. ED is a highly individualized disease, therapeutic choices of ED based on patient's situation can benefit those patients.

Topics: Administration, Oral; Adult; Aged; Alprostadil; Combined Modality Therapy; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Psychotherapy; Purines; Sildenafil Citrate; Sulfones; Testosterone; Treatment Outcome; Vasodilator Agents

To assess the acceptance, long term efficacy and preference of Sildenafil in impotent patients previously on auto-intracavernosal therapy.. The patients were the 107 men (mean age 58.4 y) on auto-intracavernosal therapy (auto-IC) for more than 6 months (mean duration 32.7 months >12 months in 100) who were consecutively seen within 6 months of the launch of Sildenafil in France. If there was no contra-indications to Sildenafil they were proposed a trial of Sildenafil at home. Following this trial they were given the possibility to change their therapy and were followed for 1 y at 3 months intervals.. Three patients had contra-indications to Sildenafil. Of the remaining 104, 45 (43%) refused the trial, mainly because they were afraid of possible cardiac risks (n=21, including 51% of the psychogenic and mixed patients compared to 8% of the predominantly organic ones). Among the 59 who tried it, Sildenafil gave good results in 46 (78%), including 100% of the predominantly psychogenic and 61.5% of the predominantly organic ones) with minimum effective doses of 25 mg in 7, 50 mg in 18 and 100 mg in 21. It failed in 9 (15%) and gave average results in 4 (penetration with a non fully satisfying erection). There was a clear relationship between the sensitivity to Sildenafil and that to Alprostadil, the vasoactive agent predominantly used for the auto-ICIs. Every 46 patients with good result of Sildenafil elected to continue with this drug, including 3 who used both Sildenafil and auto-ICIs in alternance. Every 4 patients with average results elected to continue with auto-ICI including 1 who also used Sildenafil in alternance. Five of the 50 patients with good or average results were lost to follow-up within 6 months. At the 1 y follow-up visit, 43 of the 45 others were still using Sildenafil, in alternance with auto-ICI in 1. No one reported a decrease in efficacy with time. The 2 patients with average results still in the study were on auto-ICIs.. Sildenafil is highly effective in the impotent men previously treated with auto-ICI and its efficacy is maintained at least for 1 y. When tried and effective it is preferred by most men but almost half of our patients refused trying it.

Topics: Adult; Aged; Alprostadil; Erectile Dysfunction; Follow-Up Studies; Humans; Injections; Male; Middle Aged; Patient Acceptance of Health Care; Patient Satisfaction; Penis; Phosphodiesterase Inhibitors; Piperazines; Purines; Retreatment; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

The objectives of this study were to evaluate the efficacy and tolerability of high dose sildenafil as a salvage therapy for patients refractory to the maximum recommended dose of sildenafil. Fifty four fully evaluated patients with chronic erectile failure (ED) who had previously failed to respond to a home trial of sildenafil (100 mg) with erections suitable for sexual intercourse were studied. Each man was treated at home with sildenafil at escalating doses of up to 200 mg until either maximal response or intolerable adverse effects occurred. Erectile function was quantified using the erectile function domain of the International Index of Erectile Function (IIEF) before treatment, with sildenafil 100 mg and with maximal dose of sildenafil and a global efficacy question after 4 weeks of treatment. The mean age of the study group was 59.6+/-11.2 y. 13/54 (24%) had arteriogenic ED, 16/54 (30%) had mixed vasculogenic ED, 9/54 (17%) had cavernosal veno-occlusive dysfunction, 11/54 (20%) had post radical retropubic prostatectomy ED and 5/54 (9%) had psychogenic ED. 13/54 (24.1%) responded to sildenafil at a median maximal dose of 200 mg, 4/13 required 150 mg and 9/13 required 200 mg. 41/54 (76%) failed to respond to sildenafil. Mean IIEF question 3 and 4 scores were 1.5 and 1.4 at baseline, 2.2 and 1.9 with sildenafil 100 mg, 2.8 and 2.5 with sildenafil 150 mg and 3.0 and 2.9 with sildenafil 200 mg, respectively. After 4 weeks, treatment was regarded as having improved their erections by 37%, 46.3% and 68% of patients with sildenafil 100 mg, 150 mg and 200 mg, respectively. 34/54 (63%) reported adverse effects with maximal dose sildenafil comprising headache (19), facial flushing (32), dyspepsia (14), nasal congestion (11), dizziness (5) and visual disturbances (5). 4/13 (31%) responders refused to continue treatment due to adverse effects.In conclusion, sildenafil at doses of up to 200 mg is an effective salvage therapy for 24.1% of previous sildenafil non-responders but is limited by a significantly higher incidence of adverse effects and a 31% treatment discontinuation rate.

Topics: Adult; Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Salvage Therapy; Severity of Illness Index; Sildenafil Citrate; Sulfones; Treatment Outcome

In the present study, we aimed to examine the efficacy of sildenafil in patients with an antipsychotic (olanzapine)-induced erectile dysfunction (ED). The study group comprised 10 patients who experienced ED associated with the use of olanzapine. The patients initially received 50 mg sildenafil at baseline. If clinically indicated, titration up to 100 mg was permitted. All patients were assessed by Clinical Global Impression-Improvement (CGI-I) and International Index of Erectile Dysfunction (IIEF) scales at baseline and weeks 2 and 4. At final assessment, three patients were considered 'very much improved' and four 'much improved' according to CGI-I. Our results suggest that sildenafil use is effective and well-tolerated in patients with olanzapine-induced ED.

Topics: Antipsychotic Agents; Benzodiazepines; Erectile Dysfunction; Humans; Male; Olanzapine; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Pirenzepine; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Corpus cavernosum smooth muscle relaxation and hence penile erection are regulated in part by increases in smooth muscle synthesis of the second messengers cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). The object of this study was to determine 30-month follow-up results in motivated patients desiring noninvasive medical therapy using sildenafil citrate (Viagra) in combination with intraurethral prostaglandin E(1) (PGE(1)) (Medicated Urethral System for Erection [MUSE]). Twenty-eight patients (mean +/- s.d. age, 59 +/-7.3 y; 17 who had undergone radical prostatectomy and 11 who had a diagnosis of organic erectile dysfunction) were included in this study. Detailed history taking and physical examinations were performed and vascular risk factors noted. In these patients, treatment with either 100 mg of sildenafil citrate and/or 1000 microg of MUSE had failed. None of these patients desired intracavernosal injection. Duplex Doppler ultrasonography after redosing was carried out on all patients. Dynamic infusion corpus cavernosography/cavernosometry was obtained in 17 of 28 patients, and combination therapy was initiated using 100 mg of sildenafil citrate orally 60 min before intercourse and 500 microg of MUSE intraurethrally immediately before intercourse. Independently, either 100 mg of sildenafil citrate or 1000 microg of MUSE was not efficacious in inducing an erection sufficient for vaginal penetration in any of the 28 patients. After initiating a combination therapy, at 30 months, all 28 patients were reporting erections sufficient for vaginal penetration, with 3.6 intercourse episodes per month. None of the patients crossed over to intracavernosal therapy or penile prosthesis. During therapy, eight of 28 patients reduced the dose of sildenafil citrate to 50 mg. Combination therapy with MUSE and sildenafil may be more efficacious in the salvage of patients who desire noninvasive therapy but in whom single-treatment modalities fail. Although both cAMP- and cGMP-mediated vasodilation can lead to penile erection, combining therapies that incorporate both pathways may succeed when single therapies fail.

Topics: Aged; Alprostadil; Cohort Studies; Cyclic AMP; Cyclic GMP; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Muscle, Smooth; Patient Satisfaction; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Urethra; Vasodilator Agents

The relationship between sildenafil citrate use and reported adverse cardiovascular events in men with coronary artery disease (CAD) is unclear.. To evaluate the cardiovascular effects of sildenafil during exercise in men with CAD.. Randomized, double-blind, placebo-controlled crossover trial conducted March to October 2000 at a US ambulatory-care referral center among 105 men with a mean (SD) age of 66 (9) years who had erectile dysfunction and known or highly suspected CAD.. All patients underwent 2 symptom-limited supine bicycle echocardiograms separated by an interval of 1 to 3 days after receiving a single dose of sildenafil (50 or 100 mg) or placebo 1 hour before each exercise test.. Hemodynamic effects of sildenafil during exercise (onset, extent, and severity of ischemia) assessed by exercise echocardiography.. Mean (SD) resting ejection fraction was 56% (7%) (range, 39%-68%). After sildenafil use, resting systolic blood pressure was reduced from 135 (19) mm Hg to 128 (17) mm Hg, for a mean change of -7 mm Hg (95% confidence interval [CI], -9 to -4 mm Hg; P<.001). After placebo use, the mean (SD) change was from 135 (20) mm Hg to 133 (19) mm Hg, a difference of -2 mm Hg (95% CI, -6 to 0.3 mm Hg; P =.08). The difference between mean change after sildenafil and placebo use was 4.3 (95% CI, 0.9-7.7; P =.01). Resting heart rate, diastolic blood pressure, and wall motion score index (a measure of the extent and severity of wall motion abnormalities) did not change significantly in either group. Exercise capacity was similar with sildenafil use (mean [SD], 4.5 [1.0] metabolic equivalents) and placebo use (mean [SD], 4.6 [1.0] metabolic equivalents; mean difference, 0.07; 95% CI, -.06 to 0.19; P =.29). Exercise blood pressure and heart rate increments were similar. Dyspnea or angina developed in 69 patients who took sildenafil and 70 patients who took placebo (P =.89); exercise electrocardiography was positive in 12 patients (11%) who took sildenafil and 17 patients (16%) who took placebo (P =.09). Exercise-induced wall motion abnormalities developed in similar numbers of patients after sildenafil and placebo use (84 and 86 patients, respectively; P =.53). Wall motion score index at peak exercise was similar after sildenafil and placebo use (mean [SD], 1.4 [0.4] vs 1.4 [0.4]; mean difference, 0.01; 95% CI, -0.01 to 0.03; P =.40).. In men with stable CAD, sildenafil had no effect on symptoms, exercise duration, or presence or extent of exercise-induced ischemia, as assessed by exercise echocardiography.

Topics: Adult; Aged; Blood Pressure; Coronary Artery Disease; Cross-Over Studies; Double-Blind Method; Echocardiography, Stress; Electrocardiography; Erectile Dysfunction; Exercise; Heart Rate; Hemodynamics; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) represents an important quality-of-life issue for many ageing men. Low serum testosterone level and other factors may be involved. Sildenafil is effective and well tolerated in patients with ED of various aetiologies, showing an efficacy of about 75%. However, few efficacy and adverse effect studies have focused specially on ageing men. In 150 patients below 65 years and 44 patients over 65 years, sildenafil was used to treat ED. Efficacy in the younger group (89.1%) was greater than in the older group (65.7%; p < 0.01). Mean serum luteinizing hormone (LH) and follicle-stimulating hormone concentrations (11.0 and 18.9 mIU/mL, respectively) in the older group were higher than in younger group (5.2 and 8.7 mIU/mL, respectively; p < 0.01). Serum testosterone and prolactin (PRL) were similar between groups. Older patients showed higher prevalence of diabetes mellitus, hypertension, and benign prostatic hyperplasia. Only diabetes appeared to decrease efficacy of sildenafil in older patients (p=0.019). A high prevalence of diabetes might be one of the many causes of lower efficacy rate of sildenafil in older men, although efficacy in patients even without diabetes in older men was relatively low. Sildenafil can be used safely and it is still effective for ageing male, because nearly two-thirds of our older subjects had a good response to the drug and no adverse effect was specific to older patients.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Age Distribution; Aged; Erectile Dysfunction; Follicle Stimulating Hormone; Humans; Luteinizing Hormone; Male; Middle Aged; Penis; Phosphodiesterase Inhibitors; Piperazines; Prolactin; Purines; Sildenafil Citrate; Sulfones; Testosterone; Ultrasonography

The purpose of this work was to investigate the efficacy and safety of sildenafil in combination with doxazosin for the treatment of non-organic erectile dysfunction in patients who did not respond to sildenafil. We enrolled 28 patients with non-organic erectile dysfunction, for whom 3 months of sildenafil monotherapy had failed. They were divided in two random and homogeneous groups: 14 were treated with doxazosin (4 mg daily) and sildenafil (100 mg 1 h before sexual intercourse); the other 14 patients received sildenafil and placebo. The results were assessed by means of the IIEF questionnaire before the beginning of the study, after 30 days of therapy and after 60 days. Of the 14 patients treated with doxazosin and sildenafil, 11 (78.6%) showed a statistically significant increase of IIEF; in the placebo group, only one patient (7.1%) recorded a significant IIEF increase. The differences observed in the two groups were statistically very significant (P=0.0016). Blood pressure did not show significant alterations. Side effects were minimal and even present during sildenafil monotherapy. The combination therapy with sildenafil and doxazosin resulted in the safe and effective treatment of men with non-organic erectile dysfunction for whom sildenafil alone had failed.

Topics: Adult; Doxazosin; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Retreatment; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

Oral therapy has become first line treatment for patients with mild to moderate erectile dysfunction (ED). Studies have shown that sildenafil may not be effective in all patients, and has been associated with a variety of adverse effects and an adverse interaction with nitrates and inhibitors of cytochrome P450 enzymes. The objective was to compare the efficacy and safety of three different oral combinations with the highest dose of sildenafil in men with moderate to severe ED. Randomized, double blind, unblinded active-controlled, Phase II study was carried out at three sites in Mexico. After a 4-week placebo run-in period, patients received all four of the following treatments using a 4-way cross-over design: 40 mg phentolamine (PM) +6 mg apomorphine (Apo); 40 mg PM +150 mg papaverine (Pap); 40 mg PM +6 mg Apo +150 mg Pap (Tricombo); 100 mg sildenafil (SC). With the exception of sildenafil tablets, all study medication was blinded. Moderate to severe ED was defined as a less than 50% vaginal penetration success rate during the placebo run-in period. A total of 44 patients were enrolled, of whom 36 completed all four treatment periods. All treatments produced a significant effect in primary efficacy variable (Sexual Encounter Profile) compared to baseline, however, no statistically significant differences were found between treatments. A significant period effect was observed. Also, the four treatments were found not to differ significantly in five out of six secondary efficacy variables. The lowest incidence of treatment-related adverse events (AE) occurred in the 40 mg PM +6 mg Apo group (9.8%), followed by 100 mg SC (15%), and the other two combinations (16.7 and 17.5%, respectively). Nasocongestion and headache were the most frequently reported AE. An oral combination of vasoactive agents may provide an alternative approach to sildenafil. Based on these results a combination of phentolamine and apomorphine warrants further clinical investigation.

Topics: Adrenergic alpha-Antagonists; Apomorphine; Cross-Over Studies; Double-Blind Method; Drug Combinations; Erectile Dysfunction; Humans; Male; Papaverine; Phentolamine; Piperazines; Purines; Safety; Severity of Illness Index; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

Topics: Adult; Erectile Dysfunction; Humans; Kidney Failure, Chronic; Kidney Transplantation; Male; Piperazines; Postoperative Complications; Prevalence; Purines; Safety; Sildenafil Citrate; Sulfones; Time Factors; Vasodilator Agents

Controlled trials have demonstrated the efficacy of sildenafil for "mixed etiology" erectile dysfunction, but this may not be the case if there is underlying pelvic parasympathetic nerve damage. We aimed to determine the efficacy of sildenafil after rectal excision for rectal cancer and inflammatory bowel disease.. Patients with erectile dysfunction after rectal excision were randomly assigned in a double-blind manner to sildenafil or placebo groups. After unblinding, placebo patients crossed over to open sildenafil. Primary end points were improvement in erectile function on a global efficacy question and erectile function questionnaire scores. Secondary end points were frequency and severity of side effects.. Thirty-two patients were randomly assigned, and two dropped out before randomization. Fourteen received sildenafil, and 18 received placebo. Eleven (79 percent) of 14 responded to sildenafil, on global efficacy assessment, compared with 3 (17 percent) of 18 taking placebo (mean difference, 61.9 percent; 95 percent confidence interval, 34.4 to 89.4 percent; P = 0.0009). Sildenafil improved both erectile function domain scores (mean difference, 13.3; 95 percent confidence interval, 7.9 to 18.7; P = 0.0001) and total International Index of Erectile Function scores (mean difference, 30.6; 95 percent confidence interval, 18.7 to 42.6; P < 0.0001) from pretreatment baseline scores. Placebo did not produce improvement in either erectile function (mean difference, 1.7; 95 percent confidence interval, -0.8 to 4.2; P = 0.16) or total International Index of Erectile Function scores (mean difference, 5; 95 percent confidence interval, -1.1 to 11.1; P = 0.1). Ten (100 percent) of 10 crossover patients not responding to placebo did respond to sildenafil (difference, 100 percent; P < 0.0001). Sildenafil improved both erectile function domain scores (mean difference, 16.8; 95 percent confidence interval, 9.7 to 24; P = 0.002) and total International Index of Erectile Function scores (mean difference, 29.5; 95 percent confidence interval, 15.8 to 43.2; P = 0.003) from precrossover baseline scores. Seven (50 percent) of 14 patients on sildenafil compared with 4 (22 percent) of 18 on placebo experienced side effects (difference, 28 percent; 95 percent confidence interval, -4.4 to 60.4 percent; P = 0.14), 91 percent of which were mild and well tolerated.. Sildenafil completely reverses or satisfactorily improves postproctectomy erectile dysfunction in 79 percent of patients. Side effects are usually mild and well tolerated. The damage incurred by the pelvic nerves after proctectomy, less profound than after prostatectomy, is likely to result in a partial parasympathetic nerve lesion.

Topics: Adult; Aged; Aged, 80 and over; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Inflammatory Bowel Diseases; Male; Middle Aged; Parasympathetic Nervous System; Patient Satisfaction; Pelvis; Piperazines; Placebos; Postoperative Complications; Purines; Rectal Neoplasms; Rectum; Sildenafil Citrate; Sulfones; Vasodilator Agents

The efficacy and safety of oral Sildenafil, a potent inhibitor of phosphodiesterase type 5, were evaluated in depressed men with idiopathic Parkinson's disease and erectile dysfunction. Thirty-three men were enrolled in a 4-month prospective, open-label, fixed-dose study, and received 50mg of Sildenafil in the home setting approximately 1 hour before sexual activity, not more than once daily. Efficacy was determined by responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) of the 15-item International Index of Erectile Function (IIEF). Other measures of efficacy included the five sexual function domains of IIEF, a global efficacy question, the Beck Depression Inventory (BDI) and the Hamilton Depression Rating Scale-21 (HDRS-21).. At the end of the study, improved erections were reported by 84.8% of patients. Sildenafil significantly increased patients' ability to achieve and maintain erections. Significant improvements were also observed in the IIEF domains for erectile function, orgasmic function, intercourse satisfaction and overall sexual satisfaction. BDI and HDRS scores improved from baseline to the end of the study. A clear improvement of depressive symptoms was observed in 75% of patients. Sildenafil was well tolerated in all the patients.. Treatment with oral Sildenafil improves erectile function and, indirectly, depressive symptoms in patients with idiopathic Parkinson's disease stages 1-3, and is well tolerated.

Topics: Administration, Oral; Depression; Erectile Dysfunction; Humans; Male; Middle Aged; Parkinson Disease; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones

To assess the efficacy of oral sildenafil in diabetic men with severe erectile dysfunction (ED), who are successfully treated with intracavernous injections of vasoactive drugs.. 81 impotent diabetic men (29 with type 1 and 52 with type 2) were treated for 1-7 years with self-injections. 13 men were treated with 10 microg and 15 with 20 microg of prostaglandin E1 (PGE1), and 53 with a mixture of PGE1 20 microg and papaverine 7.5-40 mg (MIX). After a 1-week washout period, they changed to oral sildenafil in titrating doses up to 100mg. The change was successful if the man achieved an erection and penetration even once.. Sildenafil was discontinued in 23 men because of insufficiency. Eleven men (13.6%), all with type 2 diabetes, responded to sildenafil (10 previously treated with 10 microg and 1 with 20 microg of PGE1, none treated with MIX). Thus, 39.2% of the treated with PGE1 responded to oral sildenafil. The response was influenced by the age, the type of diabetes (type 2) and the kind of the previously injected drug (PGE1 10 microg); it was not influenced by the duration of diabetes, ED and treatment with self-injections.. Despite the well documented efficacy of sildenafil, self-injections continue to be the solely effective therapeutic modality in many diabetic men afflicted by severe ED. Only the younger men with non-insulin-dependent diabetes, treated with low doses of PGE1 are more likely to respond to oral sildenafil and change treatment. Men with insulin-dependent diabetes or treated with mixtures of vasoactive drugs are not likely to respond to oral sildenafil.

Topics: Administration, Oral; Alprostadil; Diabetes Complications; Erectile Dysfunction; Humans; Injections; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Severity of Illness Index; Sildenafil Citrate; Sulfones; Time Factors; Vasodilator Agents

Erectile dysfunction is a common complication in patients with diabetes mellitus, which impairs quality of life, decreases self-esteem and can affect partners relationships. Sildenafil improves nitric oxide-dependent relaxation of smooth muscle in corpora cavernosa--induced by an increase in cGMP via inhibition of phosphodiesterase 5.. Multicenter, randomized, double-blind, placebo-controlled study with flexible doses of sildenafil. The study was performed in 16 centers and recruited a total of 112 subjects with diabetes mellitus who had erectile dysfunction. At the start and end of the study, the following questionnaires were administered: International Index of Erectile Function (IIEF), Global Efficacy Assessment Question and Quality of Life Questionnaire (Fugl-Meyer). Of the 112 initially recruited patients, 92 received treatment, sildenafil in 44 and placebo in 48.. A clear improvement was observed in the capacity to achieve and maintain an erection; 55.3% diabetic patients receiving sildenafil had at least one successful sexual intercourse (15.6% in the placebo group). In addition, significant improvements were seen in other aspects of the sexual activity of treated subjects. Among those treated with sildenafil, 46.3% reported a clear improvement of erections as compared to their baseline conditions (i.e, prior to treatment) vs only 14.9% in the placebo group. The percentage of a successful intercourse clearly increased, from 6 to 49%. Sildenafil was well-tolerated. Side effects were mild and transient.. Sildenafil is an effective, safe treatment for erectile dysfunction in diabetic patients.

Topics: Adult; Aged; Data Interpretation, Statistical; Diabetes Mellitus, Type 2; Double-Blind Method; Erectile Dysfunction; Humans; Logistic Models; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Placebos; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Vasodilator Agents

To assess the efficacy and safety of sildenafil citrate (Viagra, Pfizer Inc., USA) in a double-blind, placebo-controlled, dose-escalation study over a period of 26 weeks in men with erectile dysfunction of a broad spectrum of aetiology.. In all, 315 patients from five countries were randomized to receive treatment with placebo (156 men) or sildenafil (159 men). Significant concomitant medical conditions were hypertension (20%), a history of pelvic surgery (19%), diabetes mellitus (15%), and ischaemic heart disease (10%). Patients randomized to treatment received a starting dose of 25 mg of sildenafil or matching placebo, which could be increased to 50 mg and then to 100 mg of sildenafil, based on efficacy and tolerability. Assessments of efficacy comprised the 15-item International Index of Erectile Function (IIEF), including question three (ability to achieve an erection) and question four (ability to maintain an erection), a partner questionnaire, an overall efficacy question, and event-log data.. After 12 weeks of treatment, 26%, 32% and 42% of patients were taking 25, 50 and 100 mg of sildenafil, respectively. A similar distribution of doses was reported after 26 weeks of treatment. Treatment with sildenafil significantly improved the patients' abilities to achieve and maintain an erection compared with treatment with placebo (P < 0.001). Scores for four of the five sexual function domains of the IIEF (erectile function, orgasmic function, intercourse satisfaction and overall satisfaction) also improved significantly (P < 0.001). There was a significant improvement in the mean score for the erectile function domain, regardless of the aetiology of erectile dysfunction (P < 0.001). After 12 weeks and 26 weeks of treatment, 82% and 79% of patients receiving sildenafil reported improved erections, compared with 24% and 23% of patients receiving placebo, respectively (P < 0.001). Treatment-related adverse events were mild to moderate and occurred in 27% of patients receiving sildenafil, compared with 8% of patients receiving placebo.. Sildenafil is an effective and well-tolerated treatment for men with erectile dysfunction of a broad spectrum of aetiology.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Behavior; Sildenafil Citrate; Sulfones; Treatment Outcome

Erectile dysfunction is common in dialysis patients. We report our experience with sildenafil citrate in patients undergoing dialysis therapy. Male subjects attending the Outpatient Dialysis Unit at the University of Pennsylvania (Philadelphia, PA) who were prescribed sildenafil by their primary physician or nephrologist were asked to complete the International Index of Erectile Function before their first dose of sildenafil and after at least 4 weeks of therapy. Subjects' mean age was 50.3 +/- 14.63 (SD) years. Ninety-three percent of the subjects were black. Based on a global efficacy question, 66.7% of the subjects believed that treatment had improved their erections. Subjects reported no increase in the sexual desire domain despite experiencing a significant increase in erectile function, orgasmic function, and satisfaction with intercourse. Sildenafil was well tolerated in a selected group of patients who reported improved sexual function with no major adverse effects.

Topics: Adult; Aged; Cohort Studies; Erectile Dysfunction; Humans; Kidney Failure, Chronic; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Renal Dialysis; Sildenafil Citrate; Sulfones

We evaluate the clinical efficacy of sildenafil citrate for patients who are on chronic dialysis and who have concomitant erectile dysfunction.. A total of 35 men (mean age 60.7 years) on dialysis and with erectile dysfunction of various etiologies were administered 25 to 100 mg sildenafil for at least 6 months. The International Index of Erectile Function questionnaire (IIEF), a global assessment question and partner satisfaction question were used to evaluate sildenafil efficacy. Patients also reported any adverse events that occurred during treatment.. Treatment was effective for 28 of the 35 (80%) patients according to the results of the IIEF and global assessment questions. Partner satisfaction correlated with the IIEF overall response (0.79) and global assessment question results (0.86). No correlation was found between sildenafil failure and patient age, the etiology of erectile dysfunction, duration of erectile dysfunction, prior treatments, testosterone and prolactin blood levels, and the duration and etiology of renal failure. Of the 35 patients sildenafil was stopped due to intolerable headaches in 3 and because of lack of efficacy in 7.. Sildenafil is an effective and safe treatment for erectile dysfunction in most patients on chronic dialysis.

Topics: Aged; Erectile Dysfunction; Humans; Kidney Failure, Chronic; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Renal Dialysis; Sildenafil Citrate; Sulfones

Erectile dysfunction is a common, multi-factorial disorder.. To evaluate the efficacy, tolerability and frequency of use of sildenafil citrate in men with mild to moderate erectile dysfunction of no established organic cause.. This double-blind, randomised, placebo-controlled, flexible-dose, two-way crossover study was conducted at four centres in the UK in 44 men with mild to moderate erectile dysfunction of no clinically obvious organic cause. The study included two 28-day treatment periods, during which time sildenafil or placebo (25-75 mg, based on efficacy) was taken as required.. Compared with placebo, sildenafil was associated with increases in frequency of use, erections adequate for sexual intercourse and level of sexual satisfaction (P:<0.0001). More patients receiving sildenafil stated they would use the treatment again compared with those receiving placebo (P:<0.0001). There were no discontinuations due to sildenafil treatment.. Sildenafil is effective and well tolerated in men with mild to moderate erectile dysfunction of no clinically identifiable organic cause.

Topics: Adolescent; Adult; Aged; Coitus; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

To suggest a new noninvasive method for penile Doppler ultrasound (PDU) evaluation of erectile dysfunction using oral sildenafil citrate as an erection induction agent.. A total of 20 patients admitted with the complaint of erectile dysfunction were evaluated by the short form of the International Index of Erectile Function. A total score of less than 25 was accepted as erectile dysfunction and PDU was performed. The initial penile study consisted of PDU examination under visual sexual stimulation (VSS), and the peak systolic velocity, end-diastolic velocity, and resistance index were recorded. Measurements of all the parameters were repeated on the same patients after intracavernosal papaverine, intracavernosal prostaglandin E(1) (PGE(1)), and oral sildenafil citrate administration, plus VSS. All patients had these four tests in the same order at weekly intervals. Sildenafil citrate was given orally 45 minutes before Doppler investigation, and patients had VSS during the waiting period. The patients were asked about their satisfaction and comfort after each test. Statistical analysis was performed using the Wilcoxon and Mann-Whitney U tests.. The measurements with papaverine, PGE(1), and sildenafil citrate were significantly different from those after only VSS (P <0.008); however, the papaverine, PGE(1), and sildenafil citrate results were not different from each other according to the peak systolic velocity, end-diastolic velocity, and resistance index measurements (P >0.008). Patients commented that although PGE(1) was the strongest erectogenic agent, sildenafil citrate was the most convenient.. Since the results of PDU with oral sildenafil citrate in association with VSS were not statistically different, we suggest a new noninvasive erection induction method for the purpose of PDU evaluation of erectile dysfunction.

Topics: Adult; Alprostadil; Erectile Dysfunction; Hemodynamics; Humans; Impotence, Vasculogenic; Male; Middle Aged; Papaverine; Penis; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Ultrasonography

We evaluated the response of sildenafil citrate in patients with prostate cancer treated with three-dimensional conformal radiation therapy (3DCRT) whose sexual function (SF) was known prior to therapy initiation.. From March 1996 to April 1999, 24 men with median age of 68 years (range 51 to 77) had 3DCRT for localized prostate cancer (median prescribed dose to the planning target volume of 70.2 Gy). These men started taking sildenafil for relief of sexual dysfunction at a median time of 1 year after completing 3DCRT. We used the self-administered O'Leary Brief Sexual Function Inventory to evaluate in series SF and overall satisfaction at three time points. These points were (a) before initiation of all therapies (3DCRT or hormonal treatment [HT]) for prostate cancer, (b) before starting sildenafil (50 mg or 100 mg) but after completion of all therapies, and (c) at least 2 months afterward. Rates of SF were based on the number of men responding to a given question. We tested for significance of these two interventions to change SF by applying the Wilcoxon sign rank test.. Prior to all treatments, 20 (87%) of 23 men were sexually potent, with 8 (36%) of 22 fully potent (little or no difficulty for penetration at intercourse). After 3DCRT with or without HT and prior to sildenafil use, 13 (65%) of the 20 potent patients remained potent, with only 2 (11%) of 19 being fully potent. The use of sildenafil citrate resulted in 21 (91%) of 23 men being potent, with 7 (30%) being fully potent. In 16 men responding to the satisfaction question, 10 (63%) and 12 (75%) were mixed to very satisfied with their sex life before 3DCRT with or without HT and after sildenafil citrate use, respectively. This response corresponded to potency and satisfaction scores significantly decreasing and subsequently increasing on average by one unit after 3DCRT and sildenafil citrate use, respectively (P <0.05).. In men receiving 3DCRT for prostate cancer, these data indicate that sildenafil citrate is effective for restoring SF and associated satisfaction back to baseline before treatment.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Prostatic Neoplasms; Purines; Radiotherapy, Conformal; Sildenafil Citrate; Sulfones

To assess the efficacy and safety of Viagra (sildenafil citrate) in male outpatients with erectile dysfunction and patient and partner satisfaction with treatment using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS).. A total of 247 patients with erectile dysfunction of broad-spectrum etiology were treated in a randomized, double-blind, parallel-group, multicenter study conducted at outpatient clinics. Patients receiving oral sildenafil (25, 50, and 100 mg) were compared with patients receiving placebo during a 12-week period. The principal efficacy measures were responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) on the International Index of Erectile Function and three global efficacy questions. Patient and partner satisfaction with treatment were assessed, for the first time, using the EDITS questionnaire.. Efficacy scores for the International Index of Erectile Function questions and the global efficacy questions were significantly higher for patients receiving sildenafil than for those receiving placebo (P <0.001). Both patients and partners receiving sildenafil also had significantly higher EDITS scores than those receiving placebo (P <0.001). Adverse events were chiefly mild or moderate. Two patients receiving sildenafil and none receiving placebo discontinued treatment because of adverse events.. Sildenafil was an effective, well-tolerated treatment for erectile dysfunction in an outpatient setting. Partner evaluations corroborated patient assessments. The results from the EDITS questionnaire indicated that after 12 weeks of receiving sildenafil both patients and partners reported higher levels of treatment satisfaction relative to placebo.

Topics: Adult; Aged; Ambulatory Care; Double-Blind Method; Erectile Dysfunction; Female; Humans; Male; Middle Aged; Personal Satisfaction; Piperazines; Placebos; Purines; Sexual Behavior; Sexual Partners; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

We studied the effects of sildenafil on nocturnal penile erections. We prospectively evaluated 36 patients with organic or psychogenic impotence and 5 normal, potent men. All patients completed 3 sessions of consecutive nights using the RigiScan Plus device. The first two nights the patients were asked to take placebo before the session and to take 50 mg of sildenafil before the third session. In the organic impotence group the use of sildenafil induced a significant improvement in time of rigidity 60-100%, rigidity and tumescence activity unit values and rigidity and tumescence activity unit values per hour in the tip and base. In the psychogenic impotence group it caused significant improvement only in rigidity activity unit per hour in the tip. In the potent men, changes were statistically insignificant. Sildenafil improves nocturnal penile erectile activity in organic impotence. Our study shows that phosphodiesterase inhibitors can improve penile erections not induced by sexual stimulation.

Topics: Adult; Aged; Circadian Rhythm; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Reference Values; Sildenafil Citrate; Sulfones

A comprehensive investigation on the quality of partnership of male patients with erectile dysfunction (ED) after treatment with sildenafil vs. untreated patients, as perceived by both the patients and their female partners.. This report describes an observational, cross-sectional exploratory study comparing ED patients responsive to sildenafil with ED patients prior to therapy. Assessments included the 'International Index of Erectile Function' (IIEF) and the 'Partnerschaftsfragebogen' (PFB), a partnership questionnaire used in German-speaking countries. The comparability of the two study groups was examined using a stepwise logit model. Significant intergroup differences regarding demographics and history were identified and included as confounding variables in the assessment of Quality of Partnership differences using ANCOVA. A regression analysis was performed to determine the association between the mean total IIEF scores and Quality of Partnership measures.. 105 patients were included in the study. After adjustment for confounding variables, the groups varied significantly with respect to Quality of Partnership as perceived by men (mean score PFB 61.8 +/- 13.9 vs. 54.4 +/- 15.5; p<0.001) and women (mean score PFB 63.1 +/- 13.6 vs. 57.0 +/- 14.7; p = 0.006). In men, all three PFB subscales (quarreling, tenderness, togetherness) differed significantly between the two study groups. In the female partners, the tenderness and togetherness domains varied significantly. Erectile function correlated highly significantly with tenderness and togetherness in both the male patients and their partners.. Our data indicate that the Quality of Partnership reported by both the men and their female partners is significantly better in appropriately treated ED patients than in untreated controls.

Topics: Cross-Sectional Studies; Erectile Dysfunction; Female; Humans; Male; Marriage; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

Of the various methods of hemodynamic studies performed to evaluate erectile dysfunction penile color Doppler ultrasound is currently considered the best. However, intracavernous injection is invasive and has adverse effects, such as prolonged erection. We evaluated whether sildenafil may be used as a substitute for intracavernous agents when assessing impotence on color Doppler ultrasound.. A total of 42 patients with erectile dysfunction underwent color Doppler ultrasound before and after intracavernous injection of 60 mg. papaverine with genital and audiovisual sexual stimulation. Peak flow and end diastolic velocity were measured in the recorded waveforms obtained 0, 1, 5, 10 and 20 minutes after injection. The patients also underwent color Doppler ultrasound after a 50 mg. oral dose of sildenafil with genital and audiovisual sexual stimulation not before 3 days after the papaverine study. The same parameters were measured at 30, 45, 60, 75 and 90 minutes, and compared with the values obtained after papaverine injection.. Mean peak flow velocity significantly increased after oral sildenafil starting at 30 minutes and achieving a maximum value at 60 minutes. There were no significant differences in the 2 methods in mean peak velocity 1, 5, 10 and 20 minutes after papaverine injection, and 30, 45, 60, 75 and 90 minutes after oral sildenafil administration. Penile color Doppler ultrasound with intracavernous papaverine injection is accepted as the gold standard but color Doppler ultrasound with sildenafil has 90% sensitivity and 100% selectivity for demonstrating arterial insufficiency. Due to prolonged erection 5 patients (11.9%) in the papaverine group required pharmacological detumescence by intracavernous injection. No adverse effects of sildenafil were observed.. Sildenafil administration achieved increased peak flow velocity comparable to that after intracavernous papaverine injection. With no prolonged erection sildenafil emerges as a safer alternative compared to more invasive intracavernous injection.

Topics: Administration, Oral; Adult; Aged; Blood Flow Velocity; Erectile Dysfunction; Humans; Image Enhancement; Injections, Intravenous; Male; Middle Aged; Papaverine; Piperazines; Probability; Purines; Sensitivity and Specificity; Sildenafil Citrate; Sulfones; Ultrasonography, Doppler, Color

The efficacy and safety of sildenafil were evaluated in a randomised, double-blind, placebo-controlled, flexible-dose study in Taiwanese men aged 26 to 80 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months' duration. A total of 236 patients were randomised at six medical centres in Taiwan to receive either sildenafil (50 mg initially increased if necessary to 100 mg or decreased to 25 mg depending on efficacy and toleration) (n=119) or matching placebo (n=117) taken on an 'as needed' basis 1 h prior to anticipated sexual activity for a period of 12 weeks. At the end of 12 weeks, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the IIEF (International Index of Erectile Function) scale, (2) the percentage of successful intercourse attempts; and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P<0.0001). Treatment-related adverse events occurred in 43.7% of patients receiving sildenafil and 18.8% receiving placebo. The most common adverse events with sildenafil were flushing, dizziness and headache (25.2, 6.7 and 5.9% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in the population of Taiwanese men appears similar to that reported in other studies in western populations.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Coitus; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Safety; Sildenafil Citrate; Sulfones

To assess the efficacy and safety of sildenafil citrate (Viagra) in men with erectile dysfunction and parkinsonism due either to Parkinson's disease or multiple system atrophy.. Twenty four patients with erectile disease were recruited, 12 with Parkinson's disease and 12 with multiple system atrophy, into a randomised, double blind, placebo controlled, crossover study of sildenafil citrate. The starting dose was 50 mg active or placebo medication with the opportunity for dose adjustment depending on efficacy and tolerability. The international index of erectile function questionnaire (IIEF) was used to assess treatment efficacy and a quality of life questionnaire to assess the effect of treatment on sex life and whole life. Criteria for entry included a definite neurological diagnosis and a standing systolic blood pressure of 90-180 mm Hg and diastolic blood pressure of 50-110 mm Hg, on treatment if necessary. Blood pressure was taken at randomisation (visit 2) and crossover (visit 5) lying, sitting, and standing, before and 1 hour after taking the study medication in hospital.. Sidenafil citrate was efficacious in men with parkinsonism with a significant improvement, as demonstrated in questionnaire responses, in ability to achieve and maintain an erection and improvement in quality of sex life. In Parkinson's disease there was minimal change in blood pressure between active and placebo medication. In multiple system atrophy, six patients were studied before recruitment was stopped because three men showed a severe drop in blood pressure 1 hour after taking the active medication. Two were already known to have orthostatic hypotension and were receiving treatment with ephedrine and midodrine but the third had asymptomatic hypotension. However, the blood pressures in all three had been within the inclusion criterion for the study protocol. Despite a significant postural fall in blood pressure after sildenafil, all patients with multiple system atrophy reported a good erectile response and were reluctant to discontinue the medication.. Sidenafil citrate (50 mg) is efficacious in the treatment of erectile dysfunction in parkinsonism due to Parkinson's disease or multiple system atrophy; however, it may unmask or exacerbate hypotension in multiple system atrophy. As Parkinson's disease may be diagnostically difficult to distinguish from multiple system atrophy, especially in the early stages, we recommend measurement of lying and standing blood pressure before prescribing sildenafil to men with parkinsonism. Furthermore, such patients should be made aware of seeking medical advice if they develop symptoms on treatment suggestive of orthostatic hypotension.

Topics: Aged; Blood Pressure; Cross-Over Studies; Diastole; Double-Blind Method; Ephedrine; Erectile Dysfunction; Humans; Hypotension, Orthostatic; Male; Middle Aged; Midodrine; Multiple System Atrophy; Parkinson Disease; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Systole; Time Factors; Treatment Outcome; Vasoconstrictor Agents

Sildenafil citrate (Viagra) is a potent selective inhibitor of phosphodiesterase type 5 proposed for the oral treatment of erectile dysfunction (ED). The aim of this study was to evaluate its efficacy and safety when used in daily practice in patients with ED of various aetiology.. From September 1998 to April 1999, 380 patients chose sildenafil as treatment for their ED. One hundred and forty-five (38%) of them suffered from psychogenic ED, 125 (33%) organic and 110 (29%) of mixed aetiology. The grade of erection achieved and the occurrence of satisfactory sexual intercourse assessed the efficacy. Safety and tolerance were evaluated recording any side effect or adverse event.. The overall efficacy of Viagra was 77%, with a response of 100% among the group of hormonal patients, 88% for psychogenic, 72% for mixed, 69% for diabetes, 65% for vascular and 60% for neurological symptoms. A few and mild to moderate side effects were recorded.. These results indicate that the use of sildenafil citrate is an effective and well-tolerated therapy for men with ED of various aetiology with an overall success rate of 77%.

Topics: Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones

Patients undergoing radical pelvic floor surgery are often find that sexual function is impaired. In this research hypothesis, we evaluated the efficacy of alternative therapy to conventional PGE 1 injections, such as the association of Sildenafil and L-Arginine. This association is based on the principle that L-Arginine, the precursor of nitric oxide, improves the effect of Sildenafil, which is effective in the presence of nitric oxide.. The experimental plan was to make a comparative study between 2 random groups of patients selected from those undergoing radical cystectomies and prostatectomies over the past three years. 116 patients were eligible (64 prostatectomies and 52 cystectomies). The first random group was treated with Sildenafil alone and the second with Sildenafil and L-Arginine. The efficacy of treatment was evaluated using the Buckling test (pressure threshold of cavernous flexation at penile axial rigidity) once after ambulatorial administration and then by telephone interview (subjective evaluation) after administration at domicile.. The starter dose was 50 mg and was inefficient in both groups (Buckling test between 0 and 250). 100-mg doses gave significant results (Buckling test >500) in both groups, especially the second. Cardiopathic patients, diabetics and patients with retinal disorders or who were unmotivated were excluded from the study. The mean age of patients was 65.. The resumption of relatively satisfactory sexual activity was demonstrated using non-invasive pharmacological treatment.

Topics: Aged; Arginine; Erectile Dysfunction; Humans; Male; Pelvic Floor; Phosphodiesterase Inhibitors; Piperazines; Postoperative Complications; Purines; Sildenafil Citrate; Sulfones

Depressive symptoms in men with erectile dysfunction (ED) may improve under successful ED treatment. Self-reported depressive symptoms were compared in men with ED after sildenafil treatment to a group of untreated patients.. In an open study, self-reported depressive symptoms of 54 men after successful treatment with sildenafil (>4 weeks) and 51 men awaiting ED treatment were investigated with the Center of Epidemiologic Studies-Depression Scale (CES-D). CES-D items were subjected to an exploratory factor analysis and group differences in CES-D items and factors were analyzed.. Groups were comparable with respect to demographic characteristics and illness duration. CES-D total scores were lower in the group treated with sildenafil. Substantial differences were found in favor of the group treated with sildenafil, particularly in scores on a "positive affect" factor.. The findings emphasize the relevance of depression associated with ED and the importance of effective ED treatment. Although depression was generally low in this sample, hedonistic aspects were substantially enhanced in the group of ED patients after sildenafil treatment.. The open and cross-sectional study design does not permit causal inference. Selection bias and motivational aspects to participate in the study can not completely be ruled out.

Topics: Aged; Cross-Sectional Studies; Depression; Erectile Dysfunction; Humans; Male; Middle Aged; Personality Inventory; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Depressed men commonly have erectile dysfunction, and men with erectile dysfunction are frequently depressed. Since the etiologic and modulatory relationships between depression and erectile dysfunction have been poorly characterized, a 12-week, randomized, double-blind, placebo-controlled trial was conducted at 20 urologic clinics to evaluate the effects of sildenafil treatment in men with erectile dysfunction and mild-to-moderate comorbid depressive illness.. Men (N=152, mean age=56 years) with erectile dysfunction for > or =6 months (mean=5.7 years), a DSM-IV diagnosis of depressive disorder not otherwise specified, and a Hamilton Depression Rating Scale score > or =12 (mean at baseline=16.9) were randomly assigned to flexible-dose treatment with sildenafil citrate or matching placebo. Interviewer-rated and self-report instruments were used to assess changes in sexual function, depressive symptoms, and quality of life. Conservative criteria were used to classify erectile dysfunction treatment response and nonresponse.. Sildenafil was strongly associated with erectile dysfunction treatment response. Fifty-eight men met the conservative criteria for response (48 given sildenafil, 10 given placebo), and 78 men did not respond (18 given sildenafil, 60 given placebo). Mean decreases of 10.6 and 2.3 in Hamilton depression scale scores were seen in treatment responders and nonresponders, respectively; 76% of treatment responders showed a > or =50% decline in Hamilton depression scale score versus 14% of nonresponders. Quality of life was similarly improved in treatment responders.. Sildenafil is efficacious for erectile dysfunction in men with mild-to-moderate depressive illness. Improvement of erectile dysfunction is associated with marked improvement in depressive symptoms and quality of life.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Aged; Comorbidity; Depressive Disorder; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Personality Inventory; Phosphodiesterase Inhibitors; Piperazines; Placebos; Psychiatric Status Rating Scales; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Treatment Outcome

To study the pharmacokinetics of the combined use of sildenafil (which may provide an effective treatment for patients with erectile dysfunction after kidney transplantation) and tacrolimus, as interactions between them are expected because of a common elimination pathway.. Ten male patients (age 29 to 52 years) were included. Because of its importance in transplant recipients, medication remained unchanged. On day 1, tacrolimus was administered routinely, and blood samples for tacrolimus assays were drawn at predefined times. On day 2, sildenafil was added and blood was collected for assays of tacrolimus, sildenafil, and the sildenafil metabolite UK103,320 (UK) at the indicated times. Blood pressure was monitored on both study days. Sildenafil and UK were assessed by high-pressure liquid chromatography and tacrolimus was assessed by microparticle enzyme immunoassay.. No effects of sildenafil on the tacrolimus pharmacokinetics were found. However, in the patients studied, the sildenafil and UK pharmacokinetics were altered compared with the results of previous studies. The mean peak concentration of sildenafil was higher by 44% and the area under the concentration-time data increased by 90%. The elimination half-life was prolonged (4.7 hours compared with 3 hours in healthy volunteers). The area under the concentration-time data for UK was about threefold larger than in healthy volunteers, and the half-life was prolonged from 3.8 hours to 11.4 hours. Pronounced blood pressure drops were observed.. Tacrolimus or the concomitant medication or the disease itself might have altered the sildenafil and UK pharmacokinetics. Because of the drop in blood pressure, sildenafil therapy should start at the lowest dose and any antihypertensive medication should be adjusted.

Topics: Adult; Area Under Curve; Biological Availability; Blood Pressure; Drug Interactions; Drug Therapy, Combination; Erectile Dysfunction; Half-Life; Humans; Kidney Transplantation; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tacrolimus

As the effects of sildenafil are in part mediated by enhancing the action of nitric oxide and nitrates given acutely markedly reduce early wave reflection, we explored the effects of a single oral dose of sildenafil citrate (50 mg) on blood pressure and arterial wave reflection in treated hypertensive men in a single-blind randomised placebo controlled crossover study. Eight men (aged 57-76 years) with well controlled hypertension and erectile dysfunction and no contraindications to the use of sildenafil, were given either sildenafil 50 mg or placebo orally, with the second drug being given 2 weeks later. Blood pressure and heart rate with an automated digital oscillometric device (Omron) HEM-705 CP) and the augmentation index, a measure of arterial wave reflection in the aorta derived using radial applanation tonometry, were measured before and at 15-min intervals for 2 h thereafter. The extent of individual maximum reductions (mm Hg) from baseline in systolic (24 +/- 10 vs. 6 +/- 8, P < 0.05) and diastolic blood pressure (8 +/- 5 vs. 3 +/- 2, P < 0.05) occurred on the sildenafil study day. On average the brachial blood pressure at 75 min following sildenafil was 17/11 mm less than on the placebo day (P < 0.01). Augmentation index was also reduced significantly at 90 min (P < 0.05) suggesting reduced vascular tone in the arteries. The area under the brachial and aortic blood pressure and augmentation index time curve (by the trapezoidal rule corrected for baseline reading) was significantly lower (P < 0.05) on the sildenafil study day. The study shows that the peripheral vasodilatory effects of sildenafil, possibly related to nitric oxide, are accompanied by a fall in systemic blood pressure and reduced arterial wave reflection.

Topics: Aged; Amlodipine; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Blood Pressure; Cross-Over Studies; Diltiazem; Diuretics; Drug Interactions; Erectile Dysfunction; Heart Rate; Humans; Hypertension; Male; Middle Aged; Nitric Oxide; Phosphodiesterase Inhibitors; Piperazines; Pulsatile Flow; Purines; Receptors, Angiotensin; Sildenafil Citrate; Single-Blind Method; Sulfones

This study was an evaluation of whether sildenafil citrate is effective for the treatment of erectile dysfunction in men taking concomitant serotonin-reuptake-inhibiting antidepressants.. A retrospective subanalysis of combined data from 10 phase II/III double-blind, placebo-controlled, fixed- and flexible-dose trials (12-26 weeks) identified a group of men with erectile dysfunction receiving 5 to 200 mg/day of sildenafil (N=65) or placebo (N=33) and concomitant serotonin-reuptake-inhibiting antidepressants. Efficacy was measured by responses to questions from the International Index of Erectile Function on ability to achieve erection, ability to maintain erection, ejaculation frequency, orgasm frequency, and sexual desire.. Patients with erectile dysfunction receiving sildenafil and concomitant serotonergic antidepressants had significantly greater improvements in ability to achieve and maintain an erection, frequency of ejaculation, and orgasm frequency than did patients receiving placebo, without increased sexual desire.. Sildenafil significantly improved erectile dysfunction in patients taking concomitant serotonergic antidepressants.

Topics: Depressive Disorder, Major; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Retrospective Studies; Selective Serotonin Reuptake Inhibitors; Severity of Illness Index; Sildenafil Citrate; Sulfones; Treatment Outcome

Ninety percent of all men with diabetes have Type II (non-insulin-dependent) diabetes mellitus, and erectile dysfunction (ED) is common in this patient group. This study evaluated the effects of sildenafil on men with erectile dysfunction and Type II diabetes and compared the results with glycated haemoglobin concentrations and chronic diabetic complications.. Patients (mean age, 59 years) in this double-blind, placebo-controlled trial were randomised to sildenafil (25-100 mg; n = 110) or matching placebo (n = 109) for 12 weeks. Primary criteria for efficacy included questions 3 (achieving an erection) and 4 (maintaining an erection) from the International Index of Erectile Function (IIEF, score range, 0-5). Secondary outcome measures included a global efficacy question (GEQ), patient event logs, a life satisfaction checklist, and the remaining IIEF questions.. After 12 weeks, the mean scores for questions 3 and 4 had improved significantly in patients receiving sildenafil (3.42 +/- 0.23 and 3.35 +/- 0.24) compared with placebo (1.86 +/- 0.22 and 1.84 +/- 0.23; p < 0.0001). Similarly, the GEQ score was higher in the sildenafil (64.6 %) than the placebo group (10.5 %). Even when correlating efficacy with glycated haemoglobin concentrations ( < or = 8.3 % or > 8.3 %, the median concentration found in this study) or the number of diabetic complications (0 or > or = 1), the mean scores for the GEQ and questions 3 and 4 from the IIEF remained higher for all the sildenafil groups compared with the placebo groups (p < 0.0001).. Sildenafil was well-tolerated and effective in improving erectile dysfunction in men with Type II diabetes, even in patients with poor glycaemic control and chronic complications.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Double-Blind Method; Erectile Dysfunction; Glycated Hemoglobin; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Placebos; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

The patients who undergo radical pelvic surgery often found that sexual function is impaired. In this research hypothesis, we evaluated the efficacy of alternative therapy to conventional PGE 1 injections, such as the association of Sildenafil and L-Arginine. This association in based on the principle that L-Arginine, the precursor of nitric oxide, improves the effect of Sildenafil, which is effective in the presence of nitric oxide.. The experimental plan was to make a comparative study of 2 random groups of patients selected from those undergoing radical cystectomies and prostatectomies over the past three years. 116 patients were illegible (64 prostatectomies and 52 cystectomies). The fìrst random group was treated with Sildenafil alone and the second with Sildenafil and L-Arginine. The efficacy of treatment was evaluated by the Buckling test (pressure threshold of cavernous flexation at penile axial rigidity) once-after ambulatorial administration and then by telephonic interview (subjective evaluation) after home administration.. The starter dose was 50 mg and was inefficient in both groups (Buckling test between 0 and 250). 100-mg doses gave significant results (Buckling test > 500) in both groups, especially the second. Cardiopathic patients, diabetics and patients with retinal disorders were excluded from the study. The mean age of patients was 65 years.. The resumption of relatively satisfactory sexual activity was demonstrated using non-invasive pharmacological treatment.

Topics: Aged; Arginine; Erectile Dysfunction; Humans; Male; Pelvic Exenteration; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

The Sexual Health Inventory for Men (SHIM) has been shown to possess favorable statistical properties in diagnosing the presence and severity of erectile dysfunction (ED). However, the SHIM has not been compared with patient self-assessment of ED.. This article describes an independent-validation study examining the correlation and agreement between the SHIM and patient self-assessment of ED with respect to the severity of ED at baseline and after treatment, and in terms of change from baseline.. The study population consisted of 247 male outpatients with ED participating in a multicenter, double-blind, placebo-controlled, flexible-dose (25-100 mg/d) Phase IIIb clinical trial in which they were randomized equally to sildenafil citrate or placebo. Patients assessed their degree of ED as severe, moderate, minimal/mild, or no problem at baseline and after 12 weeks of treatment. They also responded to the 5 questions on the SHIM, after which their degree of ED was calculated based on the SHIM total score.. In general, the SHIM and the single-item self-assessment question produced similar descriptive profiles of the severity of ED. Kendall tau-b correlations were 0.66 (95% CI, 0.58-0.74) at baseline, 0.86 (95% CI, 0.82-0.90) after treatment, and 0.72 (95% CI, 0.67-0.77) for change from baseline. Agreement between instruments, measured by the weighted kappa statistic, mirrored the correlations at baseline and after treatment. As expected, both measures correlated moderately with improvement in erections and treatment satisfaction of both patient and partner.. The moderate-to-high correlation and agreement between the SHIM and patient self-assessment of ED validate the SHIM for use in the diagnostic classification of ED severity.

Topics: Adult; Aged; Diagnostic Tests, Routine; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Self-Examination; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

In a cross-over study we investigated the effects of sildenafil (single doses of 25- or 50mg) on cardiovascular autonomic nervous system (ANS) function assessed by serial recordings of blood pressure, conventional 12-lead electrocardiograms and standardized, time-and frequency domain indices of heart rate variability (HRV) in 21 men with erectile dysfunction. More than half of these patients had multiple comorbidities. Sildenafil induced significant mean reductions from baseline in resting blood pressure, accompanied by a reflex increase in heart rate. There were no significant changes after administration of sildenafil in any other of the ANS function indices. These preliminary findings suggest that sildenafil does not significantly affect cardiac ANS function in patients with erectile dysfunction.

Topics: Adult; Aged; Autonomic Nervous System; Baroreflex; Blood Pressure; Cross-Over Studies; Erectile Dysfunction; Heart Rate; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

To determine the efficacy of sildenafil citrate (Viagra) in patients with erectile dysfunction after three-dimensional conformal external beam radiotherapy (3D-CRT) for prostate cancer.. 406 patients with complaints of erectile dysfunction and who completed radiation at least 6 months before the study were approached by mail. 3D-CRT had been delivered (mean dose 68 Gy). Sixty patients were included and entered a double-blind, placebo-controlled, cross-over study lasting 12 weeks. They received during 2 weeks 50 mg of sildenafil or placebo; at Week 2 the dose was increased to 100 mg in case of unsatisfactory erectile response. At Week 6, patients crossed over to the alternative treatment. Data were collected using the International Index of Erectile Function (IIEF) questionnaire, and side effects were recorded.. Mean age was 68 years. All patients completed the study. For most questions of the IIEF questionnaire there was a significant increase in mean scores from baseline with sildenafil, but not with placebo. Ninety percent of the patients needed a dose adjustment to 100 mg sildenafil. Side effects were mild or moderate.. Sildenafil is well tolerated and effective in improving erectile function of patients with ED after 3D-CRT for prostate cancer.

Topics: Aged; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatic Neoplasms; Purines; Radiotherapy; Sildenafil Citrate; Sulfones

To assess the acute effects of sildenafil citrate (VIAGRA) on the intraocular pressure (IOP) of patients with chronic open-angle glaucoma.. This was a double-blind, randomized, placebo-controlled, crossover study, in which 15 patients received a single oral dose of sildenafil 100 mg or matching placebo on two separate occasions.. Fifteen subjects aged 63 +/- 14 years (mean +/- SD) with bilateral chronic open-angle glaucoma were administered a single oral dose of sildenafil 100 mg or matching placebo on two separate occasions at least 3 days apart. IOP was measured in both eyes by Goldmann ap-planation tonometry at baseline and then at 1-5 hours after dosing. Brachial artery systolic and diastolic blood pressures were determined by sphygmomanometry, and heart rate was also monitored at baseline and 1-5 hours after dosing.. Compared with placebo, no statistically or clinically significant change in IOP was detected after a single dose of sildenafil 100 mg (P =.20). Moreover, no significant change in mean systemic blood pressure (P =.12) or heart rate (P =.72) was detected after treatment with sildenafil.. At the maximum therapeutic dose of 100 mg, sildenafil did not produce any significant acute change in IOP in men with chronic open-angle glaucoma. This information is of importance for patients with glaucoma receiving sildenafil for treatment of erectile dysfunction.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Blood Pressure; Chronic Disease; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tonometry, Ocular

The aim of the present study was to evaluate the efficacy of sildenafil citrate and its effects on quality of life (QoL) in men with erectile dysfunction (ED) using data from three multicenter, double-blind, placebo-controlled clinical trials. Efficacy was evaluated using a global efficacy question (improvement of erections) and questions from the International Index of Erectile Function (IIEF) addressing the ability to achieve and maintain erections. QoL directly related to ED was evaluated using questions 13 and 14 of the IIEF, several psychometric instruments, and a questionnaire addressing men's concerns about their erection problems. Seventy-nine [corrected] percent of patients receiving sildenafil reported improved erections compared with 23% of patients receiving placebo (p < 0.0001); also reported were improvements in the ability to achieve and maintain erections with sildenafil but not with placebo (p < 0.0001). Improvements were also seen for other aspects of sexual function (overall satisfaction with sex life, sexual relationships with partners, concerns about erectile problems, p < 0.0001) and general mental health (well-being, self-control, satisfaction with relationship, health relative to 1 year ago, mental health; p < or = 0.05) following treatment with sildenafil. Thus, treatment of ED with sildenafil can significantly improve key QoL parameters related to sexual dysfunction and general mental health.

Topics: Adult; Analysis of Variance; Double-Blind Method; Erectile Dysfunction; Humans; Logistic Models; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones

Multicenter, open, prospective, before-after study.. To assess the efficacy and safety of sildenafil therapy for erectile dysfunction in patients with spinal cord injury, and the association between the response to sildenafil and factors such as causes and levels of spinal cord injury, grade of ASIA deficit, time since injury, orgasmic perception, and degree of baseline erection.. Homes of outpatients of 16 spinal cord injury units in Spain.. One hundred and seventy patients with erectile dysfunction secondary to spinal cord injury, from whom baseline data were collected on their sexual function, and who started treatment with sildenafil 50 mg. An efficacy assessment was made by the patient and his partner, and the score of the International Index of Erectile Function (IIEF) was recorded.. It was reported by 88.2% of the patients and 85.3% of their partners that treatment with sildenafil had improved their erections, regardless of the baseline characteristics of the spinal cord injury and erectile function. In responders, this improvement was confirmed by an increase from 12.5 to 24.8 points (P<0.001) of the Erectile Function Domain of IIEF. A significant improvement was also seen in patients' satisfaction with sexual activity and general satisfaction derived from sexual life. Preservation of orgasmic perception and a baseline degree of erection of 3 or 4 (P=0.006) were predictors of therapeutic success. No serious adverse events occurred.. Sildenafil is an effective, well-tolerated treatment for erectile dysfunction caused by spinal cord injury, regardless of the cause, neurological level, ASIA grade, and time since injury.. Spanish Society of Paraplegia.

Topics: Adult; Aged; Chi-Square Distribution; Drug Administration Schedule; Erectile Dysfunction; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Paraplegia; Piperazines; Predictive Value of Tests; Probability; Prospective Studies; Purines; Quadriplegia; Sildenafil Citrate; Spinal Cord Injuries; Statistics, Nonparametric; Sulfones; Treatment Outcome

In order to assess the effectiveness of sildenafil under routine conditions of use in primary care settings and to evaluate its impact on patient's life satisfaction and partner's satisfaction with treatment for erectile dysfunction (ED), an open, multicentre, observational, prospective study was designed in which 2816 patients were treated with sildenafil for at least 10 weeks. Effectiveness was assessed using the International Index of Erectile Dysfunction (IIEF), life satisfaction was measured with 'Life-satisfaction Check List' (LISAT 8), and EDITS was optionally used to assess the partner's satisfaction with ED therapy. Sildenafil was effective in 86.6% of patients. All dimensions of IIEF significantly increased with sildenafil, particularly erectile domain which overall sample mean score improved was 13.2 points (P < 0.001). The greatest increases in satisfaction with all aspects of life were seen in sex life and relationship with partner dimensions. The patients' partners, answered by a minority of partners, were highly satisfied with the treatment and its rapid action, therefore they were in favour of continuing with same. The adverse events occurring were similar to those seen in clinical research on sildenafil in the premarketing phase. No control group was included in this study.

Topics: Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Piperazines; Primary Health Care; Prospective Studies; Purines; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

We evaluated the safety and side effects of sildenafil in a group of sexually active volunteers younger than 40 years under conditions without sexual stimulation. Single oral dose of 50 mg dildenafil (n = 20) or placebo (n = 20) was randomly administered to 40 sexually active volunteers with the mean age of 26.80 +/- 5.29 in sildenafil group and 25.70 +/- 4.95 in placebo group. All the subjects were informed about the study, but not about the medicine. The following tests were performed immediately before and 90 minutes after the administration of the medicine: resting heart rate, blood pressure, electrocardiogram, visual acuity, color vision. The subjects were also asked to describe any discomfort or difference. Mann Whitney U test was used for statistical analyses. The only statistically significant difference was between heart rates before and after the administration of the sildenafil (p = 0.02). Color vision, visual acuity tests yielded no differences. The decrease in blood pressure was not significant. The most common side effects were flushing (75% and 0%), headache (50% and 5%), dyspepsia (15% and 5%), unintentional incomplete sexual arousal (15% and 0%) and palpitation (15% and 10%) in groups of sildenafil and placebo, respectively. The only serious side effect requiring medical treatment was arthralgia on the knee in one subject. Although these side effects can be acceptable, the likelihood of these side effects needs to be made clear to potential users of this medication.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Arthralgia; Blood Pressure; Double-Blind Method; Erectile Dysfunction; Flushing; Headache; Heart Rate; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Sildenafil is a selective and by oral administration potent type-5 phosphodiesterase (PDE 5) inhibitor, which increases the erection by corpus cavernosum smooth muscle relaxation. In a non-placebo controlled study, 134 patients with erectile dysfunction were treated with oral sildenafil. The aim of the study was to estimate the efficacy and adverse effects of this treatment. 51 patients (38%) had psychogenic, and 83 (62%) organic origin of the erectile dysfunction. 73 of them have already had some treatment for this problem before. The effective dose was 50 mg for 84 patients (63%), 100 mg for 32 (24%) and 25 mg for 4 patients. The treatment was effective for 120 patients (90%). The most common adverse effect was flushing in 18 (13%) and headache in 9 (7%) cases, two patients had headache and flushing together. Nasal congestion and visual disturbances were complained by two patients. Two patients reported prolonged (max. 2h) erections. Cardiological investigation was performed for cardiovascular patients and for patients with risk factors. Exact criteria of the cardiological opinion of sildenafil treatment are reviewed. Cardial or other serious adverse effects were not observed. It was not necessary to stop the treatment because of the adverse effects. The authors found, that sildenafil is an effective and safe treatment for the erectile dysfunction.

Topics: Adult; Aged; Cardiovascular Diseases; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Risk Factors; Sildenafil Citrate; Sulfones; Treatment Outcome

To evaluate the effectiveness of sildenafil (Viagra) in the treatment of male erectile dysfunction in Nairobi.. Prospective open label extension study.. Urology clinics at the Nairobi Hospital, Kenyatta National Hospital and the author's private clinic in Hurlingham, Nairobi.. Two hundred and nineteen adult male patients with erectile dysfunction.. The age range was 33-80 years with a mean of 62.5 years and a peak incidence in the 60-69 year age group. One hundred and nineteen patients (54.34%) had organic causes, 85 patients (38.81%) had psychogenic causes and 15 patients had mixed causes. Two hundred patients (91.32%) had improved sexual function after treatment with viagra. This improvement was sustained during the study period of sixteen weeks and included improved erectile and orgasmic functions and overall sexual satisfaction. One hundred and fifty seven of these patients responded to therapy with 50 mg of viagra; 40 patients with 25 mg and three patients with 100 mg of therapy. Nineteen patients (8.68%) had no improvement in sexual function after viagra administration. Seven patients (3.2%) had adverse effects which were mild and transient. They included mild headaches in three patients, mild dyspepsia in two patients and facial flushing and nausea and vomiting in one patient, respectively.. Oral sildenafil (Viagra) is an effective well tolerated and simple treatment for male erectile dysfunction in the majority of cases. The cost of treatment at about ten United States dollars for the 50 mg tablet is prohibitive and may limit its wide use by many deserving patients in this locality.. This prospective open-label extension study was carried out to evaluate the effectiveness of sildenafil (Viagra) in the treatment of male erectile dysfunction in Nairobi, Kenya. A total of 219 adult male patients with erectile dysfunction were instructed to take 50 mg, 25 mg, or 100 mg of sildenafil orally 1 hour prior to planned sexual activity, but not more than once every 24 hours. Patients were reviewed at 4-week intervals for 16 weeks to assess the efficacy and adverse effects of the drug. The age range was 33-80 years with a mean of 62.5 years and a peak incidence in the 60-69 year age group. The causes of erectile dysfunction were organic (n = 119, 54.34%), psychogenic (n = 85, 38.81%), and mixed (n = 15). 200 patients (91.32%) had improved sexual function after treatment with Viagra. This improvement included improved erectile and orgasmic functions and overall sexual satisfaction. 157 patients responded to the 50-mg treatment regimen; 40, to the 25-mg regimen; and 3, to the 100-mg regimen. No improvement in sexual function was reported in 19 patients (8.68%) after Viagra administration. In addition, 7 patients reported mild and transient adverse effects of the drug, including mild headache, dyspepsia, facial flushing, nausea, and vomiting. In conclusion, oral sildenafil (Viagra) is an effective well-tolerated and simple treatment for male erectile dysfunction in the majority of cases. However, the cost of treatment may prohibit and limit its wide use by many deserving patients in this area.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adult; Aged; Aged, 80 and over; Drug Costs; Dyspepsia; Erectile Dysfunction; Headache; Humans; Kenya; Male; Middle Aged; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Urban Health

To assess the short-term effects of sildenafil citrate on intraocular pressure in healthy male volunteers and participants in clinical trials.. Intraocular pressure and pupil diameter were measured in two placebo-controlled studies. Oral doses of sildenafil citrate (VIAGRA; Pfizer Inc, New York, New York) ranged from 10 mg to 150 mg.. No major changes in intraocular pressure or pupillometry were detected at any time (1.0-24 hours) after administration of sildenafil. Additionally, of 36 subjects with a medical history of increased intraocular pressure in the sildenafil safety database, none were reported to have a clinically significant increase of their intraocular pressure. During clinical trials, two glaucoma cases were listed as serious adverse events, but were not considered treatment related.. No clinical abnormalities were observed in intraocular pressure or pupil diameter in subjects receiving sildenafil. Currently, no evidence suggests that long-term treatment with sildenafil has an effect on intraocular pressure or is associated with the development or worsening of glaucoma.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Erectile Dysfunction; Glaucoma; Humans; Intraocular Pressure; Male; Phosphodiesterase Inhibitors; Piperazines; Pupil; Purines; Sildenafil Citrate; Single-Blind Method; Sulfones; Tonometry, Ocular

A multicenter, randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover study conducted June 1996 through January 1997.. To evaluate the effect of sildenafil citrate (VIAGRA(R)) on the quality of life (QoL) of men with erectile dysfunction (ED) caused by spinal cord injury (SCI).. Study centers in Australia, Belgium, France, Germany, Norway, Sweden and the United Kingdom.. Questions 13 and 14 of the 15-item International Index of Erectile Function (IIEF) addressed QoL issues directly related to ED in 178 men with SCI. A 5-item questionnaire addressing concerns that men had about their erection problems was also used to evaluate the impact of ED on QoL. Several commonly used psychometric instruments, including the Medical Outcomes Survey (MOS) Short Form-12, Psychological General Well-Being Index, and MOS Family Survey, assessed general QoL issues.. Significant improvements were seen for overall satisfaction with sex life (IIEF Q13), sexual relationship with partner (IIEF Q14), and concerns about erectile problems (P<0.0001). Improvements were reported in scores for the generic QoL parameters of mental health, well-being, depression, and anxiety (P<0.05 sildenafil versus placebo).. Treatment with sildenafil can significantly improve key QoL parameters in men with ED caused by SCI.. This study was funded by Pfizer Inc. Spinal Cord (2000) 38, 363 - 370.

Topics: Adult; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Health Surveys; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Treatment Outcome

The aim of this study was to evaluate the efficacy and safety of sildenafil in the treatment of erectile dysfunction (ED) in spinal cord-injury (SCI) patients. Moreover, we looked for neurological conditions permitting therapeutic success and for the ideal dose needed to achieve sufficient erections.. 41 SCI patients were prospectively examined. Sexual dysfunction was assessed by means of anamnesis, the International Index of Erectile Function (IIEF) questionnaire, and neurological examination. Psychogenic erection capacity was tested by audiovisual stimulation and reflexive erection using a vibrator device. Neurophysiological recordings and cystomanometry were performed in parallel to clinical examinations. Neurophysiological recordings included sympathetic skin responses (SSR), pudendus somatosensory evoked potentials (pSSEP), and bulbocavernous reflex (BCR). Urodynamics aimed at classifying the neurogenic bladder dysfunction (upper motoneuron lesion versus lower motoneuron lesion). Intracavernous injection tests with PGE1 were performed in all patients to exclude major organic disease. 50 mg sildenafil was first given 3 times. Thereafter, the doses were adapted according to patients' reports.. Clinically, 28 subjects preserved either reflexive erections (24) or psychogenic erections (4), 11 had both types and only 2 presented with a complete loss of erection. 38 patients (93%) had a positive response to sildenafil and reached a penile rigidity sufficient to permit sexual intercourse. 3 patients dropped out because of non-response despite having increased the dosis up to 100 mg. 22 patients (58%) showed functional erections 1 h after 50 mg sildenafil, whereas 14 (37%) required higher doses of 75-100 mg. By comparing the IIEF questionnaire scores before and after therapy, there was a significant improvement in erectile function and intercourse satisfaction from 9.2+/-4.4 SD) and 4.5 (+/-2.5 SD) to 25.5 (+/-4.2 SD) and 10.5 (+/-2.1 SD) points, respectively (p<0.05). Nearly 10% (4/41) suffered from side effects such as headache or dizziness. Two of them stopped therapy because of the side effects. At least 36 patients (88%) continue treatment with sildenafil. Absence of both psychogenic (nonsomesthetic supraspinally elicited) and reflexive (somesthetic spinally elicited) erections, confirmed by urodynamical and electrophysiological findings (SSR perineum, BCR and pSSEP), seems to exclude a successful treatment. In contrast, SCI male patients with preserved function of at least one component of the erection phenomenon (psychogenic/reflexive) responded well to sildenafil and the dose required to achieve erections sufficient for sexual intercourse did not differ between the two groups.. Sildenafil proves to be a valuable and safe therapeutic management in ED of SCI patients. Therefore, patient acceptance and satisfaction are high. The most common dose required to achieve a satisfying erection is 50 mg. The efficacy of sildenafil depends on sparing of either sacral (S2-S4) or thoracolumbar (T10-L2) spinal segments which, in this study, have been shown to be of relevance in mediating psychogenic erections in male SCI patients. Complete disturbance of any neurogenic impulses excludes successful treatment.

Topics: Adult; Electrophysiology; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Urodynamics

Intracavernous injection is a well established medical therapy for erectile dysfunction. We assessed the rate of success when patients with erectile dysfunction who were effectively treated with intracavernous injections of prostaglandin E1 were changed to oral therapy with sildenafil citrate.. Only patients effectively managing erectile dysfunction by the intracavernous injection of 20 microg. or less prostaglandin E1 for more than 6 months were eligible for study enrollment. After a 4-week run-in phase while intracavernous prostaglandin E1 therapy continued and a 48-hour washout period 176 patients with erectile dysfunction received open label sildenafil orally for 12 weeks. Satisfaction with treatment was evaluated by the 11-item erectile dysfunction index of treatment satisfaction questionnaire. A successful change to sildenafil was prospectively defined as a questionnaire score of 0 to 100 after sildenafil that was greater than or equal to the score after intracavernous prostaglandin E1.. Of the 176 patients 69% (95% confidence limit 62 to 76) successfully changed from intracavernous prostaglandin E1 injections to oral sildenafil and elected to continue oral treatment. Mean satisfaction score after sildenafil and prostaglandin E1 was 73.8 and 63.9, respectively (p <0.001). Only 3 patients (1.7%) discontinued therapy because of treatment related adverse events.. More than two-thirds of the men with erectile dysfunction who were stable on intracavernous injections of 20 microg. or less prostaglandin E1 successfully changed to oral sildenafil, as determined by maintained or enhanced treatment satisfaction.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Adult; Aged; Aged, 80 and over; Alprostadil; Confidence Intervals; Erectile Dysfunction; Humans; Injections; Male; Middle Aged; Patient Satisfaction; Penis; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents

Now that individuals with spina bifida live well into adulthood erectile dysfunction has become a recognized associated medical disorder. To our knowledge no study has dealt specifically with treatment of erectile dysfunction in men with spina bifida. Therefore, we conducted a prospective, blinded, randomized, placebo controlled, dose escalation, crossover study to determine the ability to treat erectile dysfunction in men with spina bifida with sildenafil citrate.. Erectile dysfunction was diagnosed in 15 men 19 to 35 years old with spina bifida who were assigned to take 4 sets of tablets, 5 tablets per set, in a random order. All patients took 25 and 50 mg. sildenafil and 2 identical looking sets of corresponding placebos 1 hour before planned sexual activity. Efficacy was assessed by the effect of treatment compared to baseline, that is before treatment, on rating of erections (scored from 0 to 10), duration of erections, frequency of erections based on response to question 1 (scored from 0 to 5) of the International Index of Erectile Function and confidence to obtain an erection based on response to question 15 (scored from 1 to 5) of the International Index of Erectile Function.. Improved erectile function was reported while on sildenafil by 12 (80%) men compared to baseline and placebos. There was a significant dose dependent improvement of erectile function with both 25 and 50 mg. sildenafil compared to baseline (p <0.05), as mean erectile score increased by 50% and 88%, mean duration of erections increased by 192% and 266%, mean frequency of erections increased by 61% and 96%, and mean level of confidence increased by 33% and 63%, respectively. Furthermore, 50 mg. sildenafil provided greater improvement in all 4 parameters compared to 25 mg. The placebo results were not significantly different compared to baseline for any of the parameters.. Erectile dysfunction in patients with spina bifida is a medically treatable condition. Sildenafil is effective in this patient population and improves level of sexual confidence.

Topics: Adult; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Spinal Dysraphism; Sulfones

To assess the validity of severity classes on the erectile function (EF) domain of the International Index of Erectile Function by determining their relationship with the self-assessment of EF, before and after treatment, in an independent cohort of patients.. Two hundred forty-seven men with clinically diagnosed erectile dysfunction (ED) and in a stable heterosexual relationship were enrolled in a randomized, double-blind, multicenter, placebo-controlled, parallel-group, 12-week, flexible-dose study. Patients assessed their degree of ED as severe, moderate, minimal/mild, or no problem at baseline and after treatment. They also responded to the six questions of the EF domain, with the total score indicating the following degrees of ED: severe, EF score 1 to 10; moderate, EF score 11 to 16; mild to moderate, EF score 17 to 21; mild, EF score 22 to 25; and no ED, EF score 26 to 30. Descriptive profiles of the two diagnostic instruments were compared. The correlations between the instruments were evaluated with Kendall's tau-b at baseline, after treatment at 12 weeks, and at change from baseline.. The two measures gave generally similar descriptive profiles of ED severity. The correlations were 0. 65 (95% confidence interval 0.57 to 0.73) at baseline, 0.86 (95% confidence interval 0.83 to 0.89) after 12 weeks of treatment, and 0. 73 (95% confidence interval 0.67 to 0.79) at change from baseline.. The moderate-to-high correlation between the patients' self-assessment of EF and the EF domain of the International Index of Erectile Function provides a validation of this domain for the reliable diagnostic classification of ED severity.

Topics: Adult; Aged; Confidence Intervals; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Participation; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Reproducibility of Results; Severity of Illness Index; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

To evaluate the outcome of combined therapy (using intraurethral alprostadil and oral sildenafil) in private and clinic patients with erectile dysfunction, and thus assess predictors of satisfaction.. In all, 360 men were treated for erectile dysfunction using single and/or combined therapy, comprising 214 private-practice and 166 clinic patients. Responses were evaluated using the International Index for Erectile Function (IIEF) questionnaire before and after treatment. Serum testosterone levels, education and socio-economic status were also assessed. Group 1a consisted of 33 private patients and Group 1b of 24 clinic patients who tried the maximum dose of intraurethral alprostadil monotherapy initially, followed by the maximum dose of sildenafil monotherapy, and remained dissatisfied. Group 2a consisted of 32 private patients and group 2b of 31 clinic patients who tried the maximum dose of sildenafil monotherapy initially, followed by the maximum dose of alprostadil monotherapy, and were also dissatisfied. These two groups of 65 private and 55 clinic patients then underwent combined therapy.. The mean (SD) score for erectile function was 24.1 (2) for combined therapy (a 123% improvement), and 19.8 (1. 8) (83% improvement) and 15.2 (1.6) (41% improvement) for sildenafil and alprostadil monotherapies (P < 0.05 for both patient groups). The men also reported an improvement in their satisfaction with intercourse. However, at 18 months, 60 of the 65 private patients but only 40 of the 55 clinic patients continued with combined therapy; thus, the discontinuation rate was three times greater among clinic than among private patients. Furthermore, the private patients had an overall improvement in the satisfaction score of 128%, compared with 51% for the clinic patients.. Although there were no significant differences in erectile function improvement within the two satisfied combined therapy groups, the differences in overall satisfaction and long-term withdrawal rates suggests that other factors beside motivation must be involved for success, e.g. education, persistence, realistic expectations, and certain psychological factors. Combined therapy should be considered for those patients who have a suboptimal response to monotherapy and refuse or are not candidates for surgical options. Generally, those patients with a higher education, greater persistence and more realistic expectations were more satisfied with combined therapy.

Topics: Alprostadil; Drug Combinations; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilator Agents

To evaluate the efficacy, safety, and tolerability of oral sildenafil in Asian men with erectile dysfunction of various causes (organic, psychogenic, or mixed) and of more than 6 months' duration.. In this double-blind, parallel-group trial conducted at eight centers in Malaysia, the Philippines, and Singapore, 254 men, 26 to 78 years old, were randomized to 12 weeks of sildenafil or placebo taken as needed 1 hour before anticipated sexual activity. Initially, the sildenafil (n = 127) or matching placebo (n = 127) dose was 50 mg but could be increased to 100 mg or decreased to 25 mg because of a lack of efficacy or intolerance, respectively. Efficacy was assessed by the 15-question International Index of Erectile Function, patients' event logs of sexual activity, and a global efficacy question about erections.. The two primary efficacy variables relating to achievement and maintenance of an erection sufficient for sexual intercourse, as assessed by the mean scores for International Index of Erectile Function question 3 (4.22 versus 2.59) and question 4 (4.15 versus 2.41), were both significantly higher with sildenafil than with placebo (P <0.0001). In addition, the five separate International Index of Erectile Function domains of sexual function, the percentage of successful intercourse attempts, and the global efficacy assessment of erections revealed significantly greater treatment effects in favor of sildenafil (P <0.0001 versus placebo for all variables). Treatment-related adverse events occurred in 22.8% of patients who received sildenafil and in 10.2% of those who received placebo.. Sildenafil is an effective and well-tolerated treatment for Asian men with erectile dysfunction of broad-spectrum etiology.

Topics: Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Malaysia; Male; Middle Aged; Philippines; Piperazines; Purines; Sildenafil Citrate; Singapore; Sulfones

The long-term efficacy and safety of oral Viagra (sildenafil citrate), a selective phosphodiesterase 5 inhibitor, and the effect of withdrawing treatment were evaluated in men with erectile dysfunction (ED). In 233 men with ED of psychogenic or mixed organic/psychogenic aetiology, 16 weeks of open-label, flexible-dose sildenafil treatment (10-100 mg) was followed by eight weeks of double-blind, fixed-dose, randomised withdrawal to placebo or continued treatment with sildenafil. Sildenafil was taken as needed (not more than once daily) approximately 1 h prior to sexual activity. The main outcome measures were a global efficacy question, a sexual function questionnaire, an event log of erections, and adverse event recording. In the open-label phase, 200 of 216 patients (93%) reported improved erections with sildenafil; 28 patients (12%) discontinued treatment. In the double-blind phase, the significant improvements in the frequency and duration of erections were maintained in the sildenafil group but returned to pre-treatment values in patients on placebo (P values < 0.0001 versus placebo). The most frequent adverse events in the sildenafil group during the double-blind phase were flushing (7%), headache (6%), and dyspepsia (5%). Of the 192 patients enrolled in the 1-y extension, 90% completed the study; only two patients (1%) were withdrawn due to lack of efficacy. In men with ED of psychogenic or mixed aetiology, oral sildenafil is effective and well-tolerated both at the initiation of therapy and during long-term treatment. For most patients, sildenafil treatment must be continued for improvements in erectile function to be maintained.

Topics: Adolescent; Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Placebos; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Audiovisual sexual stimulation (AVSS) is frequently employed to promote cavernosal smooth muscle relaxation (SMR) in hemodynamic diagnostic settings for erectile dysfunction. Our aim has been to adapt conventional AVSS to the particular test conditions of pharmacocavernosometry and pharmacocavernosography (DICC), by the use of virtual glasses. Thirty-seven consecutive patients undergoing DICC were randomized in two groups: no-AVSS and AVSS through commercially available virtual glasses (VG-AVSS) with tri-dimensional capabilities and stereophonic headphones. Such device partially excludes the patient from the surrounding environment. In both groups a standard dose of vasoactive agents was intracavernosally administered, and possibly repeated (re-dosing), until complete SMR was obtained (3 doses/patient maximum). Psychometric tests (State Trait Anxiety Inventory and ad hoc visual analogue scales for embarrassment, stress and pain) were administered before and after DICC. The no-AVSS group consisted of 18 patients, the AVSS group of 19. Number of needed vasoactive agent doses: in the no-AVSS group 6 patients needed 1 dose, 3 patients 2, 9 patients 3 (mean dose number: 2.17); in the AVSS group 15 patients needed 1 dose, 1 patient 2, 3 patients 3 (mean dose number: 1.37). The difference in the number of doses used in the two groups was statistically significant (Student's t-test P = 0.007). Complete SMR, regardless of the number of used doses: in the no-AVSS group 9 patients (50%) achieved complete SMR, in the AVSS group 16 patients (84.2%). The difference in the two groups was statistically significant (chi-square P = 0.026). From evaluated psychometric measures no statistically significant difference between the two groups was detected. VG-AVSS significantly promotes complete SMR without increasing test related stress or anxiety. Its induced arousal suggests the possibility of performing dynamic evaluations of the erectile function with the oral agent sildenafil in place of intracavernosally administered vasoactive agents. VG-AVSS furthermore constitutes a promising tool for the investigation of normal physiology and pathophysiology of female sexual function.

Topics: Adult; Aged; Audiovisual Aids; Erectile Dysfunction; Eyeglasses; Humans; Male; Middle Aged; Muscle Relaxation; Muscle, Smooth; Papaverine; Penis; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Pressure; Prospective Studies; Psychometrics; Purines; Sex; Sildenafil Citrate; Sulfones; User-Computer Interface; Vasodilator Agents

To assess the acute effect of sildenafil citrate on blood pressure and heart rate in men with erectile dysfunction taking concomitant antihypertensive medication.. Post-hoc subanalysis of five, 12- or 24-week, prospective, randomized, double-blind, placebo-controlled studies.. Private-practice and academic urology clinics.. A total of 1685 men with erectile dysfunction of > or = 6 months duration, of whom 667 (sildenafil n = 406, placebo n = 261) were taking antihypertensive medication (diuretic, beta-blocker, alpha-blocker, angiotensin converting enzyme inhibitor, and/or calcium antagonist). Of the patients taking antihypertensive medication, 608 (91%) completed the studies (374 of 406 receiving sildenafil, 234 of 261 receiving placebo).. The last dose of oral sildenafil (25-200 mg) or placebo was taken at home on the morning of the final clinic visit. Patients taking antihypertensive medication maintained usual dosing schedules.. Sitting systolic (SBP)/diastolic blood pressure (DBP) and heart rate at baseline and after dosing with sildenafil or placebo (end-of-treatment visit).. Mean changes from baseline in SBP/DBP for men taking antihypertensive medication were -3.6/-1.9 mmHg for those receiving sildenafil and -0.8/-0.1 mmHg for those receiving placebo compared with -2.2/-2.0 mmHg and -0.1/0.4 mmHg, respectively, for men not taking antihypertensive medication. Mean changes from baseline in heart rate for men taking antihypertensive medication were -0.6 beats/min after sildenafil and 0.9 beats/min after placebo compared with 0.4 beats/min and -0.6 beats/min, respectively, for patients not taking antihypertensive medication. Differences in SBP, DBP, and heart rate between the patients taking and those not taking antihypertensive medication were small.. The acute, short-term effects of oral sildenafil on blood pressure and heart rate in men with erectile dysfunction were small and not likely to be clinically significant in those taking concomitant antihypertensive medication.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Blood Pressure; Double-Blind Method; Drug Interactions; Erectile Dysfunction; Heart Rate; Humans; Hypertension; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Safety; Sildenafil Citrate; Sulfones

Sildenafil citrate (Viagra) has been shown to be an effective treatment for erectile dysfunction (ED) of organic aetiology. This study assessed the efficacy and tolerability of sildenafil for treating ED of psychogenic and mixed psychogenic/organic aetiology. Men with ED of psychogenic and mixed aetiology were randomised in a double-blind, fixed-dose study to placebo (n = 95) or sildenafil 10 mg (n = 90), 25 mg (n = 85), or 50 mg (n = 81) once daily for 28 days. Efficacy was evaluated with two global efficacy questions, a patient log of erectile activity, a sexual function questionnaire and a partner questionnaire. Patients receiving sildenafil had significantly more grade 3 (hard enough for penetration) or grade 4 (fully hard) erections per week than patients receiving placebo, and a greater proportion of patients receiving sildenafil reported that treatment had improved their erections (p < 0.001). Results of the sexual function questionnaire demonstrated significant improvement for patients with ED receiving sildenafil compared with patients receiving placebo for frequency, hardness and duration of erections (p < 0.01), and for enjoyment of sexual intercourse and satisfaction with sex life (p < 0.05). The results of the partner questionnaire were consistent with the results reported by patients and showed that treatment with sildenafil was associated with significant improvement in the partners' own sex lives (p < 0.001). Adverse events were mostly mild to moderate in nature. The commonest adverse events were headache, dyspepsia, flushing, myalgia, arthralgia and flu syndrome. Discontinuations due to treatment-related adverse events were few, ranging from 1.1% to 6.2% for patients receiving different doses of sildenafil and 4.2% for patients receiving placebo. Sildenafil is an effective and well-tolerated treatment for ED of psychogenic or mixed aetiology with once-daily dosing.

Topics: Adolescent; Adult; Aged; Data Interpretation, Statistical; Double-Blind Method; Erectile Dysfunction; Humans; Impotence, Vasculogenic; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

To determine the efficacy of sildenafil for the treatment of erectile dysfunction (ED) in a clinical practice setting; to evaluate the correlation between patient and partner perceptions of treatment outcomes; and to assess the relation between the severity of ED and response to treatment.. Among the first 100 men to receive sildenafil in a urology practice setting, 74 (mean + SD age 64+/-11 years) completed a validated sexual function questionnaire (International Index of Erectile Function [IIEF]) before and after a 4 to 6-week treatment period. A modified version of the same questionnaire was independently completed by partners. ED was categorized into a severity class of I to IV.. Sildenafil treatment improved erections by 71% to 95%, according to responses in key IIEF questions 3 and 4. Overall, 57 (77%) of 74 patients desired to continue treatment after the test period. Patient score on the IIEF was correlated with partner score on the modified questionnaire before and after treatment (r = 0.67 to 0.81, P <0.01). IIEF scores were reflected in a simple severity classification system. Men with the best preservation of erections (severity class I) exhibited the best responses to sildenafil, whereas men with no erections (severity class IV) were much less likely to respond to the drug and desire continuation of treatment (P <0.01). Patients with a radical prostatectomy were relatively refractory to sildenafil, except for 2 of 5 who had undergone a nerve-sparing operation.. In clinical practice, sildenafil is an effective treatment of ED, according to partner-validated questionnaire responses; and the results of treatment are predictable with an ED severity classification system.

Topics: Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Piperazines; Prospective Studies; Purines; Severity of Illness Index; Sildenafil Citrate; Sulfones

Erectile dysfunction is common in men with diabetes.. To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes.. A multicenter, randomized, double-blind, placebo-controlled, flexible dose-escalation study conducted May through November 1996.. Patients' homes and 19 clinical practice centers in the United States.. A total of 268 men (mean age, 57 years) with erectile dysfunction (mean duration, 5.6 years) and diabetes (mean duration, 12 years).. Patients were randomized to receive sildenafil (n = 136) or placebo (n = 132) as needed, but not more than once daily, for 12 weeks. Patients took the study drug or placebo 1 hour before anticipated sexual activity. The starting dose of sildenafil citrate was 50 mg, with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability, to be taken as needed.. Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events.. Two hundred fifty-two patients (94%) completed the study (131/136 in the sildenafil group, 121/132 in the placebo group). By intention-to-treat analysis, at 12 weeks, 74 (56%) of 131 patients in the sildenafil group reported improved erections compared with 13 (10%) of 127 patients in the placebo group (P<.001). The proportion of men with at least 1 successful attempt at sexual intercourse was 61 % (71/ 117) for the sildenafil group vs 22% (25/114) for the placebo group (P<.001). Adverse events related to treatment were reported for 22 (16%) of 136 patients taking sildenafil and 1 (1%) of 132 patients receiving placebo. The most common adverse events were headache (11% sildenafil, 2% placebo), dyspepsia (9% sildenafil, 0% placebo), and respiratory tract disorder (6% sildenafil, 2% placebo), predominantly sinus congestion or drainage. The incidence of cardiovascular adverse events was comparable for both groups (3% sildenafil, 5% placebo).. Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes.

Topics: Adult; Aged; Diabetes Complications; Double-Blind Method; Erectile Dysfunction; Humans; Logistic Models; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildenafil 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days.. To assay the efficacy and safety of sildenafil 50 mg and placebo.. Clinic- and home-based assessments in the United Kingdom.. A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global efficacy. questionniare, diary).. In Part I, 17/26 (65%) subjects had erections of >60% rigidity at the penile base (median duration 3.5 min) after sildenafil compared with 2/26 (8%) (median duration 0 min) alter placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildenafil and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P<0.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P<0.02). An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration (P = 0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildenafil due to adverse events.. Sildenafil is an effective, well-tolerated oral treatment for ED in SCI subjects.

Topics: Adult; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Treatment Outcome

To determine the efficacy of sildenafil for patients with erectile dysfunction after radiotherapy for localized prostate cancer.. Fifty patients with erectile dysfunction after radiotherapy were treated with sildenafil. Their median age was 68 years (range 54 to 78). All were treated with a three-dimensional conformal external beam radiotherapy approach, and the median dose prescribed to the planning target volume was 75.6 Gy. Patients were initially given 50 mg of sildenafil and instructed to use the medication on at least three occasions. They were then contacted to ascertain the efficacy of and tolerance to the medication.. Significant improvement in the firmness of the erection after sildenafil was reported in 37 patients (74%), 2 (4%) had partial improvement, and 11 (22%) had no response. Significant improvement in the durability of the erection was reported in 33 patients (66%), 3 (6%) had partial improvement, and 14 (28%) reported no improvement. Patients with partial or moderate erectile function before using sildenafil were more likely to benefit from the medication compared with those with absent function. Among 29 patients with erections classified as partial after radiotherapy, 26 (90%) had a significant response to the medication. In contrast, only 11 (52%) of 21 with erections classified as flaccid after radiotherapy had a significant response to the medication (P = 0.007).. Sildenafil improved erectile function in greater than two thirds of patients with postradiotherapy impotence. Patients with less severe dysfunction are most likely to benefit from this intervention.

Topics: Administration, Oral; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatic Neoplasms; Purines; Radiotherapy; Sildenafil Citrate; Sulfones

To evaluate the efficacy, safety, and tolerability of sildenafil in men with broad-spectrum erectile dysfunction (ED), with reference to age-matched healthy control subjects.. One hundred eleven patients were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, 12-week, flexible-dose study. Efficacy assessments included the International Index of Erectile Function (IIEF), a global assessment question, and patient event log data. In a separate, nontreatment study, 109 control subjects also completed the IIEF.. Mean IIEF scores at baseline were significantly lower for patients with ED than for control subjects without a history of ED. After treatment, mean IIEF scores for patients receiving sildenafil approached values observed in control subjects and were significantly higher than mean scores for patients receiving placebo (P<0.01). Responses to the global assessment question and patient log data corroborated the IIEF results. Sildenafil was well tolerated, with no discontinuations because of adverse events.. The results indicate that sildenafil, an effective oral therapy for the treatment of broad-spectrum ED, is associated with a near normalization of patient erectile function.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

To determine the efficacy and safety of fixed-dose oral sildenafil in patients with erectile dysfunction (ED) of various etiologies.. In a 12-week, double-blind, randomized, placebo-controlled, fixed-dose study, 514 men (mean age 56 years) with ED were randomized to receive 25, 50, or 100 mg of sildenafil or placebo. The primary etiology of ED was determined to be organic in 32% of men, psychogenic in 25%, or mixed in 43%. Sildenafil or placebo was taken in the home setting approximately 1 hour before sexual activity, not more than once daily. Efficacy was determined by responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) of the 15-item International Index of Erectile Function (IIEF). Other measures of efficacy included the five sexual function domains of the IIEF, a global efficacy question, event log data, and a partner questionnaire.. Sildenafil significantly increased patients' ability to achieve and maintain erections (P <0.0001), with efficacy increasing with increasing dose. Significant improvements were also observed in the IIEF domains for erectile function, orgasmic function, intercourse satisfaction, and overall sexual satisfaction (P <0.0001). The proportion of subjects who felt that treatment with sildenafil improved their erections was significantly greater (67% to 86%) than that with placebo treatment (24%, P <0.0001). The proportion of successful attempts at sexual intercourse also increased significantly with sildenafil treatment (P <0.001). Partner responses corroborated patient reports. Sildenafil was well tolerated at the three doses studied.. Oral sildenafil is an effective, well-tolerated treatment for ED of various etiologies.

Topics: Administration, Oral; Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Alprostadil; Erectile Dysfunction; Humans; Injections; Male; Penile Erection; Penis; Piperazines; Prospective Studies; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

To ascertain the efficacy of sildenafil citrate (Viagra) in patients with erectile dysfunction (ED) either before or after prostate brachytherapy by an open-label, nonrandomized study.. Sixty-two patients who underwent prostate brachytherapy between March 1995 and July 1998, had ED either before or after brachytherapy, and were interested in treatment with sildenafil comprised the patient population. Clinical and treatment parameters evaluated for medication efficacy included patient age at brachytherapy and at medication administration, hypertension, diabetes, smoking history, onset of ED, potency status before implant, frequency of intercourse before brachytherapy (if potent), use of neoadjuvant hormonal manipulation, use of moderate dose external beam radiation therapy before implantation, choice of isotope, V100 (the percentage of the prostate volume receiving at least 100% of the prescribed minimal peripheral dose), and sildenafil dose.. Fifty (80.6%) of 62 patients responded favorably to sildenafil. None of the treatment parameters predicted medication failure, and among the clinical parameters, only diabetes predicted failure (3 of 5) and only with borderline statistical validity (P = 0.046).. Our results suggest brachytherapy-induced impotence is as amenable to sildenafil treatment as ED from other causes. In addition, our 80.6% success rate is comparable to reported results for patients who underwent bilateral nerve-sparing radical prostatectomy and significantly better than patients who underwent unilateral nerve-sparing or non-nerve-sparing approaches.

Topics: Adenocarcinoma; Aged; Brachytherapy; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prostatic Neoplasms; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction is a common complication of spinal cord injury. This double-blind, placebo-controlled, two-way crossover study assessed the efficacy and safety of oral sildenafil in men with erectile dysfunction caused by traumatic spinal cord injury. A total of 178 men (mean age, 38 years) received placebo or sildenafil 1 hour before sexual activity for 6 weeks; after a 2-week washout period, the men received the alternate treatment for 6 weeks. The 50-mg starting dose could be adjusted to 100 or 25 mg based on efficacy and tolerability. Efficacy was assessed by using global efficacy questions, the International Index of Erectile Function (IIEF), and a patient log of erectile activity. Of 143 men with residual erectile function at baseline, 111 (78%) reported improved erections and preferred sildenafil to placebo. For all men (including those who reported no residual erectile function at baseline), 127 of 168 (76%) reported improved erections and preferred sildenafil to placebo. For all men, 132 of 166 (80%) reported that sildenafil improved sexual intercourse compared with 17 of 166 men (10%) reporting improvement with placebo. IIEF questions assessing the ability to achieve and maintain erections and satisfaction with sexual intercourse demonstrated significant improvement with sildenafil. Sildenafil was well tolerated, with a low rate of discontinuation because of treatment-related adverse events (2% vs 1% for placebo). Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction caused by spinal cord injury.

Topics: Administration, Oral; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

We undertook a prospective, blinded, randomised, placebo-controlled, dose escalation, crossover study that showed that erectile dysfunction in spina bifida is medically treatable, specifically with sildenafil citrate.

Topics: Adult; Analysis of Variance; Cross-Over Studies; Erectile Dysfunction; Humans; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Single-Blind Method; Spinal Dysraphism; Sulfones

To determine the response to sildenafil citrate (Viagra) in patients with erectile dysfunction after radiation therapy for localized prostate cancer.. Baseline and follow-up data from 21 patients presenting with erectile dysfunction after radiation treatment for clinical T1-2 prostate cancer were obtained. Two patients had undergone iodine-125 seed implantation and the remaining 19 conformal external beam irradiation. All 21 patients were considered to have erectile dysfunction as assessed by the International Index of Erectile Function (IIEF) and were prescribed sildenafil at a dosage of 50 mg, with a titration to 100 mg if needed. The mean time between the completion of radiation therapy and initiation of sildenafil was 24.6 +/- 5.8 months. The quality of the erectile function was assessed after a minimum of four doses by using the Cleveland Clinic Erectile Function (CCEF) questionnaire and the IIEF questionnaire. A positive response to sildenafil on the CCEF questionnaire was defined as an erection sufficient for vaginal penetration. The responses on the IIEF questionnaire were rated on a scale of 1 (almost never) to 5 (almost always), with 0 being no sexual activity.. On the CCEF questionnaire, 71% (15 of 21) of patients had a positive response, with a mean duration of 12.7 +/- 2.5 minutes of intercourse, and a corresponding spousal satisfaction rate of 71%. Twelve (80%) of the 15 responders required titration to the 100-mg dosage for maximal effect. The most common side effects seen were transient flushing (19%), abnormal color vision (14%), and headaches (10%). No patient discontinued the drug because of side effects. On the IIEF questionnaire, the responses to questions 3 (frequency of penetration), 4 (maintenance of erection), 7 (satisfactory intercourse), and 15 (erection confidence) increased from mean baseline scores of 1.3, 1.1, 1.2, and 1.8 to final mean scores of 4.0, 3.9, 3.2, and 3.4, respectively (P <0.001). On the global efficacy question (ability to achieve firm erections), 71% of the patients responded positively.. Sildenafil citrate can improve the ability to achieve and maintain an erection in most patients with erectile dysfunction after radiation therapy for prostate cancer.

Topics: Aged; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatic Neoplasms; Purines; Radiotherapy; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

We assess the clinical efficacy of sildenafil citrate and predictors of satisfactory outcome.. All patients treated with sildenafil citrate within the first 6 weeks of its release were evaluated with a self-administered questionnaire before and at completion of therapy to assess etiology of erectile dysfunction, level of sexual function, libido, response to previous therapies, response to therapy with sildenafil citrate and quality of life. Sexual function was measured before and during therapy using an abbreviated version of the International Index of Erectile Function, with a successful outcome defined as a level of satisfaction of 4 or 5 on a 5-point scale.. Followup was obtained in 267 of the 308 patients who entered the study. Mean age plus or minus standard deviation was 61+/-9.6 years and duration of erectile dysfunction was 4.1+/-3 years. Overall satisfaction with sildenafil citrate for the entire patient population was 65% and response to prior therapies did not affect satisfaction. There was a significant positive correlation between baseline sexual function and response to sildenafil citrate but even patients with severe erectile dysfunction had a 41% satisfaction rate. Etiology of erectile dysfunction had a significant impact on satisfaction rate, with neurogenic causes of erectile dysfunction (diabetes, prostate surgery and so forth) having significantly lower rates than psychogenic or vasculogenic erectile dysfunction.. Sildenafil citrate is a highly effective oral agent for the treatment of erectile dysfunction in clinical practice. The best predictors for response to sildenafil citrate therapy are baseline sexual function and etiology of erectile dysfunction. However, we could not identify any patient characteristic that would predict absolute failure for sildenafil citrate therapy. Therefore, all patients with erectile dysfunction who do not have specific contraindications should be considered for sildenafil citrate therapy.

Topics: Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Follow-Up Studies; Humans; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Prognosis; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Topics: Adult; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Sulfones

Erectile dysfunction continues to be a significant problem for men after radical retropubic prostatectomy despite nerve sparing techniques. Sildenafil citrate (Viagra) has proved effective for erectile dysfunction in many men. We determine the efficacy of sildenafil in men with erectile dysfunction after radical retropubic prostatectomy and examine variables that may impact the response to treatment.. A total of 84 men were prescribed sildenafil after radical retropubic prostatectomy and asked to complete a series of questionnaires, including the International Index of Erectile Function (IIEF), on erectile function before and after sildenafil administration. The importance of factors, such as patient age, time since surgery, degree of cavernous nerve sparing, preoperative prostate specific antigen, Gleason score, clinical and pathological stage, and baseline postoperative erectile function, was examined.. Of the 84 patients 45 (53%) had improved erections and 34 (40%) had improved ability for intercourse while taking sildenafil. Mean IIEF score for the erectile function domain increased from 9 to 14 (p <0.001). Orgasmic function (p = 0.004) and intercourse satisfaction (p = 0.009) also significantly improved. The degree of nerve sparing and baseline postoperative erectile dysfunction had a significant impact on the ability of sildenafil to improve erectile function (p = 0.010 and p <0.001, respectively) and total IIEF questionnaire responses (p = 0.031 and p <0.001, respectively). Age and pathological stage also appeared to have a significant effect.. Sildenafil improved erectile function and the ability to have intercourse in more than half of men after radical retropubic prostatectomy. Baseline postoperative erectile function, which is dependent on the degree of nerve sparing technique, significantly impacts the likelihood that patients will respond to sildenafil.

Topics: Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

Erectile dysfunction is a common late complication patients may experience after external-beam radiotherapy for prostate cancer. The efficacy and safety of oral sildenafil to correct sexual dysfunction caused by external-beam radiotherapy was studied in patients participating in our prospective trial.. Thirty-five assessable patients participated in this prospective pilot study. Using a 25-point scale based on the International Index of Sexual Function, erectile dysfunction was assessed weekly, during which time patients received sildenafil 100 mg orally once a week for 6 consecutive weeks. Response was defined as a score of 18 or more, corresponding to at least one successful attempt at sexual intercourse per week.. Thirty patients (86%) completed the 6-week study. Seventy-seven percent of these patients had significantly improved erectile function, allowing recovery of full capacity for sexual intercourse. Of 27 patients not receiving concomitant hormone treatment, failure to respond was observed in only four patients (15%) compared with four (50%) of eight patients receiving hormonal treatment during the study. The time course of response was gradual, with 40%, 57%, 66%, 69%, and 74% responding at weeks 1 through 5, respectively. Therapy was generally well tolerated. The most frequently reported side effects in patients were flushing (37%), transient headache (17%), and dyspepsia (9%). No patient reported priapism, and no cardiovascular event or death was observed. After response, 12 patients (34%) reported the ability to achieve and maintain an erection sufficient for intercourse in the absence of sildenafil (ie, 24 hours to 6 days after taking the medication).. This study suggests that oral sildenafil is well tolerated and can reverse erectile dysfunction after radiotherapy in a substantial proportion of prostate cancer patients.

Topics: Adult; Aged; Comorbidity; Erectile Dysfunction; Humans; Male; Middle Aged; Pilot Projects; Piperazines; Prostatic Neoplasms; Purines; Radiation Injuries; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

We assess the efficacy of sildenafil as salvage therapy for intracorporeal injection therapy nonresponse.. The study group comprised 93 patients with a mean age of 53.6 years (range 24 to 77) with chronic erectile dysfunction. In all cases a home trial of intracavernosal injection of high dose alprostadil and triple agent intracavernosal injection therapy had failed. Patients were treated with sildenafil citrate alone or in combination with intracavernosal injection therapy.. The etiology of erectile dysfunction was arteriogenic in 29 cases, cavernosal venous leakage in 36, mixed vasculogenic in 24, psychogenic in 3 and post-priapism intracavernous fibrosis in 1. Of the 32 sildenafil responders (34% of the study group) 30 required 100 and 2 required 50 mg. The 29 sildenafil intracavernosal injection (combined therapy) responders (31% of the study group) required 100 mg. sildenafil. There were 32 nonresponders (34% of the study group). Mean International Index of Erectile Function questions 3 and 4 scores were 1.7 and 1.5 at baseline, 2.3 and 1.9 with intracavernosal injection, 4.6 and 42.2 with sildenafil, and 4.1 and 4.10 with combined therapy, respectively. Of the 93 patients 29 (31%) treated with intracavernosal injection reported adverse effects, including penile pain in 27, dizziness in 5 and headache in 2. Of the patients treated with sildenafil 34 (37%) reported side effects, including headache in 30, facial flushing in 25, dyspepsia in 12, nasal congestion in 9, dizziness in 5 and visual disturbances in 1. Of the 41 patients given combined therapy 20 (49%) reported adverse effects, including penile pain in 15, headache in 15, facial flushing in 12, dyspepsia in 7, nasal congestion in 3, dizziness in 12 and syncope in 1.. Sildenafil alone or sildenafil plus intracavernosal injection is effective salvage therapy for intracavernosal injection nonresponse. Sildenafil in combination with intracavernosal injection is associated with a 33% incidence of adverse effects, including a 20% incidence of dizziness.

Topics: Adult; Aged; Alprostadil; Drug Therapy, Combination; Erectile Dysfunction; Humans; Injections; Middle Aged; Papaverine; Phentolamine; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Vasodilator Agents

Topics: Administration, Oral; Adult; Ejaculation; Erectile Dysfunction; Humans; Infertility, Male; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones

To assess the acceptability, feasibility, and early results of sildenafil (Viagra) in a nonselected cohort of 316 patients (median age 58 years) who sought treatment for male sexual dysfunction during a 10-week period.. Erectile status and activity were evaluated by questionnaire; erectile function was assessed by pharmacologic testing and visual sexual stimulation. Cardiovascular contraindications were assessed. Patients selected for the trial received treatment for 2 months. Results based on the possibility of penetration and individual satisfaction (scale from 0 to 10) were classified as good, fair, or bad. Multifactorial analysis was performed to define factors influencing the response to sildenafil.. Twenty-five percent of the patients from the initial cohort refused or did not meet the criteria for oral treatment; 25% of the remaining had a cardiovascular contraindication. At the end of the trial, 157 patients (88.7%) had completed the study; the efficacy of and satisfaction with sildenafil were considered good for 50 (31.84%), fair for 46 (29.29%), and bad for 61 (38.85%). Spontaneous nocturnal erections, organic etiologies, especially cavernovenous impotence, and previous treatment with self-intracavernous injections were significant factors influencing responses to oral treatment. Finally, 32% of the patients after completing the trial (17.2% of the initial cohort) were using sildenafil as their sole treatment, 34% chose self-intracavernous injections, and 25% decided to alternate between oral and local therapy.. In the present study, sildenafil had a 60% efficacy rate and was chosen as the sole treatment by only 30% of the patients tested. We propose pretreatment tests to help to predict the response to this medication.

Topics: Adult; Aged; Aged, 80 and over; Cohort Studies; Erectile Dysfunction; Feasibility Studies; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Adult; Aged; Aged, 80 and over; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Double-Blind Method; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

Topics: Adult; Aged; Aged, 80 and over; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Coitus; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Double-Blind Method; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Adult; Aged; Aged, 80 and over; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Female; Humans; Male; Middle Aged; Penile Erection; Perception; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Partners; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Topics: Administration, Oral; Adult; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Topics: Adolescent; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Topics: Administration, Oral; Adult; Aged; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Plethysmography; Purines; Sildenafil Citrate; Sulfones

Topics: Adult; Aged; Combined Modality Therapy; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones

Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes.. In a 24-week dose-response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question.. In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study.. Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Adult; Aged; Aged, 80 and over; Coitus; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Sildenafil citrate has been shown to be effective in a wide range of patients with erectile dysfunction and has been approved in the United States for this indication. The overall clinical safety of oral sildenafil, a potent inhibitor of phosphodiesterase type 5, in the treatment of erectile dysfunction was evaluated in more than 3700 patients (with a total of 1631 years of exposure worldwide). Safety and tolerability data were analysed from a series of double-blind, placebo-controlled studies and from 10 open-label extension studies of sildenafil in the treatment of erectile dysfunction. A total of 4274 patients (2722 sildenafil, 1552 placebo; age range 19-87 y) received double-blind treatment over a period of up to six months' duration, and 2199 received long-term, open-label sildenafil for up to 1 y. The most commonly reported adverse events (all causes) were headache (16% sildenafil, 4% placebo), flushing (10% sildenafil, 1% placebo), and dyspepsia (7% sildenafil, 2% placebo) and they were predominantly transient and mild or moderate in nature. These adverse events reflect the pharmacology of sildenafil as a phosphodiesterase type 5 inhibitor. No cases of priapism were reported. The rate of discontinuation due to adverse events (all causes) was comparable for patients treated with sildenafil (2.5%) and placebo (2.3%). In open-label extension studies, 90% of patients completed long-term sildenafil treatment, with only 2% withdrawing due to adverse events. Sildenafil is a well-tolerated oral treatment for erectile dysfunction.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Diseases; Double-Blind Method; Dyspepsia; Enzyme Inhibitors; Erectile Dysfunction; Flushing; Headache; Humans; Middle Aged; Piperazines; Placebos; Purines; Sildenafil Citrate; Sulfones

The efficacy and safety of oral sildenafil, a potent inhibitor of phosphodiesterase type 5, were evaluated in men with diabetes mellitus and erectile dysfunction (ED). Twenty-one men (aged 42-65 years) were enrolled in a double-blind, placebo-controlled, three-way crossover study conducted in two parts. In part I, the effect of a single dose (25 mg or 50 mg) of sildenafil or placebo on penile rigidity was assessed by penile plethysmography during visual sexual stimulation. In part II, daily diary records of erectile activity and a global efficacy question were used to evaluate once-daily dosing with 25 mg or 50 mg of sildenafil or placebo for 10 days. After a single 50 mg dose of sildenafil, the adjusted geometric mean duration (min) of penile rigidity >60% at the base of the penis during visual sexual stimulation was significantly increased (10.1 min) compared with placebo (2.8 min; p = 0.0053). In part II, sildenafil significantly increased the number of erections considered sufficiently hard for vaginal penetration compared with placebo (p = 0.0005). Improved erections were reported by 50% and 52% of patients treated with 25 mg and 50 mg of sildenafil, respectively, compared with 10% of those receiving placebo (p values < 0.05). Adverse events were mostly mild or moderate in nature and included muscular pains, headache, and dyspepsia. Sildenafil is a well-tolerated and potentially efficacious oral treatment for ED in men with diabetes mellitus.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Adolescent; Adult; Aged; Cross-Over Studies; Diabetes Mellitus, Type 1; Double-Blind Method; Enzyme Inhibitors; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

To determine whether the response to the new oral medication, sildenafil citrate (Viagra), was influenced by the presence or absence of the neurovascular bundles, as recent reports on its success did not specify the efficacy of the drug in patients with erectile dysfunction after radical prostatectomy.. Baseline and follow-up data from 28 healthy patients presenting with erectile dysfunction after radical prostatectomy were obtained. Patients receiving any neoadjuvant/adjuvant hormones or adjuvant radiation therapy were excluded. Patients reported what their erectile status was before surgery, before sildenafil therapy, and after using a minimum of four doses of sildenafil. Both the patients and their spouses were interviewed using the Cleveland Clinic post-prostatectomy questionnaire, which includes questions about response to therapy, duration of intercourse, spousal satisfaction, side effects, and related topics. The patients were compared on the basis of the type of surgical procedure they had undergone-nerve sparing or non-nerve sparing. A positive response to sildenafil was defined as erection sufficient for vaginal penetration.. Of the 15 patients who had bilateral nerve-sparing procedures, 12 (80%) had a positive response to sildenafil, with a mean duration of 6.92 minutes of vaginal intercourse. These 12 patients also reported a spousal satisfaction rate of 80%. All 12 of the responders had a positive response within the first three doses, and 10 of the 12 responded with the first or second dose. None of the 3 patients who had undergone a unilateral nerve-sparing procedure responded, nor did any of the 10 patients who had undergone a non-nerve-sparing procedure. The two most common side effects of the drug were transient headaches (39%) and abnormal color vision (11%). No patients discontinued the medication because of side effects.. Successful treatment of erectile dysfunction in a patient after prostatectomy with sildenafil citrate may depend on the presence of bilateral neurovascular bundles. No patient who had undergone a non-nerve-sparing procedure responded. Whether patients who undergo unilateral nerve-sparing procedures will respond to sildenafil is still unclear because of the small number of patients in our study. These findings should encourage urologists to continue to perform and perfect the nerve-sparing approach. The ability to restore potency with an oral medication after radical prostatectomy will impact our discussion with the patient on the surgical morbidity of radical prostatectomy.

Topics: Enzyme Inhibitors; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Piperazines; Prostate; Prostatectomy; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires

To evaluate the efficacy and safety of 50-mg doses of sildenafil during a 28-day period in patients with erectile dysfunction caused by spinal cord injury (cord level range, T6 through L5).. Sildenafil is an orally active, potent, and selective inhibitor of phosphodiesterase type 5, an important regulator of cyclic guanosine monophosphate in the human corpus cavernosum.. To be included in this double-blind, placebo-controlled study, all patients had to be able to achieve at least a partial reflexogenic erectile response to penile vibratory stimulation. The study utilized a single triangular sequential trial design. A total of 27 patients were randomized to receive 50 mg of sildenafil or placebo, taken orally as required (not more than once daily) approximately 1 hour before sexual activity.. After 28 days of treatment, nine of 12 patients (75%) on sildenafil and one of 14 patients (7%) on placebo reported that treatment had improved their erections (p=0.0043). Furthermore, eight of 12 patients (67%) on sildenafil and two of 13 patients (15%) on placebo indicated that they wished to continue treatment (p=0.018). A significant improvement in satisfaction with their sex life was reported by patients taking sildenafil (p=0.012). No patients discontinued treatment due to adverse events.. Oral sildenafil, taken as required (not more than once daily), significantly improves the quality of erections and satisfaction with sex life in men with erectile dysfunction caused by a spinal cord injury between T6 and L5.

Topics: Administration, Oral; Adult; Double-Blind Method; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Reflex; Sexuality; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

The efficacy and safety of oral sildenafil citrate for the treatment of erectile dysfunction (ED) were assessed in a 12-week placebo-controlled study. Men with ED of organic, psychogenic, or mixed aetiology were randomised to placebo (n = 166) or 50 mg sildenafil (n = 163), with adjustment to 100 mg or 25 mg based on efficacy and tolerability. Efficacy assessments included a global efficacy question, event log data, and an optional partner questionnaire. At the end of the study, improved erections were reported by 74% of patients receiving sildenafil versus 16% for placebo (p < 0.0001). In the final 4 weeks of treatment, 65% of all attempts at sexual intercourse were successful for all patients (responders and non-responders) receiving sildenafil versus 20% for placebo (p < 0.001). The mean number of successful attempts per month was 5.9 for patients receiving sildenafil versus 1.5 for those receiving placebo (p < 0.0001). The most common adverse events--headache, flushing, and dyspepsia--were generally mild to moderate in nature and rarely (< 1%) a reason for discontinuation of treatment. Oral sildenafil is an effective, reliable and well-tolerated treatment for ED of organic, psychogenic or mixed aetiology.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Coitus; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

To determine the efficacy and safety of sildenafil, a novel orally active inhibitor of the type-V cyclic guanosine monophosphate-specific phosphodiesterase (the predominant isoenzyme in the human corpus cavernosum) on penile erectile activity in patients with male erectile dysfunction of no established organic cause.. Twelve patients (aged 36-63 years) with male erectile dysfunction of no established organic cause were entered into a double-blind, randomized, placebo-controlled, crossover study which was conducted in two phases. In the first phase (four-way crossover), treatment efficacy was evaluated by measurements of penile rigidity using penile plethysmography during visual sexual stimulation at different doses of sildenafil (10, 25 and 50 mg or placebo). In the second phase (two-way crossover), efficacy was assessed by a diary record of penile erectile activity after single daily doses of sildenafil (25 mg) or placebo for 7 days.. The mean (95% confidence interval, CI) duration of rigidity of > 80% at the base of the penis was 1.3 min (0.4-3.1) in patients on placebo, 3.5 min (1.6-7.3; P = 0.009) on 10 mg, 8.0 min (3.7-16.7; P = 0.003) on 25 mg and 11.2 min (5.6-22.3; P < 0.001) on 50 mg of sildenafil. The mean (95% CI) duration of rigidity of > 80% at the tip of the penis was 1.2 min (0.4-2.7) on placebo and 7.4 min (2.4-8.5; P = 0.001) on 50 mg sildenafil. From the diary record of daily erectile activity, the mean (95% CI) total number of erections was significantly higher in patients receiving sildenafil was 6.1 (3.2-11.4), compared with 1.3 (0.5-2.7) in those on placebo; 10 of 12 patients reported improved erectile activity while receiving sildenafil, compared with two of 12 on placebo (P = 0.018). Six patients on active treatment and five on placebo reported mild and transient adverse events which included headache, dyspepsia and pelvic musculo-skeletal pain.. These results show that sildenafil is a well tolerated and effective oral therapy for male erectile dysfunction with no established organic cause and may represent a new class of peripherally acting drug for the treatment of this condition.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Adult; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Piperazines; Plethysmography; Purines; Sildenafil Citrate; Sulfones; Time Factors; Treatment Outcome

Sildenafil (Viagra, UK-92,480) is a novel oral agent under development for the treatment of penile erectile dysfunction. Erection is dependent on nitric oxide and its second messenger, cyclic guanosine monophosphate (cGMP). However, the relative importance of phosphodiesterase (PDE) isozymes is not clear. We have identified both cGMP- and cyclic adenosine monophosphate-specific phosphodiesterases (PDEs) in human corpora cavernosa in vitro. The main PDE activity in this tissue was due to PDE5, with PDE2 and 3 also identified. Sildenafil is a selective inhibitor of PDE5 with a mean IC50 of 0.0039 microM. In human volunteers, we have shown sildenafil to have suitable pharmacokinetic and pharmacodynamic properties (rapid absorption, relatively short half-life, no significant effect on heart rate and blood pressure) for an oral agent to be taken, as required, prior to sexual activity. Moreover, in a clinical study of 12 patients with erectile dysfunction without an established organic cause, we have shown sildenafil to enhance the erectile response (duration and rigidity of erection) to visual sexual stimulation, thus highlighting the important role of PDE5 in human penile erection. Sildenafil holds promise as a new effective oral treatment for penile erectile dysfunction.

Topics: Administration, Oral; Cross-Over Studies; Cyclic GMP; Double-Blind Method; Enzyme Inhibitors; Erectile Dysfunction; Humans; Isoenzymes; Male; Middle Aged; Penis; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Purines; Sildenafil Citrate; Sulfones; Treatment Outcome

Psychological stress is a growing global threat to male sexual potency and erection efficiency. Withania somnifera (L.) Dunal (WS), also known as Ashwagandha, is a well-known Ayurvedic herb. The roots of Withania somnifera improve the body's ability to handle stress, strengthen the immune system, promote healthy ageing, and have aphrodisiac properties with male sexual stimulation effects. Despite its widespread acceptance as an Ayurvedic stress-relieving drug with beneficial effects on male reproductive health, Withania somnifera has yet to be studied for its potential role in improving the sexual arousal and erectile dysfunction of psychologically stressed sexually sluggish males.. To investigate the therapeutic effects of purified root powder of Withania somnifera on sexual behaviour and erectile efficiency in stressed sexually sluggish male rats.. Sexually sluggish male rats were screened by premating tests after being exposed to a psychological stressor, restraint stress, 3 h/day for 30 days. Subsequently, these rats were treated with purified root powder of WS (150 or 300 mg/kg/day-PO) or sildenafil (5 mg/kg/day-PO) for 30 days. The rats were sacrificed after 24 h of the last treatment, and the effects on various factors related to sexual behaviour, penile histomorphology, serum hormones, and neurotransmitters associated with sexual arousal and penile erection were examined.. WS treatment improves prosexual and sexual behaviour in psychologically stressed sexually sluggish male rats by increasing non-contact erections and mounts, intromission, and ejaculation frequencies, while decreasing sexual exhaustion by decreasing post-ejaculation intervals and latencies. WS also modulates neurotransmitters and hormones associated with sexual desire and stress, including dopamine, serotonin, corticosterone, and prolactin. Additionally, there was also a dose-dependent increase in serum LH, FSH, and testosterone levels. The administration of WS to sexually sluggish rats resulted in significant improvements in penile histomorphology, specifically by increasing the ratio of smooth muscle (SM) to collagen. Furthermore, in sexually sluggish rats, WS treatment increased the expression of markers associated with penile erection facilitation, such as nNOS, eNOS, p-Akt, nitric oxide, acetylcholine, and cGMP. Notably, WS treatment decreased the expression of penile PDE5α in these rats in a dose-dependent manner. Remarkably, the therapeutic effects of WS are comparable to those of sildenafil.. Purified root powder of Withania somnifera was found to improve sexual arousal and erection efficiency in stressed, sexually sluggish male rats. This improvement was achieved by modulating the HPG and HPA axes as well as the NO/cGMP/PDE5α pathway involved in penile erection. Thus, our findings strongly support the potent therapeutic potential of purified root powder of WS in improving the sexual health of stressed sexually sluggish rats.

Topics: Animals; Corticosterone; Erectile Dysfunction; Humans; Male; Neurotransmitter Agents; Nitric Oxide; Plant Extracts; Plant Roots; Powders; Rats; Sexual Arousal; Sildenafil Citrate; Withania

Topics: Animals; Arginase; Body Weight; Catalase; Erectile Dysfunction; Humans; Hydrogen Peroxide; Male; Paroxetine; Plant Extracts; Rats; Rats, Wistar; Sildenafil Citrate; Superoxide Dismutase; Thiobarbituric Acid Reactive Substances

Erectile dysfunction (ED) is a disorder that often occurs in men worldwide. One of the drugs used as the first-line therapy for erectile dysfunction is sildenafil citrate (SC). Unfortunately, SC was commonly found in oral, injection, and transdermal dosage forms with some limitations, mainly related to low oral bioavailability caused by the occurrence of first-pass metabolism in the liver, and poor patient comfort and compliance. Therefore, it was essential to develop dosage forms to overcome these limitations. We developed hydrogel-forming microneedles (HFM) that can facilitate transdermal delivery of SC by penetrating the stratum corneum. HFM was made using polyvinyl alcohol (PVA) and polyvinyl pyrrolidone (PVP) as polymers and several variations of tartaric acid as crosslinking agents. The evaluation of swelling properties, mechanical resistance, and penetration ability showed that the HFM produced had good insertion properties and swelling capabilities ranging from 300% to 700%. This HFM was designed to be integrated with a polyethylene glycol (PEG) reservoir prepared using several types of PEG with different molecular weights. The ex vivo permeation study showed that up to 80% of SC (equivalent to 20.2 ± 0.29 mg/mL) was delivered transdermally from this combined dosage form. For the first time, SC has been successfully developed into an HFM that was integrated with a PEG reservoir which was non-irritating, safe, and painless. It also had promising results for increasing the effectiveness of ED therapy.

Topics: Administration, Cutaneous; Drug Delivery Systems; Erectile Dysfunction; Humans; Hydrogels; Male; Polyethylene Glycols; Proof of Concept Study; Sildenafil Citrate; Skin

Sildenafil is the first internationally approved drug for erectile dysfunction. Unsupervised and non-prescribed use of sildenafil among young Indian population has increased in last few years. Sildenafil helps in erection of penis by inhibiting the action of Phosphodiesterase-5 (PDE-5) enzyme, present in the vasculature of corpus cavernosum muscle and lengthens the duration of erection. Documented adverse effects of sildenafil are headache, flushing, nasal congestion, dyspepsia, and slight decrease in systolic and diastolic blood pressure. We present a rare case of sudden death due to cerebrovascular hemorrhage after sildenafil use and concomitant alcohol intake. The history is that a 41-year-old male with no significant past medical and surgical history was staying at a hotel room with a female friend; he had consumed 2 tablets of sildenafil (50 mg each) and alcohol at night. Next morning, he developed uneasiness following which he was taken to the Hospital where he was declared dead on arrival. The important autopsy findings include edematous brain with about 300 g of clotted blood in the right basal ganglia extending to bilateral ventricles, and in pons region. Other significant findings on microscopic examination were hypertrophic ventricular wall of heart, fatty changes in liver and acute tubular necrosis and hypertensive changes in the kidney. The findings are discussed in the light of the literature about the lethal complications of combined use of sildenafil and alcohol including cerebrovascular accidents. As a forensic pathologist it is the duty of the doctor to execute meticulous autopsy along with ancillary investigations including toxicological analysis and to correlate all these findings to determine the possible effects of drugs when present, so as to gather knowledge about potentially fatal drugs and further create public awareness regarding the same.

Topics: Adult; Erectile Dysfunction; Ethanol; Female; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Stroke

Despite their efficacy and general safety, rare but devastating adverse drug reactions have been associated with phosphodiesterase type 5 inhibitors.. To determine the safety profile of oral phosphodiesterase type 5 inhibitors with a particular focus on priapism and malignant melanoma.. In this case-non-case study, we queried the individual case safety reports for phosphodiesterase type 5 inhibitors within the World Health Organization global database of individual case safety reports (VigiBase) between 1983 and 2021. We included all individual case safety reports for sildenafil, tadalafil, vardenafil, and avanafil in men. For comparison, we also extracted the safety data from the Food and Drug Administration trials for these drugs. We assessed the safety profile of phosphodiesterase type 5 inhibitors by disproportionality analysis by measuring reporting odds ratio for their most commonly reported adverse drug reactions, once for all phosphodiesterase type 5 inhibitor reports and once for reports of oral phosphodiesterase type 5 inhibitor use in adult men (≥18 years old) with sexual dysfunction.. A total of 94,713 individual case safety reports for phosphodiesterase type 5 inhibitors were extracted. A total of 31,827 individual case safety reports were identified relating to adult men taking oral sildenafil, tadalafil, vardenafil, or avanafil for sexual dysfunction. The most common adverse drug reactions included poor drug efficacy (42.5%), headache (10.4% vs. 8.5%-27.6% [Food and Drug Administration]), abnormal vision (8.4% vs. ≤4.6% [Food and Drug Administration]), flushing (5.2% vs. 5.1%-16.5% [Food and Drug Administration]), and dyspepsia (4.2% vs. 3.4%-11.1% [Food and Drug Administration]). Priapism showed significant signals for sildenafil (reporting odds ratio = 13.81, 95% confidence interval: 11.75-16.24), tadalafil (reporting odds ratio = 14.54, 95% confidence interval: 11.56-18.06), and vardenafil (reporting odds ratio = 14.12, 95% confidence interval: 8.36-22.35). Comparing with other medications in VigiBase, sildenafil (reporting odds ratio = 8.73, 95% confidence interval: 7.63-9.99) and tadalafil (reporting odds ratio = 4.25, 95% confidence interval: 3.19-5.55) had significantly higher reporting odds ratios for malignant melanoma.. Phosphodiesterase type 5 inhibitors show significant signals correlating with priapism among a large international cohort. Further clinical study is needed to elucidate whether this is from proper or inappropriate use or other confounding conditions, as analysis of pharmacovigilance data does not allow for quantifying the clinical risk. Also, there appears to be a relationship between phosphodiesterase type 5 inhibitor use and malignant melanoma, which warrants additional study to better understand causation.

Topics: Adolescent; Adult; Erectile Dysfunction; Humans; Male; Melanoma; Melanoma, Cutaneous Malignant; Pharmacovigilance; Phosphodiesterase 5 Inhibitors; Priapism; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride; World Health Organization

Continuing research with our earlier finding of sildenafil based analogs in the search of new inhibitors of PDE5 for erectile dysfunction suggested that there is a scope of modifications at N-methylpiperazine ring with hydrophobic region followed by hydrogen bond donor or acceptor region. However, the leads identified earlier had some limitations like poor pharmacokinetic (PK) profile, low aqueous solubility and poor bioavailability. In this direction, a new series of sildenafil based analogs were designed, synthesized and screened for their PDE5 inhibitory activity. In this series compound 18 was found to have excellent in vitro activity with selectivity towards PDE5 isozyme, also the in vivo activity and pharmacokinetic profile was excellent. The cyp inhibition and CaCO

Topics: Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Triiodobenzoic Acids

Sildenafil citrate (Viagra®) is used to treat male erectile dysfunction; however, little is known about the effects of sildenafil overdose and intoxication. We report a patient who presented with cerebral infarction and rhabdomyolysis after intentional sildenafil intoxication.. A 61-year-old man visited the Emergency Department complaining of dysarthria about 1 h after taking more than 30 sildenafil tablets with the intention to commit suicide. Dysarthria and dizziness were observed, but there were no other neurological symptoms. The creatine kinase level was elevated to 3118 U/L, and the patient was diagnosed with rhabdomyolysis. Brain magnetic resonance imaging revealed multiple scattered acute cerebral infarctions in both midbrain artery branches. At 4 h post-intoxication, the dysarthria had improved and we initiated dual antiplatelet therapy for cerebral infarction. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Emergency physicians should be able to anticipate and treat complications like cerebral infarction and rhabdomyolysis after sildenafil intoxication.

Topics: Cerebral Infarction; Dysarthria; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Rhabdomyolysis; Sildenafil Citrate

Topics: Erectile Dysfunction; Humans; Male; Patient Preference; Sildenafil Citrate; Tadalafil

Topics: Erectile Dysfunction; Humans; Male; Patient Preference; Sildenafil Citrate; Tadalafil

Erectile dysfunction (ED) is a major challenge for men. The drugs for its treatment are associated with side effects. Hence, in phytomedicinal research, where Anonna senegalensis (A. senegalensis) is a candidate with abundant phytochemicals possessing various pharmacological properties, but the sex-enhancing phytochemical is elusive in the literature. This study aimed to understand the molecular interaction of its potent molecule mediating male sexual enhancement. A library of 69 compounds from A. senegalensis was docked against the ED-targeted proteins. Sildenafil citrate was used as the reference standard. Thereafter, the lead compound was screened for drug-likeness by applying the Lipinski rule of 5 (RO5), pharmacokinetic properties, and bioactivity using SwissADME and Molinspiration web servers, respectively. The results show catechin as the lead phytochemical compound with a stronger binding affinity for most of the proteins of ED. Also, catechin demonstrates good compliance with the RO5, great pharmacokinetic profiles, and could be said to be a polypharmacological molecule with good bioactivity scores. The research findings unravel the potential of catechin (a phytochemical belonging to the flavonoids class) from A. senegalensis leaf as a potential male sexual enhancement molecule via its high binding affinity for most erectile dysfunction-targeted proteins. They may require further toxicity and therapeutic evaluations in vivo.

Topics: Catechin; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Treatment Outcome

To describe the profile of patients with erectile dysfunction (ED), attending to consultation and satisfaction using sildenafil oral suspension, from the specialist's perception.. This is a nationwide multicenter, epidemiological, descriptive and observational study, with the studied population as the unit of study. Thirty urologists and/or andrologists completed a questionnaire with questions about ED patients' profile attending to their practice, sildenafil oral suspension perception of effectiveness and safeness, and their opinion about patients' satisfaction after sildenafil oral suspension treatment. Aggregate data were collected for the last 6 patients treated or on treatment with sildenafil oral suspension.. Overall, 40.9% and 24.9% of patients had moderate or severe ED, respectively. Among the patients, 73.6% were older than 50 years. The disease progression was approximately one year (11.8 months). ED etiology was mostly organic (38.1%) and mixed (31.8%). Cardiovascular comorbidities were present in 57.4%, mental health problems in 16.4% and hormonal disorders in 10.2% of the patients. The main reason for choosing sildenafil oral suspension was the ease of dose adjustment. The specialists considered that 73.4% of the patients responded satisfactorily to treatment. They also rated the perceived effectiveness and safeness of the product as very good or good.. Urologists and andrologists consider that most patients with ED achieve a high degree of satisfaction with sildenafil oral suspension. The main advantage of the treatment is the possibility of adjusting the dose according to patient's needs and circumstances.

Topics: Erectile Dysfunction; Humans; Male; Patient Satisfaction; Perception; Piperazines; Purines; Sildenafil Citrate; Spain; Surveys and Questionnaires; Treatment Outcome; Urologists

To the Editor, In 1998 Sildenafil was approved by the Food and Drug Administration as first line therapy for erectile dysfunction. Since then, phosphodiesterase type 5 inhibitors (PDE5i) represent the first-line treatment of erectile dysfunction (ED), improving physiological erectile function, sexual orgasmic function, psychological self-esteem, couples' relationship, and quality of life. [...].

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Quality of Life; Sildenafil Citrate

Topics: Erectile Dysfunction; Humans; Male; Piperazines; Sildenafil Citrate; Treatment Outcome; Young Adult

The erectile dysfunction is defined as an inability to achieve or maintain an erection sufficient for sexual intercourse lasting more than 3 months. According to literature, about 90 million men worldwide suffer from erectile dysfunction of different severity.. To evaluate the efficacy and safety of the dispersed form of sildenafil ("Ridzhamp" 50 mg), compared with the standard tablets of sildenafil (50 mg).. The study included 60 men aged 27 to 67 years (average age 40.2 years) with moderate erectile dysfunction (11-15 points according to IIEF-5). In group I (n=30), patients took a dispersible form of the drug sildenafil, 50 mg ("Ridzhamp") 60 minutes before sexual intercourse; in group II (n=30), a standard form of the drug sildenafil was prescribed at a dosage of 50 mg, 60 minutes before sexual intercourse.. Positive dynamics according to IIEF-5 score was found in all the study groups. In group I, IIEF-5 score increase by 53.85%, while in group II by 50% (p<0.05). The average onset of erection in group I was 45+/-2.2 min, while in group II it was 51+/-1.9 min. In the main group (group I) one patient (3.33%) complained of persistent headache after taking the drug, and therefore refused the therapy. In the comparison group (group II) one patient (3.33%) reported dyspeptic disorders while taking the drug, 1 patient (3.33%) reported dizziness. All patients in the main group noted the convenience of taking the "Ridzhamp".. Our results indicate the comparable efficiency of the dispersed form of sildenafil (group I) and the standard tablet form of the drug (group II). All patients in the main group (group I) noted a faster onset of erections, as well as the convenience of "Ridzhamp" and the ability to take the drug without water intake.

Topics: Adult; Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tablets; Treatment Outcome

Topics: Drug Interactions; Erectile Dysfunction; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Penile Erection; Piperazines; Sildenafil Citrate

To evaluate the results of using Sildenafil in the form of an oral spray (Gent) for the treatment of erectile dysfunction (ED) in men with type 2 diabetes mellitus (DM) and prediabetes.. A total of 60 patients were divided into two groups of 30 people. The group 1 included patients with prediabetes, while group 2 consisted of patients with type 2 DM. All men had proven ED. The severity of ED was assessed using the International Index of Erectile Function (IIEF-5). To assess the state of penile blood flow, all patients underwent Doppler ultrasound before and after treatment. Patients with prediabetes used Sildenafil in the form of oral spray (Gent) 25 mg (2 doses) 1 time per day for 1 month, patients with type 2 diabetes received 50 mg (4 injections) every other day for 1 month. In addition, most of the subjects took metformin and followed diet therapy.. In patients of both groups, the administration of Sildenafil oral spray led to a decrease in body weight, waist circumference, a decrease in insulin and Hemoglobin A1C level without changing of hypoglycemic therapy in those with type 2 DM. In men with prediabetes, a decrease in fasting insulin levels was found. During treatment, half of the persons with impaired glucose metabolism had an increase in the testosterone level. According to IIEF-5, a decrease in the severity of ED in both groups of patients was seen. In men with prediabetes, the average IIEF-5 score increased from 15.98 to 21.57 points (p<0.05), while in patients with type 2 DM it improved from 12.18 to 18.44 points (p<0.05). Doppler ultrasound indicated a significant increase in the maximum systolic blood flow velocity and arterial resistivity index after treatment with Sildenafil oral spray in patients with both prediabetes and type 2 diabetes.. Sildenafil oral spray can be effectively used for the treatment of ED in men with type 2 DM and prediabetes.

Topics: Diabetes Mellitus, Type 2; Erectile Dysfunction; Humans; Insulins; Male; Oral Sprays; Piperazines; Prediabetic State; Purines; Sildenafil Citrate; Treatment Outcome

The use of lemon (Citrus limon) and lime (Citrus aurantifolia) juices for the treatment of erectile dysfunction (ED) is fast becoming common practice, even though there is dearth of information on the effect of such functional food and drug combination in the management of ED. This study evaluated the effect of lemon and lime juices on the erectogenic properties of sildenafil. ED was induced with L-NAME (40 mg/kg body weight). The rats were divided into 11 groups (n = 6) and given various doses of the test samples. Immediately after the sexual behavior studies, the animals were sacrificed and the penile and brain tissues were isolated. The results revealed that lime and lemon juices improved sexual behavior in rats by improving NO production and inhibiting the activities of PDE-5, arginase, ACE, MAO, ATPdase, AMPdase, and activated antioxidant enzymes. Furthermore, lime at 1.0 ml/kg significantly improved the therapeutic properties of sildenafil. While, lemon (0.5 and 1.0 ml/kg) and lime (0.5 ml/kg) did not show any synergistic effect. This study revealed that lime and lemon juices could improve erectile function and combining lime juice with sildenafil could be very effective in the management of ED. PRACTICAL APPLICATIONS: The therapeutic management of erectile dysfunction has involved maximizing NO production through the modulation of macromolecules such as phosphodiesterase-5 and arginase with the use of drugs such as sildenafil. Combining such drugs with functional foods such as lime and lemon juices is becoming common practice. However, there is dearth of report on the effect of lime and lemon juices on the erectogenic potentials of sildenafil. The present study shows that combining 1 ml/kg lime juice (got from 2 lime fruits) with sildenafil will boost the erectogenic properties of the drug. While combining lime (0.5 ml/kg) and lemon (0.5 and 1.0 ml/kg) juices with the drug did not have any synergistic effect.

Topics: Animals; Citrus; Erectile Dysfunction; Fruit and Vegetable Juices; Humans; Male; NG-Nitroarginine Methyl Ester; Rats; Sildenafil Citrate

Sales of substandard and falsified medical products (SF) are rising rapidly everywhere around the globe. The wide and easy access to these products is an alarming issue to the global health systems and undermined the health of patients, especially with the thrive of online commerce. To tackle this threat to public health, new ways to access these products should be identified and detection technologies should be strengthened. The overarching aim of this study was to investigate if herbal supplements sold online claiming to be natural alternatives to Viagra® were amongst these SF medical products and how effective different analytical techniques are in providing information about these products. 3 products which claimed to be herbal supplements for men sexual performance were purchased from an e-commerce platform. Two products were received as unregistered generic sildenafil citrate tablets manufactured in India (and thus different to the products information on the website) while one product was received in the same packaging as shown on the website, claiming to be an herbal product. Nevertheless, all products were proven to contain sildenafil citrate, the active pharmaceutical ingredients in Viagra® after the comprehensive analytical tests. The results elucidated that the quality standards for the unregistered generic sildenafil citrate tablets were fulfilled according to the British Pharmacopeia, but the falsified product failed the quality tests and contained approximately 200 mg sildenafil citrate, which is equivalent to 2-fold of the daily maximum dose. Furthermore, physical characterisations, including powder x-ray diffraction and thermal analysis were performed and revealed that the polymorphic forms of sildenafil citrate were different, demonstrating the importance of employing thermal analysis in addition to the conventional analysis techniques for the substandard and falsified medical products. These techniques provided valuable insights into the physical form of the active ingredient in these products. What is more, the ease with which these SF products were obtained and confirmed to be misleading consumers emphasises the need for tighter regulation for e-commerce websites in line with those enforced on online pharmacies.

Topics: Counterfeit Drugs; Dietary Supplements; Erectile Dysfunction; Humans; Male; Sildenafil Citrate; Tablets

Botulinum toxin A (BTX-A) has a variety of uses in medicine. Some evidence suggests that intracavernosal (ic) BTX-A injection administered in addition to phosphodiesterase type 5 inhibitors (PDE5-Is) could effectively treat erectile dysfunction (ED) in insufficient responders to PDE5-Is.. To provide experimental pharmacological evidence for the use of onabotulinumtoxinA ic alone or in combination with PDE5-Is for difficult-to-treat ED. We thus compared the effects of BTX-A ic alone and BTX-A ic combined with PDE5-I iv, and a placebo treatment ic or iv.. Erectile function was evaluated following cavernous nerve electrical stimulation (6 V, 1-millisecond pulse, 45-second duration) at different frequencies (0, 2, 3, 4, 5, 7.5, and 10 Hz) in 4 groups (n = 8 / group) of anesthetized, spontaneously hypertensive rats, a robust animal model of ED of vascular origin. Rats were treated by onabotulinumtoxinA 10U or saline ic 1 week prior to erectile function testing and sildenafil (0.3 mg/kg) or saline iv 4 minutes prior to testing. Frequency-response curves were compared with a 2 way ANOVA.. Both onabotulinumtoxinA ic, and sildenafil iv significantly improved erectile responses in spontaneously hypertensive rats, however the effect was greatly amplified when the treatments were combined.. Intracavernosal pressure and/or mean arterial pressure ratios were significantly increased by sildenafil and onabotulinumtoxinA ic versus the control condition. OnabotulinumtoxinA 10U ic combined with sildenafil iv significantly potentiated erectile responses. Area under the curve and/or mean arterial pressure ratio increased by 19% with sildenafil iv, by 15% with onabotulinumtoxinA ic and by 58% with the combined treatment following cavernous nerve electrical stimulation at 6V, 1 ms, 10 Hz: these stimulation parameters elicited the maximal erectile response.. These data provide a pharmacological rationale for the combined administration of onabotulinumtoxinA ic and sildenafil iv since the effects of both treatments were potentiated when their administration was combined.. First evidence of a synergistic pro-erectile effect of BTX-A combined with PDE5-I, however the mechanism behind the pro-erectile effect of BTX-A ic remains hypothetical.. These results support further studies into the mechanisms behind the pro-erectile effect of BTX-A ic, as well as multicenter randomized control trials to evaluate the safety and efficacy of BTX-A ic combined with sildenafil for difficult-to-treat ED. Giuliano F., Joussain C., Denys P., et al. Intracavernosal OnabotulinumtoxinA Exerts a Synergistic Pro-Erectile Effect When Combined With Sildenafil in Spontaneously Hypertensive Rats. J Sex Med 2022;19:899-906.

Topics: Animals; Botulinum Toxins, Type A; Erectile Dysfunction; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Rats; Rats, Inbred SHR; Sildenafil Citrate

Massularia acuminata stem is often used in folkloric medicine in the management of erectile dysfunction (ED), without full scientific basis for its action. Thus, the effects of aqueous extract of M. acuminata stem (MAS) on sexual activity, hormonal action, enzymatic activity and levels of molecules associated with erectile function were assessed. ED was induced by single intraperitoneal injection of 50 mg/kg body weight of streptozotocin in rats and treated with sildenafil citrate or MAS (50 or 100 mg/kg) orally for 2 weeks. The results revealed that there was significant (p < 0.05) reduction in mounting and intromission frequencies, testosterone, luteinizing hormone, and nitric oxide levels, as well as elevation in mounting and intromission latencies, phosphodiesterase 5, arginase, acetylcholinesterase, adenosine triphosphatidase, and adenosine deaminase activities, nitric oxide, thiobarbituric acid reactive species, and glycated haemoglobin levels were observed in ED rats in comparison with the control rats. Treatment with MAS or sildenafil citrate significantly (p < 0.05) modulated the sexual behaviour, biochemical parameters and histological architecture, with 100 mg/kg of MAS having the best erectogenic effects. Furthermore, phenolic characterization revealed that catechin and kaempferol as the main phenolic compounds present in MAS, that can act in synergistically or additively with other phytochemicals to confer erectogenic effect.

Topics: Acetylcholinesterase; Animals; Erectile Dysfunction; Humans; Luteinizing Hormone; Male; Nitric Oxide; Penile Erection; Plant Extracts; Rats; Rats, Wistar; Sildenafil Citrate; Streptozocin

Diabetic erectile dysfunction (DMED) refers to erectile dysfunction secondary to diabetes. Erectile dysfunction is characterized by a persistent inability to achieve and maintain an erection sufficient to permit satisfactory sexual activity.. Based on the Web of Science core collection database, we firstly analyzed the quantity and quality of publications in the field of DMED, secondly profiled the publishing groups in terms of country, institution, author's publication and cooperation network, and finally sorted out and summarized the hot topics of research.. From 2001 to 2022, a total of 1,403 articles relating to this topic were published in 359 journals. They represent the global research status, potential hotspots, and future research directions. The number of DMED-related publications and citations has steadily increased over the few past decades. Academic institutions from Europe and the United States have played a leading role in DMED research. The country, institution, journal, and author with the most publications were the United States (294), INHA University (39), the Journal of Sexual Medicine (156), and Ryu, Ji-Kan (29), respectively. The most common keywords were erectile dysfunction (796), men (256), diabetes (254), diabetes mellitus (239), prevalence (180), corpus cavernosum (171), dysfunction (155), mellitus (154), nitric-oxide synthase (153), and expression (140). The main keyword-based research topics and hotspots in the DMED field were oral sildenafil, smooth muscle relaxation, nitric oxide synthase, gene therapy, metabolic syndrome, cavernous nerve injury, stem cell, and penile prosthesis.. The terms oral sildenafil, smooth muscle relaxation, nitric oxide synthase, gene therapy, metabolic syndrome, cavernous nerve injury, stem cell, and penile prosthesis will be at the forefront of DMED-related research.

Topics: Animals; Bibliometrics; Diabetes Mellitus, Experimental; Erectile Dysfunction; Humans; Male; Metabolic Syndrome; Rats; Rats, Sprague-Dawley; Sildenafil Citrate

Topics: Aggression; Erectile Dysfunction; Humans; Male; Sildenafil Citrate; Sulfones

Erectile dysfunction (ED) is a major care problem worldwide. Tadalafil and sildenafil are the two most common phosphodiesterase-5 inhibitors (PDE5is) used to treat ED.. This study aimed to evaluate patient data of a large online prescription platform (OPP), specifically analyzing preference for tadalafil over sildenafil.. Data from a prospectively collected German OPP were retrospectively analyzed. This dataset included patients with a history of taking one or both substances (n = 26 821).. ED patient baseline characteristics were derived from medical questionnaires for PDE5i prescriptions between May 2019 and May 2020. Order behavior was analyzed in patients who ordered both substances over time. We applied Kruskal-Wallis tests, χ² tests, and fisher's exact tests for statistical analysis.. Baseline characteristics were comparable for both PDE5is in patients with a median age of 49 yr (sildenafil [interquartile range {IQR} 38-57]; tadalafil [IQR 39-56]), a median body mass index (BMI) of 26 kg/m² (sildenafil [IQR 24.54-29.03]; tadalafil [IQR 24.49-28.69]), ED onset time of >12 mo (sildenafil [87%]; tadalafil [88%]), and the presence of morning erections (sildenafil [62%]; tadalafil [61%]). Tadalafil prescriptions increased significantly from 30% (first order) to 80% (last order) in patients who had already tested both drugs. Patients with age ≤40 yr, BMI ≤25 kg/m², and sustained morning erections preferred tadalafil to sildenafil.. Using database information from an OPP, preference for tadalafil was shown for patients who had tested both PDE5is. This preference was particularly pronounced in patients with age ≤40 yr, BMI ≤25 kg/m², and sustained morning erections. A well-managed OPP can be used for research on more complex health services.. Analysis of large online prescription platforms provide the benefit of identifying young treatment-naïve patients with early-stage disease, which is highlighted by the fact that about two-thirds of our patients analyzed still maintained spontaneous morning erections. Patients who had tested tadalafil once developed preference for this drug.

Topics: Carbolines; Erectile Dysfunction; Humans; Male; Patient Preference; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Retrospective Studies; Sildenafil Citrate; Sulfones; Tadalafil

Patients undergoing radical prostatectomy (RP) have a high incidence of postoperative erectile dysfunction (ED) refractory to treatment by oral phosphodiesterase-5 inhibitors (PDE5i). In the present studies, we investigated if a topically applied, nitric oxide microparticle delivery system (NO-MP) might act synergistically with an oral PDE5i (sildenafil) to improve erectile function outcomes in a rat model of RP. Thirty-five Sprague-Dawley rats underwent bilateral transection of the cavernous nerve (CN) for 1 week. After 1 week, animals were orally administered 0, 0.05, or 0.005 mg sildenafil/kg and the erectile response following topical application to the penile shaft of 250 or 100 mg NO-MP, or blank-MP, was monitored over a 2-h timeframe by recording the intracorporal pressure normalized to systemic blood pressure (ICP/BP, N = 5 animals/treatment group). Oral treatment with sildenafil by itself resulted in no observable erectile response. However, a combination of orally administered 0.05 sildenafil/kg with topical application of 250 mg NO-MP, compared to 250 mg NO-MP by itself, resulted in significantly more spontaneous erections (4.6 compared to 2 erections per hour, t-test; p value = 0.043), with a significantly faster onset for the first erectile response (11 compared to 22 min; t-test, p value = 0.041). Our results demonstrate a synergistic effect between orally administered PDE5i and topically applied NO-MP in eliciting an erectile response. Furthermore, they suggest a potential novel therapeutic approach to treat men with ED resulting from RP, through combination therapy of a topically applied NO-MP and an orally administered PDE5i.

Topics: Animals; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Nitric Oxide; Penile Erection; Phosphodiesterase 5 Inhibitors; Prostatectomy; Rats; Rats, Sprague-Dawley; Sildenafil Citrate

Topics: Cost-Benefit Analysis; Erectile Dysfunction; Humans; Male; Sildenafil Citrate; Sulfones

Topics: Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Trochlear Nerve Diseases

Topics: Chromatography, High Pressure Liquid; Chromatography, Liquid; Dietary Supplements; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Tandem Mass Spectrometry; Vardenafil Dihydrochloride

The Medicines and Healthcare Products Regulatory Agency in the United Kingdom (UK) formally reclassified sildenafil citrate 50 mg tablets as a pharmacy medicine (sildenafil-P) in 2017 for adult men with erectile dysfunction (ED). A 1-year prospective real-world observational study was conducted to track men's health behaviour, particularly their healthcare resource utilisation (HCRU) and quality of life (QoL) before and after the availability of sildenafil-P.. Adult men with ED aged ≥18 years provided data at baseline (prior to launch of sildenafil-P) and every 3 months after the launch. Demographics, health characteristics, treatments at baseline and HCRU, including number of pharmacist and physician/nurse practitioner visits over time are reported. QoL-related outcomes were assessed via the Self-Esteem and Relationship Questionnaire (SEAR), 2-Item Patient Health Questionnaire and ratings of sexual satisfaction. Generalised linear models were used to assess the association of sildenafil-P use with total physician/nurse practitioner and pharmacist visits and QoL-related outcomes at 12 months.. Overall, 1162 men completed the survey at all 5 time points. The mean ± SD age was 59.02 ± 12.06 years; 55.42% reported having a moderate-to-severe ED. Hypertension (37.52%) and hypercholesterolaemia (31.50%) were the most common risk factors for ED. At baseline, 62.99% were not using any ED treatment. After adjusting for baseline visits/other covariates, mean physician/nurse practitioner (3.68 vs 2.87; P = .003) and pharmacist visits for any reason (2.10 vs 1.34; P < .001) at 12 months were significantly higher among sildenafil-P users than those who never used sildenafil-P. Sildenafil-P users also had significantly higher SEAR total and domain (sexual relationship and self-esteem) scores at 12 months.. Following the reclassification to a pharmacy medicine in the UK, sildenafil-P was associated with a higher number of physician/nurse practitioner and pharmacist visits for any reason. Sildenafil-P use was also associated with better QoL, although group differences were small in magnitude.

Topics: Adolescent; Adult; Aged; Erectile Dysfunction; Health Personnel; Humans; Male; Middle Aged; Pharmacies; Piperazines; Prospective Studies; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; United Kingdom

In recent years, there has been an increase in the use of phosphodiesterase type 5 inhibitors (PDE5i) that are purchased from abroad without a doctor's diagnosis via the Internet or other means. We report six cases in which nonprescription use of PDE5i may have led to death. Among the four deceased individuals who were believed to have experienced sudden cardiac death, three (cases 1-3) had a history of cardiovascular disease, which is a contraindication, and the remaining case (case 4) involved combined use of multiple PDE5i. Sildenafil (0.063 µg/mL, 0.087 µg/mL) was detected in two of the four cases of sudden cardiac death. Tadalafil (0.096 µg/mL) was detected in one of the remaining two cases, and tadalafil (0.197 µg/mL) and vardenafil (0.011 µg/mL) were detected in the other case. Sildenafil (0.032 µg/mL), tadalafil (0.062 µg/mL), and ethanol were detected in a traffic accident case with a history of contraindications. In a case of asphyxiation by vomit aspiration, autopsy showed 90% stenosis in the anterior descending branch of the coronary artery, and sildenafil (0.063 µg/mL) was detected. To the best of our knowledge, this is the first report of postmortem blood levels of tadalafil and vardenafil likely contributing to the cause of death. Despite all the warnings about the dangers of using PDE5 inhibitors, cases of PDE5i contributing to death are still identified during autopsies. Therefore, raising public awareness of the risks of the risks associated with the imported drug use by individuals is necessary.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Diseases; Contraindications, Drug; Death, Sudden, Cardiac; Erectile Dysfunction; Forensic Medicine; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Risk; Sexual Behavior; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Topics: Animals; Calcineurin; Convulsants; Erectile Dysfunction; Humans; Male; Nitric Oxide; Oxytocin; Phosphodiesterase 5 Inhibitors; Receptors, Opioid; Sildenafil Citrate

Unapproved ingredients included in herbal medicines and dietary supplements have been detected as adulterated synthetic drugs used for erectile dysfunction. Extraction from a dietary supplement was performed to isolate the compounds by HPLC analysis. The structural characterization was confirmed using mass spectrometry (ESI-TOF/MS and LC-MS/MS),

Topics: Chromatography, High Pressure Liquid; Cyclic Nucleotide Phosphodiesterases, Type 5; Dietary Supplements; Erectile Dysfunction; Gene Expression Regulation, Enzymologic; Herbal Medicine; Humans; Magnetic Resonance Spectroscopy; Male; Mass Spectrometry; Models, Molecular; Molecular Structure; Phosphodiesterase 5 Inhibitors; Piperazines; Sildenafil Citrate; Sulfones

Topics: Coronary Artery Disease; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

Much theory asserts that sexual intimacy sustains mental health. Experimental tests of such theory remain rare and have not provided compelling evidence because ethical, practical, and cultural constraints bias samples and results. An epidemiologic approach would, therefore, seem indicated given the rigor the discipline brings to quasi-experimental research. For reasons that remain unclear, however, epidemiologist have largely ignored such theory despite the plausibility of the processes implicated, which engender, for example, happiness, feelings of belonging and self-worth, and protection against depression. We use an intent-to-treat design, implemented via interrupted time-series methods, to test the hypothesis that the monthly incidence of suicide, a societally important distal measure of mental health in a population, decreased among Swedish men aged 50-59 after July 2013 when patent rights to sildenafil (i.e., Viagra) ceased, prices fell, and its use increased dramatically. The test uses 102 pre, and 18 post, price-drop months. 65 fewer suicides than expected occurred among men aged 50-59 over test months following the lowering of sildenafil prices. Our findings could not arise from shared trends or seasonality, biased samples, or reverse causation. Our results would appear by chance fewer than once in 10,000 experiments. Our findings align with theory indicating that sexual intimacy reinforces mental health. Using suicide as our distal measure of mental health further implies that public health programming intended to address the drivers of self-destructive behavior should reduce barriers to intimacy in the middle-aged populations.

Topics: Age Distribution; Cause of Death; Erectile Dysfunction; Humans; Incidence; Male; Middle Aged; Risk Factors; Sex Distribution; Sexual Behavior; Sildenafil Citrate; Suicide; Sweden

Erectile dysfunction (ED) is defined as the inability to achieve and/or maintain penile erection sufficient for satisfactory sexual relations, and aging is one of the main risk factors involved. The D-(+)-Galactose aging model is a consolidated methodology for studies of cardiovascular aging; however, its potential for use with ED remain unexplored. The present study proposed to characterize a new experimental model for ED, using the D-(+)-Galactose aging model. For the experiments, the animals were randomly divided into three groups receiving: vehicle (CTL), D-galactose 150 mg/kg (DGAL), and D-(+)-galactose 150 mg/Kg + sildenafil 1.5 mg/Kg (DGAL+SD1.5) being administered daily for a period of eight weeks. All of the experimental protocols were previously approved by the Ethics Committee on the Use of Animals at the Federal University of Paraíba n° 9706070319. During the treatment, we analyzed physical, molecular, and physiological aspects related to the aging process and implicated in the development of ED. Our findings demonstrate for the first time that D-(+)-Galactose-induced aging represents a suitable experimental model for ED assessment. This was evidenced by an observed hyper-contractility in corpora cavernosa, significant endothelial dysfunction, increased ROS levels, an increase in cavernous tissue senescence, and the loss of essential penile erectile components.

Topics: Aging; Animals; Disease Models, Animal; Electric Stimulation; Erectile Dysfunction; Galactose; Male; Penile Erection; Penis; Rats; Rats, Wistar; Reactive Oxygen Species; Sildenafil Citrate

Berberine is an isoquinoline alkaloid, found in several plants. Diabetes induces erectile dysfunction (ED) via reduction in some hormones and enzymes implicated in sexual function. This study aimed to investigate the role of berberine on crucial biomolecules linked to penile function in diabetic rats. Sixty-three (63) adult male rats were used and distributed into nine groups (each = 7). Group I-IV normal rats administered with citrate buffer (pH 4.5), sildenafil citrate (SD, 5.0 mg/kg), 50 and 100 mg/kg of berberine, respectively, via oral gavage. Rats in groups V-IX were diabetic rat with ED treated with buffer, SD, 50 and 100 mg/kg of berberine, and acarbose (25 mg/kg ACA) respectively. The result revealed that histological architecture in penile tissues were altered in diabetic groups treated with berberine, sildenafil citrate and acarbose when compared to the diabetic control group. Treatment with berberine, increased testosterone, luteinizing hormone and follicle-stimulating hormone in diabetic rat with ED. Also, reduced prolactin level and acetylcholinesterase, angiotensin-1 converting enzyme, adenosine deaminase and arginase activities were observed in berberine treated diabetic rat with ED. Molecular docking analysis revealed that berberine had strong binding affinities for these enzymes. Thus, berberine could represent a potential therapeutic agent for diabetes-induced ED.

Topics: Animals; Berberine; Diabetes Mellitus, Experimental; Erectile Dysfunction; Humans; Male; Molecular Docking Simulation; Penile Erection; Penis; Rats; Sildenafil Citrate

Erectile dysfunction (ED) is one of the main challenges occurring among men worldwide, and is characterised by trouble getting or keeping steady erection during sexual intercourse. Various drugs like sildenafil, a phosphodiesterase-5 inhibitor (PDE-5) are freely available in the pharmacies, though normally associated with several adverse. This study was designed to assess the molecular relations obtainable between catechin, garcinal, garcinoic acid and d-tocotrienol compounds isolated from Garcinia kola and targeted receptor linked to ED. These processes include the molecular docking of catechin, garcinal, garcinoic acid, d-tocotrienol, and sildenafil to receptor: PDE-5 via AutoDock Vina. Following the docking of catechin, garcinal, garcinoic acid and d-tocotrienol with the PDE-5-receptor protein, we observed that all are protein inhibitors with garcinoic acid showing better binding affinity -10.0 kcal/mol with PDE-5 receptor relevant to ED. Hence, the results provided insights into the development of garcinoic acid as a replacement for present ED management, with further analysis worth considering.

Topics: Erectile Dysfunction; Garcinia kola; Humans; Male; Molecular Docking Simulation; Phosphodiesterase 5 Inhibitors; Seeds; Sildenafil Citrate

This article discusses the physiological mechanisms of erection and the pathophysiological basis of erectile dysfunction. Parameters characterizing the features of the pharmacokinetics and pharmacodynamics of drugs from the group of phosphodiesterase type 5 inhibitors (PDE-5i) are presented. The clinical efficacy and possible adverse effects of the most significant PDE-5i are considered. These include sildenafil, tadalafil, vardenafil, udenafil, avanafil. There are also data on less known PDE-5i, which include lodenafil and mirodenafil.

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Topics: Commerce; Erectile Dysfunction; Humans; Male; Sildenafil Citrate

While the intima-media thickness (IMT) of the cavernous artery was used for diagnosis for vascular erectile dysfunction (ED) with more accuracy than the peak systolic velocity, the role of the IMT in predicting treatment responses remained unexamined. A total of 136 patients with ED were enrolled. The baseline clinical and laboratory characteristics were collected. Penile Doppler ultrasonography (PDU) was performed on all patients by a blinded sonographer. Sildenafil was administrated to all patients with an adjusted dose of 50 or 100 mg on demand over a period of 3 months. A follow-up was conducted on all patients using the Erectile Hardness Score (EHS) questionnaire along with the visual and tactile version of the standardised EHS tool. The peak systolic velocity (PSV) and IMT were compared between sildenafil responders and sildenafil nonresponders, while receiver operator characteristic (ROC) curves were used to calculate the cut-off values and compare the test power respectively. There was no statistical difference from the baseline characteristics. The IMT of cavernous artery was more accurate than PSV to predict the sildenafil response (AUC = 0.809, 0.626 respectively). IMT could predict sildenafil responders more accurately than PSV, and the cut-off value of the IMT of the cavernous artery was less than 0.22 mm.

Topics: Arteries; Carotid Intima-Media Thickness; Erectile Dysfunction; Humans; Male; Penis; Sildenafil Citrate

Erectile dysfunction (ED) is a common male disorder. Although orally-administered phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are now recognized as the primary pharmacological treatment method for ED, 20%-30% of the patients treated with PDE5 inhibitors exhibit no significant effects. This study aims to investigate the influencing factors of ED in young adults with no response to PDE5 inhibitors. ED patients who would take PDE5 inhibitors were included and investigated with a questionnaire. Patients with no response to PDE5 inhibitors (tadalafil and sildenafil) served as study group, and those with response to PDE5 inhibitors as control group. Then Chi square test and logistic regression analysis were applied to find the potential influencing factors. In total, 378 ED patients were included. Ninety-three (24.6%) cases were non-responsive to PDE5 inhibitors, and the remaining 285 (75.4%) responded to PDE5 inhibitors. In multiple logistic regression analysis, we found that history of drinking (OR=3.152; 95%CI 1.672-6.975), spousal noncooperation (OR=2.994; 95%CI 1.589-5.638), number of fixed sex partners (OR=0.358; 95%CI 0.132-0.651), duration of ED (OR=3.356; 95%CI 1.352-8.333), and depression (OR=3.689; 95%CI 1.579-8.979) could be the influencing factors for ED patients' non-response to PDE5 inhibitors. In conclusion, history of drinking, spousal noncooperation, number of fixed sex partner, long duration of ED, and depression could be the influencing factors for ED patients' non-response to PDE5 inhibitors. Patients and doctors should pay attention to these factors.

Topics: Adolescent; Adult; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Treatment Outcome; Young Adult

In 1998, sildenafil was marketed as the first FDA-approved oral drug for the treatment of erectile dysfunction (ED). During the last two decades, the commercialization of other synthetic phosphodiesterase 5 (PDE5) inhibitors has been paralleled by the rise of remedies based on natural molecules from different chemical classes (flavonoids, polyphenols and alkaloids in general). In this work, a set of

Topics: Binding Sites; Biological Products; Computer Simulation; Cyclic Nucleotide Phosphodiesterases, Type 5; Drug Evaluation, Preclinical; Erectile Dysfunction; Humans; Male; Medicine, Traditional; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

To explore the effect of Coridius Decoction on penile erection hardness, IIEF-5 scores and the testosterone level in ED patients.. We selected 120 ED patients diagnosed and treated in our hospital between July 2018 and January 2020 and, using the random number table, divided them into a control (n = 55) and an observation (n = 65), the former treated with oral sildenafil and the latter with warm Coridius Decoction in addition, both for 8 weeks and followed up for 6 months. We compared the TCM syndrome scores, clinical effects, penile erection hardness, IIEF-5 scores, testosterone (T) level and adverse reactions between the two groups of patients.. The TCM syndrome score, compared with the baseline, was significantly decreased in the observation (9.81 ± 0.61 vs 17.63 ± 1.16, P < 0.05) and the control group (17.56 ± 1.23 vs 13.18 ± 0.75, P < 0.05) after treatment, even lower in the former than in the latter group (P < 0.01). The total therapeutic effectiveness rate was markedly higher in the observation group than in the control (92.31% ［60/65］ vs 80.00% ［44/55］, P < 0.05). After medication, the erection hardness score (EHS) was dramatically higher than the baseline in the observation (4.21 ± 0.55 vs 2.55 ± 0.73, P < 0.01) and the control group (3.14 ± 0.54 vs 2.61 ± 0.73, P < 0.01), and so were the IIEF-5 score (18.58 ± 5.26 vs 12.00 ± 4.68, P < 0.05 and 15.29 ± 4.70 vs 11.94 ± 5.54, P < 0.05) and the T level (［13.27 ± 4.21］ vs ［9.43 ± 4.31］ nmol/L, P < 0.05 and ［10.74 ± 4.15］ vs ［9.01 ± 4.72］ nmol/L, P < 0.05), both even higher in the former than in the latter group (P < 0.01). There were no statistically significant differences in the incidence rates of adverse reactions between the observation and control groups (6.15% ［4/65］ vs 3.64% ［2/55］, P = 0.834).. Coridius Decoction is safe and effective for the treatment of ED, which can significantly improve the clinical symptoms, increase penile erectile hardness and the T level, and repair the erectile function of the patient.

Topics: Erectile Dysfunction; Hardness; Humans; Male; Penile Erection; Sildenafil Citrate; Testosterone

Phosphodiesterase type 5 inhibitors represent the standard treatment of erectile dysfunction after nerve-sparing prostatectomy. Avanafil is a second-generation phosphodiesterase type 5 inhibitor with a high selectivity for phosphodiesterase type 5 isoform. To date, there are no studies comparing the outcomes of avanafil versus sildenafil in this scenario. In this study, we evaluated the efficacy and safety of avanafil versus sildenafil as a drug for post-prostatectomy rehabilitation. Overall, 160 patients submitted to robot-assisted nerve-sparing prostatectomy for localized prostate cancer at three hospitals were enrolled for the present study. After 6 months of treatment, patients in the two groups showed no significantly different sexual function scores, except for the Erection Hardness Score and Sexual Encounter Profile-Q2 that were higher in the Sildenafil group. Adverse events in the Avanafil group occurred in four (5%) patients and in 16 (20%) patients in the Sildenafil group. According to our experience, in patients undergoing nerve-sparing prostatectomy, penile rehabilitation with avanafil compared to sildenafil showed a lower ability to produce a valid erection in the initial phase of sexual intercourse, a difference that disappears in the continuation of the same. Avanafil showed a greater tolerance profile with a lower rate of AEs and discontinuation of therapy due to AEs.

Topics: Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Organ Sparing Treatments; Phosphodiesterase 5 Inhibitors; Postoperative Complications; Prospective Studies; Prostate; Prostatectomy; Prostatic Neoplasms; Pyrimidines; Robotic Surgical Procedures; Sildenafil Citrate; Treatment Outcome

It is an interesting clinical phenomenon that when evaluating the erectile function of men with erectile dysfunction by couples, respectively, using the erectile hardness model, there will exist the evaluation difference between men and their female partners. This phenomenon reflects the problem of communication and cognition between husband and wife in ED patients. To explore the influencing factors associated with this clinical phenomenon, we conducted this interesting, observational, and cross-sectional field survey. We enrolled 385 couples from the andrology clinics of the first affiliated hospital of Anhui Medical University from December 2017 to December 2018. The demographic data of couples, the medical history, sexuality and the characteristics of ED, and anxiety and depression of the couples were collected through face-to-face interview and questionnaires. The couples were divided into two groups containing 238 couples and 147 couples, respectively. We divided couples into difference group including couples which have inconsistent evaluation results from touching the erectile hardness model and no difference group including couples which have consistent evaluation results from touching the erectile hardness model, respectively. The difference group where the couples share different evaluation results reported higher erectile hardness grade from men than from their female partners (male > female: 73.11%

Topics: Adult; Aged; Anxiety; Cross-Sectional Studies; Depression; Erectile Dysfunction; Female; Hardness; Humans; Interpersonal Relations; Male; Middle Aged; Penile Erection; Personal Satisfaction; Sexual Behavior; Sexual Partners; Sexuality; Sildenafil Citrate; Surveys and Questionnaires

While phosphodiesterase type-5 inhibitors (PDE5Is) are highly effective for the treatment of erectile dysfunction (ED) and well tolerated, updated data on prescription patterns have been limited in real-world settings.. To describe men in the United States who are prescribed PDE5Is for ED treatment and to evaluate patterns of initiation, switching, and treatment overlap.. This retrospective claims study used MarketScan Commercial and Medicare Supplement Databases from January 1, 2010, to December 31, 2015, to identify initial PDE5I claims (index date) for sildenafil, tadalafil, and/or vardenafil. Adults aged ≥18 years with ED were identified between July 1, 2010, and December 31, 2014, allowing for a 6-month preindex and 12-month follow-up period from the index date.. Outcomes included patient demographics and treatment-related patterns after treatment initiation.. A total of 106,206 identified patients met all inclusion criteria. Of these, 51,694, 40,193, and 14,319 had initial claims for sildenafil, tadalafil, and vardenafil, respectively. Mean age was 50.35 years, and comorbidities included dyslipidemia (44.17%), hypertension (43.09%), diabetes (15.32%), and depression (10.61%). More patients (48.67%) initiated on sildenafil than tadalafil (37.85%) or vardenafil (13.48%). Rate of switching was lower in the 60 days after the end of day supply of the initial prescription in the sildenafil cohort (2.71%) compared with the tadalafil (2.81%) and vardenafil (3.88%) cohorts (P < .001 for sildenafil vs tadalafil or vardenafil). Treatment overlap was lower in the sildenafil cohort (0.35%) than in the tadalafil (0.75%) and vardenafil (0.62%) groups (P < .001 for sildenafil vs tadalafil or vardenafil).. These findings provide insight into updated patterns of PDE5I prescriptions in the United States and may aid in clinical decision-making.. Strengths include the large sample size, long data coverage period, and the real-world nature of the study. Limitations include the retrospective study design, use of data collected with a primary focus of claims, and lack of further details regarding reasons that drive switching. Actual rates of ED and impact on prescription patterns may be underestimated because the claims database only captured patients electing to visit a health-care provider.. Among men with ED in the United States, rates of switching and treatment overlap were low for all PDE5Is but were found to be the lowest for sildenafil compared with tadalafil and vardenafil. Mulhall JP, Chopra I, Patel D, et al. Phosphodiesterase Type-5 Inhibitor Prescription Patterns in the United States Among Men With Erectile Dysfunction: An Update. J Sex Med 2020;17:941-948.

Topics: Adult; Aged; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Medicare; Middle Aged; Phosphodiesterase 5 Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Prescriptions; Purines; Retrospective Studies; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; United States; Vardenafil Dihydrochloride

Topics: Chromatography, High Pressure Liquid; Dietary Supplements; Drug Contamination; Drugs, Chinese Herbal; Erectile Dysfunction; Food Safety; Humans; Limit of Detection; Male; Molecular Structure; Sildenafil Citrate; Tadalafil; Tandem Mass Spectrometry

Diabetic foot (DF), is one of the most serious and prevalent complications of diabetes mellitus (DM). Disruption in tissue oxygenation due to atherosclerosis in peripheral veins has an important place in DF development. In recent years, phosphodiesterase type 5 (PDE5) inhibitor drugs like sildenafil, which cause peripheral vasodilation, are used commonly in cases of erectile dysfunction, pulmonary hypertension and cardiac insufficiency. In that sense, PDE5 inhibitors, which cause vasodilation in peripheral veins, can increase blood build up in tissues of patients with DF and its stand-alone usage or its usage with already used treatments can increase tissue healing speed and quality.

Topics: Diabetes Mellitus; Diabetic Foot; Erectile Dysfunction; Humans; Hypertension, Pulmonary; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

Topics: Angiography, Digital Subtraction; Antihypertensive Agents; Erectile Dysfunction; Headache Disorders, Primary; Humans; Magnetic Resonance Imaging; Male; Mesencephalon; Middle Aged; Self Medication; Sildenafil Citrate; Subarachnoid Hemorrhage; Tomography, X-Ray Computed; Vasodilator Agents

Phosphodiesterase-5 inhibitors are the first-line therapy for erectile dysfunction (ED) after radical prostatectomy (RP). This single-centre open-label uncontrolled study evaluated the efficacy and safety of the new sildenafil orodispersible film (ODF) in ED treatment after RP. Sildenafil 100 mg ODF was administered twice a week for 3 months to patients under 75 years of age, with a Framingham cardiovascular risk score < 20% and a pre-operative International Index of Erectile Function (IIEF)-5 score ≥ 17, who had undergone open RP between 2016 and 2018. Erectile function was assessed pre-operatively, post-operatively and after treatment through the IIEF-5 score, the Sexual Encounter Profile Question (SEP-Q) 2 and SEP-Q3; adverse events (AE) were also investigated after 3 months. A total of 65 patients with a median (25th-75th percentile) post-operative IIEF-5 score of 8 (7-9) were treated. Nine (13.8%) patients reported AE of mild/moderate grade and discontinued treatment. A significant IIEF-5 score median (25th-75th percentile) increase of 10 (0-12) was found after treatment in the other 56 patients (p < .001). Sildenafil 100 mg ODF was effective in ED after RP in terms of improved IIEF-5 score and improved SEP-Q2 and SEP-Q3 in 67.9% of patients. It could represent a valid alternative for those patients with low compliance to tablet intake.

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Prostatectomy; Sildenafil Citrate; Treatment Outcome

To examine the association between phosphodiesterase-5 (PDE-5) inhibitor use and incidence of colorectal cancer among patients with erectile dysfunction treated in the Veterans Affairs (VA) Healthcare System.. A retrospective cohort study using the Veterans Affairs Informatics and Computing Infrastructure was conducted, with data spanning January 2001-December 2016. Patients were followed up from index until (i) the first diagnosis of colorectal cancer, (ii) death, or (iii) the end of study period. Statistical analyses evaluated demographics and baseline characteristics between cohorts (PDE-5 exposed or not) and the effect of additional dosages of each specific PDE-5 inhibitor using adjusted multivariate Cox proportional hazards models.. A total of 221,538 patients met the study inclusion criteria, 192,691 patients in the PDE-5 cohort and 29,227 patients in the never use PDE-5 cohort. The multivariate Cox proportional hazards model results revealed that the those who had any exposure to a PDE-5 inhibitor have an 18% lower hazard of colorectal cancer (adjusted hazard ratio [HR] = 0.816, 95% confidence interval [CI] = 0.754-0.882). For each additional 100-mg dosage of sildenafil and 10-mg dosage of tadalafil, the hazard of colorectal cancer is reduced by 2.4% (adjusted HR = 0.976, 95% CI = 0.973-0.979) and 1.7% (adjusted HR = 0.983, 95% CI = 0.972-0.996), respectively.. PDE-5 inhibitor usage in patients with erectile dysfunction is associated with a lower hazard of colorectal cancer compared with patients not exposed to PDE-5 inhibitors.

Topics: Aged; Colorectal Neoplasms; Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Incidence; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Proportional Hazards Models; Retrospective Studies; Sildenafil Citrate; Tadalafil; United States; United States Department of Veterans Affairs; Veterans Health Services

Testosterone (T) deficiency is associated with erectile dysfunction (ED). The relaxant response of T on the corporal smooth muscle through a non-genomic pathway has been reported; however, the in vitro modulating effects of T on human corpus cavernosum (HCC) have not been studied.. To compare the effects of various concentrations of T on nitric oxide (NO)-dependent and nitric oxide-independent relaxation in organ bath studies and elucidate its mode of action, specifically targeting the cavernous NO/cyclic guanosine monophosphate (cGMP) pathway.. Human corpus cavernosum (HCC) samples were obtained from men undergoing penile prosthesis implantation (n = 9). After phenylephrine (Phe) precontraction, the effects of various relaxant drugs of HCC strips were performed using organ bath at low (150 ng/dL), eugonadal (400 ng/dL), and hypergonadal (600 ng/dL) T concentrations. The penile tissue measurements of endothelial nitric oxide synthase (eNOS), neuronal (n)NOS, and phosphodiesterase type 5 (PDE5) were evaluated via immunostaining, Western blot, cGMP and nitrite/nitrate (NOx) assays.. Relaxation responses to ACh and EFS in isolated HCC strips were significantly increased at all T levels compared with untreated tissues. The sildenafil-induced relaxant response was significantly increased at both eugonadal and hypergonadal T levels. Normal and high levels of T are accompanied by increased eNOS, nNOS, cGMP, and NOx levels, along with reduced PDE5 protein expression.. This study reveals an important role of short-term and modulatory effects of different concentrations of T in HCC. T positively regulates functional activities, inhibition of PDE5 expression, and formation of cGMP and NOx in HCC. These results demonstrate that T indirectly contributes to HCC relaxation via downstream effects on nNOS, eNOS, and cGMP and by inhibiting PDE5. This action provides a rationale for normalizing T levels in hypogonadal men with ED, especially when PDE5 inhibitors are ineffective. T replacement therapy may improve erectile function by modulating endothelial function in hypogonadal men.

Topics: Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Hormone Replacement Therapy; Humans; Male; Middle Aged; Nitric Oxide; Nitric Oxide Synthase Type I; Nitric Oxide Synthase Type III; Penile Induration; Penis; Sildenafil Citrate; Testosterone

Topics: Arginine; Erectile Dysfunction; Humans; Male; Piperazines; Sildenafil Citrate

Developing topical sildenafil for local treatment of erectile dysfunction has been of great interest in pharmaceutical research. Sildenafil citrate (SC) exhibited a well-documented success for treatment of several types of erectile dysfunction. However, its oral use is limited by serious adverse effects, poor bioavailability, delayed onset, and drug-drug interactions. This work is the first to design and assess sildenafil-loaded bilosomes for topical local treatment of erectile dysfunction. Different sildenafil-loaded bilosomes were prepared and characterized. Permeability of selected formulations was conducted through full-thickness human skin. Optimized bilosomes integrating sodium tauroglycocholate (STGC) showed spherical shape with good particle size (133 nm), high zeta potential (-53.6 mV) and high entrapment efficiency (87.45%). Ex-vivo permeability study revealed that about 39% of the applied dose permeated within 15 min. Furthermore, in-vivo appraisal of therapeutic efficacy was performed using aged male Sprague-Dawley rats. After single application of 2 mg/kg sildenafil loaded in STGC-bilosomes, behavioral and biochemical evaluation was carried out. Behavioral assessment recorded an increased rats' potency manifested as 2 folds increase in intromission frequency and intromission ratio compared to untreated group. That was accompanied by significant increase in cGMP concentration in corpora cavernosa (P < 0.0001) confirming increased potency. In conclusion, STGC-bilosomes could provide topical treatment of impotence with 20% of the oral dose and fast onset of action (10 min).

Topics: Animals; Erectile Dysfunction; Humans; Male; Particle Size; Rats; Rats, Sprague-Dawley; Sildenafil Citrate; Skin Absorption

Infertility is a global health problem with about 15 percent of couples involved. About half of the cases of infertility are related to male-related factors. A major cause of infertility in men is oxidative stress, which refers to an imbalance between levels of reactive oxygen species (ROS) and antioxidants. Erectile dysfunction drugs (EDD), known as phosphodiesterase inhibitors (PDEIs), have been used for the treatment of ED. It has been shown that oxidative stress plays an important role in the progression of erectile dysfunction. Oxidative stress can be alleviated or decreased by non-antioxidants and antioxidant enzymes. The present study was undertaken to determine if these compounds could have a role in the incidence of infertility, especially after long-term use. Therefore, the present study aims to investigate the effect of EDD on the activities of antioxidant enzymes, free radical levels as well as the protein expression of different cytochrome P450 isozymes involved in the steroidogenesis of different hormones. In addition, the activity of both 17β-hydroxysteroid dehydrogenase and 17-ketosteroid reductase were assayed. The architectures of both livers and testes cells were investigated under the influence of EDD.. A daily dose of Sildenafil (1.48 mg/kg), Tadalafil (0.285 mg/kg) and Vardenafil (0.285 mg/kg) were administered orally to male rabbits for 12 week. Western immunoblotting, ELISA, spectrophotometric and histopathological techniques were used in this study.. The present study showed that Sildenafil, Vardenafil, and Tadalafil treatments significantly decreased the levels of glutathione and free radicals in both livers and testes of rabbits. Also, Vardenafil and Sildenafil induced the activity of superoxide dismutase and catalase whereas, glutathione S-transferase, glutathione reductase, and glutathione peroxidase activities inhibited in livers of rabbits. The protein expression of cytochrome P450 isozymes (CYP 11A1, 21A2, and 19C) which are involved in the steroidogenesis was markedly changed in both livers and testes of rabbits after their treatments for 12 weeks. After the treatment of rabbits with these medication, the protein expression of CYP11A1 was slightly down-regulated in both livers and testes except Sildenafil up-regulated such protein expression. In addition, the protein expressions of CYP11A1 and CYP 19C in both livers and testes were down-regulated after treatment of rabbits with Sildenafil, Vardenafil, and Tadalafil for 12 weeks. Also, these drugs inhibited the activity of both 17β-hydroxysteroid dehydrogenase and 17-ketosteroid reductase in testes of rabbits. Moreover, Sildenafil, Vardenafil, and Tadalafil-treated rabbits showed a decrease in spermatocytes and the number of sperms in the testes.. It is concluded that ED drugs induced the activities of both SOD and catalase which consequently decreased MDA level. Decrement in MDA levels and oxidative stress could therefore sustain the erection for a long period of time. On the other hand, it is not advised to use these drugs for a long-term since the protein expressions of CYP isozymes involved in steroidogenesis as well as the numbers of spermatocytes in testes were decreased.

Topics: Animals; Antioxidants; Cytochrome P-450 Enzyme System; Erectile Dysfunction; Glutathione; Isoenzymes; Liver; Male; Oxidative Stress; Rabbits; Sildenafil Citrate; Steroids; Tadalafil; Testis; Thiobarbituric Acid Reactive Substances; Vardenafil Dihydrochloride

To study the efficacy and safety of using sildenafil in patients with erectile dysfunction (ED) and concomitant cardiovascular diseases (CVD) who underwent transurethral resection of the prostate (TURP).. A total of 59 patients (age from 50 to 75 years) with a diagnosis of benign prostatic hyperplasia (BPH), requiring surgical treatment due to inefficiency of drug therapy, I-PSS score more than 20 points), who were sexually active, but had erectile dysfunction (IIEF score < 21), coronary heart disease (NYHA class I) and stage 1-2 hypertension with stable blood pressure. All patients underwent bipolar TURP. From the first day after the TURP, therapy was prescribed as following: tamsulosin 0.4 mg once a day for 90 days, ciprofloxacin 500 mg twice a day for 10 days. In addition, the patients received treatment for comorbidities. In the main group (n=30), men additionally received sildenafil (EFFEX Sildenafil Evalar) 50 mg daily for 60 days, starting from the 30th day postoperatively. We have chosen this drug from an economic standpoint.. At baseline, all patients in both groups had hemodynamic and microcirculatory disorders in the prostate, which got worse in the early postoperative period. During the long-term follow-up, hemodynamic and microcirculatory impairments decreased. This effect was more pronounced in patients who received sildenafil. In addition, patients had an improvement in sexual function. During follow-up, there was no adverse effects of sildenafil on hemodynamic parameters (blood pressure, heart rate).. Our results allow to recommend sildenafil in order to restore sexual function postoperatively in patients with BPH, including those with concomitant cardiovascular disorders.

Topics: Erectile Dysfunction; Humans; Male; Microcirculation; Prostatic Hyperplasia; Sildenafil Citrate; Transurethral Resection of Prostate; Treatment Outcome

To explore the clinical value of phosphodiesterase type-5 inhibitors (PDE-5i) combined with RigiScan-based audiovisual sexual stimulation (AVSS) test in comparison with that of nocturnal penile tumescence (NPT) test in evaluation of erectile function.. A total of 166 ED patients, aged 21－63 (mean 31) years, with a disease course of 3 months to 10 years (mean 14 months), underwent NPT test or PDE-5i + RigiScan-based AVSS test from 2017 to 2018. We compared the results of the diagnostic strategies. Normal NPT patterns were presumed to indicate psychogenic and abnormal ones to indicate organic ED.. Compared with the results of NPT test, no statistically significant difference was observed in the accuracy rate between Viagra + AVSS test and Cialis + AVSS test (P > 0.05). PDE-5i + RigiScan-based AVSS test achieved a sensitivity of 78.9% and a specificity of 90.7% in the diagnosis of psychogenic ED and an overall accuracy rate of 81.9%. According to the results of PDE-5i + RigiScan-based AVSS test, the patients fell into a normal and an abnormal erection group, with significant differences between the two groups in age, disease course, IIEF-5 score and maintenance time of penile tip rigidity ≥60% (P < 0.05). ROC curve analysis indicated that PDE-5i + RigiScan-based AVSS test accurately manifested the erectile function of the patients.. Compared with NPT test, PDE -5i combined with RigiScan-based AVSS test is simple, inexpensive, practical and with a high sensitivity and specificity, and therefore can be used as the first-choice strategy for etiological diagnosis of ED.

Topics: Adult; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Young Adult

Specialized diagnostic evaluation of erectile dysfunction (ED) may require an intracavernous injection test (IIT) or penile duplex ultrasound (PDU).. Our primary objective was to compare the prognostic value of IIT and PDU for treatment efficacy and patient satisfaction with first-line sildenafil citrate.. After 200 patients were screened, a total of 77 patients with ED had a standardized PDU by a blinded third party, and peak systolic velocity (PSV), end diastolic flow (EDF), and resistive index (RI) in timely intervals were recorded. The erection hardness score (EHS) was used to score erection rigidity during the test and was also noted. Patients also completed a briefed International Index of Erectile Function (IIEF-5) questionnaire and were started on open-label 100 mg sildenafil citrate at baseline. The IIEF-5 and erectile dysfunction inventory of treatment satisfaction (EDITS) questionnaires were repeated and completed at 6 months' follow-up. Improvement, cure, and satisfaction were defined as an increase of 4 points in IIEF-5 with an IIEF-5 score higher than 21 points and EDITS score higher than 50, respectively. Receiver operating characteristic curves were drawn and the area under the curve (AUC) was calculated and compared.. EHS did not have a different or larger AUC than PSV, EDF, and RI for improvement, cure, and satisfaction with sildenafil citrate.. The patient's mean age was 58.76 ± 10.27 years and almost half of the patients had moderate ED according to the IIEF-5 (42.8%). Improvement, cure, and satisfaction were high among participants (77.9%, 64.9%, and 67.5%, respectively). The erection rigidity EHS also showed an excellent-to-good ability to predict improvement, cure, and patient satisfaction (AUC = 0.921, 0.873, and 0.898, respectively) with sildenafil citrate.. There is no point in performing more than an IIT when a specialized diagnostic evaluation is required for diagnostic or medico-legal reasons because PDU is time-consuming and requires both hardware and ultrasound skills with no added prognostic value.. This is the first prospective study to directly compare IIT with PDU, and validated disease-specific questionnaires were used to assess both clinical efficacy and satisfaction. Moreover, the PDU was performed by a blinded third party. However, this was a single-center study and the population included was small.. PDU parameters add no prognostic value to determining erection rigidity during a standard IIT. Erection rigidity during IIT, as assessed with the EHS, suffices as a prognostic tool. Morgado A, Diniz P, Silva CM. Is There a Point to Performing a Penile Duplex Ultrasound? J Sex Med 2019;16:1574-1580.

Topics: Adult; Aged; Erectile Dysfunction; Humans; Injections; Male; Middle Aged; Patient Satisfaction; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Prognosis; Prospective Studies; Sildenafil Citrate; Surveys and Questionnaires; Treatment Outcome; Ultrasonography, Doppler, Duplex

Topics: Behind-the-Counter Drugs; Erectile Dysfunction; Humans; Male; Norway; Physician-Patient Relations; Sildenafil Citrate; Taboo; Urological Agents

The etiology of radiation-induced erectile dysfunction (ED) is complex and multifactorial, and it appears to be mainly atherogenic.. To focus on vascular aspects of radiation-induced ED and to elucidate whether the protective effects of sildenafil are mediated by attenuation of oxidative stress and apoptosis in the endothelial cells.. Bovine aortic endothelial cells (BAECs), with or without pretreatment of sildenafil (5 μM at 5 minutes before radiation), were used to test endothelial dysfunction in response to external beam radiation at 10-15 Gy. Generation of reactive oxygen species (ROS) was studied. Extracellular hydrogen peroxide (H. Single high-dose radiation therapy induced NADPH oxidases (NOXs) activation and ROS generation via the proapoptotic ASMase/ceramide pathway. The radio-protective effect of sildenafil on BAECs was due to inhibition of this pathway.. Here, we demonstrate for the first time that radiation activated NOXs and induced generation of ROS in BAECs. In addition, we showed that sildenafil significantly reduced radiation-induced O. This study demonstrated that sildenafil protects BAECs from radiation-induced oxidative stress by reducing NOX-induced ROS generation, thus resulting in decreased endothelial dysfunction. Therefore, it provides a potential mechanism to better understand the atherogenic etiology of postradiation ED. Wortel RC, Mizrachi A, Li H, et al. Sildenafil Protects Endothelial Cells From Radiation-Induced Oxidative Stress. J Sex Med 2019;16:1721-1733.

Topics: Animals; Apoptosis; Cattle; Endothelial Cells; Erectile Dysfunction; Hydrogen Peroxide; Male; NADPH Oxidases; Nitric Oxide; Oxidative Stress; Penile Erection; Reactive Oxygen Species; Sildenafil Citrate

Topics: Color Perception Tests; Color Vision; Color Vision Defects; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil

This cross-sectional comparative study aimed to compare serum L-carnitine and 25(OH)D levels between men with ED non-responding for oral sildenafil citrate and healthy volunteers. Overall, 192 men, recruited from two University Hospitals, were allocated into two equal groups of matched age; healthy potent men and men with ED non-responders for oral sildenafil citrate. Oral sildenafil citrate non-responders self-reported inadequate erectile responses after four attempts using 100 mg with the manufacturer's guidelines relative to meals, associated medications, and sexual stimulation/arousal. Exclusion criteria were: diabetes, cardiovascular disorders, beta blockers treatment, morbid obesity, thyroid disorders, post-radical prostatectomy, and hepatic/renal failure. All participants were subjected to; history taking, clinical examination, validated IIEF-5 questionnaire, estimation of serum L-carnitine by calorimetric method and serum 25(OH)D by ELISA method. Compared with potent controls, ED men non-responders for oral sildenafil citrate showed significant decreases in the mean serum L-carnitine level (16.8 ± 3.6 uM/L versus 66.3 ± 11.9 uM/L, P = 0.001), the mean serum 25(OH)D level (21.2 ± 7.1 ng/ml versus 54.6 ± 7.9 ng/mL, P = 0.001) and IIEF-5 score (7.8 ± 2.6 versus 23.9 ± 1.3). Serum L-carnitine showed significant positive correlation with IIEF-5 scores (r = 0.873, P = 001), serum 25(OH)D (r = 0.796, P = 0.001) and significant negative correlation with the age (r = -0.515, P = 0.001). Serum 25(OH)D showed significant positive correlation with IIEF-5 scores (r = 0.855, P = 0.001) and significant negative correlation with the age (r = -0.223, P = 0.005). It is concluded that normal homeostasis of serum L-carnitine and 25(OH)D play a role in male sexual health being significantly decreased in ED non-responding for oral sildenafil citrate.

Topics: 25-Hydroxyvitamin D 2; Administration, Oral; Adult; Carnitine; Case-Control Studies; Cross-Sectional Studies; Egypt; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Sildenafil Citrate; Surveys and Questionnaires

The widespread use of phosphodiesterase-5 inhibitors has attracted broad attention of counterfeiters to develop illicit erectile products with inaccurate amounts, unknown toxicity, and purity of active ingredients. Correspondingly, intake of these products endangers consumer health and needs to be screened for precautionary actions to reduce this risk. Therefore, in this study, a sensitive and rapid analytical method has been developed for simultaneous determination of selected phosphodiesterase-5 inhibitors present in illicit erectile medications and human urine. Quantification of the analytes was performed by liquid chromatography coupled with quadrupole-time-of-flight tandem mass spectrometry system. The chromatographic separation was successfully achieved with a run period of 8 min. Low detection limits were obtained in the range of 1.63-9.81 ng/g with relative standard deviations below 7.72% obtained using the replicate measurements of lowest concentration in calibration plots. The analytical performance of the proposed method proved good linearity, low detection limits, good accuracy and precision with high percent recoveries for human urine samples. Developed method was successfully applied to real samples including four different brands of illicit erectile medications. The results obtained revealed the presence of high levels of sildenafil in analyzed samples. The behaviors of selected phosphodiesterase-5 inhibitors were also studied in simulated gastric conditions.

Topics: Chromatography, Liquid; Erectile Dysfunction; Humans; Illicit Drugs; Male; Pyrimidines; Sildenafil Citrate; Stomach; Tadalafil; Tandem Mass Spectrometry; Vardenafil Dihydrochloride

Erectile dysfunction medicines such as Cialis and Viagra are very popular worldwide and are between the most prevalent counterfeit medicines in Brazil. A range of analytical methods has been used to analyze Cialis and Viagra, such as ATR-FTIR, GCMS and UPLC-MS. Until now, there are no data available of DSC methods for analysis of counterfeit medicines of Cialis and Viagra. DSC is a thermal analysis that provides useful information of physico-chemical events, and however is almost not used for forensic purposes. In this study, thermal analysis of 25 counterfeit Viagra and Cialis seized by Brazilian Federal Police were performed by DSC and compared to their authentic medicines and analytical standards, along with chemometric tools. Authentic samples of Viagra displayed a similar thermal profile with the API, while Cialis were different with additional endothermic peaks, that could be related to excipients interference. Thermograms of Viagra counterfeit samples were similar to authentic samples, while Cialis showed an enlargement and displacement of endothermic peaks. Also, some Cialis counterfeit samples showed melting peaks attributed to sildenafil, the API of Viagra, instead tadalafil, confirming previous results obtained by UPLC-MS. Multivariate analysis with application of Hierarchical Cluster Analysis classified different groups of samples, including a cluster with counterfeit Cialis and Viagra, indicating the use of same API for both counterfeit medicines and possibly the same illicit production; and a cluster with authentic Viagra and counterfeit Cialis, confirming the addition of sildenafil instead tadalafil to Cialis counterfeit samples. Here for the first time we described the use of DSC for chemical profiling of Cialis and Viagra and showed that even when applied to a small group of samples, DSC along with chemometric tools can be considered as a good auxiliary method in forensic casework samples. DSC provided useful data to perform the identification of counterfeit and authentic medicines, with low cost and a simple method.

Topics: Brazil; Calorimetry, Differential Scanning; Cluster Analysis; Counterfeit Drugs; Erectile Dysfunction; Excipients; Humans; Male; Phosphodiesterase 5 Inhibitors; Principal Component Analysis; Sildenafil Citrate; Tadalafil

With the aim of overcoming the high toxicity of PnTx2-6 (or δ-CNTX-Pn2a), a toxin from the venom of the armed spider (Phoneutria nigriventer), the 19-aminoacid peptide, PnPP-19 (P nigriventer potentiator peptide), was synthesized based on molecular modeling studies of PnTx2-6. PnPP-19 improved the erectile function of normotensive rats and mice, without eliciting side effects, and no signs of toxicity were observed. In addition, PnPP-19 was able to potentiate the effect of sildenafil.. To evaluate the efficacy of PnPP-19 in hypertensive and diabetic mouse/rat models in restoring erectile function, after topical administration; verify the biodistribution of PnPP-19 administration (topical and intravenous), permeation, and cyclic guanosine monophosphate (cGMP)/nitric oxide via implication.. PnPP-19 seems to be an indicated drug to be tested to treat ED in diabetic and hypertensive patients.. PnPP-19, although active by topical application and showing safety to human beings (not shown), has low permeability, about 10% of the applied dose.. Our results showed that PnPP-19 may emerge as a potent new drug that can be topically administered, becoming a promising alternative for erectile dysfunction treatment. Nunes da Silva C, Pedrosa Nunes K, De Marco Almeida F, et al. PnPP-19 Peptide Restores Erectile Function In Hypertensive And Diabetic Animals Through Intravenous And Topical Administration. J Sex Med 2019;16:365-374.

Topics: Administration, Intravenous; Administration, Topical; Animals; Cyclic GMP; Diabetes Mellitus, Experimental; Erectile Dysfunction; Male; Mice; Mice, Inbred C57BL; Nitric Oxide; Penile Erection; Peptides; Phosphodiesterase 5 Inhibitors; Rats; Rats, Inbred SHR; Rats, Sprague-Dawley; Rats, Wistar; Sildenafil Citrate; Spider Venoms; Streptozocin; Tissue Distribution

Sexual dysfunction is a side effect of the antidepressant drug paroxetine. Anogeissus leiocarpus is a medicinal plant with a wide range of biological activities which include antioxidant and antiulcer properties. With these in mind, we investigated the effect of Anogeissus leiocarpus stem bark extract on paroxetine-induced sexual dysfunction in male Wistar rats. Forty-two adult male Wistar rats were divided into seven experimental groups: normal control, PAR (10 mg/kg), PAR + sildenafil (5 mg/kg), ALE (50 and 100 mg/kg) and PAR + ALE (50 and 100 mg/kg). The experiment lasted for 21 days, after which the rats were subjected to sexual behavioral test. Various biochemical assays (phosphodiesterase-5, arginase, acetylcholinesterase, nitric oxide and MDA) were carried out on the penile tissue homogenate. From our findings, paroxetine significantly altered sexual behavior in male rats and increased phosphodiesterase-5, arginase and acetylcholinesterase activities with a concomitant decrease in nitric oxide level. Furthermore, paroxetine altered antioxidant status which revealed by increased MDA level and reduced thiol level. However, treatment with Anogeissus leiocarpus stem bark extract reversed the altered sexual behavior in male rats and boosted antioxidant status. In addition, administration of Anogeissus leiocarpus stem bark extract resulted in a significant attenuation of phosphodiesterase-5, arginase and acetylcholinesterase activities in paroxetine-induced rats. In view of the aforementioned findings, Anogeissus leiocarpus could be considered a promising natural agent in erectile dysfunction management.

Topics: Animals; Antioxidants; Arginase; Combretaceae; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Male; Malondialdehyde; Nitric Oxide; Paroxetine; Penis; Plant Extracts; Plants, Medicinal; Rats; Rats, Wistar; Sexual Behavior; Sexual Dysfunction, Physiological; Sildenafil Citrate

The penile duplex ultrasound (PDU) has been used as a diagnostic tool in erectile dysfunction (ED) management. It is currently recommended that peak systolic velocity (PSV) and end-diastolic flow (EDF) should be recorded on both the right and left cavernosal arteries. However, the clinical utility of bilateral recordings is unknown. Our primary objective is to assess the clinical utility of bilateral recordings in ED treatment with sildenafil. A total of 77 patients were included. All patients had a standardised PDU and also completed the IIEF-5 and started on-demand treatment with sildenafil at 100 mg at baseline. The IIEF-5 and EDITS were completed at the 6-month follow-up. The Spearman test was used to assess correlation. Receiver operating characteristic (ROC) curves were drawn, and the area under the curve (AUC) was calculated. Improvement, cure and satisfaction were high (77.9%, 64.9% and 67.5%, respectively), and the median IIEF-5 and EDITS were 25(22; 25) and 81.81(63.63; 88.63) respectively. The lowest PSV had the highest positive correlation with IIEF-5 and EDITS (p = 0.436 and 0.379, respectively), and it could predict improvement, cure and satisfaction with a fair-to-good accuracy (AUC = 0.837, 0.750 and 0.749 respectively). The present study shows bilateral penile blood-flow assessment is important, and attention should be focused on the lowest bilateral PSV.

Topics: Aged; Arteries; Blood Flow Velocity; Dose-Response Relationship, Drug; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Patient Satisfaction; Penis; Regional Blood Flow; Sildenafil Citrate; Treatment Outcome; Ultrasonography, Doppler, Duplex; Urological Agents

Spending on direct-to-consumer advertising (DTCA) for prescription pharmaceuticals has risen to record levels, five times as much as in 1996 in inflation-adjusted dollars. Major health care provider organizations have called for additional regulation of DTCA. These organizations argue that the negative impact of such advertising outweighs the informational value claimed by the pharmaceutical industry. The industry maintains that further restrictions on DTCA are not warranted because it is successfully self-regulating via "guiding principles" for DTCA as certified by firm executives.. The authors measured recent industry spending on DTCA and used regression models of Nielsen Monitor-Plus data to assess pharmaceutical firm self-regulation after the public disclosure of noncompliance with industry self-regulatory principles, specifically regarding the exposure of children and adolescents to broadcast advertisements for erectile dysfunction drugs.. Public disclosure of noncompliance with self-regulatory DTCA standards did not bring advertising into compliance. Results demonstrate that firms failed to meet the industry standard during every quarter of the six-year period of this study.. Results support previous research findings that pharmaceutical self-regulation is a deceptive blocking strategy rather than a means for the industry to police itself. Policy recommendations include broadcast restrictions on adult content and deincentivizing DTCA via tax reform.

Topics: Adolescent; Child; Direct-to-Consumer Advertising; Drug Industry; Erectile Dysfunction; Guideline Adherence; Guidelines as Topic; Humans; Male; Prescription Drugs; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride; Vasodilator Agents

Even if oral type 5 phosphodiesterase inhibitors (PDE5i) seem an effective treatment for erectile dysfunction (ED), the drop-out is high among patients. For this reason, pharmaceutical companies are encouraged to develop new administration routes, such as the orally disintegrating film. The aim of this study was to analyse the prescription habit of Italian andrologists affiliated to Italian Society of Andrology (SIA) in the era of new oro-dispersible formulation of sildenafil. A 12-items dedicated questionnaire has been distributed to 77 urologists andrologists. As a result of the questionnaire, sildenafil is still the preferred drug of Italian andrologists as it is considered the safest and the most effective. It combines the speed of action and the discretion of the intake that are very important issues for the adherence to the treatment according to the Italian sample. Physicians have also reported the positive feedback of the patients taking sildenafil film as they consider the oro-dispersible formulation either comparable or superior to the old tablet. In conclusion this new formulation has given a new life to an old molecule like sildenafil, and Italian andrologists considered this new pharmaceutical formulation as a good tool to improve the patient's adherence to the treatment and quality of life.

Topics: Andrology; Erectile Dysfunction; Health Care Surveys; Humans; Italy; Male; Phosphodiesterase 5 Inhibitors; Practice Patterns, Physicians'; Sildenafil Citrate

A cross-sectional survey was conducted in Egypt from November 2015 to June 2016. Sexually active adult men were interviewed by a questionnaire designed by the authors. All the participants were evaluated by the abridged 5-item version of the International Index of Erectile Function (IIEF). A total of 3,000 sexually active Egyptian males participated in this study, 946 (31.53%) reported using PDE5Is at least once, and 2054 (68.47%) have never used them. The majority of those who used PDE5Is obtained them for recreational purposes mainly for pleasure (58.35%) and to increase duration/frequency of the intercourse (15.6%). Only 26.05% used PDE5Is to treat ED. The main source of obtaining PDE5Is was friends, relatives and colleagues (62.79%); 25.16% of users obtained the drug by themselves, and 6.66% were prescribed the drug by a pharmacist. Only 5.39% of users obtained the drug after a specialist physician consultation. Sildenafil was the most commonly used PDE5I (90.6%), and most of the users (88.05%) used them in an occasional manner even in the presence of erectile dysfunction, while 11.95% used the drug in a regular manner for every intercourse. PDE5Is are frequently used by the Egyptian male population, and most of them seemed to take them as recreational medications.

Topics: Adult; Coitus; Cross-Sectional Studies; Egypt; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase 5 Inhibitors; Pleasure; Prevalence; Sildenafil Citrate; Surveys and Questionnaires

A 69 years old male with erectile dysfunction lasting 2 years, took 50 mg of sildenafil for having sex with his wife at about 6 o'clock in the morning. One hour later his wife detected that he had an anterograde memory impairment: this was interpreted as a confusional state. The neurological examination suggested a transient global amnesia (TGA). EEG and cerebral magnetic resonance imaging were non-informative and memory deficits resolved within 24 h. Therefore, a TGA was diagnosed. Since no other trigger was detectable, sildenafil was deemed responsible for its occurrence.

Topics: Aged; Amnesia, Transient Global; Erectile Dysfunction; Humans; Male; Sildenafil Citrate; Vasodilator Agents

In comparison to other antidepressant drugs, erectile dysfunction (ED) is more pronounced in paroxetine use. On the other hand, orange (Citrus sinensis) peels commonly consumed in various forms are used in folkloric medicine for ED management. Thus, this study evaluated the effect of orange peels infusion on sexual behaviour, nitric oxide (NO) level and some enzymes (arginase, phosphodiesterase-5 [PDE-5], acetylcholinesterase [AChE] and adenosine deaminase [ADA]) in paroxetine-treated rats. Erectile dysfunction was induced with paroxetine (10 mg/kg body weight). The animals were grouped into five (n = 6): normal rats; paroxetine-induced rats; paroxetine-induced rats treated with sildenafil citrate (5 mg/kg); paroxetine-induced rats treated with orange peels infusion (50 mg/kg); Paroxetine induced rats treated with orange peel infusions (100 mg/kg). The results revealed a significant decrease in sexual behaviour, NO level and the activities of antioxidant enzymes, while there was a significant increase in arginase, PDE-5, AChE and ADA activities in paroxetine-induced rats. However, orange peel infusions ameliorated erectile dysfunction in paroxetine-treated rats. This study showed some possible biochemical basis underlying the use of orange peels infusion in erectile dysfunction management.

Topics: Acetylcholinesterase; Adenosine Deaminase; Animals; Antidepressive Agents, Second-Generation; Antioxidants; Arginase; Citrus sinensis; Cyclic Nucleotide Phosphodiesterases, Type 5; Disease Models, Animal; Erectile Dysfunction; Female; GPI-Linked Proteins; Humans; Male; Membrane Proteins; Nitric Oxide; Paroxetine; Penile Erection; Penis; Plant Extracts; Rats; Sexual Behavior; Sildenafil Citrate; Treatment Outcome

Arginase 1 (ARG1) and arginase 2 (ARG2) compete with nitric oxide synthases for the substrate l-arginine. Here we aim to assess whether arginase 1 and 2 plasma levels, plasma arginase activity or genetic factors are associated with altered responsiveness to sildenafil. We studied 71 post-prostatectomy erectile dysfunction (ED) patients (PED group) and 72 clinical ED patients (CED). Patients responded to the International Index of Erectile Function questionnaire before and after the treatment. We found positive and negative correlations between plasma levels of arginase 1 and sildenafil responsiveness in the PED and CED groups, respectively. PED group also presented negative correlation between plasma arginase activity and sildenafil responsiveness. Sildenafil poor responders have shown higher plasma arginase activity in PED and higher arginase 1 levels on CED groups. In addition, variant genotypes for the rs2781659, rs2781667 and rs17599586 polymorphisms were associated with reduced arginase activity, as well as the GTTT ARG1 haplotype in CED group.

Topics: Adult; Aged; Arginase; Enzyme Activation; Erectile Dysfunction; Humans; Male; Middle Aged; Polymorphism, Genetic; Sildenafil Citrate; Treatment Outcome; Vasodilator Agents

Background Studies have reported misuse of sildenafil citrate for recreational purpose, not least by healthy young men. This is becoming a major concern, for medical and other reasons. Objective The aim of this study was to document the characteristics of sildenafil citrate users and to explore the dispensing practices of the medicine in selected community pharmacies in Addis Ababa, Ethiopia. Setting Data was collected in community pharmacies in Addis Ababa, Ethiopia. Method A survey, using a self-administrated questionnaire, was conducted among customers who purchased sildenafil citrate from community pharmacies. Simple descriptive statistics were used to analyse data. Also, semi-structured interviews were conducted with community pharmacists. These were analysed thematically. Main outcome measures Socio-demographic characteristics (survey), themes (interviews). Results All survey respondents (n = 197) were men, 57.9% were below 40 years old, 53.8% had never been married and 58.4% had used sildenafil citrate before. A minority (16.2%) were diagnosed with erectile dysfunction. The main reason for buying sildenafil citrate was experimentation (45.7%). Pharmacists reported that sildenafil citrate was often dispensed without a prescription. The reason for this was, according to the interviewees, competition in the market. Also, the medicine was often dispensed without adequate information or counselling. Conclusions Selling and buying sildenafil citrate without a prescription seems to be common practice in pharmacies in Addis Ababa. It is crucial to strengthen the regulatory activity to protect customers from health risks. In addition pharmacy professionals should be supported to work in accordance with professional and legal standards.

Topics: Adult; Community Pharmacy Services; Cross-Sectional Studies; Erectile Dysfunction; Ethiopia; Humans; Male; Middle Aged; Pharmacists; Professional Role; Sildenafil Citrate; Vasodilator Agents

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Sildenafil Citrate

Product placement can be presented through edutainment. A drug such as Viagra is introduced or impotence is branded in movies and TV series in different ways to raise awareness of impotence disorder and Viagra as a solution. This study aims to analyze strategies of framing and branding Viagra and impotence disorder, based on a qualitative method analysis of 40 movies and TV series. Findings show that Viagra is shown as not only for older men but also for young and healthy men. Out of 40 movies and TV series in the study sample, in 14 (32.5%), the age of the target audience ranged from 20 to 40 years, in 12 (31.6%) movies and series, the age of the target audience was over 40, and in 12 (31.6%) movies and series, the target audience was very old (over 70). Viagra is shown as not only treating impotence but is presented as a wonder drug that provides a solution for psychological and social needs. The movies show usage instructions, side effects, and risks, and how to store the drug. We recommend that the viewing audience be educated for critical viewing of movies/series in order to empower viewers and give them tools for their decision-making processes concerning their health.

Topics: Adult; Advertising; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Motion Pictures; Qualitative Research; Sildenafil Citrate; Television; Young Adult

Western cultural perceptions that favour spontaneous sex may create unrealistic expectations for erectile dysfunction (ED) treatment. Little is known about how users of phosphodiesterase type 5 inhibitors (PDE5Is) plan sexual activity and timing of their preactivity PDE5I ingestion. Because various PDE5Is vary in their duration of action and dosage regimen, this may be an important consideration in selecting the optimal agent for the ED patient.. To better understand the sexual habits of PDE5I users.. Men from 7 countries (Brazil, China, Italy, Japan, Russia, Taiwan, Turkey) were screened online for age, self-reported comorbidities and ED medication use in the prior 3 months. After screening, eligible participants were asked to complete a 7-question, self-administered online survey containing questions regarding sexual habits and behaviours.. Survey questions focused primarily on advanced planning of sexual intercourse and timing of PDE5I ingestion but also addressed the frequency of sexual intercourse and ED medication use.. Of the 1458 respondents (response rate: 48%; median age: 48 years [interquartile range (IQR), 44-55]), 83% always/sometimes planned a specific time for intercourse in advance; 72% planned a specific time for sexual intercourse up to several hours in advance. Of respondents who planned in advance, more than half planned specific days of the week (55%) and times of the day (60%) for sexual intercourse. The time to sexual intercourse after dosing was ≤1 hour for 70% and ≤4 hours for 96% of men. The median frequency of sexual intercourse was 6 times/month (IQR, 4-10), with ED medication taken a median of 5 times/month (IQR, 3-8).. Sexual activity is usually planned by ED medication users several hours in advance, and the vast majority are attempting activity within a short time after ingestion of the agent. These data should aid clinicians in the selection of the optimal PDE5I.

Topics: Adult; Aged; Brazil; China; Coitus; Drug Administration Schedule; Erectile Dysfunction; Habits; Humans; Italy; Japan; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Russia; Sildenafil Citrate; Surveys and Questionnaires; Tadalafil; Taiwan; Time Factors; Turkey; Vardenafil Dihydrochloride

Well known risk factors for diabetic erectile dysfunction include impaired nitric oxide synthesis and endothelial dysfunction. We proposed to evaluate the efficacy of nitric oxide donor, molsidomine in rat model of diabetic erectile dysfunction.. Streptozotocin (52mg/kg, ip) induced diabetic male rats were treated with molsidomine (5 and 10mg/kg, po) for 8 weeks. The sexual behaviour of male rat in presence of the female rat in oestrous phase was observed at the end of study. The effect of treatment on serum testosterone level, sperm parameters and penile tissue histopathology was also evaluated. Further anti-inflammatory activity and antioxidant potential of molsidomine was evaluated by in vitro method. In silico docking study was carried out to appreciate binding conformation of the molsidomine to its plausible target, phosphodiesterase enzyme.. Molsidomine significantly and dose dependently increased sexual behaviour, sperm count and serum testosterone level in diabetic rats. Further, the protective effect of molsidomine was also substantiated by pathological changes in the architect of the penile tissue. Molsidomine showed good membrane stability accounting for its significant anti-inflammatory action and also significantly scavenged DPPH radical activity showing its antioxidant action. Molsidomine was found to settle well in the active site of PDE-5 enzyme with less binding affinity than the standard drug sildenafil.. The results highlight the rationale behind the repositioning of molsidomine therapy for the management of diabetic erectile dysfunction.

Topics: Animals; Anti-Inflammatory Agents; Antioxidants; Diabetes Mellitus, Experimental; Drug Repositioning; Erectile Dysfunction; Female; Male; Molsidomine; Nitric Oxide Donors; Penile Erection; Penis; Protective Agents; Rats; Rats, Wistar; Sildenafil Citrate; Streptozocin; Testosterone

Stimulation of thermogenic pathways appears to be a promising approach to find new ways of tackling metabolic diseases like obesity and diabetes mellitus type 2. Thermogenic, weight reducing and insulin sensitizing effects of phosphodiesterase 5 (PDE 5) inhibitors have recently been postulated, suggesting that modulators of endogenous cGMP signaling have the therapeutic potential to treat metabolic disorders. However, most studies have been performed in vitro or in animals that were not glucose intolerant. We, thus, aimed to test the metabolic effects of the PDE 5 inhibitor sildenafil by treating diet-induced obese (DIO) mice orally for 8 days. Surprisingly, our results revealed no changes in body temperature, brown adipose tissue (BAT) thermogenesis and gene expression in BAT and inguinal white adipose tissue (iWAT), thus excluding a thermogenic or 'browning' effect of sildenafil in preexisting obesity. In contrast, sildenafil-treated DIO mice displayed changes in liver metabolism and glucose homeostasis resulting in impaired glucose tolerance (P < 0.05), demonstrating for the first time an unfavorable metabolic effect of increased hepatic cGMP signaling in obesity. As sildenafil is commonly prescribed to treat pulmonary arterial hypertension and erectile dysfunction in diabetic and/or obese patients, follow up studies are urgently required to re-evaluate the drug safety.

Topics: Adipose Tissue; Adipose Tissue, Brown; Adipose Tissue, White; Animals; Blood Glucose; Cyclic GMP; Erectile Dysfunction; Glucose Intolerance; Homeostasis; Hypertension; Liver; Male; Mice, Inbred C57BL; Mice, Obese; Obesity; Phosphodiesterase 5 Inhibitors; Signal Transduction; Sildenafil Citrate; Thermogenesis

The experience in the management of erectile dysfunction shows that taking even the most effective medications in tablet form may be inconvenient due to the need for natural settings for intimacy. The phosphodiesterase type 5 inhibitor sildenafil, presented in the orally disintegrating film formulation (Dynamic Forward), differs from all forms of the drug for the treatment of erectile dysfunction available in the Russian pharmaceutical market. The drug in the form of a film makes it possible to realize a pathogenetic approach to treating ED without changing the patients habitual way of life.

Topics: Administration, Oral; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tablets

Topics: Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Respiratory System; Sildenafil Citrate; Sleep Apnea, Obstructive

Clinical study and practice data have shown sildenafil improves sexual function in men with erectile dysfunction (ED). However, some men treated with placebo in double-blind, placebo-controlled sildenafil studies also report improved erectile function as measured by International Index of Erectile Function (IIEF)-Erectile Function Domain (EFD) scores.. This analysis estimated the relationship between post-baseline IIEF-EFD scores and demographic variables, including co-morbidities, in men with ED receiving placebo in flexible-dose sildenafil studies.. Placebo-treated participants in the intent-to-treat population of 42 double-blind, placebo-controlled, flexible-dose, sildenafil studies were included. A participant was classified as a placebo responder if the IIEF-EFD score was ≥26 at the last visit.. Variables assessed were age (<45, 45-64, ≥65 years), race, body mass index, co-morbidities (cardiovascular disease/hypertension, diabetes mellitus, depression), date the last study dose was taken, study completion date, ED etiology (psychogenic, organic, mixed), history of cigarette smoking, ED duration, baseline IIEF-EFD score (≤10, 11-16, ≥17), and treatment duration. Stepwise multivariate logistic regression models assessed the odds of being a responder vs a non-responder for each variable.. A total of 4,360 men were included; 13.5% were responders. Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds = 20.2, P < .0001), were younger than 45 years (odds = 7.3, P < .0001), had mild ED (baseline IIEF-EFD ≥17; odds >100, P < .0001), and did not have diabetes (odds = 4.5, P < .0001). The likelihood of a placebo response decreased as ED duration increased (odds = 0.74, P < .0001). The frequency of common adverse events was similar between placebo responders and non-responders.. These findings contribute to the improved understanding of predictors of placebo response in sildenafil clinical studies. Elucidation of these factors may contribute to the development of further interventions and treatment strategies and best practices for clinical trials.. Strengths of this analysis include the large and diverse population and the duration of follow-up. Limitations include those associated with retrospective analyses and the inability to ascertain to what extent other demographic factors might have contributed to the placebo responses or how these placebo responses might be related to the natural course of ED.. Certain demographics, co-morbidities, and condition characteristics predicted the odds of a placebo response in sildenafil clinical studies of ED. Underlying reasons behind a placebo response warrant further evaluation. Mulhall JP, Carlsson M, Stecher V, et al. Predictors of Erectile Function Normalization in Men With Erectile Dysfunction Treated With Placebo. J Sex Med 2018;15:866-872.

Topics: Adult; Aged; Double-Blind Method; Erectile Dysfunction; Humans; Logistic Models; Male; Middle Aged; Patient Satisfaction; Penile Erection; Phosphodiesterase Inhibitors; Placebo Effect; Randomized Controlled Trials as Topic; Retrospective Studies; Sildenafil Citrate; Sulfones

Phosphodiesterase-5 inhibitors (PDE-5Is) are the first-line medical treatments for erectile dysfunction (ED), but are often restricted in public formularies. This study assesses PDE-5I usage among active-duty service members before and after the addition of sildenafil to the formulary of the Military Health System (MHS) in 2012. To assess, a cross-sectional evaluation was conducted, utilizing encounter and pharmaceutical claims data from the Military Health System Data Repository between 2010 and 2014. Separate zero-inflated, negative binomial models were used to assess changes in usage rates by prescription and by number of pills issued, for 37 947 patients. Increased PDE-5I usage was noted with select comorbidities, notably mental health and neurologic conditions. There was significant proportional variation in medication distribution following inclusion of sildenafil within the MHS formulary, with a minimal demographic impact on medication models. The average number of prescriptions decreased, while the quantity of distributed medications increased. A significant portion of PDE-5I recipients were young men, under 25 years old, who received medications on the first visit, which invites speculation about the effectiveness of treatment and appropriateness of use. Future studies aimed at evaluating prevalence in younger population may be of benefit.

Topics: Adult; Cross-Sectional Studies; Drug Utilization Review; Erectile Dysfunction; Humans; Male; Middle Aged; Military Personnel; Phosphodiesterase 5 Inhibitors; Practice Patterns, Physicians'; Sildenafil Citrate; United States

The commerce of falsified drugs has substantially grown in recent years due to facilitated access to technologies needed for copying authentic pharmaceutical products. Attenuated Total Reflectance coupled with Fourier Transform Infrared (ATR-FTIR) spectroscopy has been successfully employed as an analytical tool to identify falsified products and support legal agents in interrupting illegal operations. ATR-FTIR spectroscopy typically yields datasets comprised of hundreds of highly correlated wavenumbers, which may compromise the performance of classical multivariate techniques used for sample classification. In this paper we propose a new wavenumber interval selection method aimed at selecting regions of spectra that best discriminate samples of seized drugs into two classes, authentic or falsified. The discriminative power of spectra regions is represented by an Interval Importance Index (III) based on the Two-Sample Kolmogorov-Smirnov test statistic, which is a novel proposition of this paper. The III guides an iterative forward approach for wavenumber selection; different data mining techniques are used for sample classification. In 100 replications using the best combination of classification technique and wavenumber intervals, we obtained average 99.87% accurate classifications on a Cialis

Topics: Brazil; Counterfeit Drugs; Erectile Dysfunction; Fraud; Humans; Male; Models, Chemical; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Spectroscopy, Fourier Transform Infrared; Statistics, Nonparametric; Tadalafil; Urological Agents

Erectile dysfunction (ED) is a disorder found in males throughout the world, which negatively affects relationships with partners with advancing age. Hence, in this study, we tested a combined novel treatment of electro-acupuncture (EA) and sildenafil citrate against ED. In addition to EA therapy, the sildenafil citrate, a phosphodiesterase 5 inhibitor, is a widely recognized drug that has achieved considerable success in the treatment of ED. However, the combined effect of both the EA and sildenafil has not yet been investigated. Hence, we aimed to examine the effect of EA on the pharmacokinetics and pharmacodynamics of sildenafil in rat plasma. The pharmacokinetic parameters were determined using ultra performance liquid chromatography (UPLC) after EA and sildenafil administration (10 mg/Kg). Following this, the pharmacodynamics was studied via blood flow pattern using developing Doppler images of the lower body and penis. The pharmacokinetic studies demonstrated that sildenafil significantly increases by administration of low-frequency EA. Further, the pharmacodynamic studies using Doppler imaging revealed an elevated blood flow in rat penis compared with lower body during combined treatment of sildenafil and low-frequency EA. These data indicate a synergistic therapeutic effect of EA and sildenafil for the treatment of ED.

Topics: Administration, Intravenous; Analysis of Variance; Animals; Area Under Curve; Catheterization; Electroacupuncture; Erectile Dysfunction; Male; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Rats; Rats, Sprague-Dawley; Sildenafil Citrate; Vasodilator Agents

Topics: Animals; Aphrodisiacs; Erectile Dysfunction; Male; Orchidaceae; Penile Erection; Piperazines; Plant Extracts; Purines; Rats; Sildenafil Citrate; Sperm Motility; Sulfones

This study sought to compare the effects of quercetin and rutin on some enzymes linked to erectile function as well as antioxidant status in penile tissue of paroxetine - induced erectile dysfunction in rats. Animals were randomly divided into twelve groups: normal control (NC), sildenafil (SD), quercetin (QA) (25 and 50 mg/kg), rutin (RU) (25 and 50 mg/kg), PAR (10 mg/kg); PAR + SD; PAR + QA, PAR + RU (25 and 50 mg/kg). After 14 days' treatment, phosphodiesterase-5' (PDE-5'), arginase, adenosine deaminase (ADA), acetylcholinesterase (AChE) and angiotensin-I converting enzyme (ACE) activities as well as malondialdehyde (MDA) and non-protein thiol levels were determined in rat penile tissues. Elevated levels of PDE-5', arginase, AChE, ADA and ACE activities and MDA were observed in PAR-induced rats with concomitant decrease in non-protein thiol levels when compared to the NC group. However, treatment with SD, QA and RU significantly reduced the activities of AChE, PDE-5', arginase, ADA and ACE and MDA levels and elevated non-protein thiol levels in penile tissues of PAR-induced rats. Furthermore, administration of QA and RU in PAR-induced rats modulated the key enzymes relevant to erection, improved antioxidant status and could be potential functional food ingredients and nutraceuticals in the prevention and/or management of erectile dysfunction.

Topics: Animals; Antioxidants; Disease Models, Animal; Enzymes; Erectile Dysfunction; Male; Malondialdehyde; Paroxetine; Penile Erection; Quercetin; Rats; Rutin; Sildenafil Citrate

Variability in prices of medications is a well-known phenomenon; however, this variability has not been quantified in the realm of erectile dysfunction (ED) medications. ED medications are ideal for this quantification, because they are often not covered by insurances; therefore, the cost is the most direct reflection of price variability among pharmacies as they affect the patients.. To evaluate the variability in cash prices for phosphodiesterase type 5 inhibitors (PDEIs) for ED. We also evaluated whether certain types of pharmacies consistently offer better pricing than others, and whether there was any correlation with demographic factors.. 331 pharmacies were contacted within a 25-mile radius of our institution to obtain the cash price for 4 commonly used ED medications with prespecified doses. After exclusion, 323 pharmacies were categorized as chain, independent, wholesale, or hospital-associated. Cash prices for the specified medications were evaluated. In addition, we identified demographic and socioeconomic factors to determine if these had an impact on median drug pricing within each zip code.. The main outcome was the cost for patients to fill each prescription.. Independent pharmacies provided the lowest cost for 3 of 4 of the PDEIs. The largest price difference for 10 tablets of 100 mg sildenafil between all pharmacies was 38,000%. The median cost difference between independent pharmacies and chain pharmacies for sildenafil was >900%, and >1,100% for independent pharmacies vs hospital-associated pharmacies. Demographic and socioeconomic factors had no impact on the cost.. Our goal is to promote patient counseling among practitioners and to empower patients to shop for the best prices for their medications.. A strength of the study is the large cohort that was surveyed; however, a weakness is that the large majority of the cohort was comprised of chain pharmacies. Mail pharmacies could not be evaluated as they required a valid prescription before offering prices.. The drastic differences in cash prices for the PDEIs give us an insight into the variability and cost-inflation of medications in the United States. These patterns hold true for other essential medications as well, and improved transparency will allow patients to make informed decisions when choosing where to purchase their medications. It may also encourage certain pharmacies to provide medications at more affordable prices. Mishra K, Bukavina L, Mahran A, et al. Variability in prices for erectile dysfunction medications-Are all pharmacies the same? J Sex Med 2018;15:1785-1791.

Topics: Drugs, Generic; Erectile Dysfunction; Humans; Male; Pharmacies; Phosphodiesterase 5 Inhibitors; Prescription Drugs; Sildenafil Citrate; United States

To evaluate treatment response in men with erectile dysfunction (ED) and concomitant comorbidities.. Data were pooled from 42 placebo-controlled, flexible-dose sildenafil trials. In most trials, the sildenafil dose was 50 mg, taken ~1 hour before sexual activity but not more than once daily, with adjustment to 100 or 25 mg as needed. The overall population (N=9413) was stratified by age (<45, 46-64, ≥65 years). Treatment response was defined as a minimal clinically important difference (MCID) from baseline in the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score of >2, >5 and >7 for men with mild, moderate and severe ED at baseline, respectively, or an IIEF-EF domain score ≥26 (no ED) at end-point.. In the overall population, treatment response using the IIEF-EF MCID definition was significantly greater (P<.0001) with sildenafil vs placebo in men with no comorbidity (77% vs 33%), cardiovascular disease/hypertension only (71% vs 27%), diabetes only (63% vs 24%) or depression only (78% vs 29%). Using an IIEF-EF score ≥26, treatment response was significantly greater (P<.0001) with sildenafil vs placebo in men with no comorbidity (49% vs 17%), cardiovascular disease/hypertension only (48% vs 12%), diabetes only (40% vs 12%) or depression only (60% vs 17%). With each definition, the treatment response for each age and comorbidity was significantly greater (P≤.0065) with sildenafil vs placebo.. The treatment response was significantly greater with sildenafil vs placebo in men with ED and each comorbidity regardless of age.

Topics: Aged; Cardiovascular Diseases; Depression; Diabetes Mellitus, Type 2; Erectile Dysfunction; Health Status; Humans; Hypertension; Male; Middle Aged; Remission Induction; Risk Factors; Severity of Illness Index; Sildenafil Citrate; Vasodilator Agents

Myostatin is present in striated myofibers but, except for myometrial cells, has not been reported within smooth muscle cells (SMC). We investigated in the rat whether myostatin is present in SMC within the penis and the vascular wall and, if so, whether it is transcriptionally expressed and associated with the loss of corporal SMC occurring in certain forms of erectile dysfunction (ED). Myostatin protein was detected by immunohistochemistry/fluorescence and western blots in the perineal striated muscles, and also in the SMC of the penile corpora, arteries and veins, and aorta. Myostatin was found in corporal SMC cultures, and its transcriptional expression (and its receptor) was shown there by DNA microarrays. Myostatin protein was measured by western blots in the penile shaft of rats subjected to bilateral cavernosal nerve resection (BCNR), that were left untreated, or treated (45 days) with muscle-derived stem cells (MDSC), or concurrent daily low-dose sildenafil. Myostatin was not increased by BCNR (compared with sham operated animals), but over expressed after treatment with MDSC. This was reduced by concurrent sildenafil. The presence of myostatin in corporal and vascular SMC, and its overexpression in the corpora by MDSC therapy, may have relevance for the stem cell treatment of corporal fibrosis and ED.

Topics: Animals; Erectile Dysfunction; Gene Expression; Immunohistochemistry; Male; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Myostatin; Penile Erection; Penis; Rats; Sildenafil Citrate; Stem Cells

The last decade has seen a breakthrough in the treatment of erectile dysfunction (ED) with the advent of phosphodiesterase-5 inhibitors. There are few population-based observational studies on the prevalence of use of these drugs. We conducted a cross-sectional population-based study in the city of Pelotas (Brazil). Our sample comprised 1,082 men aged 20 years or older who answered a confidential and self-administered questionnaire. Prevalence of EDD use was 5% (IC95% = 4%;7%). ED and advanced age were strongly associated with a higher prevalence of EDD use. ED prevalence in men who used EDD was 68%, which was much higher than the one found in the entire sample (27%). The use of EDD was more frequently reported among separated men, respondents with higher level of education and those without ED. A high proportion of respondents (68%) did not seek medical advice on the use of EDD. Sildenafil was the most commonly used drug (38%) but non-regulated and non-evidence-based drugs were also frequently used (14%). Prevalence of EDD use is higher among individuals with ED, opposing to the notion of recreational use of EDD.

Topics: Adult; Age Factors; Brazil; Cross-Sectional Studies; Educational Status; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Prevalence; Sildenafil Citrate; Surveys and Questionnaires; Young Adult

Topics: Adult; Anesthesia, Spinal; Anesthetics, Local; Angiography, Digital Subtraction; Cerebral Angiography; Cerebral Veins; Elective Surgical Procedures; Erectile Dysfunction; Fibrinolytic Agents; Hernia, Inguinal; Herniorrhaphy; Humans; Intracranial Thrombosis; Male; Phosphodiesterase 5 Inhibitors; Post-Dural Puncture Headache; Sildenafil Citrate; Tomography, X-Ray Computed; Urological Agents; Venous Thrombosis

Sildenafil is the most used treatment of erectile dysfunction, however a large part of patients do not respond to therapy. This drug enhances nitric oxide (NO) signaling, and therefore factors that alter NO production may impact this drug responsiveness. Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of all NO synthases, and is metabolized by Dimethylarginine Dimethilaminohydrolase (DDAH) 1 and 2. Here we aimed to assess the relationship between plasma levels of ADMA and nitrite (marker of nitric oxide production) with Sildenafil responsiveness. We also studied genetic polymorphisms in DDAH1 and DDAH2 genes and their relation with biochemical and clinical data. Were included here 140 patients, divided in Clinical Erectile Dysfunction (CED) or Post-Prostatectomy Erectile Dysfunction (PPED) groups. Erectile function was evaluated before and after Sildenafil on-demand treatment using the International Index for Erectile Function Questionnaire. We have found that nitrite was associated with worse response to Sildenafil (r = - 0.25, P = 0.040). rs1554597 and rs18582 DDAH1 polymorphisms were associated with changes in ADMA levels in CED (B = - 0.23, P = 0.002; B = - 0.15, P = 0.017 for both variant genotypes, respectively). Finally, DDAH2 polymorphisms were associated with altered responsiveness to Sildenafil in PPED (B = +0.19, P = 0.027).

Topics: Amidohydrolases; Arginine; Biomarkers; Erectile Dysfunction; Humans; Male; Nitrites; Phosphodiesterase 5 Inhibitors; Polymorphism, Genetic; Sildenafil Citrate

To make a real-world study on the efficacy and safety of traditional Chinese medicine (TCM) combined with sildenafil in the treatment of erectile dysfunction (ED) that failed to respond to TCM medication.. This study included 1 038 ED patients with the International Index of Erectile Function-5 (IIEF-5) scores ≤21 and improvement <30% after 4 weeks of TCM medication, differentially diagnosed with kidney-yang or kidney-yin deficiency syndrome. We administered TCM combined with sildenafil (Viagra, Pfizer Pharmaceutical Co., Ltd) at 100 mg 1 hour before sexual intercourse. After 2 and 4 weeks of medication, we recorded the scores in IIEF-5, erection hardness, Sexual Encounter Profile question 2 (SEP-2: whether vaginal penetration is successful), SEP-3 (whether sexual intercourse is successful), and TCM Syndromes Scale as well as the indexes of routine blood, urine, liver function, and renal function of the patients, and compared them with those obtained before treatment.. No serious adverse reactions were observed in any of the patients. Compared with the baseline, the patients achieved significantly increased IIEF-5 scores after 2 and 4 weeks of medication (15.01 ± 2.25 vs 16.96 ± 2.55 and 19.41 ± 2.82, P <0.05), penileelectionhardness remarkably improved at 4 weeks (3.36% vs 44.58%, P<0.05), and the positive answers to SEP-2 and SEP-3 both markedly increased at 2 (38.11% vs 90.49%, P<0.05; 22.01% vs 63.77% , P<0.05) and 4 weeks (38.11% vs 96.95% , P<0.05; 22.01% vs 89.73%, P<0.05).. TCM combined with sildenafil is safe and effective in the treatment of ED in Chinese men, which can significantly improve the IIEF-5 score and erection hardness of the patients.. 目的: 观察真实世界中药联合西地那非治疗中药无效型勃起功能障碍（ED）疗效及安全性。方法: 选取1038例中药治疗无效（服用4周中药，治疗后IIEF-5评分改善率<30%且≤21分）的ED患者，重新辨证为肾阳虚证、肾阴虚证，中药同时联合西地那非100 mg性生活前1 h服用，在2、4周后观察患者IIEF-5、勃起硬度分级（EHS）、性生活日志问题2（SEP2）、性生活日志问题3（SEP3）、中医证候评分及血常规、尿常规、肝功能( ALT) 、肾功能( BUN、Cr)等指标，并与治疗前对比。结果: 所有患者未发现严重的不良反应。治疗2、4周后IIEF-5评分［(16.96±2.55)分、(19.41±2.82)分］均有不同程度提高，差异有统计学意义(P<0.05)；治疗4周后EHS4比例（44.58%）上升，与治疗前EHS4（3.36%）相比有统计学差异（P<0.05）；治疗2、4周后，SEP2肯定回答的比例分别为90.49%,96.95%，与治疗前（38.11%）比较，均有统计学差异（P<‚0.05）。治疗2、4周后，SEP3肯定回答的比例分别为63.77%、89.73%，与治疗前（22.01%）比较，均有统计学差异（P<‚0.05）。结论: 真实世界研究发现中药联合西地那非治疗ED是安全、有效的，能有效提高ED患者IIEF5评分，提高勃起硬度。.

Topics: Aged; Asian People; Coitus; Drug Therapy, Combination; Drugs, Chinese Herbal; Erectile Dysfunction; Humans; Male; Medicine, Chinese Traditional; Penile Erection; Sildenafil Citrate; Treatment Outcome; Yang Deficiency; Yin Deficiency

To investigate the effects of two different dosages of sildenafil on patients with erectile dysfunction (ED), a total of 3,674 patients with ED were recruited to answer questionnaires designed specifically for this study. There were 977 patients in the 50 mg group and there were 2,697 patients in the 100 mg group. Both 50 mg and 100 mg of sildenafil therapy increased the ED patients' average monthly frequency of sexual intercourse, improved erectile function state in self-assessment, and elevated sexual satisfaction and enjoyment. Despite a higher rate of concomitant diseases, patients in the higher dosage of sildenafil group had a better outcome in the average monthly frequency of sexual intercourse and sexual enjoyment compared with those in the lower dosage. Such a study might be helpful for health care providers to choose sildenafil dosage for patients with ED.

Topics: Adult; Age Distribution; Dose-Response Relationship, Drug; Erectile Dysfunction; Humans; Male; Middle Aged; Sildenafil Citrate; Surveys and Questionnaires; Vasodilator Agents

The aim of this study was to investigate the effect of resveratrol (RVT) on sildenafil-induced relaxations of isolated corpus cavernosum in non-diabetic and diabetic aged rats.. A total of 13 male aged rats (72-80 weeks old) were randomized into two groups including non-diabetic aged rats and diabetic aged rats. Diabetes was induced in aged rats by streptozotocin (single i.p. dose of 45 mg/kg body weight) administration. At the end of the 12th week, corpus cavernosum strips of rats were suspended in an organ bath system. The corpus cavernosum relaxation was evaluated by sildenafil in the presence or absence of RVT (10. Induction of diabetes resulted in significant inhibition of sildenafil-induced corpus cavernosum relaxation in aged rats. The diminished relaxation in response to sildenafil was significantly improved by acute RVT incubation in both non-diabetic and diabetic aged rats; however, the magnitude of potentiation induced by RVT was more pronounced in diabetic aged rats. The potentiating effect of RVT was significantly inhibited by L-NG-nitroarginine methyl ester (L-NAME, 10. RVT improves sildenafil-induced relaxations of corpus cavernosum in both diabetic and non-diabetic aged rats probably by potentiating the activity of NOS, and this effect seems to be more manifest in diabetic aged group.

Topics: Animals; Diabetes Mellitus, Experimental; Drug Synergism; Erectile Dysfunction; Humans; Male; Nitric Oxide; Penis; Phosphodiesterase 5 Inhibitors; Random Allocation; Rats; Rats, Wistar; Resveratrol; Sildenafil Citrate; Stilbenes

Use of ED medication can be seen as a marker for ED. ED is associated with increasing age, exposure to traumatic events and physical injuries in military veterans. The objective of this study was to assess the prevalence of use of ED medication in Dutch military personnel in the period 2003-2012 and to assess its association with age and psychotropic medication use. Data on dispensing of ED medication, age and co-medication with psychotropic medication of all Dutch military personnel between 2003 and 2012 were collected. The prevalence of ED medication use in each year was estimated, stratified for age and use of psychotropic medication. The number of ED medication users increased a hundredfold from 0.09 to 9.29 per 1000 per year between 2003 and 2012. ED medication was more often used by men over 40 than under 40 (prevalence in 2012: 2.4% vs 0.2%, OR (2003-2012, adjusted for calendar year) 15.6, 95% CI 13.5-17.9) and by men using psychotropic medication (prevalence in 2012: 3.8% vs 0.9%, OR (2003-2012, adjusted for calendar year) 3.13, 95% CI 2.66-3.67). This study shows a strong increase between 2003 and 2012 in a number of ED medication users in male Dutch military personnel. ED medication use increases with age and with psychotropic medication use.

Topics: Adult; Clinical Pharmacy Information Systems; Erectile Dysfunction; Humans; Male; Military Personnel; Netherlands; Psychotropic Drugs; Risk Factors; Sildenafil Citrate; Surveys and Questionnaires; Tadalafil

The development of novel therapeutic options is imperative in patients with erectile dysfunction, especially those non-responsive to phosphodiesterase type 5 inhibitors. LDD175, a potent BKCa channel opener, has a relaxation effect on the in vitro cavernosal smooth muscle strip.. To investigate the effect of LDD175 on erectile function using in vivo animal disease model.. Male Sprague-Dawley rats were assigned to a normal control group and seven diabetic groups: diabetic control, sildenafil (1 and 5 mg/kg), LDD175 (5 and 10 mg/kg), LDD175 5 mg/kg plus sildenafil 1 mg/kg, and LDD175 10 mg/kg plus tetraethylammonium.. Intracavernosal pressure (ICP), ratio of ICP to mean arterial pressure (MAP), and the area under curve of ICP/MAP of eight groups were compared using in vivo pelvic nerve stimulation.. The ICP, ICP/MAP ratio, and area under curve of the ICP/MAP ratio of the normal control rats increased with an increase in electrical field stimulation voltage. All parameters in the diabetic control group were significantly lower than those in the normal control rats, with an electrical field stimulation ranging from 1 to 5 V (P < .05). LDD175 improved the erectile response in diabetic rats in a dose-dependent manner. The combination of sildenafil (1 mg/kg) and LDD175 (5 mg/kg) showed a significant additive effect (P < .05) on the improvement of erectile function compared with sildenafil (1 mg/kg) alone. The enhancement of erectile function by LDD175 was completely blocked by tetraethylammonium.. The results showed that the BKCa channel opener LDD175 improved erectile function in an in vivo diabetic rat model. Furthermore, combination therapy of LDD175 and sildenafil had an additive effect on the improvement of erectile function in diabetic rats. LDD175 could be a new candidate for the treatment of erectile dysfunction.

Topics: Animals; Benzofurans; Diabetes Mellitus, Experimental; Disease Models, Animal; Erectile Dysfunction; Indoles; Male; Muscle, Smooth; Penile Erection; Phosphodiesterase 5 Inhibitors; Rats; Rats, Sprague-Dawley; Sildenafil Citrate

Topics: Erectile Dysfunction; Humans; Male; Patient Satisfaction; Personal Satisfaction; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome

Topics: Erectile Dysfunction; Humans; Male; Patient Satisfaction; Personal Satisfaction; Phosphodiesterase Inhibitors; Sildenafil Citrate; Surveys and Questionnaires; Treatment Outcome

Abnormal vision has been reported by 3% of patients treated with sildenafil citrate (Viagra). Although many men use Viagra for an extended period for treatment of erectile dysfunction, the implications of the long term-daily use of it on the retina and optic nerve are unclear.. To investigate the effect of chronic daily use of sildenafil citrate in a dose equivalent to men preferred therapeutic dose on the histology of the retina and optic nerve of adult male rat.. Eighteen adult male Wistar rats were equally divided into three groups. Group I: control. Group II: treated with sildenafil citrate orally (10mg/kg/day) for 8 weeks. Group III (withdrawal): treated as group II and then left for 4 weeks without treatment. Specimens from the retina and optic nerve were processed for light and electron microscopy.. In sildenafil citrate treated group, the retina and optic nerve revealed vacuolations and congested blood capillaries with apoptotic endothelial and pericytic cells, and thickened basal lamina. Caspase-3 (apoptotic marker) and CD31 (endothelial marker) expression increased. Glial cells revealed morphological changes: Müller cells lost their processes, activated microglia, astrocytic clasmatodendrosis, degenerated oligodendrocytes surrounded by disintegrated myelin sheathes of the optic nerve fibers. The retina and optic nerve of the withdrawal group revealed less vacuolations and congestion, and partial recovery of the glial cells.. Chronic treatment with sildenafil citrate (Viagra) caused toxic effect on the structure of the retina and optic nerve of the rat. Partial recovery was observed after drug withdrawal.

Topics: Animals; Disease Models, Animal; Ependymoglial Cells; Erectile Dysfunction; Humans; Male; Neuroglia; Optic Nerve; Rats; Retina; Sildenafil Citrate; Vision Disorders

Intracellular cyclic guanosine monophosphate (cGMP) concentrations are regulated by degradation enzymes (phosphodiesterases) and by active transport across the plasma membrane by multidrug resistance proteins (MRPs) 4 and 5.. To evaluate the functional effect of MRP-4 inhibition and the role of MRP-4-mediated cGMP export in mouse corpora cavernosa.. Isometric tension of mouse corpora cavernosa was measured after cumulative addition of MK-571, an inhibitor of MRP-4, or sildenafil, a phosphodiesterase type 5 inhibitor. In addition, the effect of MRP-4 inhibition on cGMP-independent and cGMP-dependent relaxations was studied. In vivo intracavernosal pressure and mean arterial pressure measurements were performed after intracavernosal injection of MK-571. The effect of MRP-4 inhibition on cGMP content was determined using an enzyme immunoassay kit.. Measurement of the effect of MK-571 on cGMP content, relaxant responses of mouse corpora cavernosa to cGMP-independent and cGMP-dependent vasodilating substances, and determination of the ratio of intracavernosal pressure to mean arterial pressure after intracavernosal injection of MK-571.. MK-571 and sildenafil relaxed the corpora cavernosa concentration dependently, with sildenafil being the more potent relaxing compound. Furthermore, MK-571 enhanced relaxing responses to cGMP-dependent substances, such as sodium nitroprusside, sildenafil, acetylcholine, and electrical field stimulation, with the latter even under in vitro diabetic conditions. In contrast, cGMP-independent relaxations were not altered by MRP-4 inhibition. Intracavernosal administration of MK-571 significantly increased intracavernosal pressure, with minimal effect on mean arterial pressure. The cGMP analysis showed that MRP-4 inhibition was accompanied by increased cGMP levels.. MRP-4, at least when targeted locally in the penis or when combined with a phosphodiesterase type 5 inhibitor, might be a valuable alternative strategy for the treatment of (diabetic) erectile dysfunction.. This study is the first to demonstrate an in vitro direct relaxant and an in vivo pro-erectile effect of the MRP-4 inhibitor, MK-571, on mouse corpora cavernosa. However, the functional effect of MRP-5-mediated export in mouse corpora cavernosa was not explored, which has been suggested to play the predominant role in cGMP export.. Inhibition of MRP-4 increases basal and stimulated levels of cGMP, leading to corpora cavernosa relaxation and penile erection. Therefore, in addition to degradation of cGMP, export of cGMP by MRP-4 could contribute substantially to regulating cGMP levels in mouse corpora cavernosa. Boydens C, Pauwels B, Vanden Daele L, Van de Voorde J. Inhibition of Cyclic GMP Export by Multidrug Resistance Protein 4: A New Strategy to Treat Erectile Dysfunction? J Sex Med 2017;14:502-509.

Topics: Animals; ATP Binding Cassette Transporter, Subfamily B; Cyclic GMP; Dose-Response Relationship, Drug; Erectile Dysfunction; Male; Mice; Multidrug Resistance-Associated Proteins; Nitric Oxide; Nitroprusside; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Phosphoric Diester Hydrolases; Sildenafil Citrate

The commonly utilized phosphodiesterase type 5 inhibitors do not lead to satisfactory penile erection after radical prostatectomy mainly because of insufficient nitric oxide drive from the damaged cavernous nerves. The aim of this study was to assess the efficacy and mechanisms of icariin in combination with daily sildenafil on neurogenic erectile dysfunction and penile atrophy in a rat model of bilateral cavernous nerves injury. Sixty male Sprague-Dawley rats injected with 5-ethynyl-2-deoxyuridine (50 mg/kg) at postnatal day 1 for the purpose of tracking endogenous stem cells in penis. Forty-eight rats of bilateral cavernous nerves injury were randomized equally into gavage feeding of vehicle, sildenafil (10 mg/kg), icariin (1.5 mg/kg) and sildenafil + icariin, respectively. Twelve sham-operated rats served as control. The intracavernous pressure and mean arterial pressure was measured and mid-penile cross sections were histologically examined 5 weeks after surgery. Western blotting of cavernous tissue protein was also performed. Animals treated with sildenafil + icariin had significantly higher mean intracavernous pressure/mean arterial pressure ratio relative to other rats with bilateral cavernous nerves injury (p < 0.05). The circumference and mean cross-sectional area of the paired corpus cavernosum were effectively preserved in the sildenafil + icariin. Treatment with sildenafil + icariin significantly increased the cavernous cyclic guanosine monophosphate concentration compared with the icariin group (p < 0.05). In addition, the numbers of neuronal nitric oxide synthase-positive nerves and 5-ethynyl-2-deoxyuridine-positive cells co-expressing S100 in the icariin-treated groups were greater compared with the bilateral cavernous nerves injury control group (p < 0.05). These data suggest that the combined use of icariin and daily sildenafil holds promise as a potential therapy for neurogenic erectile dysfunction in the future. The underlying mechanisms appears to involve two aspects: (i) icariin promotes differentiation of endogenous stem cells to Schwann cells, which help to repair the damaged neural pathway for erection; (ii) on this basis, sildenafil can further improve penile engorgement through the cyclic guanosine monophosphate-dependent smooth muscle relaxation.

Topics: Animals; Atrophy; Blotting, Western; Disease Models, Animal; Erectile Dysfunction; Flavonoids; Fluorescent Antibody Technique; Male; Penile Erection; Penis; Prostatectomy; Rats; Rats, Sprague-Dawley; Sildenafil Citrate

Inhibitors of the cGMP-degrading phosphodiesterase (PDE) 5 have achieved blockbuster status in the treatment of penile erectile dysfunction (PED). Their repurposing is currently being proposed to treat certain solid tumours and various other diseases. In cruel irony, however, it appears from recent clinical studies that PDE5 inhibitors may increase the risk of malignant melanoma by negating newly identified brakes on proliferation and metastasis provided by PDE5A.

Topics: Cell Proliferation; Erectile Dysfunction; Humans; Male; Melanoma; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

Lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) are frequent problems in older men worldwide. We evaluated the effect of short- and long-term sildenafil treatment on erectile function in rats with surgically induced partial bladder outlet obstruction (PBOO).. A total of 60 male Sprague-Dawley rats were randomized in five groups: (1) control (sham-operated); (2) PBOO for 3 weeks; (3) PBOO for 6 weeks; (4) sildenafil (1.5 mg/rat/day) treated PBOO for 3 weeks; and (5) sildenafil treated PBOO for 6 weeks. We assessed erectile function by measuring intracavernous pressures (ICP), mean arterial pressure (MAP) and total ICP after cavernous nerve stimulation. Corpus cavernous smooth muscle (CCSM) strips were isolated and evaluated for relaxation responses using organ-bath preparation. Neuronal nitric oxide synthase (nNOS) expression was determined immunohistochemically.. Experimental PBOO at 3 and 6 weeks showed decreased erectile response based on ICP/MAP ratio, total ICP and decreased expression of nNOS, which returned to normal after prolonged daily treatment with sildenafil. CCSM strips from PBOO rats displayed reduced relaxation responses to both electrical field stimulation (EFS) and acetylcholine (ACh) as well as nNOS enzyme intensity when compared to untreated PBOO group, which was reversed by treatment with sildenafil for 6 weeks.. Daily sildenafil treatment prevents development of ED in PBOO rats in a time dependent manner. Further studies are needed to explore the effectiveness of sildenafil in patients with BPH/LUTS in association with ED.

Topics: Animals; Disease Models, Animal; Erectile Dysfunction; Male; Muscle Relaxation; Muscle, Smooth; Rats; Rats, Sprague-Dawley; Sildenafil Citrate; Time Factors; Treatment Outcome; Urinary Bladder Neck Obstruction; Urological Agents

Sexual impairment is an established risk factor in diabetes mellitus affecting about 75% of male diabetic population. In diabetes overexpression of arginase leads to decreased production of NO and diminished erectile response. Inhibition of arginase enzyme can lead to improvement in diabetes induced sexual dysfunction. In the present study diabetes mellitus was induced in adult male rats by intraperitoneal injection of single dose of streptozotocin (65mg/kg) in 0.1M Citrate buffer pH 4.5 and after 72h fasting serum glucose level was checked by glucose oxidase-peroxidase method and those animals showing FSG above 250mg/dl were selected. Diabetic animals were divided into four groups comprising six animals in each. l-Norvaline, potent arginase inhibitor was administered at a dose of 10mg/kg ip to the different groups of diabetic animals for a period of 30 days. Sildenafil at a dose of 5mg/kg orally was used as a standard drug. Mating behavior tests were performed at 0, 15th and 30th days. After 30 days, various biochemical and hormonal parameters (nitrates, LDH, urea, testosterone), testicular parameters (total protein, nitrates, LDH, total cholesterol, LDL, triglycerides, VLDL, HDL) were evaluated to find out the effect of l-Norvaline in sexual impairment. Sperm analysis was also carried out for the treated rats. l-Norvaline showed significant improvement in serum nitrates, urea, LDH, testosterone and testicular protein level as compared with diabetic group. It also improved sperm motility, count and viability in diabetic rats. Sildenafil showed no improvement in above parameters except restoration in serum nitrates level.

Topics: Animals; Arginase; Blood Glucose; Diabetes Mellitus, Experimental; Enzyme Inhibitors; Erectile Dysfunction; Hormones; Injections, Intraperitoneal; Male; Rats; Rats, Wistar; Sexual Behavior, Animal; Sildenafil Citrate; Sperm Count; Sperm Motility; Testis; Valine

Puchta P. You're the flight surgeon: erectile dysfunction. Aerosp Med Hum Perform. 2016; 87(2):152-155.

Topics: Adult; Aerospace Medicine; Erectile Dysfunction; Humans; Male; Occupational Health; Sildenafil Citrate; Stress, Psychological; Urological Agents; Vasodilator Agents

Erectile dysfunction (ED) is a common sequel of pelvic fracture urethral disruption. Those patients with nocturnal erections may respond favourably to sildenafil; however, little is known about the response to sildenafil in patients with absent nocturnal erections. The aim was to evaluate the response to the treatment of sildenafil 50 mg taken once daily in the patients with absent nocturnal erections. From January 2008 to December 2011, a total of 28 patients with absent nocturnal erections were evaluated. We recorded nocturnal penile tumescence and rigidity with an erectometer. If nocturnal erections were absent for three nights, patients were administrated sildenafil 100 mg at bedtime and tested again at the fourth night. Penile duplex ultrasound with intracavernous injection was performed to define the cause of ED. All patients received a daily dose of sildenafil 50 mg for 12 weeks. Response to sildenafil treatment was defined as sustained erections allowing vaginal penetration and intercourse. Twenty-three (78%) patients completed the daily sildenafil treatment, and follow-up was available. The nocturnal erections at the fourth night in 13 patients (46.4%) were improved. About 61.5% (8/13) reported effective response to daily sildenafil. The improvement of nocturnal erections induced by sildenafil taken at bedtime might predict the response to sildenafil taken daily.

Topics: Adult; Erectile Dysfunction; Fractures, Bone; Humans; Male; Middle Aged; Pelvic Bones; Penile Erection; Penis; Phosphodiesterase Inhibitors; Sildenafil Citrate; Treatment Outcome

Sexual dysfunction is common after traumatic brain injury (TBI) but evaluation of treatment interventions have been sparse.. To report on the treatment of sexual dysfunction for two males with severe TBI.. Case one was treated for erectile dysfunction (ED). After a medical examination which found no underlying physiological problems, Sildenafil was prescribed. Scores on the Golombok Rust Inventory of Sexual Satisfaction Impotence subscale found that scores had improved from the dysfunction range at baseline to the functional range at 6 weeks follow-up. There was some reduction in this improvement at 3 months follow-up, maybe associated with a co-morbid deterioration of emotional state. Case two was treated for idiopathic delayed ejaculation (DE). A standard sex therapy intervention was employed that resulted in the resolution of the problem, documented on the Sex Behavior sub-scale of the Derogatis Inventory for Sexual Functioning-Self Report (comparing baseline to post intervention and follow-up scores).. The case reports show promise for the treatment of sexual dysfunction after severe TBI using standard medical and sex therapy treatments. In the future, controlled evaluations are required to demonstrate the efficacy of such interventions.

Topics: Adult; Behavior Therapy; Brain Injuries, Traumatic; Erectile Dysfunction; Humans; Male; Middle Aged; Sexual Dysfunction, Physiological; Sildenafil Citrate; Urological Agents; Young Adult

Sildenafil, an oral phosphodiesterase type 5 inhibitor, has been extensively investigated for the treatment of erectile dysfunction in randomized controlled trials.. To assess the efficacy and safety of sildenafil vs placebo according to age subgroups (<65, 65-74, and ≥75 years) in 11,364 men with erectile dysfunction using pooled data from 48 randomized, double-blinded, placebo-controlled, parallel-group, flexible-dose trials.. Most trials had a 12-week treatment duration. The starting sildenafil dose was 50 mg, taken 1 hour before sexual activity, with subsequent adjustment to 100 or 25 mg based on efficacy and safety. Men taking nitrate therapy or nitric oxide donors and men with severe cardiac failure, unstable angina, or recent stroke or myocardial infarction were excluded. Efficacy analyses included all subjects with baseline and at least one postrandomization evaluation. Safety analyses included subjects who received study medication.. The International Index of Erectile Function and a global assessment question ("Did the treatment improve your erections?").. Mean International Index of Erectile Function scores for question 3 (frequency of penetration), question 4 (maintenance of erections after penetration), and the erectile function domain were statistically significantly improved with sildenafil vs placebo for each age subgroup; orgasmic function, intercourse satisfaction, sexual desire, and overall satisfaction domain scores also were statistically significantly improved with sildenafil vs placebo. The percentage of men reporting improved erections on the global assessment question was statistically significantly higher with sildenafil vs placebo for all age subgroups; the percentage with sildenafil tended to decrease with increasing age (<65 years, 80%; 65-74 years, 69%; ≥75 years, 59%). The most common adverse events with sildenafil were headache and flushing in each age subgroup.. Sildenafil is an effective and well-tolerated treatment for erectile dysfunction regardless of patient age, including men at least 75 years old.

Topics: Aged; Coitus; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Humans; Male; Penile Erection; Sexual Behavior; Sildenafil Citrate

Topics: Anecdotes as Topic; Drug Prescriptions; Erectile Dysfunction; Female; Germany; Humans; Male; Middle Aged; Office Nursing; Physician-Patient Relations; Physicians, Women; Sildenafil Citrate

Diabetes and cardiovascular disease are risk factors for erectile dysfunction (ED). Selective inhibitors of the type 5 phosphodiesterase are the first option for treating ED. However, it is unknown why there are patients with low response to this treatment. Polymorphisms in the PDE5A gene may influence the response to PDE5 inhibitors treatment.. The aim of this study is to analyze the relationship between PDE5A polymorphisms, diabetes, and the efficacy of sildenafil treatment.. A Spanish prospective cohort of 170 Caucasian male patients diagnosed with ED and ischemic heart disease treated with angioplasty was studied.. ED was evaluated according to the 5-item version of the International Index for Erectile Function before and after treatment with sildenafil 50 mg. The gene sequence of the PDE5A gene was analyzed for the presence of rs12646525 and rs3806808 polymorphisms. Glucose and glycosylated hemoglobin levels were measured in blood serum samples. The relationship between treatment response, genotype, and glycemic status was analyzed.. Patients with G-allele of rs3806808 polymorphism showed a worse response to the treatment compared to TT-homozygote patients. Nondiabetic G-allele carriers showed a worse treatment response than TT-homozygotes patients. These differences were not seen in diabetic patients. There were no significant differences in treatment response according to the rs12646525 polymorphism in total population or according to the glycemic status. Logistic regression analysis showed that nondiabetic carriers of the major allele of both the rs12646525 and rs3806808 polymorphism had a significantly higher likelihood to respond to the treatment than diabetic patients carriers of the minor allele (P < .05).. The response to sildenafil treatment depends on polymorphisms in the PDE5A gene and the glycemic status of the patients.

Topics: Aged; Cardiovascular Diseases; Cyclic Nucleotide Phosphodiesterases, Type 5; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Polymorphism, Genetic; Prospective Studies; Risk Factors; Sildenafil Citrate; Treatment Outcome

Topics: Age Factors; Aged; Drug Administration Routes; Erectile Dysfunction; Humans; Male; Middle Aged; Quality of Life; Randomized Controlled Trials as Topic; Sildenafil Citrate; Treatment Outcome

Topics: Double-Blind Method; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Prospective Studies; Sildenafil Citrate; Treatment Outcome

Several severe drug interactions have been reported when sildenafil, a potent drug for the treatment of erectile dysfunction, is co-administered with drugs or herbal remedies that inhibit cytochrome P450 (CYP) 3A4. This study evaluates the effects of two citrus fruit juices, lemon and Seville orange, on the pharmacokinetics of sildenafil in male healthy subjects following a single oral dose.. We conducted an open-label, three-way crossover study in nine healthy male volunteers. Participants received a single oral dose of sildenafil (50 mg) after pretreatment with 250 mL of either water (control), undiluted lemon juice, or Seville orange juice for 3 consecutive days. All subjects were monitored for adverse effects during the study period. Plasma samples were collected for 12 h after dosing and analyzed for sildenafil concentration.. Compared with pretreatment with water, Seville orange juice significantly increased the area under the plasma concentration-time curve from time zero to infinity and the peak plasma concentration of sildenafil by 44 % (90 % confidence interval [CI] 30-60) and 18 % (90 % CI 108-129), respectively, without affecting the time to reach peak plasma concentration. Additionally, Seville orange juice significantly reduced the apparent oral clearance of sildenafil by 30 % (90 % CI 63-75) without affecting its elimination half-life. In contrast, lemon juice did not cause any significant alterations in the pharmacokinetics of sildenafil. There was no significant treatment-related adverse effects reported during the study.. Although it is considered as a moderate CYP3A4 inhibitor, Seville orange only caused a mild increase in exposure to sildenafil after a single oral dose, without manifestation of any adverse effects. The enhanced bioavailability of sildenafil by Seville orange may be attributed to inhibition of its intestinal first-pass effect (CYP3A4 and or p-glycoprotein). Lemon juice, in contrast, had no effects on the pharmacokinetics of sildenafil.

Topics: Administration, Oral; Adult; Area Under Curve; Biological Availability; Chromatography, High Pressure Liquid; Citrus; Citrus sinensis; Cross-Over Studies; Erectile Dysfunction; Food-Drug Interactions; Fruit and Vegetable Juices; Half-Life; Healthy Volunteers; Humans; Male; Sildenafil Citrate; Urological Agents; Young Adult

There must be a large market for active pharmaceutical ingredients of illegal source to support the huge and lucrative business of trade in illegal medicines. The active substances found in illegal pharmaceuticals may differ from their legal counterparts concerning purity and associated risks for the health of the user. In this study we show two examples in which the active substance sildenafil, used in erectile dysfunction products, was not of European Pharmacopeia quality. In one case milligram-scale amounts of a 2-mercaptobenzothiazole contamination were found, in another case the mesylate salt rather than the monograph based citrate was used. For the user of products containing these active substances, the risks of side effects increase through the inherent properties of the impurity and the chance of overdosing. The fact that the users are most likely not aware of the poor quality of the products adds up to the health risk of using prescription medication without consulting medical professionals.

Topics: Counterfeit Drugs; Erectile Dysfunction; Humans; Male; Sildenafil Citrate; Spectroscopy, Fourier Transform Infrared; Tandem Mass Spectrometry

Erectile dysfunction (ED) is a major health problem and is mainly associated with the persistent inability of men to maintain sufficient erection for satisfactory sexual performance. Millions of men are using sildenafil, vardenafil, and/or tadalafil for ED treatment. Cytochrome P450s (CYPs) play a central role in the metabolism of a wide range of xenobiotics as well as endogenous compounds. Susceptibility of individuals to the adverse effects of different drugs is mainly dependent on the expression of CYPs proteins. Therefore, changes in activities of phase I drug-metabolising enzymes [arylhydrocarbon hydroxylase (AHH), dimethylnitrosamine N-demethylase (DMN-dI), 7-ethoxycoumarin-O-deethylase (ECOD), and ethoxyresorufin-O-deethylase ((EROD)] and the protein expression of different CYPs isozymes (CYP1A2, CYP2E1, CYP2B1/2, CYP3A4, CYP2C23, and CYP2C6) were determined after treatment of male rats with either low or high doses of sildenafil (Viagra), tadalafil (Cialis), and/or vardenafil (Levitra) for 3 weeks. The present study showed that low doses of tadalafil and vardenafil increased DMN-dI activity by 32 and 23%, respectively. On the other hand, high doses of tadalafil, vardenafil, and sildenafil decreased such activity by 50, 56, and 52%, respectively. In addition, low doses of tadalafil and vardenafil induced the protein expression of CYP2E1. On the other hand, high doses of either tadalafil or sildenafil were more potent inhibitors to CYP2E1 expression than vardenafil. Moreover, low doses of both vardenafil and sildenafil markedly increased AHH activity by 162 and 247%, respectively, whereas high doses of tadalafil, vardenafil, and sildenafil inhibited such activity by 36, 49, and 57% and inhibited the EROD activity by 39, 49, and 33%, respectively. Low and high doses of tadalafil, vardenafil, and sildenafil inhibited the activity of NADPH-cytochrome c reductase as well as its protein expression. In addition, such drugs inhibited the expression of CYP B1/2 along with its corresponding enzyme marker ECOD activity. It is concluded that changes in the expression and activity of phase I drug-metabolising enzymes could change the normal metabolic pathways and might enhance the deleterious effects of exogenous as well as endogenous compounds.

Topics: Animals; Cytochrome P-450 CYP2J2; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme System; Dose-Response Relationship, Drug; Drug Interactions; Erectile Dysfunction; Isoenzymes; Liver; Male; Metabolic Detoxication, Phase I; Phosphodiesterase 5 Inhibitors; Rats; Risk Assessment; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

There is no consensus on the best oral phosphodiesterase type 5 inhibitor (PDE5I) for patients undergoing penile rehabilitation after surgical nerve injury.. To determine the mechanism of PDE5I on cultured neuronal cells and the effectiveness of local drug delivery using nanospheres (NSPs) to sites of nerve injury in a rat model of bilateral cavernous nerve injury (BCNI).. The effects of sildenafil, tadalafil, and vardenafil on cyclic adenosine monophosphate, cyclic guanosine monophosphate, and cell survival after exposure to hypoxia and H. Viability of neuronal cells was measured. Intracavernous pressure changes after cavernous nerve electrostimulation and expression of neurofilament, nitric oxide synthase, and actin in mid-shaft of penis were analyzed 14 days after injury.. Sildenafil and rolipram significantly decreased cell death after exposure to H. Sildenafil showed the most profound neuroprotective effect compared with tadalafil and vardenafil. Sildenafil- or rolipram-loaded NSP delivery to the site of nerve injury prevented erectile dysfunction and led to increased neurofilament, nitric oxide synthase, smooth muscle content in rat penile tissue after BCNI.

Topics: Animals; Cyclic GMP; Erectile Dysfunction; Humans; Hydrogen Peroxide; Male; Muscle, Smooth; Nitric Oxide Synthase; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Prostatectomy; Rats; Rats, Sprague-Dawley; Sildenafil Citrate; Trauma, Nervous System

To present a case of oral syphilis in an old patient.. Syphilis seems to be resurging mainly in the young. However, in the last twenty years, the elderly have become more susceptive to infectious diseases due to a more frequent use of sildenafil.. An 83-year-old man was referred to our clinic complaining of burning mouth. His medical history revealed papular lesions on chest and penis glans, which had been diagnosed and treated as scabiosis 2 months prior to our assessment. The intra-oral examination showed erosive and patch lesions on the bilateral lip commissures, the palate and the border of the tongue. Initially, oral herpes was suspected. However, both the serological test and the cytology were negative. Therefore, syphilis was hypothesised. Non-treponemic (VDRL) and treponemic tests (FTA-ABS) were reagent and secondary syphilis was confirmed. The treatment consisted of penicillin G benzathine 2.4 million IU/IM for 4 weeks. Both oral and skin lesions had complete remission.. The present case illustrates that syphilis should be suspected in old patients with oral atypical lesions.

Topics: Aged, 80 and over; Anti-Bacterial Agents; Cardiolipins; Cholesterol; Diagnostic Errors; Erectile Dysfunction; Fluorescent Treponemal Antibody-Absorption Test; Humans; Insecticides; Ivermectin; Male; Mouth; Penicillin G Benzathine; Phosphatidylcholines; Scabies; Sildenafil Citrate; Stomatitis, Herpetic; Syphilis; Unsafe Sex; Urological Agents

Erectile dysfunction negatively affects men and women in relationships; however, the subjective experience of erectile dysfunction and phosphodiesterase-type 5 inhibitor therapy remains poorly understood. The authors therefore characterized participants' subjective understanding of erectile dysfunction and phosphodiesterase-type 5 inhibitor therapy using individual interviews with affected heterosexual men (n = 58) and women (n = 65). Responses were characterized by 6 psychosocial domains: explanation of the experience, emotional responses, socially expected responses, value of sex, communication with the partner, and treatment expectations. The findings may aid clinicians in relating to men with erectile dysfunction and thus potentially improve effectiveness of therapy.

Topics: Adult; Erectile Dysfunction; Female; Humans; Interpersonal Relations; Male; Middle Aged; Patient Satisfaction; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Qualitative Research; Sexual Behavior; Sexual Partners; Sildenafil Citrate; Sulfonamides

Judaism has a positive attitude to sexual relations within a marriage, and views such sexual relations as important not only for procreation but also as part of the framework of marriage. This is true for any age group, and sexuality is seen as an essential element of marriage for couples of advanced age. In this article, the authors present the views of Jewish law and thought regarding sexuality among older couples. The authors illustrate this using 3 case studies of couples who sought guidance in the area of sexuality. In addition, this area of counseling benefits greatly from an ongoing relationship and dialogue between expert rabbis in the field and therapists treating older Orthodox Jewish patients for sexual dysfunction. The triad relationship of couple, therapist, and rabbi enhances the ability to treat and assist such couples to seek treatment and overcome their difficulties.

Topics: Aged; Aging; Bible; Erectile Dysfunction; Female; Humans; Judaism; Male; Marriage; Middle Aged; Morals; Religion and Psychology; Religious Philosophies; Sex Counseling; Sexuality; Sildenafil Citrate

An advantage of sexuality after 60 years of age is the increased need for couple involvement to promote desire, pleasure, eroticism, and satisfaction inherent to the healthy aging process. This case study clinically explores the complex psychobiosocial interactions for understanding, assessing, and treating sexual problems for couples age 60 years and older, emphasizing the Good Enough Sex approach of variable, flexible, and shared sexual pleasure. Aging couples are discouraged from appraising their sexual experiences within the parameters of the pass/fail binary of the traditional individual performance model and are instead encouraged to embrace the evolving elasticity of their sexual experiences. The Good Enough Sex model espouses an approachable and satisfying alternative for the promotion of sexual function and satisfaction throughout the life span, with particular interest in late adulthood sexual health.

Topics: Age Factors; Aged; Combined Modality Therapy; Erectile Dysfunction; Female; Humans; Libido; Male; Medication Adherence; Qualitative Research; Quality of Life; Recurrence; Self Concept; Sex Counseling; Sexual Behavior; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Sildenafil Citrate

Erectile dysfunction (ED) is a common male sexual disorder worldwide. Three oral phosphodiesterase type 5 inhibitors (PDE5Is) - sildenafil, tadalafil and vardenafil - are available for treatment of ED. This study quantitatively evaluated the therapeutic efficacy and safety of these medications to assist treatment decision making.. We used multiple criteria decision analysis (MCDA) to assess the totality of risk-benefit of PDE5Is. We created two models: (i) the overall model included 'overall improvement in erections' and 'any adverse events' and (ii) the detailed model included 'erectile function domain', 'ability for sexual intercourse', 'duration of erection last', 'serious adverse events', 'headache', 'flushing' and 'dyspepsia'. We calculated a synthetic utility for each drug accounting for all of its benefits and risks.. Considering the overall risk-benefit, vardenafil had the highest synthetic utility among three medications; in the order of synthetic utilities: vardenafil (0.568), tadalafil (0.478) and sildenafil (0.437). However, when specific risk and benefit criteria were assessed, tadalafil had the highest synthetic utility (0.602) according to the conjoint evaluation (synthetic utility for vardenafil is 0.491 and sildenafil is 0.442, respectively). The sensitivity analysis based on the uncertainties of weight on risks of any adverse events (including serious adverse events and headache) suggested our results were robust.. This study provides a useful approach that comprehensively and systematically assesses and compares the risk-benefit of several treatment alternatives. Our study not only rank treatment alternatives by synthetic utilities based on the risk-benefit balance but also compare specific risk and benefit criteria between these medicines. Our results provide valuable evidence that can guide clinicians and patients in making treatment decisions.

Topics: Adult; Aged; Erectile Dysfunction; Humans; Male; Middle Aged; Penile Erection; Phosphodiesterase 5 Inhibitors; Risk Assessment; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride

Erectile dysfunction (ED) is frequently associated to hypertension and antihypertensive drugs; however, the penile morphological aspects on these situations are poorly known.. Evaluate the penile morphology of untreated hypertensive rats and rats treated with enalapril or sildenafil alone or in combination to verify the hypothesis that morphological alterations promoted by hypertension on corpus cavernosum could be ameliorated by the use of angiotensin-converting enzyme inhibitors and/or phosphodiesterase type 5 inhibitors.. Fifty male rats were assigned into five groups: normotensive rats, untreated spontaneously hypertensive rats (SHRs), and SHR treated with enalapril or sildenafil alone or in combination. Blood pressure was measured weekly. At the conclusion of the study, the rats were euthanized, and their penises were collected for histomorphometrical analysis.. The cross-sectional areas of the penis, tunica albuginea, and corpus cavernosum were measured. The density of the corpus cavernosum structures was quantified.. Both groups of SHR rats treated with enalapril became normotensive. Untreated SHR showed no difference in penile and cavernosal cross-sectional area compared with normotensive rats; however, those rats treated with enalapril or sildenafil alone demonstrated an increase in these parameters. Rats receiving combination therapy showed no cross-sectional area differences compared with normotensive rats. Cavernosal connective tissue density was increased, while the sinusoidal spaces were diminished in untreated SHR. All treatments were effective in maintaining connective tissue density in comparison with normotensive animals. Cavernosal smooth muscle density was similar in all groups, with the exception of the combination therapy group, which demonstrated a reduction in smooth muscle.. Hypertension promoted structural alterations in the corpus cavernosum that may be related to ED. Enalapril- and sildenafil-treated animals had preservation of normal corpus cavernosum structure and an increase in penile and cavernosal cross-sectional area. The combination of these drugs showed less benefit than individual use.

Topics: Angiotensin-Converting Enzyme Inhibitors; Animals; Antihypertensive Agents; Blood Pressure; Enalapril; Erectile Dysfunction; Humans; Male; Penis; Piperazines; Purines; Rats; Rats, Inbred SHR; Rats, Inbred WKY; Sildenafil Citrate; Sulfonamides

To investigate the effect of sildenafil on platelet function and cyclic guanosine monophosphate (cGMP) levels in patients with erectile dysfunction, we evaluated the association between erectile function and platelet responses after administration of 100 mg sildenafil. Erectile responses were monitored after 8 daily doses of the drug. Adenosine diphosphate (ADP) and collagen-induced platelet aggregation and simultaneous adenosine triphosphate (ATP) release and cGMP levels were determined before and after sildenafil therapy. Basal levels for platelet aggregation, ATP release and cGMP were compared with age-matched controls. There was no difference among basal levels of platelet responses between patients and controls, except for ADP-induced platelet aggregation (P = 0.04). It was significantly higher in the patient group. Analysis of the responses to sildenafil revealed that for the patients who showed a positive erectile response, there was a significant increase in platelet cGMP (P = 0.028) and a decrease in ADP-induced platelet aggregation (P = 0.04). However, for those who showed a negative or poor erectile response, there was no change in platelet cGMP levels and platelet functions. Sildenafil did not affect collagen-induced platelet responses although cGMP levels of the responders increased. It is concluded that sildenafil increases platelet cGMP in the patients with positive erectile response. Therefore, it has been speculated that platelet cGMP may be used as an index for erectile response.

Topics: Adult; Aged; Blood Platelets; Case-Control Studies; Cyclic GMP; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Platelet Aggregation; Sildenafil Citrate

Sexual enhancement medication presents a large market for counterfeit versions. We report here a case of hypoglycemia caused by an illicit sexual enhancement medication containing an extremely large amount of the sulfonylurea drug glibenclamide together with a moderate amount sildenafil citrate.

Topics: Adult; Blood Glucose; Drug Combinations; Erectile Dysfunction; Glyburide; Humans; Hypoglycemia; Hypoglycemic Agents; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

To evaluate the early effect of sildenafil on the retinal nerve fiber layer (RNFL) thickness.. Sixty eyes of 60 patients were enrolled in the study. The patients underwent RNFL analysis by scanning laser polarimetry (Nerve Fiber Analyzer, GDx VCC:5.3.3; Laser Diagnostic Technologies, San Diego, CA, USA) before and after a single 100 mg dose of sildenafil. Sixty eyes of 60 volunteers of similar age and sex distribution were taken as the control group. The RNFL thickness parameters evaluated included temporal, superior, nasal, inferior, temporal (TSNIT) average, superior average (SA), inferior average (IA), TSNIT standard deviation (SD), and nerve fiber index (NFI).. The mean age of the patients was 53,52 ± 9,26 years. The mean pre- and post-treatment TSNIT, SA, IA, TSNIT SD, and NFI of the patients were 57.46 ± 4.94 µ versus 56.90 ± 4.59 microns (µ), 68.93 ± 6,12 µ versus 67,79 ± 5,49 µ, 66,71 ± 7.10 µ versus 66.31 ± 6.82 µ, 24 ± 3.86 µ versus 23.40 ± 4.05 µ, and 16.50 ± 6.08 µ versus 14.92 ± 6.76 µ, respectively. There were no statistically significant differences between pre- and post-treatment RNFL thicknesses (p = 0.527, p = 0.281, p = 0.754, p = 0.416, p = 0.185, respectively).. A single 100 mg dose of sildenafil seems to have no unfavorable effect on RNFL thickness in the acute phase of treatment.

Topics: Adult; Aged; Case-Control Studies; Erectile Dysfunction; Humans; Male; Middle Aged; Nerve Fibers; Phosphodiesterase 5 Inhibitors; Retina; Retinal Neurons; Sildenafil Citrate

Despite effective control of blood glucose levels in diabetic patients, complaints of diabetes-associated erectile dysfunction (ED) persist. Resveratrol has been indicated to possess anti-diabetic effects and therapeutic potential for ED. This study was conducted to observe the effect of resveratrol alone or in combination with sildenafil on ED in streptozotocin (STZ)-induced diabetic rats.. Among 58 adult male STZ-induced (60 mg/kg) diabetic Sprague-Dawley rats, 48 STZ-induced diabetic rats were randomized equally to four groups: untreated diabetic rats, resveratrol (25mg/kg), sildenafil (5mg/kg) or resveratrol (25mg/kg) plus sildenafil (5mg/kg) through oral gavage for 8 weeks. Additionally, 12 age-matched rats were chosen as controls. Intracavernous pressure (ICP) and mean arterial blood pressure (MAP) were used to measure erectile function. The cavernous level of cyclic guanosine monophosphate (cGMP), protein and mRNA of endothelial NO synthase (eNOS), neuronal NOS (nNOS), and phosphodiesterase-5 (PDE5) was measured.. Treatment with either resveratrol or sildenafil improved ICP/MAP compared to the untreated diabetic rats (P<0.05). Treatment with resveratrol increased nNOS and eNOS expression, inhibited PDE5 expression, and increased the cavernous cGMP level compared to the untreated diabetic rats. Resveratrol significantly decreased superoxide anion and ROS production. Two-way ANOVA indicated that resveratrol in combination with sildenafil therapy had a significant synergistic effect in improving ICP/MAP and cavernous cGMP levels.. Resveratrol improves diabetes-associated ED in rats. Combination therapies with resveratrol and sildenafil have a synergistic effect in improving ED. The mechanisms might be attributed to its anti-oxidative properties and NO-cGMP signaling pathway upregulation.

Topics: Animals; Antioxidants; Blood Pressure; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Diabetes Complications; Diabetes Mellitus, Experimental; Erectile Dysfunction; Male; Nitric Oxide Synthase Type I; Nitric Oxide Synthase Type III; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Rats; Resveratrol; Second Messenger Systems; Sildenafil Citrate; Stilbenes; Sulfonamides

The purpose of this descriptive study was to assess frequency of phosphodiesterase type (PDE-5) inhibitor use (sildenafil, tadalafil, ardenafil) in community settings.. A retrospective record review was conducted to determine PDE-5 inhibitor use in older males (mean age 79.2) residing in three assisted living communities (n=126), or living in private homes with home care services (n=109).. Two participants from assisted living had PDE-5 inhibitors listed on medication profiles, while no participants from the home care setting had any listed.. Many factors may have contributed to the absence of PDE-5 inhibitors in records, including comorbidities precluding use; fear of side effects; reluctance to report use; and lack of erectile dysfunction diagnosis to name a few. It is unknown whether sexual function, or the need for PDE-5 inhibitors was ever assessed by providers. Future research is warranted given the aging population and the benefits of holistic assessments.

Topics: Drug Prescriptions; Erectile Dysfunction; Home Care Services; Housing for the Elderly; Humans; Male; Phosphodiesterase 5 Inhibitors; Retrospective Studies; Sildenafil Citrate; Tadalafil

Topics: Drug Eruptions; Erectile Dysfunction; Humans; Male; Melanoma; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Skin Neoplasms

We report a patient who suffered consecutive cranial neuropathies where each event was immediately preceded by the use of oral PDE-5 inhibitors. A discussion of the etiology of the events including possible interaction with other medications is included.

Topics: Aged; Cranial Nerve Diseases; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil

A method was established for rapid screening and quantifying 11 illegally added anti-impotence preparations (yohimbine, acetildenafil, nor-acetildenafil, homosildenafil, hydroxy-homosildenafil, sildenafil, vardenafil, thioaildenafil, tadalafil, pseudovardenafil, dapoxetine) in health care products by high performance liquid chromatography-high resolution mass spectrometry. The samples were extracted with methanol and analyzed by positive mode in the MS detection. The results showed that the limits of detection were 25.0 ng/mLexcept for nor-acetildenafil (5.0 ng/mL), the linear ranges were 5.0-200.0 ng/mL except for nor-acetildenafil (25.0-500.0 ng/mL) with the correlation coefficients not less than 0.999 0. The recoveries were in the range of 82.0%-105.9% with the relative standard deviations of 4.7%-16.5%. This method is accurate, simple and rapid, and can be used in rapid screening and quantitative analysis of the 11 illegally added anti-impotence in health care products.

Topics: Benzylamines; Chromatography, High Pressure Liquid; Drug Contamination; Erectile Dysfunction; Humans; Indole Alkaloids; Male; Mass Spectrometry; Naphthalenes; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride; Vasodilator Agents

To search for the optimal strategies for sperm collection from the patient with temporary penile erectile dysfunction (ED) on the day of oocyte pick-up ( OPU) in in vitro fertilization embryo transfer (IVF-ET).. We retrospectively analyzed 93 cases of temporary ED on the OPU day of IVF-ET from January 2011 to May 2014, with fresh semen for 45 cases (group A), cryopreserved sperm before oocyte retrieval for 30 cases (group B), and frozen oocytes for 18 cases (group C). Group A was again subdivided into A1 (n = 18) and A2 n = 27) , the former intervened with oral sildenafil while the latter left untreated. We compared the rates of fertilization, high-quality embryo, and pregnancy among different groups.. No statistically significant differences were found among groups A, B and C in the age of the males and females, duration of infertility, numbers of obtained and mature oocytes, and rates of cleavage, or in the percentages of normal fertilization (80.78% vs 80.43% vs 84.77%), high-quality embryo (53.27% vs 52.97% vs 47.69%) and pregnancy (60.00% vs 56.77% vs 44.44%) (all P > 0.05). The rate of 3PN was markedly lower in group C (0.63%) than in A (9. 61%) and B (4.34%) (P < 0.05). There were no significant differences between groups A1 and A2 in the age of the males and females, duration of infertility, numbers of obtained and mature oocytes, and the rates of fertilization, cleavage, high-quality embryo, and pregnancy (all P > 0.05).. On the OPU day of IVF-ET, oral sildenafil can help temporary ED men to achieve penile erection and ejaculation without affecting the outcomes of assisted reproduction. Cryopreserved sperm can be used in case of predicted temporary ED and frozen oocytes can also be employed if sperm retrieval fails. However, to avoid puncture injury to the epididymis or testis, fresh semen should be the first choice.

Topics: Cryopreservation; Embryo Transfer; Erectile Dysfunction; Female; Fertilization; Fertilization in Vitro; Humans; Male; Oocyte Retrieval; Oocytes; Penis; Pregnancy; Retrospective Studies; Sildenafil Citrate; Sperm Retrieval; Spermatozoa

A patient-reported outcome is any report on the status of a patient's health condition that comes directly from the patient. Clear and meaningful interpretation of patient-reported outcome scores are fundamental to their use as they can be valuable in designing studies, evaluating interventions, educating consumers, and informing health policy makers involved with regulatory, reimbursement, and advisory agencies. Interpretation of patient-reported outcome scores, however, is often not well understood because of insufficient data or lack of experience or clinical understanding to draw from. This article provides an update review on two broad approaches--anchor-based and distributed-based--aimed at enhancing the understanding and meaning of patient-reported outcome scores. Anchor-based approaches include percentages based on thresholds, criterion-group interpretation, content-based interpretation, and clinical important difference. Distributed-based approaches include effect size, probability of relative benefit, and responder analysis and cumulative proportions. A third strategy called mediation analysis, which can elucidate a health condition measured by a patient-reported outcome in the context of an intervention's mechanism of action, is also highlighted and illustrated. Mediation analysis in the context of interpretation of patient-reported outcome scores is a relatively new development. The logic and rationale of the three methods are expressed generally. While the three approaches themselves are not new, some applications of them taken from their examples published in the past few years are original and coalesced in this article to add real-life implications of the different methodologies in one integrated report.

Topics: Analgesics; Clinical Trials as Topic; Data Interpretation, Statistical; Erectile Dysfunction; Female; Fibromyalgia; gamma-Aminobutyric Acid; Humans; Macular Degeneration; Male; Patient Outcome Assessment; Piperazines; Pregabalin; Purines; Sickness Impact Profile; Sildenafil Citrate; Sulfonamides; Surveys and Questionnaires; Urological Agents

The administration of phosphodiesterase 5 inhibitor commencing at the time of castration might preserve erectile function.. To determine if sildenafil citrate treatment could improve erectile function after castration. To determine if sildenafil citrate treatment reduces collagenisation and apoptosis in erectile tissue after castration.. In all, 60 Sprague-Dawley rats were studied; the rats were divided into the following groups: sham - no orchidectomy (S), control - orchidectomy only (O) and treatment - orchidectomy plus sildenafil treatment (V), with 10 rats per group. Erectile haemodynamics assessment was done at 7 days (S7, O7, V7) and at 28 days (S28, O28, V28) yielding a total of six groupings. Functional assessment measured the mean maximum intracavernosal pressure-mean arterial pressure (ICP/MAP) ratio. TUNEL assay was used to define apoptotic indices (AIs) and Masson's trichrome staining was used to evaluate smooth muscle-collagen (SM-C) ratios.. The S28 group had the highest and the O7 group the lowest ICP/MAP ratio, at a mean (sd) of 70 (6)% and 36 (6)%, respectively. Both treatment groups, V7 [42 (12)%] and V28 [49 (13)%] showed statistically significant improvements over their corresponding control groups: O7 [36 (6)%] and O28 [37 (9)%] (P < 0.05). However, ICP/MAP values for V7 and V28 remained significantly below the S28 group (P < 0.001). There were no significant differences in ICP/MAP values between the 28-day and 7-day ICP/MAP ratios within each group (S, O, V). There were no significant differences in SM-C ratio between the O and V groups (O7 vs V7, P = 0.45; O28 vs V28, P = 0.16). There were no significant differences in AIs between the O and V groups (O7 vs V7, P = 0.54; O28 vs V28, P = 0.8).. Daily treatment with sildenafil improved erectile function in rats after castration. ICP/MAP ratios increased significantly in the treatment groups compared with the control groups with the greatest erectile function occurring 28 days from administration. In this series of experiments the improved erectile function recovery with sildenafil after surgical castration cannot be explained by smooth muscle protection and decreased collagenisation. The improved erectile function with sildenafil after surgical castration cannot be explained by reduced apoptosis in erectile tissue.

Topics: Animals; Disease Models, Animal; Erectile Dysfunction; Hemodynamics; Male; Orchiectomy; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Random Allocation; Rats; Rats, Sprague-Dawley; Sildenafil Citrate; Sulfones

This exploratory study examines the experience of three gay couples managing sexual dysfunction as a result of undergoing a radical prostatectomy. Semi-structured interviews were conducted as part of a larger study at an urban hospital in Toronto, Ontario, Canada. Interview transcripts were transcribed verbatim, and analyzed using interpretative phenomenological analysis. The authors clustered 18 subordinate themes under 3 superordinate themes: (a) acknowledging change in sexual experience (libido, erectile function, sexual activity, orgasmic function); (b) accommodating change in sexual experience (strategies: emphasizing intimacy, embracing plan B, focus on the other; barriers: side-effect concerns, loss of naturalness, communication breakdown, failure to initiate, trial and failure, partner confounds); and (c) accepting change in sexual experience (indicators: emphasizing health, age attributions, finding a new normal; barriers: uncertain outcomes, treatment regrets). Although gay couples and heterosexual couples share many similar challenges, we discovered that gay men have particular sexual roles and can engage in novel accommodation practices, such as open relationships, that have not been noted in heterosexual couples. All couples, regardless of their level of sexual functioning, highlighted the need for more extensive programming related to sexual rehabilitation. Equitable rehabilitative support is critical to assist homosexual couples manage distress associated with prostatectomy-related sexual dysfunction.

Topics: Adaptation, Psychological; Adult; Communication; Erectile Dysfunction; Gender Identity; Homosexuality, Male; Humans; Interpersonal Relations; Interview, Psychological; Libido; Male; Middle Aged; Orgasm; Penile Prosthesis; Piperazines; Postoperative Complications; Prostatectomy; Purines; Sexual Behavior; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sulfones; Urinary Incontinence

There has been little data regarding the role of intracavernosal injection (ICI) treatment, its discontinuation rate and the reasons of withdrawal in patients with erectile dysfunction (ED) in the era of phosphodiesterase type 5 (PDE5) inhibitors. The aim of this study was to investigate the rate of withdrawal and its associated reasons in patients undergoing ICI therapy. Patients who were prescribed with ICI treatment two times or more were included since the introduction of sildenafil in Korea in 1999. Telephone surveys were performed to evaluate intercourse rates, withdrawal rates and their associated reasons, adverse events and the patients' satisfaction with their sex lives after the ICI treatments. Two hundred and ninety-four men were contacted by telephone. The mean age was 61.8 ± 7.9 years with a follow-up duration of 25.6 ± 32.1 months. At the last follow-up, 79.9% had discontinued the treatment. Most patients had previously failed PDE5 inhibitor treatment prior to the ICI therapy, and more than half had two or more risk factors of ED. Adequate penile rigidity after ICI therapy was restored in 60.2% of patients. The reasons for discontinuation of ICI were poor response (43.1%), inconvenience of use (18.3%), switch to other treatments (10.7%), loss of libido (6.7%), adverse events (5.5%) and return of spontaneous erection (2.8%). Pain was the most common adverse event in the withdrawal group, whereas prolonged erection was most common in the continuing group. Following ICI treatment, PDE5 inhibitors were the most common therapeutic option (63.1%). The overall satisfaction rate regarding sex life was significantly high in the treatment-continuing group. In conclusion, patients on ICI treatment had severe ED and high withdrawal rates in the era of PDE5 inhibitors. The most common reason for treatment discontinuation was poor response. Before initiating ICI treatments, sufficient counselling is necessary.

Topics: Alprostadil; Coitus; Erectile Dysfunction; Humans; Injections; Male; Middle Aged; Papaverine; Patient Satisfaction; Penile Erection; Phentolamine; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Self Administration; Sildenafil Citrate; Sulfones; Treatment Outcome; Treatment Refusal

Despite the fact that urogenito-sexual complications significantly impact the quality of life of diabetic patients, a robust in vivo experimental model is lacking. Bladder and erectile function in the Type 2 diabetic Goto-Kakizaki (GK) rat and responses to standard-of-care treatments for each disorder have been assessed. GK rats (n = 25, 18-wk-old, GK/Par colony) and age-matched Wistar rats (n = 23), characterized for their metabolic parameters, were used. Bladder function was assessed by cystometry in conscious rats treated by intravenous solifenacin (1 mg/kg). Subsequently, erectile function was assessed under anesthesia following electrical stimulation of the cavernous nerve in presence of intravenous sildenafil (0.3 mg/kg). GK rats displayed detrusor overactivity with a significant increase in frequency/amplitude of nonvoiding contractions during the filling phase, together with an increase in bladder capacity, intercontraction interval, voided volume, and maximal pressure of voiding contraction. Solifenacin significantly decreased parameters characterizing voiding contractions without modifying voiding efficiency. Erectile function in GK rats was markedly impaired and remained so after sildenafil treatment despite a significant improvement. GK rats display both bladder and erectile dysfunctions and respond at least partially to standard-of-care treatments for each disorder, thus representing a suitable model to investigate the pathophysiology and assess the efficacy of new therapeutic agents for Type 2 diabetes-associated bladder and erectile complications.

Topics: Animals; Diabetes Complications; Diabetes Mellitus, Type 2; Erectile Dysfunction; Male; Penile Erection; Piperazines; Purines; Quinuclidines; Rats; Rats, Wistar; Sildenafil Citrate; Solifenacin Succinate; Sulfones; Tetrahydroisoquinolines; Urinary Bladder; Urinary Bladder Diseases; Urination; Urological Agents; Vasodilator Agents

The United Kingdom is unusual in that a significant proportion of patients with erectile dysfunction (ED) have their treatment fully reimbursed by the National Health Service (NHS). This may have consequences for the choice of treatment and for compliance with treatment.. The aim of this study was to evaluate the use and cost implications of phosphodiesterase type 5 inhibitor in an NHS setting.. Basic demographics and data on ED management for patients treated from January 2000 to April 2011 were obtained from a prospectively accrued database. We reviewed drug usage and costs as well as switching between drugs. Patients were given the choice of all available therapies and were followed up annually.. Switching, compliance, and costs of treating ED under the "severe distress" criteria in the NHS were reviewed for this study.. Two thousand one hundred fifty-nine patients qualified for reimbursed therapy. Two hundred twenty-six patients were excluded from further analysis owing to missing data. Patients were followed up on an annual basis. The mean patient age was 60.2 years (min 23, max 90), and the mean follow-up was 50.8 months (min 1, max 127). Six hundred ninety-six were started on sildenafil, 990 on tadalafil, 163 on vardenafil, and 84 on intracavernosal alprostadil. Eighteen percent of patients initially started on the scheme and stopped medication unilaterally. Of the patients, 12.3% changed their medication during follow-up. The cost of drugs increased year by year from £257,100 in 2007 to £352,519 in 2011.. Our real-life observational study shows that in our institution, dropout of therapy is unusual. We hypothesize that this reflects, in part, the reimbursement issue. We also found that switching between drugs was unusual, although there are several possible explanations for that. Although this is a successful system for the patients, the hospital, which bears the costs of medication, is finding this an increasing economic drain.

Topics: Adult; Aged; Aged, 80 and over; Ambulatory Care; Carbolines; Drug Costs; Erectile Dysfunction; Humans; Imidazoles; Longitudinal Studies; Male; Middle Aged; Patient Compliance; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; State Medicine; Sulfones; Tadalafil; Triazines; United Kingdom; Vardenafil Dihydrochloride; Young Adult

To evaluate the clinical efficacy of sildenafil for the improvement of penile erection hardness in erectile dysfunction (ED) patients and to determine the relationship between this improvement in erection hardness and social and psychological functioning.. From 2007 to 2008, a total of 4507 men diagnosed with ED were enrolled from 46 centers in China; 4039 of these patients were treated with sildenafil and asked to complete the Erectile Function domain of the International Index of Erectile Function, Erection Hardness Score, and Quality of Erection Questionnaire. The patients were divided into 5 groups on the basis of their age (group A: 20-30 years; group B: 31-40 years; group C: 41-50 years; group D: 51-60 years; and group E: >60 years).. A total of 3837 (95.0%) patients completed the entire study. After sildenafil treatment, the vast majority (96.3%) of the men were able to achieve grade 3-4 erection hardness. Patients with a better baseline erection hardness were more able to achieve grade 4 hardness after treatment (P <.001). Comparisons of the Erection Hardness Score improvement before and after treatment between the age-categorized groups also showed that the erection hardness improvement was much greater in men older than 50 years.. Sildenafil can help the vast majority of Chinese ED patients achieve grade 3-4 erection hardness. Grade 4 hardness can improve the patients' sexual life to a greater extent than grade 3 hardness. A marked improvement in erection hardness can be achieved in patients older than 50 years.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; China; Cross-Sectional Studies; Erectile Dysfunction; Humans; Male; Middle Aged; Outpatients; Patient Satisfaction; Penile Erection; Phosphodiesterase 5 Inhibitors; Piperazines; Prospective Studies; Purines; Severity of Illness Index; Sexual Behavior; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Treatment Outcome; Young Adult

Topics: Erectile Dysfunction; Humans; Male; Melanoma; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Skin Neoplasms; Sulfones

The RAS/RAF/mitogen-activated protein kinase and extracellular signal-regulated kinase (ERK) kinase/ERK cascade plays a crucial role in melanoma cell proliferation and survival. Sildenafil citrate (Viagra) is a phosphodiesterase (PDE) 5A inhibitor commonly used for erectile dysfunction. Recent studies have shown that BRAF activation down-regulates PDE5A levels, and low PDE5A expression by BRAF activation or sildenafil use increases the invasiveness of melanoma cells, which raises the possible adverse effect of sildenafil use on melanoma risk.. To evaluate the association between sildenafil use and risk of incident melanoma among men in the United States.. Our study is a prospective cohort study. In 2000, participants in the Health Professionals' Follow-up Study were questioned regarding sildenafil use for erectile dysfunction. Participants who reported cancers at baseline were excluded. A total of 25,848 men remained in the analysis.. The incidence of skin cancers, including melanoma, squamous cell carcinoma (SCC), and basal cell carcinoma (BCC), was obtained in the self-reported questionnaires biennially. The diagnosis of melanoma and SCC was pathologically confirmed.. We identified 142 melanoma, 580 SCC, and 3030 BCC cases during follow-up (2000-2010). Recent sildenafil use at baseline was significantly associated with an increased risk of subsequent melanoma with a multivariate-adjusted hazard ratio (HR) of 1.84 (95% CI, 1.04-3.22). In contrast, we did not observe an increase in risk of SCC (HR, 0.84; 95% CI, 0.59-1.20) or BCC (1.08; 0.93-1.25) associated with sildenafil use. Moreover, erectile function itself was not associated with an altered risk of melanoma. Ever use of sildenafil was also associated with a higher risk of melanoma (HR, 1.92; 95% CI, 1.14-3.22). A secondary analysis excluding those reporting major chronic diseases at baseline did not appreciably change the findings; the HR of melanoma was 2.24 (95% CI, 1.05-4.78) for sildenafil use at baseline and 2.77 (1.32-5.85) for ever use.. Sildenafil use may be associated with an increased risk of developing melanoma. Although this study is insufficient to alter clinical recommendations, we support a need for continued investigation of this association.

Topics: Aged; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Melanoma; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Skin Neoplasms; Sulfones; United States

Erectile dysfunction (ED) is very prevalent in the older population, although the ageing-related mechanisms involved in the development of ED are poorly understood. We propose that age-induced differences in nerve- and endothelium-mediated smooth muscle contractility in the corpus cavernosum (CC) could be found between a senescent-accelerated mouse prone (SAMP8) and senescent-accelerated mouse resistant (SAMR1) strains. We analysed the changes in muscle tension induced by electrical field stimulation (EFS) or agonist addition 'in vitro', assessing nerve density (adrenergic, cholinergic and nitrergic), the expression of endothelial nitric oxide synthase (eNOS), cGMP accumulation and the distribution of interstitial cells (ICs) by immunofluorescence. We observed no change in both the nerve-dependent adrenergic excitatory contractility at physiological levels of stimulation and in the nitrergic inhibitory response in SAMP8 animals. Unlike cholinergic innervation, the density of adrenergic and nitrergic nerves increased in SAMP8 mice. In contrast, smooth muscle sensitivity to exogenous noradrenaline (NA) was slightly reduced, whereas cGMP accumulation in response to EFS and DEA/NO, and relaxations to DEA/NO and sildenafil, were not modified. No changes in the expression of eNOS and in the distribution of vimentin-positive ICs were detected in the aged animals. The ACh induced atropine-sensitive biphasic endothelium-dependent responses involved relaxation at low concentrations that turned into contractions at the highest doses. CC relaxation was mainly because of the production of NO together with some relaxant prostanoid, which did not change in SAMP8 animals. In contrast, the contractile component was considerably higher in the aged animals and it was completely inhibited by indomethacin. In conclusion, a clear imbalance towards enhanced production of contractile prostanoids from the endothelium may contribute to ED in the elderly. On the basis of these data, we propose the senescence-accelerated mouse model as a reliable tool to analyse the basic ageing mechanisms of the CC.

Topics: Aging; Animals; Cyclic GMP; Electric Stimulation; Erectile Dysfunction; Male; Mice; Models, Animal; Muscle Contraction; Muscle Relaxation; Muscle, Smooth; Nitric Oxide Synthase Type III; Piperazines; Purines; Sildenafil Citrate; Sulfones

The aim of this study was to prepare sildenafil citrate as solid lipid nanoparticles (SLNs), in order to find an innovative way for alleviating the disadvantages associated with commercially available sildenafil citrate tablets. These limitations include poor solubility and extensive first-pass metabolism, resulting in low (40%) bioavailability and short elimination half-life (4 h).. SLNs were prepared by hot homogenization followed by ultrasonication. Solubility of sildenafil citrate in different solid lipids was measured, effect of process variables as surfactant type and concentration, homogenization time, ultrasonication time and charge-inducing agent on the particle size, zeta potential and encapsulation efficiency were also determined. Furthermore, in vitro drug release, stability and in vivo pharmacokinetics were studied in rabbits Results: The best SLN formula consisted of 2% precirol ATO5, 0.5% phosphatidylcholine, 2.5% gelucire 44/14, 0.125% stearylamine, had an average particle size of 28.5 nm with 95.34% entrapment efficiency and demonstrated a controlled drug release over 24 h. An in vivo pharmacokinetic study revealed enhanced bioavailability by > 1.87 fold, and the mean residence time was longer than that for the commercially available tablet.. SLN could be a promising carrier for sustained/prolonged sildenafil citrate release with enhanced oral bioavailability.

Topics: Administration, Oral; Animals; Biological Availability; Chemistry, Pharmaceutical; Delayed-Action Preparations; Drug Carriers; Drug Stability; Erectile Dysfunction; Half-Life; Lipids; Male; Nanoparticles; Particle Size; Pharmaceutical Preparations; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Rabbits; Sildenafil Citrate; Solubility; Sulfones

Herbs have been used as an aphrodisiac since ages. Cinnamomum cassia is an important ingredient of many Ayurvedic formulations to treat male sexual disorder including erectile dysfunction (ED).. The objective of the present study was to evaluate erectogenic and aphrodisiac activity of methanol extract of C. cassia bark in young male rats.. Methanol extract of C. cassia was screened in vitro for arginase inhibition potential and IC50 was determined. Effect of the extract was observed in vitro on phenylephrine pre-contracted isolated rat corpus cavernosum smooth muscle (CCSM) at 0.1, 1, 10, and 100 μg/mL. Young male Wistar rats were dosed with extract at 100 mg/kg body weight for 28 days and its effects on sexual behavior and penile smooth muscle : collagen level were observed.. Effect of C. cassia was studied on arginase activity in vitro and sexual behavior of young male rats.. C. cassia inhibited arginase activity in vitro with an IC50 of 61.72 ± 2.20 μg/mL. The extract relaxed phenylephrine pre-contracted isolated rat CCSM up to 43% and significantly increased (P < 0.05) sexual function of young male rats. Treatment with the extract also increased smooth muscle level and decreased collagen level in rat penile tissue.. The study proves usefulness of methanol extract of C. cassia bark for increasing sexual function.

Topics: Animals; Aphrodisiacs; Arginase; Cinnamomum aromaticum; Drug Therapy, Combination; Erectile Dysfunction; Male; Muscle, Smooth; Penis; Phosphodiesterase 5 Inhibitors; Phytotherapy; Piperazines; Plant Extracts; Purines; Rats; Rats, Wistar; Sexual Behavior, Animal; Sildenafil Citrate; Sulfones; Testosterone

The efficacy of oral pharmacotherapy for erectile dysfunction (ED) (i.e., type 5 phosphodiesterase[PDE5] inhibitors) is significantly reduced in diabetic patients. Nebivolol is a selective β1-blocker used for treatinghy pertension that has been shown to increase the efficacy of sildenafil to reverse ED in diabetic rats.. To evaluate the effects of nebivolol on the efficacy of the PDE5 inhibitors, sildenafil, tadalafil, and vardenafil to relax human corpus cavernosum (HCC) and vasodilate human penile resistance arteries (HPRA) from diabetic patients with ED (DMED). The influence of nebivolol on the capacity of these three PDE5 inhibitors to stimulate cyclic guanosine monophosphate (cGMP) production in HCC was also evaluated.. HCC and HPRA were obtained from organ donors without ED (NEND; n = 18) or patients with diabetes undergoing penile prosthesis implantation (DMED; n = 19). Relaxations of HCC strips and HPRA to sildenafil,tadalafil, and vardenafil were evaluated in organ chambers and wire myographs. cGMP content in HCC was determined by ether extraction and quantification by ELISA.. Effects of nebivolol on PDE5 inhibitor-induced relaxation of HCC, vasodilation ofHPRA and cGMP accumulation in HCC.. Treatment with nebivolol (1 μM) significantly potentiated sildenafil-, tadalafil- and vardenafil-induced relaxations of HCC and vasodilations of HPRA from both NEND and DMED. Enhancement of relaxant capacity by nebivolol resulted in reversion of the impairment of PDE5 inhibition-induced responses in DMED and it was accompanied by enhancing the ability of PDE5 inhibitors to increase cGMP in HCC restoring reduced cGMP levelsin HCC from DMED.. Nebivolol potentiated the capacity of PDE5 inhibitors to relax vascular structures of erectile tissue from diabetic patients by enhancing the nitric oxide (NO)/cGMP pathway in these tissues. These effects suggest a potential therapeutic utility of nebivolol as an adjunct to PDE5 inhibitors for the treatment of ED associated with diabetes.

Topics: Arteries; Benzopyrans; Carbolines; Cyclic GMP; Diabetes Mellitus, Type 2; Drug Synergism; Erectile Dysfunction; Ethanolamines; Humans; Imidazoles; Male; Middle Aged; Muscle Relaxation; Muscle, Smooth, Vascular; Nebivolol; Nitric Oxide; Penile Erection; Penis; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Sildenafil potentiates the nitric oxide (NO) signaling pathway. Since neuronal NOS is very important in the penis, we assessed whether NOS1 polymorphisms are associated with altered responsiveness to sildenafil in erectile dysfunction (ED).. Patients (n = 137) were divided as clinical ED or postoperative ED. They were subdivided as good responders or poor responders to sildenafil, and genotypes for rs41279104 and rs2682826 NOS1 polymorphisms were determined.. We found that the rs41279104 CT genotype was associated with good responders in postoperative ED patients, while rs2682826 CT genotype was associated with good responders in postoperative ED, and the TT genotype associated with good responders in both groups. Finally, the CT haplotype was associated with good responders in postoperative ED.. NOS1 polymorphisms are associated with responsiveness to sildenafil in ED. Original submitted 20 November 2013; Revision submitted 31 January 2014.

Topics: Erectile Dysfunction; Haplotypes; Humans; Male; Middle Aged; Nitric Oxide Synthase Type I; Piperazines; Polymorphism, Genetic; Postoperative Period; Purines; Sildenafil Citrate; Sulfones

Topics: Aged; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Life Style; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Pyrimidines; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride

In this study, the effect of change in chromatographic process variables on the retention behavior of four drugs employed in erectile dysfunction therapy on a calixarene stationary phase is described. Three of these drugs are known to treat erectile dysfunction, namely, sildenafil citrate, tadalafil, and apomorphine hydrochloride, and one drug that is used as opioid analgesic, tramadol hydrochloride, which is quiet widely misused to treat premature ejaculation. The results indicate the importance of considering the structure and pKa values of drugs to be separated along with mobile phase composition. A new optimized, rapid, and accurate liquid chromatography method is also established for simultaneous determination of sildenafil citrate, tadalafil, and apomorphine hydrochloride in pharmaceutical preparations and bulk powders. The chromatographic separation of the three pharmaceuticals was achieved on a calixarene column in less than 10 min using a binary mobile phase of 35% acetonitrile and 65% 50 mM sodium perchlorate pH2.5 at 1 mL/min flow rate. The method was validated for system efficiency, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability, and robustness. Statistical analysis proved that the method enabled reproducible and selective quantification of all three analytes in bulk drugs and in pharmaceutical preparations.

Topics: Apomorphine; Buffers; Calixarenes; Carbolines; Chromatography, High Pressure Liquid; Erectile Dysfunction; Humans; Hydrogen-Ion Concentration; Limit of Detection; Male; Pharmaceutical Preparations; Piperazines; Purines; Reproducibility of Results; Sildenafil Citrate; Sulfonamides; Tadalafil

Sildenafil is a potent and selective inhibitor of phosphodiesterase-5 (PDE5) and is considered first-line therapy for erectile dysfunction. Nowadays, Sildenafil is used extensively throughout the world on patients with pulmonary hypertension. However, few studies have evaluated the possible side effects of chronic Sildenafil treatment on the male reproductive system, specifically in the prostate. In the present study, it was demonstrated via morphological and ultrastructural analysis that chronic treatment with Sildenafil induced an enhancement of the glandular activity of the prostate. In addition, mice treated with Sildenafil showed a significant increase in testosterone serum levels. However, no statistically significant differences were observed in nitric oxide serum levels, or in sGC, eNOS, PSA and TGF-β prostatic expression. In conclusion, the present study suggests that chronic use of Sildenafil does not cause evident prostatic damage, and therefore, can be used pharmacologically to treat a variety of disorders.

Topics: Animals; Erectile Dysfunction; Humans; Hypertension, Pulmonary; Male; Mice; Mice, Inbred C57BL; Nitric Oxide; Nitric Oxide Synthase Type III; Piperazines; Prostate; Prostate-Specific Antigen; Purines; Sildenafil Citrate; Sulfonamides; Testosterone; Transforming Growth Factor beta

To evaluate the results of nocturnal penile erection test and response to daily sildenafil in patients with erectile dysfunction (ED) due to pelvic fracture urethral disruption.. From January 2010 to January 2012, we included 38 patients with ED due to pelvic fracture urethral disruption. The mean age was 33.1 years (range, 22-49 years). All were evaluated subjectively and objectively by the International Index of Erectile Function-5, nocturnal penile tumescence and rigidity (NPTR) test, and penile Doppler ultrasonography. Patients received daily sildenafil 50 mg for 3 months.. Thirty-one patients were followed up: 54.8% showed response to sildenafil defined as reporting successful vaginal penetration and intercourse. Patients with neurogenic, arterial, and venous EDs did not differ in efficiency rates (P = .587). However, the penile erectile rigidity recorded by NPTR test affected efficiency significantly (P = .046). Patients with tip rigidity >40% had the highest response rate (76.9%), but the response rate for patients with tip rigidity <20% was only 22.2%.. NPTR recording can reveal resident erectile function in patients with ED due to trauma and is significant for selecting pharmacologic treatment as optimal therapy.

Topics: Administration, Oral; Adult; Circadian Rhythm; Cohort Studies; Diagnostic Techniques, Urological; Drug Administration Schedule; Erectile Dysfunction; Fractures, Bone; Humans; Injury Severity Score; Male; Middle Aged; Multiple Trauma; Pelvic Bones; Penile Erection; Piperazines; Purines; Retrospective Studies; Sildenafil Citrate; Sulfones; Ultrasonography, Doppler; Urethra; Young Adult

Topics: Advertising; Aged; Erectile Dysfunction; Ethics, Medical; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfonamides

In this study, four unapproved analogues of Sildenafil (SDF) were photodegraded under synthetic sunlight in artificial freshwater. Homosildenafil (H-SDF), hydroxyhomo-sildenafil (HH-SDF), norneosildenafil (NR-SDF) and thiosildenafil (T-SDF) were selected because they are frequently detected as adulterants in natural herbal products. Using UPLC-Orbitrap (Q Exactive)-MS, six photoproducts common to H-SDF, HH-SDF and T-SDF and nine unique transformation products of different molecular weights were identified based on their high-resolution (+)ESI product ion spectra. Mass spectral analysis of deuterated H-SDF, labeled on the N-ethyl group, allowed to gain mechanistic insight into the fragmentation pathway of the substituted piperazine ring and to support the postulated photoproduct structures. The mass spectral fragmentation confirmed the stepwise destruction of the piperazine ring eventually producing a sulfonic acid derivative (C17 H20 N4 O5 S: 392.1151 Da). In contrast, the photodegradation of NR-SDF, which lacks a piperazine ring in its structure, formed only two prominent photoproducts originating from N,N-dealkylation of the sulfonamide followed by hydrolysis. The current work constitutes the first study on the photodegradation of analogs of erectile dysfunction drugs and the first detection of two transformation products (m/z 449 and 489) in environmental samples.

Topics: Erectile Dysfunction; Fresh Water; Humans; Male; Photolysis; Piperazine; Piperazines; Purines; Pyrimidines; Sildenafil Citrate; Spectrometry, Mass, Electrospray Ionization; Sulfonamides; Sulfones; Sunlight; Tandem Mass Spectrometry; Vasodilator Agents; Wastewater; Water Pollutants, Chemical

To investigate the effect of Bushengzhuyang Fang (Yangjing Capsule, YJC) on penile erectile function and its action mechanisms in rats.. Fifty-six male SD rats were randomly divided into seven groups of equal number: blank control, daidzein, daidzein + testosterone, daidzein + sildenafil, daidzein + low-dose YJC, daidzein + medium-dose YJC, and daidzein + high-dose YJC. The rats in the blank control group were treated intragastrically with normal saline and those in the other groups with daidzein at the dose of 100 mg per kg per day for 30 days. Then the last five groups received additionally testosterone (4 mg per kg per day), sildenafil (2.5 mg per kg per day), low-dose YJC, (0.315 mg per kg per day), medium-dose YJC (0.63 mg per kg per day), and high-dose YJC (1. 26 mg per kg per day), respectively. At 0, 30 and 60 days of treatment, we observed the apomorphine-induced spontaneous erectile response and pathological changes in the corpus cavernosum of the rats, recorded the number of penile erection and erectile incubation period, and determined the serum levels of testosterone (T) and luteinizing hormone (LH).. At 30 days of treatment, the number of apomorphine-induced erections was decreased, the erectile incubation period prolonged, and the serum levels of T and LH reduced remarkably in all groups of rats (P < 0.05). Compared with the findings at 30 days, the number of penile erections was significantly decreased at 60 days in the daidzein group (1.39 ± 0.42 vs 2.67 ± 0.33, P < 0.05) and daidzein + low-dose YJC group (1.33 ± 0.49 vs 2.83 ± 0.61, P < 0.05); the erectile incubation period was markedly ex- tended ([16.33 ± 3.11] vs [8.50 ± 0.93] min and [15.50 ± 3.21] vs [8.63 ± 1.54] min, P < 0.05); and the serum levels of T ([5.34 ± 0.89] vs [1.24 ± 0.30] ng/ml and [5.28 ± 1.12] vs [2.07 ± 0.76] ng/ml, P < 0.05) and LH ([3.62 ± 0.37] vs [2.09 ± 0.12] ng/ml and [3.79 ± 0.28] vs [2.17 ± 0.33] ng/ml, P < 0.05) were significantly reduced in the daidzein and daidzein + low-dose YJC groups, respectively. Pathological examination revealed slightly decreased cavernous sinuses and blood vessels in the corpus cavernosum of the rats in the daidzein + testosterone, daidzein + sildenafil, daidzein + medium-dose YJC, and daidzein + high-dose YJC groups as compared with those in the blank control group.. High-dose Yangjing Capsule is efficacious for the recovery of erectile function in rats, especially for phytoestrogen-induced erectile dysfunction.

Topics: Animals; Apomorphine; Drugs, Chinese Herbal; Erectile Dysfunction; Humans; Isoflavones; Luteinizing Hormone; Male; Penile Erection; Penis; Phytoestrogens; Phytotherapy; Piperazines; Purines; Rats; Rats, Sprague-Dawley; Sildenafil Citrate; Sulfonamides; Testosterone; Vasodilator Agents

Topics: Adult; Coitus; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents; Vomiting

We have evaluated the influence of calcium-activated potassium channels (KCa ) activation on cGMP-mediated relaxation in human penile tissues from non-diabetic and diabetic patients, and on the effects of PDE5 inhibitors on erectile responses in control and diabetic rats.. Cavernosal tissues were collected from organ donors and from patients with erectile dysfunction (ED). Relaxations of corpus cavernosum strips (HCC) and penile resistance arteries (HPRA) obtained from these specimens were evaluated. Intracavernosal pressure (ICP) increases to cavernosal nerve electrical stimulation were determined in anaesthetized diabetic and non-diabetic rats.. Concentration-dependent vasodilation to the PDE5 inhibitor, sildenafil, in HPRA was sensitive to endothelium removal, NO/cGMP pathway inhibition and KCa blockade. Accordingly, activation of KCa with NS-8 (10 μM) significantly potentiated sildenafil-induced relaxations in HPRA (EC50 0.49 ± 0.22 vs. 5.21 ± 0.63 μM). In HCC, sildenafil-induced relaxation was unaffected by KCa blockade or activation. Potentiating effects in HPRA were reproduced with an alternative PDE5 inhibitor (tadalafil) and KCa activator (NS1619) and prevented by removing the endothelium. Large-conductance KCa (BK) and intermediate-conductance KCa (IK) contribute to NS-8-induced effects and were immunodetected in human and rat penile arteries. NS-8 potentiated sildenafil-induced enhancement of erectile responses in rats. Activation of KCa recovered the impaired relaxation to sildenafil in diabetic HPRA while sildenafil completely reversed diabetes-induced ED in rats only when combined with KCa activation.. Activation of KCa improves vasodilatory capacity of PDE5 inhibitors in diabetic and non-diabetic HPRA, resulting in the recovery of erectile function in diabetic rats. These results suggest a therapeutic potential for KCa activation in diabetic ED.

Topics: Adult; Aged; Animals; Benzimidazoles; Carbolines; Cyclic GMP; Diabetes Mellitus, Experimental; Dose-Response Relationship, Drug; Electric Stimulation Therapy; Erectile Dysfunction; Humans; Male; Middle Aged; Nitric Oxide; Penis; Phosphodiesterase 5 Inhibitors; Piperazines; Potassium Channels, Calcium-Activated; Purines; Rats; Rats, Sprague-Dawley; Sildenafil Citrate; Sulfones; Tadalafil; Vasodilation; Vasodilator Agents

Cross-sectional analysis of electronic medical and pharmacy records.. To examine associations between use of medication for erectile dysfunction or testosterone replacement and use of opioid therapy, patient age, depression, and smoking status.. Males with chronic pain may experience erectile dysfunction related to depression, smoking, age, or opioid-related hypogonadism. The prevalence of this problem in back pain populations and the relative importance of several risk factors are unknown.. We examined electronic pharmacy and medical records for males with back pain in a large group model health maintenance organization during 2004. Relevant prescriptions were considered for 6 months before and after the index visit.. There were 11,327 males with a diagnosis of back pain. Males who received medications for erectile dysfunction or testosterone replacement (n = 909) were significantly older than those who did not and had greater comorbidity, depression, smoking, and use of sedative-hypnotics. In logistic regressions, the long-term use of opioids was associated with greater use of medications for erectile dysfunction or testosterone replacement compared with no opioid use (odds ratio, 1.45; 95% confidence interval, 1.12-1.87, P < 0.01). Age, comorbidity, depression, and use of sedative-hypnotics were also independently associated with the use of medications for erectile dysfunction or testosterone replacement. Patients prescribed daily opioid doses of 120 mg of morphine-equivalents or more had greater use of medication for erectile dysfunction or testosterone replacement than patients without opioid use (odds ratio, 1.58; 95% confidence interval, 1.03-2.43), even with adjustment for the duration of opioid therapy.. Dose and duration of opioid use, as well as age, comorbidity, depression, and use of sedative-hypnotics, were associated with evidence of erectile dysfunction. These findings may be important in the process of decision making for the long-term use of opioids.. 4.

Topics: Adult; Age Factors; Aged; Analgesics, Opioid; Androgens; Back Pain; Carbolines; Comorbidity; Cross-Sectional Studies; Depression; Drug Prescriptions; Erectile Dysfunction; Hormone Replacement Therapy; Humans; Imidazoles; Insurance, Health; Logistic Models; Male; Middle Aged; Piperazines; Prevalence; Purines; Sildenafil Citrate; Smoking; Sulfones; Tadalafil; Testosterone; Triazines; United States; Urological Agents; Vardenafil Dihydrochloride

The possible effects of sildenafil citrate administration at therapeutic dosage on visual acuity, color vision, intraocular pressure, macular thickness, macular volume, and central serous chorioretinopathy in patients with erectile dysfunction were evaluated. The study consisted of 43 male patients diagnosed as having erectile dysfunction according to the first five question version of International Index of Erectile Function (IIEF-5). All patients were given sildenafil citrate 50 mg po 2 to 3 times/week for a month. The patients were evaluated at the first week and at the end of the treatment. The macular thickness and volume assessments with optic coherence tomography did not differ significantly in foveal, parafoveal areas, parafoveal superior hemisphere, parafoveal inferior hemisphere, parafoveal temporal, superior, nasal, and inferior quadrants. Central serous chorioretinopathy was not found in any of the patients.

Topics: Adult; Aged; Central Serous Chorioretinopathy; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents

Erectile dysfunction medications such as sildenafil citrate (Viagra) or tadalafil (Cialis) are commonly prescribed worldwide. They are selective phosphodiesterase-5 inhibitor and partial phosphodiesterase-6 inhibitors causing smooth muscle relaxation in the corpus cavernosum, allowing penile vasodilatation and erection in response to sexual stimuli. Over the years, there have been an increasing number of case reports concerning patients who developed ischemic optic neuropathy soon after the ingestion of these drugs. Although a cause and effect relationship between usage of the drugs and the development of ischemic optic neuropathy is difficult to prove, it is common nowadays to advise patients, especially those suffering from diabetes, hypertension, and ischemic heart disease, regarding the potential risk of visual loss due to ischemic optic neuropathy and treatment with erectile dysfunction drugs. Patients who were diagnosed with ischemic optic neuropathy soon after the ingestion of these erectile dysfunction drugs should be warned about a similar event in their fellow eye and should be advised regarding drug discontinuation.

Topics: Aged; Carbolines; Erectile Dysfunction; Humans; Male; Middle Aged; Optic Neuropathy, Ischemic; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil

To assess persistence/adherence rates of phosphodiesterase type-5 inhibitor (PDE5I) on-demand dosing in Latin American men with erectile dysfunction (ED), and explore patient characteristics and treatment factors that may be predictive for PDE5I persistence and adherence.. Men from Brazil, Mexico, and Venezuela with ED who were naïve to PDE5Is were prescribed sildenafil, tadalafil, vardenafil, or lodenafil on-demand dosing and asked to provide information about PDE5I use at baseline and at 1, 3, and 6 months. Patients were persistent if they used ≥1 dose during the 4 week period prior to each evaluation. Patients were adherent if they complied with dosing instructions during most recent dose. Main outcome measures included Persistence and Adherence Questionnaire (PAQ), Partner Relationship Questionnaire (PRQ), Self-Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence and adherence.. A total of 511 men were enrolled; most had mild to moderate ED (77.1%); 317 patients (62.0%) were prescribed tadalafil, 116 (22.7%) sildenafil, 75 (14.7%) vardenafil, and 3 (0.6%) lodenafil (not further analyzed). A total of 340 patients (66.5%) were 'persistent' at 6 months; 345 (67.5%) were 'adherent'. Persistence and adherence were associated with age, education level, and ED duration. Reasons for non-persistence included medication cost and lack of efficacy. Study limitations included its design, brief observation period, its bias observed toward tadalafil selection; its dependence on patient self-reporting, limited number of factors that were analyzed for persistence/adherence association, its small number of participating patients and Latin American countries, and inherent differences in PDE5I preference and medical practices.. Approximately two-thirds of PDE5I-naïve, Latin American men with ED were persistent and adherent after 6 months of therapy. Factors like education level, ED severity, and ED duration were associated with persistence and adherence; additional study is warranted to investigate the predictive value of these factors.

Topics: Carbolines; Carbonates; Erectile Dysfunction; Humans; Imidazoles; Latin America; Male; Medication Adherence; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Prospective Studies; Purines; Pyrimidines; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Tadalafil; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Erectile dysfunction (ED) negatively impacts quality of life. Phosphodiesterase type 5 inhibitors (PDE5Is) are effective in treating ED; however, rates of discontinuation remain high.. To assess on-demand PDE5I treatment persistence and adherence through 6 months in Middle Eastern and North African (MENA) men with ED in a prospective, non-interventional, observational trial.. Enrolled men were ≥18 years old from Saudi Arabia, Egypt, and the United Arab Emirates, PDE5I naïve, and sexually active. PDE5Is were selected per routine clinical practice. Persistence was defined as use of ≥1 dose during the prior 4 weeks, adherence as compliance with dosing instructions during the most recent dose. Logistic regression models were used to identify factors associated with persistence and adherence.. Persistence and Adherence Questionnaire; Partner Relationship Questionnaire; Self-Esteem and Relationship Questionnaire; International Index of Erectile Function (IIEF); Erectile Dysfunction Inventory of Treatment Satisfaction.. Patients' (n = 493) mean age was 49.8 years, mean BMI was 29.3, and the majority (n = 354, 71.8%) were from Saudi Arabia. Tadalafil was the most prescribed PDE5I (69.6%), versus sildenafil (15.4%), or vardenafil (15.0%). Patients' mean IIEF-Erectile Function scores improved from moderate to mild and Erection Hardness Scores (SD) improved from 1.8 (1.0) at baseline to 3.5 (0.7) at 6 months. At 6 months, 64.9% of patients were treatment persistent (tadalafil, 68.8%, sildenafil, 65.8%, and vardenafil, 45.9%) and 59.6% were adherent. Factors significantly predictive (p < 0.05) of persistence at 6 months included age, employment status, and ED severity. Factors significantly predictive of adherence were age, employment status, and duration of ED. Interpretation of differences between drugs was limited by substantial differences in prescription rates between countries.. At 6 months, 64.9% of men were treatment persistent. In this study, age, employment status, ED severity, and duration of ED were associated with persistence and/or adherence.

Topics: Carbolines; Egypt; Erectile Dysfunction; Humans; Imidazoles; Male; Medication Adherence; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Prospective Studies; Purines; Saudi Arabia; Self Concept; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Tadalafil; Treatment Outcome; Triazines; United Arab Emirates; Vardenafil Dihydrochloride

A 56-year-old man presented with a 12-year history of erectile dysfunction, which caused him extreme distress with episodes of depression. Attempts with sildenafil did not improve his erections. We tried intracavernous injection of alprostadil which enabled the patient to achieve a moderate erection. Thus, we instructed the patient for self-injection, which led to sufficient erections over the following months. We then restarted with tadalafil as a monotherapy which then was successful.

Topics: Alprostadil; Carbolines; Erectile Dysfunction; Humans; Injections; Male; Middle Aged; Penis; Piperazines; Purines; Self Administration; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Outcome; Vasodilator Agents

The purpose of this study was to explore attitudes about condoms that may affect condom use by heterosexual men ages 50 and older who were sexually active and currently using prescribed oral phosphodiesterase type 5 inhibitor medications (Viagra(®), Cialis(®), or Levitra(®)) for treatment of erectile dysfunction. The study was part of a larger study that explored the need for safer-sex health promotion and education for these men. Fifty men completed factor subscales of the Condom Attitude Scale. Subscales were scored and analyzed. Positive factors were found with regard to the Interpersonal Impact, Inhibition, Perceived Risk, Perceived Seriousness, and Global Attitudes subscales. Factors with negative or neutral responses included the Effect on Sexual Experience, Relationship Safety, and Promiscuity subscales. Independent t tests revealed no differences between married and nonmarried men for the mean score on any of the subscales, but there was a difference on the Global Attitude Scale, with younger men having a more positive global attitude than older men. Study findings can be used in the development of health promotion educational activities on condom use as a safer-sex practice.

Topics: Carbolines; Condoms; Erectile Dysfunction; Female; Health Behavior; Health Promotion; Heterosexuality; Humans; Imidazoles; Male; Middle Aged; Piperazines; Purines; Safe Sex; Sexual Partners; Sexually Transmitted Diseases; Sildenafil Citrate; Sulfones; Tadalafil; Triazines; Vardenafil Dihydrochloride; Vasodilator Agents

Many products labeled "herbal" or "all natural" (herbal/natural) that claim to enhance sexual performance and imply use for the treatment of erectile dysfunction (ED) are marketed as over-the-counter (OTC) dietary supplements. However, adulteration with undeclared phosphodiesterase type 5 (PDE5) inhibitors appears widespread.. To assess the availability, cost, origin, categorical content, and adulteration with PDE5 inhibitors of purported herbal/natural OTC dietary supplements claiming to naturally enhance sexual performance.. Pfizer Global Security coordinated sample collection (all from convenience stores and filling stations in two U.S. metropolitan areas except for seven from U.S. Customs seizures) and liquid chromatography/mass spectrometry examination.. Adulteration with synthetic PDE5 inhibitors.. Ninety-one samples labeled as 58 distinct products and priced from $2.99 to $17.99 were evaluated. Origin/manufacture was claimed as United States (n = 62), apparently Asian (n = 15), and not clearly identified (n = 14). Although no sample claimed to include synthetic substances, 74 (81%) contained PDE5-inhibitor pharmaceutical ingredients, including tadalafil and/or sildenafil (n = 40, of which 18 contained >110% of the highest approved drug product strength) or PDE5-inhibitor analogs (n = 34). Pronounced heterogeneity of contents between samples within individual products indicated minimal quality control during manufacture. Labeling was inadequate (e.g., lacking lot number and/or expiry date) for 17 products (23 samples) and inconsistent between samples within a given product (e.g., in manufacturer, lot number, and/or expiry date) for seven of 17 products having multiple samples. Only 14 samples warned against concomitant nitrate use.. Ethical pharmaceutical companies are concerned for an unsuspecting public when their products are counterfeited, mislabeled, and illegally offered for sale in an unsafe manner. Because of the dangers of adulteration with synthetic PDE5 inhibitors, absent safety warnings, and lack of quality or consistent manufacture, men with ED unknowingly risk their health by using OTC herbal/natural products that claim to enhance sexual performance.

Topics: Carbolines; Chromatography, Liquid; Dietary Supplements; Drug Labeling; Erectile Dysfunction; Humans; Male; Mass Spectrometry; Nonprescription Drugs; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Tadalafil; United States

Given that the Internet is now a major source of information regarding health and mental health problems, and that it is in the interest of the pharmaceutical industry to influence public and professional opinion, this study evaluated 70 websites about erectile dysfunction. The 31 drug company-funded websites (44%) were, compared with the 39 websites that are not industry funded, significantly more biased toward biological factors in general, and toward medication in particular (p < .01). The high proportion of websites that are industry sponsored, and the bias of those websites, confirms previous studies on depression, posttraumatic stress disorder, schizophrenia, and attention deficit hyperactivity disorder, and demonstrates that drug companies are using their financial might to manipulate public and professional opinion on the Internet.

Topics: Adult; Advertising; Attitude of Health Personnel; Conflict of Interest; Consumer Health Information; Erectile Dysfunction; Ethics, Pharmacy; Humans; Internet; Machiavellianism; Male; Middle Aged; Piperazines; Public Opinion; Purines; Sildenafil Citrate; Sulfonamides

To sum up the experience in administering oral tadalafil on alternate days for the treatment of erectile dysfunction (ED) that fails to respond to on-demand medication.. We retrospectively analyzed the clinical data of 15 cases of ED treated with oral tadalafil on alternate days from September 2010 to March 2012. All the patients had failed to respond to on-demand medication of sildenafil previously.. After 4 weeks of tadalafil treatment, 11 (73.3%) of the cases were remarkably improved, with significant difference in IIEF-5 scores before and after treatment (P < 0.05). Transient adverse reactions were observed in the other 4 cases, including mild headache in 2, slight backache in 1, and facial flush in 1.. Oral tadalafil on alternate days is safe and effective in the treatment of ED that fails to respond to on-demand medication of sildenafil.

Topics: Administration, Oral; Adult; Carbolines; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Retrospective Studies; Sildenafil Citrate; Sulfones; Tadalafil; Treatment Failure; Treatment Outcome

Topics: Dietary Supplements; Drug Contamination; Erectile Dysfunction; Humans; Male; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sexual Behavior; Sildenafil Citrate; Sulfones; United States; United States Food and Drug Administration

We have used a long-acting nitric oxide (NO)-releasing polymer to develop injectable biodegradable microspheres capable of localized NO release over prolonged periods of time.. The aim of this study was to evaluate the therapeutic potential of these microspheres for diabetes-related erectile dysfunction (ED) in the rat model.. NO-releasing microspheres were incubated in physiologic buffer, and in vitro NO release was measured using a Griess assay. To ensure no migration, microspheres were fluorescently tagged and injected into the corpus cavernosum of adult rats, and fluorescent imaging was performed weekly for 4 weeks, at which point rats were sacrificed. To assess physiologic efficacy, diabetes was induced in 40 rats using streptozotocin (STZ), whereas 10 rats were kept as age-matched controls. Diabetic rats were divided into four groups: no treatment, sildenafil, NO-releasing microspheres, and combination therapy. For each rat, the cavernosal nerve (CN) was stimulated at various voltages, and intracavernosal pressure (ICP) and mean arterial pressure (MAP) were measured via corpus cavernosum and carotid artery catheterization, respectively. Long-term efficacy was determined by injecting diabetic rats with microspheres and measuring erectile response at predetermined intervals for up to 5 weeks.. Erectile response was determined via calculation of mean peak ICP/MAP and area under curve (AUC) for each experimental group.. Under physiologic conditions in vitro, microspheres continued NO release for up to 4 weeks. Fluorescent imaging revealed no detectable signal in tissues besides cavernosal tissue at 4 weeks postinjection. Upon CN stimulation, peak ICP/MAP ratio and AUC of diabetic rats improved significantly (P < 0.05) in microsphere and combination therapy groups compared with no treatment and sildenafil groups. In long-term efficacy studies, microspheres augmented the effect of sildenafil for 3 weeks following injection (P < 0.05).. NO-releasing microspheres significantly improved erectile response in diabetic rats for 3 weeks and hence offer a promising approach to ED therapy, either as monotherapy or combination therapy.

Topics: Animals; Diabetes Mellitus, Experimental; Drug Therapy, Combination; Erectile Dysfunction; Male; Microspheres; Nitric Oxide; Nitric Oxide Synthase Type III; Penile Erection; Piperazines; Purines; Rats; Rats, Sprague-Dawley; Sildenafil Citrate; Streptozocin; Sulfones

Topics: Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Testosterone

In the recent literature, great attention has been given to the evaluation of the real effectiveness of the phosphodiesterase type 5 inhibitors (PDE-5i), usually prescribed for the erectile dysfunction (ED), in the treatment of the lower urinary tracts symptoms (LUTS). The aim of this study was the evaluation of the acute effects of sildenafil on the uroflowmetric parameters.. Within September 2011 and February 2012, twenty-seven patients, affected by ED with a IIEF-5 score ≤21 and a contextual IPSS within 8 e 19, have been selected and enrolled in this study. Two uroflowmetric measurements with suprapubic ultrasound valuation of the post voiding residual (PVR) were performed on each patient, 2 hours before and after the administration of sildenafil (50 mg).. The average age of the patients came out within di 47.3±9.4 years. On the baseline, the average of the Qmax registered has been 15.6±3.3 mL/s, the average Qave has been 8.2±3.2 mL/s and the average resulted 32.5±11.4 mL. After the mono-administration of sildenafil 50 mg, the average Qmax value, the Qave one and the RPM one turned out into 17.7±5.1 mL/s, 10.1±3.5 mL/s and 22.6±9.6 mL. The differences within the standard values, were considered statistically relevant (P<0.05).. Actually, the study shows that, in the acute phase, the administration of sildenafil 50 mg leads to effects on the uroflowmetric standards on men affected by LUTS and DE.

Topics: Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Urodynamics

Topics: Adult; Carbolines; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Semen; Sildenafil Citrate; Specimen Handling; Sulfones; Tadalafil