sildenafil-citrate and Dyspepsia

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

Altered duodenal sensorimotor responses to acid have been reported in a subset of patients with functional dyspepsia. To investigate whether NO is involved in these abnormalities, the effect of sildenafil (activates the NO pathway) on duodenal motor and sensory responses to acid in healthy humans was evaluated.. A barostat-manometry catheter including an infusion tube was positioned in the duodenum of 12 healthy volunteers. Duodenal motility and dyspeptic symptoms were evaluated during the whole study. A first series of stepwise isobaric distensions was performed while participants scored their perception of upper abdominal sensations at the end of every distension step. Next, the duodenum was infused with sildenafil 50 mg or saline, followed by duodenal acid infusion. During duodenal acidification, a second sequence of stepwise isobaric distensions with the assessment of sensations was repeated.. Acid infusion did not induce dyspeptic symptoms with both placebo and sildenafil pretreatment. Duodenal motility decreased after sildenafil infusion, whereas it was not affected by placebo. Acid-induced increase in motility was, however, observed in both conditions, and no difference between the conditions was found. Duodenal acidification decreased thresholds for discomfort and increased perception scores during duodenal distensions in both groups, but again no difference was observed between placebo and sildenafil pretreatment.. Sildenafil does not affect duodenal motor, mechanosensory, and chemosensory responses to acid in healthy controls. Therefore, it is less likely that the NO pathway plays a role in the altered response to acid in functional dyspepsia patients.

Topics: Adult; Cyclic GMP; Double-Blind Method; Duodenum; Dyspepsia; Female; Gastrointestinal Motility; Healthy Volunteers; Humans; Hydrochloric Acid; Male; Nitric Oxide; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Young Adult

Oral sildenafil and intravenous epoprostenol have independently been shown to be effective in patients with pulmonary arterial hypertension.. To investigate the effect of adding oral sildenafil to long-term intravenous epoprostenol in patients with pulmonary arterial hypertension.. A 16-week, double-blind, placebo-controlled, parallel-group study.. Multinational study at 41 centers in 11 countries from 3 July 2003 to 27 January 2006.. 267 patients with pulmonary arterial hypertension (idiopathic, associated anorexigen use or connective tissue disease, or corrected congenital heart disease) who were receiving long-term intravenous epoprostenol therapy.. Patients were randomly assigned to receive placebo or sildenafil, 20 mg three times daily, titrated to 40 mg and 80 mg three times daily, as tolerated, at 4-week intervals. Of 265 patients who received treatment, 256 (97%) patients (123 in the placebo group and 133 in the sildenafil group) completed the study.. Change from baseline in exercise capacity measured by 6-minute walk distance (primary end point) and hemodynamic measurements, time to clinical worsening, and Borg dyspnea score (secondary end points).. A placebo-adjusted increase of 28.8 meters (95% CI, 13.9 to 43.8 meters) in the 6-minute walk distance occurred in patients in the sildenafil group; these improvements were most prominent among patients with baseline distances of 325 meters or more. Relative to epoprostenol monotherapy, addition of sildenafil resulted in a greater change in mean pulmonary arterial pressure by -3.8 mm Hg (CI, -5.6 to -2.1 mm Hg); cardiac output by 0.9 L/min (CI, 0.5 to 1.2 L/min); and longer time to clinical worsening, with a smaller proportion of patients experiencing a worsening event in the sildenafil group (0.062) than in the placebo group (0.195) by week 16 (P = 0.002). Health-related quality of life also improved in patients who received combined therapy compared with those who received epoprostenol monotherapy. There was no effect on the Borg dyspnea score. Of the side effects generally associated with sildenafil treatment, the most commonly reported in the placebo and sildenafil groups, respectively, were headache (34% and 57%; difference, 23 percentage points [CI, 12 to 35 percentage points]), dyspepsia (2% and 16%; difference, 13 percentage points [CI, 7 to 20 percentage points]), pain in extremity (18% and 25%; difference, 8 percentage points [CI, -2 to 18 percentage points]), and nausea (18% and 25%; difference, 8 percentage points [CI, -2 to 18 percentage points]).. The study excluded patients with pulmonary arterial hypertension associated with other causes. There was an imbalance in missing data between groups, with 8 placebo recipients having no postbaseline walk assessment compared with 1 sildenafil recipient. These patients were excluded from the analysis.. In some patients with pulmonary arterial hypertension, the addition of sildenafil to long-term intravenous epoprostenol therapy improves exercise capacity, hemodynamic measurements, time to clinical worsening, and quality of life, but not Borg dyspnea score. Increased rates of headache and dyspepsia occurred with the addition of sildenafil.

Topics: Administration, Oral; Adolescent; Adult; Aged; Antihypertensive Agents; Double-Blind Method; Drug Therapy, Combination; Dyspepsia; Epoprostenol; Female; Headache; Hemodynamics; Humans; Hypertension, Pulmonary; Injections, Intravenous; Male; Middle Aged; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Time Factors; Vasodilator Agents; Walking

Sildenafil citrate (Viagra Pfizer, New York, NY) is indicated for the treatment of erectile dysfunction in men. The nitric oxide-cyclic guanosine monophosphate pathway (NO-cGMP) involved in penile erection and enhanced by sildenafil may also play a role in some components of the female sexual arousal response. The efficacy and safety of sildenafil were evaluated in estrogenized and estrogen-deficient women with sexual dysfunction that included female sexual arousal disorder (FSAD).. Patients were randomized to receive 10-100 mg sildenafil or matching placebo. To assess efficacy, patients completed two global efficacy questions (GEQ), the Life Satisfaction Checklist (LSC), an event log of sexual activity, and a 31-item sexual function questionnaire (SFQ). To assess safety, adverse event (AE) data were recorded.. A total of 577 estrogenized and 204 estrogen-deficient women were randomized to treatment. All were diagnosed with FSAD, but it was the primary presenting symptom in only 46% and 50% of women, respectively. Differences in efficacy between sildenafil and placebo were not significant for any patient or partner end points (e.g., the two GEQ, the sexual event logs, the LSC, and the SFQ). The main AE were headache, flushing, rhinitis, nausea, visual disturbances, and dyspepsia, which were generally mild to moderate in nature.. Any genital physiological effect of sildenafil was not perceived as improving the sexual response in estrogenized or estrogen-deficient women with a broad spectrum of sexual dysfunction that included FSAD. Whether more specific subgroups of women with FSAD could potentially benefit from treatment with sildenafil is an area for future research.

Topics: Adult; Analysis of Variance; Dose-Response Relationship, Drug; Double-Blind Method; Dyspepsia; Estradiol; Estrogen Replacement Therapy; Female; Flushing; Headache; Humans; Middle Aged; Nausea; Piperazines; Purines; Rhinitis; Sexual Behavior; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Sildenafil Citrate; Statistics as Topic; Sulfones; Surveys and Questionnaires; Treatment Outcome; Vasodilator Agents; Vision Disorders

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

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

Topics: Administration, Oral; Adolescent; Adult; Aged; Antihypertensive Agents; Double-Blind Method; Drug Therapy, Combination; Dyspepsia; Epoprostenol; Female; Headache; Hemodynamics; Humans; Hypertension, Pulmonary; Injections, Intravenous; Male; Middle Aged; Piperazines; Purines; Sildenafil Citrate; Sulfones; Vasodilator Agents; Walking

Sildenafil citrate (Viagra) has been shown to be an effective treatment for erectile dysfunction. Initial studies reported a high tolerability and low incidence of certain characteristic adverse reactions. We sought to evaluate the incidence of side effects of sildenafil citrate, independent of industry support and constraints, utilizing a heterogeneous cohort of patients from a university-based practice.. A prospective, open-label, flexible-dose study of 256 patients treated with sildenafil citrate for erectile dysfunction was performed at a single institution. The patients were questioned explicitly about the occurrence of headache, flushing, dyspepsia, nasal congestion, visual changes, and other side effects.. The adverse reactions most commonly observed were flushing (30.8%), headache (25. 4%), nasal congestion (18.7%), and heartburn (10.5%). All events were short lived and mild in nature. In the present study, 31.6% of patients experienced one or more adverse events. However, no one withdrew from the study because of the severity of these events. There was a significant association between higher doses and the occurrence of side effects.. The incidence of adverse events attributable to sildenafil citrate may be higher than initially reported, but an explanation may be the methodology of data collection and the industry-independent nature of this study. The side-effect profile is dose related and mild. Sildenafil citrate remains a safe and well-tolerated treatment for erectile dysfunction.

Topics: Adult; Aged; Dizziness; Dyspepsia; Erectile Dysfunction; Flushing; Headache; Humans; Incidence; Male; Middle Aged; Nose; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Sulfones; Vision, Ocular