vardenafil-dihydrochloride and Postoperative-Complications

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

More than one-third of men may experience erectile dysfunction (ED) after nerve-sparing radical retropubic prostatectomy. A recent study has shown that vardenafil, a phosphodiesterase 5 inhibitor, could significantly improve the key indices of erectile function in men after unilateral or bilateral nerve-sparing radical retropubic prostatectomy. Few adverse events were observed in the study.

Topics: Double-Blind Method; Erectile Dysfunction; Humans; Imidazoles; Male; Phosphodiesterase Inhibitors; Piperazines; Postoperative Complications; Prostatectomy; Randomized Controlled Trials as Topic; Spheroids, Cellular; Sulfones; Triazines; Vardenafil Dihydrochloride

Topics: Bosentan; Child; Drug Therapy, Combination; Endothelin Receptor Antagonists; Heart Defects, Congenital; Humans; Hypertension, Pulmonary; Phosphodiesterase 5 Inhibitors; Postoperative Complications; Randomized Controlled Trials as Topic; Vardenafil Dihydrochloride

Phosphodiesterase type 5 inhibitors (PDE5-I) have acquired an established role in the treatment of post-prostatectomy erectile dysfunction (ED). Several trials in men with ED and lower urinary tract symptoms associated with benign prostatic hyperplasia suggest that PDE5-I could improve both erectile function and urinary symptoms.. To assess the role of vardenafil in continence recovery after bilateral nerve sparing radical prostatectomy (BNS-RP).. Thirty-nine patients with prostate cancer were recruited. After BNS-RP, patients were double-blinded assigned to three arms: a) vardenafil on demand; b) vardenafil nightly; and c) placebo.. Urinary function (UF) and urinary bother (UB) of University of California-Los Angeles Prostate Cancer Index questionnaire were assessed preoperatively and at 1, 3, 6, 9, 10, and 12 months. Twelve-month outcomes were compared to 1 month with a t-test. The differences in UF and UB (at 3, 6, 9, 10, and 12 months) between the three treatment arms were calculated by an analysis of variance. With ALLFIT we estimated half-maximal recovery times (ER50) and maximal recovery (R(max)) in three groups.. The improvement of UF and UB between 1 and 12 months was significant in all arms except for placebo (UF: P = 0.125; UB: P = 0.089). Nightly resulted in greater UF at 3, 6, and 9 months and greater UB at 6 months compared with placebo (P = 0.042, P = 0.044 and P = 0.039); after nightly administration, patients presented higher UB than after on-demand use, 3 and 6 months postoperatively (P = 0.036 and P = 0.017). ALLFIT demonstrated a similar ER50 in all groups (2.6 months for both UF and UB) and indicated that nightly administration induced significant improvements in R(max) compared with placebo (both <0.0001).. Vardenafil can improve continence recovery after BNS-RP compared with placebo. The daily use of vardenafil seems to provide better continence rate, although it does not seem to influence the timing needed to achieve full continence.

Topics: Aged; Double-Blind Method; Drug Administration Schedule; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Postoperative Complications; Prostatectomy; Prostatic Neoplasms; Sulfones; Triazines; Urinary Incontinence; Urodynamics; Vardenafil Dihydrochloride

Erectile dysfunction (ED) profoundly affects the quality of life. The prevalence of ED in renal transplant recipients is reported by high as 50% to 60%. We evaluated the efficacy and safety of vardenafil in these patients with ED as well as its effects on graft function and on cylosporine or tacrolimus concentrations. Thirty-nine recipients with ED and serum creatinine values<2 mg/dL were treated with vardenafil. ED was assessed using the self-administered International Index of Erectile Function (IIEF). ED was diagnosed by using penile color-Doppler ultrasonography and intracavernosal injection. Vardenafil efficacy was assessed by readministering the IIEF questionnaire after 4 weeks of therapy. Serum creatinine levels, creatinine clearances, and cyclosporine/tacrolimus concentrations were measured before and after vardenafil therapy. Twenty-one recipients with ED served as placebo controls and 15 without ED as another control group. The IIEF scores improved from 12.80+/-3.5 to 26.46+/-2.4 in vardenafil-treated patients with ED (P<.001). Renal function and cyclosporine/tacrolimus concentrations did not change with vardenafil therapy. Side effects were observed in 7 (18%) patients: headache in three, palpitations in one, flushing in two, and dyspepsia in one. This study demonstrated that ED improved with vardenafil in renal transplant recipients with ED. For 4 weeks vardenafil therapy was free of side effects. Renal function tests did not change. Also, no dose change in immunosuppressive drugs was required during 4 weeks of verdanafil therapy.

Topics: Adult; Creatinine; Erectile Dysfunction; Humans; Imidazoles; Kidney Transplantation; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Postoperative Complications; Prospective Studies; Sulfones; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Nerve sparing radical retropubic prostatectomy (NS-RRP) results in erectile dysfunction in a significant number of patients. Vardenafil, a potent and selective phosphodiesterase type 5 inhibitor, is generally safe. It improves International Index of Erectile Function erectile function domain scores, and penetration and erection maintenance success rates in patients who have undergone NS-RRP. We report additional parameters important to patient perceptions regarding erection quality and satisfaction with sexual experience following NS-RRP.. A total of 440 men at 58 centers throughout the United States and Canada participated in this randomized, placebo controlled, double-blind trial with 3 phases, namely baseline (4-week untreated period), treatment (12 weeks) and followup (7 days). Participants received placebo (145), 10 mg vardenafil (146) or 20 mg vardenafil (149) at home on demand but no more than once per calendar day. Efficacy and satisfaction with erection quality and sexual experience were determined during the trial.. The 10 and 20 mg vardenafil doses were significantly superior to placebo for the International Index of Erectile Function domains for intercourse satisfaction, orgasmic function and overall satisfaction with sexual experience (vs placebo p <0.0009). Significant improvement in the satisfaction rate with erection hardness were demonstrated for each vardenafil dose compared with placebo (p <0.0001). Vardenafil was generally well tolerated. Common adverse events were headache, vasodilatation and rhinitis.. In this difficult to treat population of men with erectile dysfunction subsequent to NS-RRP on demand treatment with vardenafil during a 3-month period significantly improved key aspects of the sexual experience important to patient quality of life.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Cyclic Nucleotide Phosphodiesterases, Type 5; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Follow-Up Studies; Humans; Imidazoles; Male; Middle Aged; Orgasm; Patient Satisfaction; Penile Erection; Penis; Phosphodiesterase Inhibitors; Phosphoric Diester Hydrolases; Piperazines; Postoperative Complications; Prostatectomy; Quality of Life; Sulfones; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

An experimental study was performed to evaluate the effects of Vardenafil on ischemia-reperfusion (I/R) injury in an experimental volvulus model by histochemical and biochemical methods.. Thirty-five male Wistar rats were divided in five groups (n = 7). In Group 1, a 5 cm segment of small intestine 2 cm proximal to cecum was excised to have a control group. In the second group, 5 cm segment of small intestine 2 cm proximal to cecum was rotated 360° clockwise direction and sutured with 4/0 polyglactin to generate an experimental model of volvulus. At the end of 2 h of ischemia, the same intestinal segment was sampled. In group 3, after achieving ischemia similar to group 2, two hours of reperfusion injury was obtained by removing the sutures. Rats in Group 4 received vardenafil after 1.5 h of ischemia and then 2 h of reperfusion. And finally, in Group 5, vardenafil was administered 2 h before laparotomy and 5 cm of intestine was removed without I/R injury. Intestinal segments were evaluated for total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) with biochemical and histopathological analysis.. Serum TOS levels and OSI were not significantly different between groups (p = 0.910, P = 0,43 respectively). The serum TAS level was decreased in group 3 as compared to vardenafil groups 4 and 5, without a statistical significance (p = 0.428). In histopathologic analysis, we found that vardenafil, partially reduced I/R injury. The villus structure was preserved but, congestion and inflammation were moderate.. Vardenafil partially reduced I/R injury histopathologically on intestine. Our study shows that it does not have statistically antioxidant effect on intestinal I/R injury in experimental model of volvulus. However, effects of vardenafil in I/R injury of liver, kidney, heart, testis, over and brain which were cited in literature were not confirmed with I/R injury on intestine.

Topics: Animals; Antioxidants; Disease Models, Animal; Drug Evaluation, Preclinical; Intestinal Volvulus; Intestine, Small; Male; Oxidative Stress; Postoperative Complications; Rats; Rats, Wistar; Reperfusion Injury; Vardenafil Dihydrochloride; Vasodilator Agents

Recently, the infarct reducing and cardioprotective effects of phosphodiesterase-5-inhibitors were described. In this study, we investigated these effects on ischemia/reperfusion injury in a rat model of heart transplantation. Three groups were assigned for our study: a vardenafil preconditioning group, an ischemic control, and a nonischemic control. Hemodynamic parameters were significantly increased in the vardenafil group (Pmax: 82+/-4 vs. 110+/-12 vs. 127+/-13 mm Hg; dP/dtmax: 1740+/-116 vs. 3197+/-599 vs. 4397+/-602 mm Hg/sec; ischemic control vs. vardenafil vs. nonischemic control; P<0.05 vs. ischemic control). Furthermore, we recorded increased ATP levels and significantly less apoptosis in the treatment group after terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (apoptosis index: 27.23%+/-1.54% vs. 16.77%+/-1.42% vs. 18.86%+/-1.07%; ischemic control vs. vardenafil vs. nonischemic control; P<0.05 vs. ischemic control). Our current results support the concept that the cGMP-PKG-pathway plays an important role in ischemia/reperfusion injury. We could show that up-regulating this pathway has a preconditioning-like effect and can effectively reduce ischemia/reperfusion injury.

Topics: Animals; Aorta, Abdominal; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Heart Transplantation; Hemodynamics; Imidazoles; Male; Myocardial Contraction; Phosphodiesterase Inhibitors; Piperazines; Postoperative Complications; Rats; Rats, Inbred Lew; Reperfusion Injury; Sulfones; Systole; Transplantation, Heterotopic; Transplantation, Isogeneic; Triazines; Vardenafil Dihydrochloride; Vena Cava, Inferior; Ventricular Function, Left

Assess acceptance of and discontinuation rate from erectile dysfunction (ED) treatment in patients after bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP).. We analyzed acceptance and discontinuation data of 100 consecutive, age-comparable, preoperatively self-reported potent BNSRRP patients who at the discharge from the hospital received a phosphodiesterase type 5 inhibitor (PDE5-I) prescription. Patients were informed of the pharmacokinetic properties of the available compounds and the option of on-demand versus rehabilitative therapy. Thereafter, patients did not receive any specific counseling throughout the entire follow-up period and freely decided to use or not use any ED therapy. Complete preoperative data were obtained on hospital admission and included a medical and sexual history and the International Index of Erectile Function (IIEF). The IIEF was completed every 6 mo postoperatively, and patients participated in a semi-structured interview about the treatment adherence at the 18-mo follow-up.. Forty-nine (49%) patients freely decided not to start any ED therapy (group 1). Of the remaining patients, 36 (36%) opted for an as-needed PDE5-I (group 2), whereas 15 (15%) decided to use a daily PDE5-I (group 3). At the 18-mo follow-up, the overall discontinuation rate from both treatment modalities was 72.6% (eg, 72.2% vs. 73.3% in group 2 vs. group 3; p=0.79). Treatment effect below expectations was the main reason for treatment discontinuation, followed by loss of interest in sex due to partner's causes.. Almost 50% of BNSRRP patients freely decided not to start any ED treatment postoperatively. Roughly 73% of patients who started therapy eventually discontinued it.

Topics: Carbolines; Erectile Dysfunction; Follow-Up Studies; Humans; Imidazoles; Male; Middle Aged; Patient Compliance; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Postoperative Complications; Prostate; Prostatectomy; Prostatic Neoplasms; Purines; Quality of Life; Sildenafil Citrate; Sulfones; Surveys and Questionnaires; Tadalafil; Time Factors; Treatment Outcome; Treatment Refusal; Triazines; Vardenafil Dihydrochloride