Efficacy Of Vardenafil In Men Research Articles

Comparable Efficacy of Once-Daily Versus On-Demand Vardenafil in Men with Mild-to-Moderate Erectile Dysfunction: Findings of the RESTORE Study

Comparable Efficacy of Once-Daily Versus On-Demand Vardenafil in Men with Mild-to-Moderate Erectile Dysfunction: Findings of the RESTORE Study

Real-Life Safety and Efficacy of Vardenafil in the Treatment of Erectile Dysfunction—Results from 30,010 U.S. Patients

Clinical trials show that vardenafil produces effective and satisfactory first-dose success rates and reliability for erection and intercourse in men with erectile dysfunction (ED). This study was conducted to evaluate real-life efficacy, safety, and acceptance of vardenafil in men with ED. This open-label, prospective study, conducted in 6,740 U.S. centers, included an initial visit and one or two follow-up visits within a 2-month period of the first vardenafil dose. Vardenafil was administered in 5-20 mg doses. Efficacy variables included first-dose success rates for vaginal penetration, maintenance of erection, and satisfaction based on physician and patient assessments. Safety was assessed by adverse events (AEs). A total of 30,010 men were included in the safety/intent-to-treat (S/ITT) analysis, with 26,043 men in the adjusted S/ITT population. Vardenafil improved erectile function in 78% of men, with 75% rating overall efficacy as "satisfying" or "very satisfying." The overall rates of successful penetration and maintenance with vardenafil following the first dose were 78% and 68%, respectively. For men with mild and moderate ED, first-dose success rates for penetration were 89% and 82%, respectively, and for maintenance, 82% and 71%, respectively. First-dose penetration and maintenance of erection rates were 76% and 66%, respectively, for men with self-reported hypertension, and 70% and 60%, respectively, for men with diabetes mellitus. At study end, 67% of patients preferred to continue using vardenafil. The most frequently reported AEs were headache (4%) and flushing (2%). Vardenafil was well tolerated, with a "satisfied/very satisfied" tolerability rating in 75% of cases as assessed by the physician. This observational study demonstrated the tolerability and efficacy of vardenafil in men with ED and comorbidities. Vardenafil provided a high rate of first-dose intercourse success and a favorable safety profile in patients with and without comorbid disease.

Extended Duration of Efficacy of Vardenafil When Taken 8 Hours Before Intercourse: A Randomized, Double-Blind, Placebo-Controlled Study

ObjectivesThis study explored the efficacy of vardenafil in men with erectile dysfunction (ED) when taken 8hours before sexual intercourse. MethodsA 10-week, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study of vardenafil (5, 10 or 20mg) was conducted in men with ED for >6 months who failed ≥50% of intercourse attempts during a 4-week treatment-free run-in period. Sexual Encounter Profile Question 3 (SEP3) was the primary efficacy measure; secondary measures included SEP2, International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS). Adverse-event and safety monitoring were conducted throughout. Results383 patients were randomized to vardenafil (n=194) or placebo (n=189). Patients treated with vardenafil 8hours before sexual activity achieved clinically meaningful (≥18%) and statistically significantly greater least-squares mean per-patient SEP3 and SEP2 success rates over weeks 2–10, compared with patients receiving placebo (SEP3 69% vs 34%; SEP2 81% vs 51%; both p<0.001). SEP3 and SEP2 measures demonstrated the significant superiority of vardenafil over placebo from week 2 onwards (p<0.001). Measurements of IIEF-EF domain score, GAQ, GCQ and EQS showed that vardenafil led to significantly greater improvements in erectile function, compared with placebo (all p<0.001). Vardenafil was generally well tolerated. ConclusionsThe extended duration of efficacy of vardenafil up to 8hours postdose may provide couples with more flexibility in their sexual life than anticipated.

Efficacy and Tolerability of Vardenafil in Men With Mild Depression and Erectile Dysfunction: The Depression-Related Improvement With Vardenafil for Erectile Response Study

Erectile dysfunction and depression are highly associated. Previous studies have shown benefits of phosphodiesterase-5 inhibitor treatment for erectile dysfunction associated with antidepressant therapy or subsyndromal depression. The present study assessed the safety and efficacy of vardenafil in men with erectile dysfunction and untreated mild depression. In this 12-week, multicenter, randomized, flexible-dose, parallel-group, double-blind study, 280 men with erectile dysfunction for at least 6 months and untreated mild major depression received placebo or vardenafil, 10 mg/day, for 4 weeks, with the option to titrate to 5 mg/day or 20 mg/day after each of two consecutive 4-week intervals. Endpoints included International Index of Erectile Function erectile function domain and 17-item Hamilton Depression Rating Scale (HAM-D) scores. Vardenafil produced statistically significant and clinically meaningful improvement in all erectile function parameters. The International Index of Erectile Function erectile function domain score was 22.9 with vardenafil compared to 14.9 with placebo. The HAM-D score was lower in the vardenafil group (7.9) than in the placebo group (10.1). Treatment with vardenafil was the most important predictor for return to normal erectile function. Improvement in International Index of Erectile Function erectile function domain score was the most important predictor of remission in depressive symptoms. Vardenafil was well tolerated and highly efficacious in men with erectile dysfunction and untreated mild major depression. Significant improvements in erectile function and depression were observed in patients treated with vardenafil versus placebo. Erectile dysfunction treatment should be considered a component of therapy for men with depression and erectile dysfunction.

Efficacy of Vardenafil in Men with Erectile Dysfunction: A Flexible-Dose Community Practice Study

Objective: To determine the efficacy and tolerability of flexible dosing with vardenafil in a broad population of men with erectile dysfunction (ED). Methods: 10-week, open-label, flexible-dose study starting with vardenafil 10 mg, titrating to 5 mg or 20 mg at weeks 2 and 6 based on efficacy and tolerability, set in 78 community practice centers in Germany and France. Participants comprised 398 men aged ≥18 years with ED. Main outcome measures were self-reported improvement in erections according to a Global Assessment Question (GAQ), diary questions from the Sexual Encounter Profile (SEP2 and SEP3), and the erectile function domain score from the International Index of Erectile Function (IIEF) questionnaire. Results: In a last observation carried forward (LOCF) analysis, a total of 92% (336/366) of men with ED reported an improvement of erections according to the GAQ. Per-patient success rates for penetration (SEP2) and maintenance (SEP3) of erection for intercourse were 89% (348/390) and 78% (303/390), respectively. Mean erectile function domain scores increased from 13.9 at baseline to 25.9 at LOCF. Vardenafil was generally well tolerated; headache (6%, 25/398) and flushing (6%, 24/398) were the most frequent adverse events. Conclusions: In this community practice setting, vardenafil was shown to be a highly effective and generally well-tolerated treatment for men with ED when dosing was titrated by the physician to individual patient requirements.

906: Influence of Prior Sildenafil Use on the Efficacy of Vardenafil in Men with Erectile Dysfunction: Retrospective Analysis of a Two Year Study

You have accessJournal of UrologyDiscussed Poster, Monday, May 10, 2004, 8:00 am - 12:00 pm1 Apr 2004906: Influence of Prior Sildenafil Use on the Efficacy of Vardenafil in Men with Erectile Dysfunction: Retrospective Analysis of a Two Year Study Gerald B. Brock, Hartmut Porst, Christian G. Stief, Manfred Beneke, Ernst Ulbrich, and Inigo Saenz de Tejada Gerald B. BrockGerald B. Brock More articles by this author , Hartmut PorstHartmut Porst More articles by this author , Christian G. StiefChristian G. Stief More articles by this author , Manfred BenekeManfred Beneke More articles by this author , Ernst UlbrichErnst Ulbrich More articles by this author , and Inigo Saenz de TejadaInigo Saenz de Tejada More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(18)38155-2AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "906: Influence of Prior Sildenafil Use on the Efficacy of Vardenafil in Men with Erectile Dysfunction: Retrospective Analysis of a Two Year Study." The Journal of Urology, 171(4S), p. 240 © 2016 by American Urological AssociationFiguresReferencesRelatedDetails Volume 171Issue 4SApril 2004Page: 240 Advertisement Copyright & Permissions© 2016 by American Urological AssociationMetricsAuthor Information Gerald B. Brock More articles by this author Hartmut Porst More articles by this author Christian G. Stief More articles by this author Manfred Beneke More articles by this author Ernst Ulbrich More articles by this author Inigo Saenz de Tejada More articles by this author Expand All Advertisement Loading ...