Exhibition Hall (Room 517-AB) | Male - Sexual Dysfunction Time: - |
Exhibition Hall (Room 517-AB) | Female - Sexual Dysfunction Time: - |
Efficacy and Tolerability of Flexible-Dose Vardenafil When Taken 8 hours Before Intercourse: The Extended Duration of Vardenafil in Erectile Dysfunction (EXTEND) Trial.
Porst, Hartmut1, Sharlip, Ira2, Hatzichristou, Dimitrios3, Rubio-Aurioles, Eusebio4, Gittleman, Marc5, Stancil, Britt-Nicole6, Wilkins, H Jeffrey7, Pommerville, Peter8, Arango de Montis, Ivan*,, 1 Practice of Urology and Andrology, Hamburg, Germany2 Pan Pacific Urology, San Francisco, CA, USA3 2nd Department of Urology and Center for Sexual and Reproductive Health, Thessaloniki, Greece4 Asociación Mexicana Para la Salud Sexual, Tlalpan, Mexico5 South Florida Medical Research, FL, USA6 GlaxoSmithKline, NC, USA7 GlaxoSmithKline, PA, USA8 Can-Med Clinical research Inc, Victoria, BC, Canada
ABSTRACT- Objective: To evaluate the efficacy of vardenafil in men with erectile dysfunction (ED) when taken 8 hours prior to sexual intercourse. Methods: Men with ED for >6 months and who failed ≥50% of intercourse attempts during a 4-week treatment-free run-in period, were randomized to flexible-dose vardenafil or placebo for 10 weeks. Patients were instructed to take study drug 8 hours before attempting sexual intercourse. The starting dose of vardenafil was 10 mg, with the option to titrate to 5 mg or 20 mg at Weeks 2 and 6. Efficacy measures included Sexual Encounter Profile questions 2 (penetration) and 3 (maintenance of erection), Erectile Function (EF) domain score of the International Index of Erectile Function, and the Global Assessment Question (GAQ). Data from Weeks 2 to 10 for doses taken 8 ± 2 hours before sexual intercourse were used in the analysis. Results: A total of 383 patients were randomized to vardenafil (n=194) or placebo (n=189). Most had severe (36%) or moderate (31%) ED at baseline; mean EF domain score was 13.3. Over Weeks 2-10, least square (LS) mean per-patient success rates were significantly greater with vardenafil compared with placebo for penetration (81% vs. 51%, p<0.001) and maintenance of erection (69% vs. 34%, p<0.001). At Week 10, LS mean EF domain score was significantly higher in the vardenafil group (22.8) compared with placebo (14.9) (p<0.001). Significantly more patients reported improved erections according to positive responses to GAQ with vardenafil (77%) compared with placebo (27%, p<0.001). Vardenafil was generally well tolerated; the most common (≥5%) treatment-emergent adverse events (vardenafil/placebo %) were headache (15/3), flushing (7/2), and nasal congestion (5/0). Conclusion: Vardenafil, when taken at 8 ± 2 hours before intercourse, demonstrated superior efficacy compared with placebo in men with mainly severe or moderate ED, providing penetration and maintenance of erection success rates of 81% and 69%, respectively, and improving EF domain score into the 'mild' range. These results demonstrate that patients can successfully use vardenafil when intercourse is attempted up to 8 hours after dosing.
Key words: erectile dysfunction, vardenafil, PDE5 inhibitor, duration of action