62: Efficacy and tolerability of vardenafil in men with erectile dysfunction: Findings from a multinational Asian study.

Autor: Tan, Hui Meng, Chin, Chong Min, Chua, Chong beng, Gatchalian, Edsal, Kongkanand, Apichat, Moh, Clarence Lei Chang
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Zdroj: Indian Journal of Urology; Supplement2, Vol. 24, pS75-S75, 1/3p
Abstrakt: Introduction: Erectile dysfunction (ED) is a highly prevalent condition in Asian men. This multinational study investigated the efficacy and tolerability of the phosphodiesterase type 5 inhibitor, vardenafil, in Asian men with ED of broad-spectrum aetiology. Methods: A prospective, randomised, double-blind, placebo-controlled, fixed-dose, parallel-group study was conducted in six countries in Asia (Malaysia, Singapore, Thailand, the Philippines, Hong Kong and Indonesia). Men aged >20 years with ED of >6 months duration were enrolled. After a 4-week baseline period, participants were randomised 4:1 to receive 12 weeks of treatment with either vardenafil 10 mg or placebo. Primary efficacy variables included the International Index of Erectile Function, erectile function domain (IIEF-EF) score and Sexual Encounter Profile questions 2 (SEP-2) and 3 (SEP-3). Results: Men (n=358; mean age=54.6 years) were randomised to treatment with either vardenafil (n=285) or placebo (n=73). Mean baseline IIEF-EF domain scores were 14.8 for vardenafil and 13.6 for placebo (consistent with moderate ED). After 12 weeks of treatment, vardenafil was associated with significant improvements in IIEF-EF domain scores compared with placebo (vardenafil 22.4 vs placebo 14.3; P<0.001) and also in least squares (LS) mean SEP-2 (vardenafil 82.2 vs placebo 43.6; P<0.001) and SEP-3 success rates (vardenafil 66.1 vs placebo 24.0; P<0.001). The majority of adverse events reported for the vardenafil group were mild and transient in nature. Conclusions: Vardenafil 10 mg is highly effective and well-tolerated for the treatment of ED in Asian men. This study was supported financially by Bayer HealthCare. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index