The efficacy and safety of vardenafil in East Asian men with erectile dysfunction.

Author(s): Chen KK, Paick JS, Ishii N, Vardenafil Study Group

Affiliation(s): Taipei Veteran General Hospital, Taipei, Taiwan. kkchen@vghtpe.gov.tw

Publication date & source: 2007-05, J Sex Med., 4(3):753-61.

Publication type: Controlled Clinical Trial; Randomized Controlled Trial

INTRODUCTION: Previous clinical studies assessing the efficacy and safety of vardenafil, an oral phosphodiesterase type 5 inhibitor, in men with erectile dysfunction (ED) have consisted mostly of Caucasian patients. AIM: The aim of this article is to describe the efficacy and safety of vardenafil in men of East Asian ethnicity with ED. METHODS: Data were pooled from two 12-week, double-blind studies that included 306 East Asian men randomized to placebo or 10 mg of vardenafil. MAIN OUTCOME MEASURES: Efficacy variables included the International Index of Erectile Function-erectile function (IIEF-EF) domain score, questionnaires of Sexual Encounter Profile (SEP2 and SEP3), and a Global Assessment Question (GAQ). Safety assessments included laboratory tests, vital signs, 12-lead electrocardiogram recordings, and patients' reporting of adverse events. RESULTS: A total of 306 East Asian men with ED were treated with placebo (N = 151) or vardenafil (N = 155). Mean baseline IIEF-EF domain scores (placebo, 13.4; vardenafil, 14.2) were consistent with moderate ED. At end point, the patients treated with vardenafil had a significantly greater increase in IIEF-EF domain score compared with placebo (24.2 vs. 15.9; P < 0.0001). The average per patient penetration (SEP2) success rate was significantly higher in the vardenafil group compared with placebo (88% vs. 58%; P < 0.0001). Moreover, the average per patient intercourse completion (SEP3) success rate was significantly higher in the vardenafil group compared with placebo (69% vs. 23%; P < 0.0001). Positive GAQ responses were reported by 85% of patients receiving vardenafil, compared with 33% of those receiving placebo. The most frequent adverse events were vasodilatation (primarily facial flushing), rhinitis, and headache, all of which were of mild intensity. CONCLUSIONS: Vardenafil is an effective, well-tolerated oral drug for the treatment of East Asian men with moderate ED of broad-spectrum etiology.