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. Chen K-K, Paick J-S, and Ishii N. The efficacy and safety of vardenafil in East Asian men with erectile dysfunction. J Sex Med 2007;4:753–761.