Ethnicity and age as factors in sildenafil treatment of erectile dysfunction.

Introduction: Sildenafil has been evaluated in >16 000 men with erectile dysfunction (ED) in double-blind, placebo-controlled trials.

Aim: To assess efficacy and safety of sildenafil in ED by ethnicity (white, black Asian) and age (≤45, 46-60, ≥61 years).

Methods: Data were pooled from 38 double-blind, placebo-controlled, flexible-dose trials. Most had starting sildenafil doses of 50 mg once daily, ~1 hour before sexual activity, with adjustment to 100 or 25 mg as needed.

Main Outcome Measures: Change from baseline in International Index of Erectile Function erectile function (IIEF-EF) domain score assessed with analysis of covariance and a Global Assessment Question (GAQ; "Did the treatment improve your erections?") at endpoint assessed with logistic regression analysis.

Results: 4120 and 3714 men received sildenafil and placebo, respectively (2740 and 2671 White; 407 and 385 Black; 973 and 658 Asian). For sildenafil vs. placebo groups, overall treatment differences for IIEF-EF domain and GAQ were significant for each ethnic and age group (P<.0001); significant treatment-by-ethnicity and treatment-by-age interactions were also observed for change in IIEF-EF domain scores (P<.05), with differences significantly greater for White vs. Black (P<.0001), White vs. Asian (P=.0163), and Asian vs. Black (P=.0036) men. A significant treatment-by-ethnicity interaction was observed for GAQ (P=.0004). The OR comparison for GAQ was significantly greater (P=.0001) with sildenafil vs. placebo in White (OR=11.2) or Asian (OR=12.4) men vs. Black men (OR=5.1). Adverse-event rates were generally similar, with some age variations.

Conclusions: Sildenafil is effective and well-tolerated regardless of ethnicity or age; however, treatment effects can vary.