Ethnicity and age as factors in sildenafil treatment of erectile dysfunction
Abstract
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.…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 4,120 participants or records.
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