095 Efficacy and Safety of Sildenafil by Age in Men With Erectile Dysfunction

Abstract

Sildenafil, an oral phosphodiesterase type 5 inhibitor, has been extensively investigated for the treatment of erectile dysfunction (ED) in randomized controlled trials. However, published data are limited on the treatment response to sildenafil in men with ED according to age ≥65 years. We assessed the efficacy and safety of sildenafil versus placebo according to age subgroups (<65, 65–74, and ≥75 years) in 11,364 men with ED using pooled data from 48 randomized, double-blind, placebo-controlled, parallel-group, flexible-dose trials. Most trials had a 12-week treatment period. The starting sildenafil dose was 50 mg, taken 1 hour before sexual activity, with subsequent adjustment to 100 or 25 mg based on efficacy and safety. Men taking nitrate therapy/nitric oxide donors and men with severe cardiac failure, unstable angina, or recent stroke or myocardial infarction were excluded. Efficacy analyses included all subjects with baseline and ≥1 post-randomization evaluation. Safety analyses included all subjects who received study drug. The primary efficacy outcomes were the change from baseline to week 12 in International Index of Erectile Function (IIEF) scores and a Global Assessment Question (GAQ; “Did the treatment improve your erections?”) at week 12.