095 Efficacy and Safety of Sildenafil by Age in Men With Erectile Dysfunction
Section snippets
Objectives
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,
Material and Methods
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
Results
The age range in the overall population was 19–87 y in the sildenafil group and 18–89 y in the placebo group. Mean IIEF scores for question 3 (frequency of penetration), question 4 (maintenance of erections after penetration), and the Erectile Function Domain were statistically significantly improved with sildenafil versus placebo for each of the 3 age subgroups (all P <0.001); Orgasmic Function, Intercourse Satisfaction, Sexual Desire, and Overall Satisfaction Domain scores also were
Conclusions
Sildenafil is an effective and well-tolerated treatment for ED regardless of patient age. Sexual function can continue with aging for most sildenafil-treated men with ED, including men aged ≥75 years.
Disclosure
Work supported by industry: yes, by Pfizer Inc (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.