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

INTRODUCTION

Sildenafil, an oral phosphodiesterase type 5 inhibitor, has been extensively investigated for the treatment of erectile dysfunction in randomized controlled trials.

AIM: To assess the efficacy and safety of sildenafil vs placebo according to age subgroups (<65, 65-74, and ≥75 years) in 11,364 men with erectile dysfunction using pooled data from 48 randomized, double-blinded, placebo-controlled, parallel-group, flexible-dose trials.

METHODS

Most trials had a 12-week treatment duration. 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 or 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 at least one postrandomization evaluation. Safety analyses included subjects who received study medication.

MAIN OUTCOME MEASURES: The International Index of Erectile Function and a global assessment question ("Did the treatment improve your erections?").

RESULTS

Mean International Index of Erectile Function 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 vs placebo for each age subgroup; orgasmic function, intercourse satisfaction, sexual desire, and overall satisfaction domain scores also were statistically significantly improved with sildenafil vs placebo. The percentage of men reporting improved erections on the global assessment question was statistically significantly higher with sildenafil vs placebo for all age subgroups; the percentage with sildenafil tended to decrease with increasing age (<65 years, 80%; 65-74 years, 69%; ≥75 years, 59%). The most common adverse events with sildenafil were headache and flushing in each age subgroup.

CONCLUSION

Sildenafil is an effective and well-tolerated treatment for erectile dysfunction regardless of patient age, including men at least 75 years old.