Efficacy and Safety of Sildenafil by Age in Men With Erectile Dysfunction.
Sildenafil, an oral phosphodiesterase type 5 inhibitor, has been extensively investigated for the treatment of erectile dysfunction in randomized controlled trials.



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.



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.



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



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.



Sildenafil is an effective and well-tolerated treatment for erectile dysfunction regardless of patient age, including men at least 75 years old.
San Diego Sexual Medicine, Alvarado Hospital, San Diego, CA, USA. Electronic address: dr.irwingoldstein@gmail.com.
Irwin
I
Goldstein
Pfizer Inc., New York, NY, USA.
Li-Jung
LJ
Tseng
Pfizer Inc., New York, NY, USA.
Dana
D
Creanga
Pfizer Inc., New York, NY, USA.
Vera
V
Stecher
University Urology Associates, New York, NY, USA.
Jed C
JC
Kaminetsky
D000368:Aged; D003075:Coitus; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D010410:Penile Erection / Q000187:drug effects*; D012725:Sexual Behavior / Q000187:drug effects*; D000068677:Sildenafil Citrate / Q000008:administration & dosage* / Q000009:adverse effects
D000068677:Sildenafil Citrate
Age Groups; Elderly; Erectile Dysfunction; Middle Age; Phosphodieterase Type 5 Inhibitors; Sildenafil