Efficacy and Safety of Oral Sildenafil in the Treatment of Erectile Dysfunction: A Double‐blind, Placebo‐controlled Study of 329 Patients

SUMMARY The efficacy and safety of oral sildenafil citrate for the treatment of erectile dysfunction (ED) were assessed in a 12‐week placebo‐controlled study. Men with ED of organic, psychogenic, or mixed aetiology were randomised to placebo (n=166) or 50 mg sildenafil (n=163), with adjustment to 100 mg or 25 mg based on efficacy and tolerability. Efficacy assessments included a global efficacy question, event log data, and an optional partner questionnaire. At the end of the study, improved erections were reported by 74% of patients receiving sildenafil versus 16% for placebo (p<0.0001). In the final 4 weeks of treatment, 65% of all attempts at sexual intercourse were successful for all patients (responders and non‐responders) receiving sildenafil versus 20% for placebo (p<0.001).The mean number of successful attempts per month was 5.9 for patients receiving sildenafil versus 1.5 for those receiving placebo (p<0.0001). The most common adverse events – headache, flushing, and dyspepsia – were generally mild to moderate in nature and rarely (<1%) a reason for discontinuation of treatment. Oral sildenafil is an effective, reliable and well‐tolerated treatment for ED of organic, psychogenic or mixed aetiology.