EFFICACY AND SAFETY OF ORAL SILDENAFIL IN THE TREATMENT OF ERECTILE DYSFUNCTION - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF 329 PATIENTS

The efficacy and safety of oral sildenafil citrate for the treatment o f erectile dysfunction (ED) were assessed in a 12-week placebo-control led study. Men with ED of organic, psychogenic, or mixed aetiology wer e randomised to placebo (n=166) or 50 mg sildenafil (n=163), with adju stment 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 e rections 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 (r esponders and non-responders) receiving sildenafil versus 20% for plac ebo (p<0.001), The mean number of successful attempts per month was 5. 9 for patients receiving sildenafil versus 1.5 for those receiving pla cebo (p<0.0001). The most common adverse events - headache, Rushing, a nd dyspepsia - were generally mild to moderate in nature and rarely (< 1%) a reason for discontinuation of treatment. Oral sildenafil is an e ffective, reliable and well-tolerated treatment for ED of organic, psy chogenic or mixed aetiology.