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

International Journal of Clinical Practice - Tập 52 Số 6 - Trang 375-379 - 1998
Harin Padma‐Nathan1, WD Steers2, P Wicker3
1Department of Urology University of Southern California, and The Male Clinic Santa Monica California
2Department of Urology, University of Virginia, Charlottesville
3Pfizer Central Research, Groton, Connecticut, USA

Tóm tắt

SUMMARYThe 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.

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International Journal of Clinical Practice

Tập 52 Số 6

375-379

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