Medline ® Abstract for Reference 36
of 'Treatment of male sexual dysfunction'
Men with mild erectile dysfunction benefit from sildenafil treatment.
Bénard F, Carrier S, Lee JC, Talwar V, Defoy I
J Sex Med. 2010 Nov;7(11):3725-35. Epub 2010 Oct 4.
INTRODUCTION: Sildenafil treatment has not been evaluated in a double-blind, placebo-controlled (DBPC) trial specific to men with mild erectile dysfunction (ED), defined by a 22-25 score on the International Index of Erectile Function-erectile function domain (IIEF-EF).
AIM: To assess sildenafil efficacy in sexually dissatisfied men with mild ED.
MAIN OUTCOME MEASURES: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), IIEF, Quality of Erection Questionnaire (QEQ), Erection Hardness Score (EHS 4=completely hard/fully rigid), general efficacy questions (GEQs), event log questions (hardness sufficient for penetration, duration sufficient for successful intercourse, ejaculation/orgasm, and second erection within 24 hours), and analog scales (erection firmness, reliability, and maintenance, and general sexual performance).
METHODS: Eight-week DBPC flexible-dose (25, 50, or 100 mg) trial with 6-week, open-label (OL) extension.
RESULTS: One hundred and seventy-six men were randomized (mean±standard deviation: age, 50±12 year; ED duration, 3.5±3.2 year). Most had organic or mixed ED. For sildenafil vs. placebo, 66% vs. 89% titrated to 100 mg and efficacy at DBPC end was better, including the EDITS Index score (least squares mean [standard error], 80.3 [2.3]vs. 62.1 [2.5]; P<0.0001); treatment satisfaction (EDITS Index score>50 in 89% vs. 63%; P=0.0001); no ED (IIEF-EF≥26 in 58% vs. 39%; P<0.05); GEQs (≥4.9-fold greater odds of improved erections and ability to have sexual intercourse); and EHS 4 (47.2% vs. 25.2% of occasions; P<0.0001). At OL end, 93% of men were satisfied (EDITS Index score>50), 77% had no ED, and≥89% were GEQ responders; mean scores on IIEF domains, the QEQ, and analog scales were>80% of the maximum; 60% of occasions had EHS 4; and event log responses were positive on>80% of occasions, except for second erections (41.9%). Headache, nasal congestion, and flushing, mostly mild to moderate, were the most common adverse events.
CONCLUSION: Men with mild ED derive substantial benefit from sildenafil treatment.
CHUM-St-Luc Hospital, Montreal, QC, Canada. firstname.lastname@example.org