Article type
Year
Abstract
Objective: To determine the efficacy and safety of sildenafil in treatment of male erectile dysfunction.
Methods: MEDLINE, HealthSTAR, Current Contents and Cochrane Library databases (January 1995 through September 1999); bibliographies of retrieved articles and review articles; conference proceedings abstracts; Urology journals; Cochrane Controlled Trials Register; CENTRAL register; FDA internet site. Trials eligible if they included men with erectile dysfunction, compared sildenafil with control, were randomized, were at least 7 days duration and assessed clinically relevant outcomes. Two reviewers independently evaluated study quality and extracted data using pretested forms.
Results: Seventeen trials involving 4110 men met inclusion criteria. Compared with placebo, sildenafil improved success rate of intercourse attempts (46.5% vs. 19.5%, RBI=2.94 [95%CI=2.26-3.82]), percent of men experiencing any successful intercourse (81.7% vs. 52.4%, RBI=1.76 [95%CI= 1.44-2.17]) and percent of men reporting improvement in erectile function (68.9% vs. 18.5%, RBI=3.75 [95%CI=3.02-4.66]). Adverse events in men receiving sildenafil included headache (17.3%), flushing (13.8%), dyspepsia (6.9%) and visual disturbances (3.9%); all were significantly less likely with placebo. Men randomized to sildenafil dropped out of trials less often overall (8.8% vs. 14.6% for placebo, RRI=0.59 [95%CI=0.50-0.71]) and no more often secondary to adverse effects. Five men died on or within 30 days of study drug or withdrew from studies because of death; four had been randomized to sildenafil.
Conclusions: Sildenafil improves erectile function and is generally well tolerated. Extensive trial exclusion criteria and incomplete subgroup data limit generalizability of results. The possible association of sildenafil with mortality warrants further exploration.
Methods: MEDLINE, HealthSTAR, Current Contents and Cochrane Library databases (January 1995 through September 1999); bibliographies of retrieved articles and review articles; conference proceedings abstracts; Urology journals; Cochrane Controlled Trials Register; CENTRAL register; FDA internet site. Trials eligible if they included men with erectile dysfunction, compared sildenafil with control, were randomized, were at least 7 days duration and assessed clinically relevant outcomes. Two reviewers independently evaluated study quality and extracted data using pretested forms.
Results: Seventeen trials involving 4110 men met inclusion criteria. Compared with placebo, sildenafil improved success rate of intercourse attempts (46.5% vs. 19.5%, RBI=2.94 [95%CI=2.26-3.82]), percent of men experiencing any successful intercourse (81.7% vs. 52.4%, RBI=1.76 [95%CI= 1.44-2.17]) and percent of men reporting improvement in erectile function (68.9% vs. 18.5%, RBI=3.75 [95%CI=3.02-4.66]). Adverse events in men receiving sildenafil included headache (17.3%), flushing (13.8%), dyspepsia (6.9%) and visual disturbances (3.9%); all were significantly less likely with placebo. Men randomized to sildenafil dropped out of trials less often overall (8.8% vs. 14.6% for placebo, RRI=0.59 [95%CI=0.50-0.71]) and no more often secondary to adverse effects. Five men died on or within 30 days of study drug or withdrew from studies because of death; four had been randomized to sildenafil.
Conclusions: Sildenafil improves erectile function and is generally well tolerated. Extensive trial exclusion criteria and incomplete subgroup data limit generalizability of results. The possible association of sildenafil with mortality warrants further exploration.