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Sildenafil for Male Erectile Dysfunction
A Systematic Review and Meta-analysis
Howard A. Fink, MD, MPH;
Roderick Mac Donald, MS;
Indulis R. Rutks, BS;
David B. Nelson, PhD;
Timothy J. Wilt, MD, MPH
Arch Intern Med. 2002;162:1349-1360.
Objective To determine the efficacy and safety of sildenafil citrate in the treatment
of male erectile dysfunction.
Data Sources The MEDLINE, HealthSTAR, Current Contents, and Cochrane Library databases
(January 1, 1995, through December 31, 2000); bibliographies of retrieved
articles and review articles; conference proceedings abstracts; the Food and
Drug Administration Web site; and the manufacturer.
Study Selection Trials were eligible if they included men with erectile dysfunction,
compared sildenafil with control, were randomized, were of at least 7 days'
duration, and assessed clinically relevant outcomes.
Data Extraction Two reviewers independently evaluated study quality and extracted data
in a standardized fashion.
Data Synthesis Twenty-seven trials (6659 men) met the inclusion criteria. In results
pooled from 14 parallel-group, flexible as-needed dosing trials, sildenafil
was more likely than placebo to lead to successful sexual intercourse, with
a higher percentage of successful intercourse attempts (57% vs 21%; weighted
mean difference, 33.7; 95% confidence interval [CI], 29.2-38.2; 2283 men)
and a greater percentage of men experiencing at least 1 intercourse success
during treatment (83% vs 45%; relative benefit increase, 1.8; 95% CI, 1.7-1.9;
2205 men). In data pooled from 6 parallel-group, fixed-dose trials, efficacy
appeared slightly greater at higher doses. Treatment response appeared to
vary between patient subgroups, although relative to placebo, sildenafil significantly
improved erectile function in all evaluated subgroups. In trials with parallel-group
design and flexible dosing, men randomized to receive sildenafil were less
likely than those receiving placebo to drop out for any reason and no more
likely to drop out due to an adverse event or laboratory abnormality. Specific
adverse events with sildenafil included flushing (12%), headache (11%), dyspepsia
(5%), and visual disturbances (3%); all adverse events were significantly
less likely to occur with placebo. Sildenafil was not significantly associated
with serious cardiovascular events or death.
Conclusions Sildenafil improves erectile function and is generally well tolerated.
Treatment response seems to vary between patient subgroups, although sildenafil
has greater efficacy than placebo in all evaluated subgroups.
From the Geriatric Research Education and Clinical Center (Dr Fink),
the Section of General Internal Medicine (Drs Fink and Wilt), and the Center
for Chronic Disease Outcomes Research and the Veterans Affairs Coordinating
Center of the Cochrane Review Group in Prostate Diseases and Urologic Malignancies
(Drs Fink, Nelson, and Wilt and Messrs Mac Donald and Rutks), Veterans Affairs
Medical Center, Minneapolis, Minn.
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