Richard L. Siegel, MD; Dale B. Glasser, PhD
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Siegel R., Glasser D.; Cost-Effectiveness of Sildenafil. Ann Intern Med. 2001;134:250. doi: 10.7326/0003-4819-134-3-200102060-00020
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Published: Ann Intern Med. 2001;134(3):250.
TO THE EDITOR:
The article by Smith and Roberts (1) clearly demonstrates the cost-effectiveness of sildenafil for the treatment of erectile dysfunction. We applaud them for conducting such high-quality research.
However, we are concerned about the statement implying that sildenafil causes “severe adverse effects … sudden death, myocardial infarction, and arrhythmia, among others.” This statement appears to be based on a misinterpretation of reports of spontaneous adverse events (such as the U.S. Food and Drug Administration's MedWatch system).
The sildenafil clinical trial database now includes 36 double-blind, placebo-controlled studies and 46 open-label studies, with more than 11 000 person-years of observation for sildenafil and over 700 person-years for placebo. The incidence of serious adverse events, such as myocardial infarction and death, in these trials has remained consistently low; no differences have been noted between men randomly assigned to sildenafil and those assigned to placebo, even among patients with known cardiovascular conditions or risk factors (2). Prospective studies (3) and retrospective database reviews (4) have shown no difference in serious cardiovascular adverse events between sildenafil and placebo recipients and have reported no deleterious effects on key cardiac measures, including coronary artery blood flow (5) and rate–pressure product.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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