Clinical trials of sildenafil citrate (Viagra) demonstrate no increase in risk of myocardial infarction and cardiovascular death compared with placebo.
We pooled data regarding myocardial infarction (MI) and cardiovascular death from more than 120 clinical trials of sildenafil citrate (Viagra) conducted from 1993 to 2001. During placebo-controlled trials, the rate of MI or cardiovascular death was 0.91 (95% CI: 0.52-1.48) per 100 person-years (PY) of follow-up among sildenafil-treated patients compared with 0.84 (95% CI: 0.39-1.60) per 100 PY of follow-up among placebo-treated patients. The relative risk of MI or cardiovascular death was 1.08 (95% CI: 0.45-2.77) for sildenafil compared with placebo (p = 0.88). During open-label studies, the rate of MI or cardiovascular death was 0.56 (95% CI: 0.44-0.72) per 100 PY of follow-up. This analysis showed that the rates of MI and cardiovascular death were low and comparable between men treated with sildenafil and those treated with placebo. The use of sildenafil was not associated with an increase in the risk of MI or cardiovascular death.
Mittleman
M A
MA
Institute for Prevention of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts 02215, USA.
Glasser
D B
DB
Orazem
J
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D002986:Clinical Trials as Topic; D006801:Humans; D018783:Impotence, Vasculogenic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced; D010879:Piperazines / Q000009:adverse effects*; D011687:Purines; D012307:Risk Factors; D000068677:Sildenafil Citrate; D013450:Sulfones; D014665:Vasodilator Agents / Q000009:adverse effects*
D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; D000068677:Sildenafil Citrate