Clinical Trials of Sildenafil Citrate (Viagra®) Demonstrate No Increase in Risk of Myocardial Infarction and Cardiovascular Death Compared With Placebo

SUMMARY We pooled data regarding myocardial infarction (Ml) 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 Ml 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 Ml 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 Ml 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 Ml 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 Ml or cardiovascular death.