Evaluation of acute risk for myocardial infarction in men treated with sildenafil citrate.

Sexual intercourse is a rare trigger of acute myocardial infarction (MI). In the 2 hours after intercourse, the risk for MI is increased twofold to fourfold. However, there is limited information on the risk for MI after intercourse in men receiving treatment for erectile dysfunction. This study aimed to evaluate whether the use of sildenafil citrate in men with erectile dysfunction is associated with the triggering of acute MI. A self-matched case-crossover approach was used to evaluate the incidence of MI in men enrolled in 80 clinical trials of sildenafil at sites worldwide from 1993 to 2000. The risk for MI was assessed during 2 hazard periods: within 24 and within 6 hours after the ingestion of sildenafil. Relative risk was estimated using the Mantel-Haenszel estimator for sparse person-time data. A total of 69 MIs were observed during >11,000 person-years of exposure to sildenafil. The mean time between the last dose of sildenafil and the onset of MI was 14 +/- 2.9 days. The relative risk for MI was 0.80 (95% confidence interval [CI] 0.52 to 1.26) within 24 hours after taking sildenafil and 0.79 (95% CI 0.33 to 1.87) within 6 hours after taking sildenafil. In conclusion, these data indicate that sildenafil was not associated with short-term risk for MI and are consistent with the growing body of evidence that sildenafil use is not associated with an increased risk for cardiovascular events.