Update on clinical trials of tadalafil demonstrates no increased risk of cardiovascular adverse events.

INTRODUCTION: Cardiovascular disease and erectile dysfunction (ED) share similar risk factors and often occur concomitantly. Therefore, men with ED may be at increased risk for cardiovascular adverse events.

AIM: The aim of this retrospective analysis was to evaluate the cardiovascular adverse events in clinical trials of tadalafil, an effective medication for the treatment of ED.

METHODS: An integrated analysis of cardiovascular adverse events was performed on a database from 35 controlled clinical trials (placebo [N = 2,118] and tadalafil [N = 5,228]) and eight open-label trials of tadalafil (tadalafil [N = 6,939]). Some patients in controlled trials also received tadalafil in the open-label extension phase of four trials. Across all trials, the dose range of tadalafil was 2-25 mg, with the majority of patients receiving tadalafil 20 mg. This analysis represents an update of previous published results.

RESULTS: In 35 controlled tadalafil clinical trials, the incidence of cardiovascular adverse events was low and comparable in tadalafil- and placebo-treated patients. The rate of myocardial infarction (MI) across all controlled and open-label studies was 0.33 per 100 patient-years in tadalafil-treated patients (N = 10,460, patient exposure = 5,088 patient-years). The MI rate in tadalafil-treated patients was comparable to that in placebo-treated patients (0.41 per 100 patient-years; N = 2,118; 489 patient-years), and to that in an age-standardized male population (0.6 per 100 patient-years). The cardiac mortality rate in tadalafil-treated patients across all studies (N = 10,460) was 0.12 per 100 patient-years which was not increased compared with the cardiac mortality rate of 0.26 per 100 patient-years reported in an age-standardized male population.

CONCLUSIONS: In tadalafil clinical trials, the incidence of cardiovascular adverse events in patients receiving tadalafil was low and comparable to placebo. Tadalafil did not increase the rate of MI or cardiac mortality compared with reported rates from epidemiological studies. This favorable cardiovascular safety profile for tadalafil is important, because men with ED commonly have cardiovascular disease and may seek medical therapy for ED.