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Cardiovascular outcomes among sildenafil users: results of the International Men's Health Study.

Mittleman MA, Maclure M, Lewis MA, Hall GC, Moore N, Giuliano F, Porst H, Hedelin H, Martin-Morales A, Sobel RE, Reynolds R, Glasser DB

Cardiovascular Epidemiology Research Unit, Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.

AIM: To assess the incidence of serious cardiovascular disease (CVD) events [i.e. myocardial infarction (MI) and stroke] and all-cause mortality in men with erectile dysfunction (ED) who received prescriptions for sildenafil. METHODS: The International Men's Health Study (IMHS) was a prospective, observational cohort study of patients with ED and a new or existing prescription for sildenafil. Baseline and follow-up questionnaires provided information on demographics, CVD risk factors and ED. Postevent questionnaires were mailed to patients following possible nonfatal CVD events to collect information related to exposure to sildenafil/ED treatments before the event. RESULTS: Thirty-five CVD events were reported in 30 patients in the analysis set (n = 3813). The incidence of all-cause mortality, MI and stroke was 0.4, 0.6 and 0.1 per 100 patient-years of observation respectively. Among the six men who reported using sildenafil in the month before a nonfatal CVD event, two reported use in the 24 h before the event. CONCLUSION: The results of the IMHS support previous reports that ED and CVD are often comorbid and share risk factors.

Published 11 February 2008 in Int J Clin Pract, 62(3): 367-73.
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