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


CONCLUSIONS
The results of the IMHS support previous reports that ED and CVD are often comorbid and share risk factors.
Mittleman
M A
MA
Cardiovascular Epidemiology Research Unit, Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.
Maclure
M
M
Lewis
M A
MA
Hall
G C
GC
Moore
N
N
Giuliano
F
F
Porst
H
H
Hedelin
H
H
Martin-Morales
A
A
Sobel
R E
RE
Reynolds
R
R
Glasser
D B
DB
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000150:complications / Q000401:mortality; D015331:Cohort Studies; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D054526:Men's Health; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects*; D010879:Piperazines / Q000009:adverse effects*; D011446:Prospective Studies; D011687:Purines / Q000009:adverse effects; D012307:Risk Factors; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000009:adverse effects*
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate