| Authors | Ridker PM, Cook NR, Lee IM, Gordon D, Gaziano JM, Manson JE, Hennekens CH, Buring JE | |
| Title | A Randomized Trial of Low-Dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women | |
| Full source | N Engl J Med. 2005 Mar 7; [Epub ahead of print] | |
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| Abstract | Background
Randomized trials have shown that low-dose aspirin decreases the risk of
a first myocardial infarction in men, with little effect on the risk of
ischemic stroke. There are few similar data in women. Methods We randomly
assigned 39,876 initially healthy women 45 years of age or older to receive
100 mg of aspirin on alternate days or placebo and then monitored them for
10 years for a first major cardiovascular event (i.e., nonfatal myocardial
infarction, nonfatal stroke, or death from cardiovascular causes). Results During follow-up, 477 major cardiovascular events were confirmed in the aspirin group, as compared with 522 in the placebo group, for a nonsignificant reduction in risk with aspirin of 9 percent (relative risk, 0.91; 95 percent confidence interval, 0.80 to 1.03; P=0.13). With regard to individual end points, there was a 17 percent reduction in the risk of stroke in the aspirin group, as compared with the placebo group (relative risk, 0.83; 95 percent confidence interval, 0.69 to 0.99; P=0.04), owing to a 24 percent reduction in the risk of ischemic stroke (relative risk, 0.76; 95 percent confidence interval, 0.63 to 0.93; P=0.009) and a nonsignificant increase in the risk of hemorrhagic stroke (relative risk, 1.24; 95 percent confidence interval, 0.82 to 1.87; P=0.31). As compared with placebo, aspirin had no significant effect on the risk of fatal or nonfatal myocardial infarction (relative risk, 1.02; 95 percent confidence interval, 0.84 to 1.25; P=0.83) or death from cardiovascular causes (relative risk, 0.95; 95 percent confidence interval, 0.74 to 1.22; P=0.68). Gastrointestinal bleeding requiring transfusion was more frequent in the aspirin group than in the placebo group (relative risk, 1.40; 95 percent confidence interval, 1.07 to 1.83; P=0.02). Subgroup analyses showed that aspirin significantly reduced the risk of major cardiovascular events, ischemic stroke, and myocardial infarction among women 65 years of age or older. Conclusions In this large, primary-prevention trial among women, aspirin lowered the risk of stroke without affecting the risk of myocardial infarction or death from cardiovascular causes, leading to a nonsignificant finding with respect to the primary end point. Notice: To coincide with presentations at the annual meeting of the American College of Cardiology, this article has been published at www.nejm.org on March 7, 2005. It will appear in the March 31 issue of the Journal. Click on "PDF" for the full text. Copyright 2005 Massachusetts Medical Society. |
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