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A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women.
N Engl J Med 2005; 352(13):1293-304NEJM

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.

Authors+Show Affiliations

Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15753114

Citation

Ridker, Paul M., et al. "A Randomized Trial of Low-dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women." The New England Journal of Medicine, vol. 352, no. 13, 2005, pp. 1293-304.
Ridker PM, Cook NR, Lee IM, et al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N Engl J Med. 2005;352(13):1293-304.
Ridker, P. M., Cook, N. R., Lee, I. M., Gordon, D., Gaziano, J. M., Manson, J. E., ... Buring, J. E. (2005). A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. The New England Journal of Medicine, 352(13), pp. 1293-304.
Ridker PM, et al. A Randomized Trial of Low-dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women. N Engl J Med. 2005 Mar 31;352(13):1293-304. PubMed PMID: 15753114.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. AU - Ridker,Paul M, AU - Cook,Nancy R, AU - Lee,I-Min, AU - Gordon,David, AU - Gaziano,J Michael, AU - Manson,Joann E, AU - Hennekens,Charles H, AU - Buring,Julie E, Y1 - 2005/03/07/ PY - 2005/3/9/pubmed PY - 2005/4/6/medline PY - 2005/3/9/entrez SP - 1293 EP - 304 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 352 IS - 13 N2 - 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. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/15753114/A_randomized_trial_of_low_dose_aspirin_in_the_primary_prevention_of_cardiovascular_disease_in_women_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa050613?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -