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Cited by 1,945Antiplatelet Therapy and Cardiovascular DiseasesInflammatory mediators and NSAID effectsLipoproteins and Cardiovascular Health

A Randomized Trial of Low-Dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women

Ridker, Paul M, Cook, Nancy R., Lee, I-Min, Gordon, David, Gaziano, J. Michael, Manson, JoAnn E., Hennekens, Charles H., Buring, Julie E.·2005·New England Journal of Medicine
DOI 10.1056/nejmoa050613
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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.

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Crossref · 10.1056/nejmoa050613

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  • Ridker et al. (2005) did not find any effect of acetylsalicylic acid on the prevention of cardiovascular accidents in women.

    “no effect on the prevention of cardiovascular accidents,”

    From Health From a Gender Perspective (2017) · cites this paper as Ridker et al., 2005

  • The best-known and most complete study, that of Ridker et al. (2005), did not find any effect of acetylsalicylic acid (100 mg every other day) on the prevention of heart attacks in women.

    “and the best-known and most complete study, that of Ridker et al. (2005), did not find any effect of acetylsalicylic acid (100 mg every other day) on the prevention of heart attacks in women,”

    From Health From a Gender Perspective (2017) · cites this paper as Ridker et al., 2005

  • Preventive effects of aspirin only appear in women older than age 65 years.

    “Preventive effects only appear in women older than age 65 years.”

    From Health From a Gender Perspective (2017) · cites this paper as Ridker et al., 2005

  • Ridker et al. (2005) found a higher incidence of gastrointestinal bleeding among women.

    “and, on the other hand, it did find a higher incidence of gastrointestinal bleeding among women.”

    From Health From a Gender Perspective (2017) · cites this paper as Ridker et al., 2005

  • The WHS was a completed randomized trial (1992-2004) testing aspirin and vitamin E for preventing cardiovascular disease and cancer among 39,876 healthy women, ≥45 years, living throughout the US.

    “The WHS is a completed randomized trial (1992-2004) testing aspirin and vitamin E for preventing cardiovascular disease and cancer among 39,876 healthy women, ≥45 years, living throughout the US.[32-34]”

    From Using accelerometers to measure physical activity in large-scale epidemiological studies: issues and challenges (2014) · cites this paper as [34]

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Authors
Ridker, P. M., Cook, N. R., Lee, I.-M., Gordon, D., Gaziano, J. M., Manson, J. E., Hennekens, C. H., & Buring, J. E.
Affiliations
  • Brigham and Women's Hospital (US)
  • Florida Atlantic University (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2005-03-31
Volume
352
Issue
13
Pages
1293-1304
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa050613
OpenAlex
W2138597449
Cited by
1,945
References
24
Citations by year
2026: 21 · 2025: 38 · 2024: 36 · 2023: 49 · 2022: 52 · 2021: 58 · 2020: 54 · 2019: 74 · 2018: 65 · 2017: 64 · 2016: 70 · 2015: 62 · 2014: 90 · 2013: 105 · 2012: 124
FWCI
132.63
Type
journal article
Language
en
Open access
closed
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (5r01hl043851-10)
  • National Heart, Lung, and Blood Institute (HL43851)
  • National Cancer Institute (CA-47988, R01CA047988)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
  • Health Sciences › Medicine › Pharmacology › Inflammatory mediators and NSAID effects
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Keywords
low-dose aspirin, primary prevention, cardiovascular disease, women, ischemic stroke, hemorrhagic stroke, myocardial infarction, cardiovascular mortality, gastrointestinal bleeding, bleeding risk, aspirin safety, cardiovascular risk reduction, women's health, cardiovascular disease prevention, cardiovascular risk factors, cardiovascular risk stratification
MeSH terms
Age Factors, Aged, Anti-Inflammatory Agents, Non-Steroidal, Aspirin, Cardiovascular Diseases, Double-Blind Method, Female, Follow-Up Studies, Humans, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Primary Prevention, Risk, Risk Factors, Incidence, Proportional Hazards Models, Cyclooxygenase Inhibitors, Stroke

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