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Cited by 796Inflammatory mediators and NSAID effectsAntiplatelet Therapy and Cardiovascular DiseasesMetabolism, Diabetes, and Cancer

Low-Dose Aspirin in the Primary Prevention of Cancer: The Women’s Health Study: A Randomized Controlled Trial

Cook, Nancy R., Lee, I-Min, Gaziano, J. Michael, Gordon, David, Ridker, Paul M, Manson, JoAnn E., Hennekens, Charles H., Buring, Julie E.·2005·JAMA
DOI 10.1001/jama.294.1.47
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Abstract

CONTEXT: Basic research and observational evidence as well as results from trials of colon polyp recurrence suggest a role for aspirin in the chemoprevention of cancer. OBJECTIVE: To examine the effect of aspirin on the risk of cancer among healthy women. DESIGN, SETTING, AND PARTICIPANTS: In the Women's Health Study, a randomized 2 x 2 factorial trial of aspirin and vitamin E conducted between September 1992 and March 2004, 39 876 US women aged at least 45 years and initially without previous history of cancer, cardiovascular disease, or other major chronic illness were randomly assigned to receive either aspirin or aspirin placebo and followed up for an average of 10.1 years. INTERVENTION: A dose of 100 mg of aspirin (n=19 934) or aspirin placebo (n=19 942) administered every other day. MAIN OUTCOME MEASURES: Confirmed newly diagnosed invasive cancer at any site, except for nonmelanoma skin cancer. Incidence of breast, colorectal, and lung cancer were secondary end points. RESULTS: No effect of aspirin was observed on total cancer (n = 2865; relative risk [RR], 1.01; 95% confidence interval [CI], 0.94-1.08; P = .87), breast cancer (n = 1230; RR, 0.98; 95% CI, 0.87-1.09; P = .68), colorectal cancer (n = 269; RR, 0.97; 95% CI, 0.77-1.24; P = .83), or cancer of any other site, with the exception of lung cancer for which there was a trend toward reduction in risk (n = 205; RR, 0.78; 95% CI, 0.59-1.03; P = .08). There was also no reduction in cancer mortality either overall (n = 583; RR, 0.95; 95% CI, 0.81-1.11; P = .51) or by site, except for lung cancer mortality (n = 140; RR, 0.70; 95% CI, 0.50-0.99; P = .04). No evidence of differential effects of aspirin by follow-up time or interaction with vitamin E was found. CONCLUSIONS: Results from this large-scale, long-term trial suggest that alternate day use of low-dose aspirin (100 mg) for an average 10 years of treatment does not lower risk of total, breast, colorectal, or other site-specific cancers. A protective effect on lung cancer or a benefit of higher doses of aspirin cannot be ruled out.

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  • 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 [32]

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Authors
Cook, N. R., Lee, I.-M., Gaziano, J. M., Gordon, D., Ridker, P. M., Manson, J. E., Hennekens, C. H., & Buring, J. E.
Affiliations
Brigham and Women's Hospital (US)
Corresponding author
Cook, Nancy R.
ORCID
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2005-07-06
Volume
294
Issue
1
Pages
47
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.294.1.47
OpenAlex
W2051700726
Cited by
796
References
39
Citations by year
2026: 10 · 2025: 12 · 2024: 15 · 2023: 19 · 2022: 20 · 2021: 22 · 2020: 33 · 2019: 22 · 2018: 29 · 2017: 28 · 2016: 43 · 2015: 44 · 2014: 60 · 2013: 58 · 2012: 64
FWCI
39.12
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA (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 › Pharmacology › Inflammatory mediators and NSAID effects
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Metabolism, Diabetes, and Cancer
Keywords
low-dose aspirin, chemoprevention, primary cancer prevention, cancer incidence, breast cancer, colorectal cancer, lung cancer, cancer mortality, Women's Health Study, non-melanoma skin cancer, vitamin E, healthy women, nonsteroidal anti-inflammatory drugs, bleeding risk, cardiovascular risk
MeSH terms
Aspirin, Double-Blind Method, Drug Administration Schedule, Female, Humans, Middle Aged, Neoplasm Invasiveness, Neoplasms, Risk Factors, Incidence, Cyclooxygenase Inhibitors

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