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Cited by 590Antiplatelet Therapy and Cardiovascular DiseasesInflammatory mediators and NSAID effectsAging, Health, and Disability

Effect of aspirin on disability-free survival in the healthy elderly

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McNeil, John J., Woods, Robyn L., Nelson, Mark R., Reid, Christopher M., Kirpach, Brenda, Wolfe, Rory, Storey, Elsdon, Shah, Raj C. +19 more·2018·New England Journal of Medicine
DOI 10.1056/nejmoa1800722PMC PMC6426126
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Abstract

BACKGROUND: Information on the use of aspirin to increase healthy independent life span in older persons is limited. Whether 5 years of daily low-dose aspirin therapy would extend disability-free life in healthy seniors is unclear. METHODS: From 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or physical disability. Participants were randomly assigned to receive 100 mg per day of enteric-coated aspirin or placebo orally. The primary end point was a composite of death, dementia, or persistent physical disability. Secondary end points reported in this article included the individual components of the primary end point and major hemorrhage. RESULTS: A total of 19,114 persons with a median age of 74 years were enrolled, of whom 9525 were randomly assigned to receive aspirin and 9589 to receive placebo. A total of 56.4% of the participants were women, 8.7% were nonwhite, and 11.0% reported previous regular aspirin use. The trial was terminated at a median of 4.7 years of follow-up after a determination was made that there would be no benefit with continued aspirin use with regard to the primary end point. The rate of the composite of death, dementia, or persistent physical disability was 21.5 events per 1000 person-years in the aspirin group and 21.2 per 1000 person-years in the placebo group (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11; P=0.79). The rate of adherence to the assigned intervention was 62.1% in the aspirin group and 64.1% in the placebo group in the final year of trial participation. Differences between the aspirin group and the placebo group were not substantial with regard to the secondary individual end points of death from any cause (12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group), dementia, or persistent physical disability. The rate of major hemorrhage was higher in the aspirin group than in the placebo group (3.8% vs. 2.8%; hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001). CONCLUSIONS: Aspirin use in healthy elderly persons did not prolong disability-free survival over a period of 5 years but led to a higher rate of major hemorrhage than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).

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  • One RCT found that 100 mg aspirin versus placebo in healthy adults older than 65 did not reduce dementia, death, physical disability, or cardiovascular disease over 4.7 years.

    “One RCT found 100 mg aspirin versus placebo in 19 114 healthy adults older than 65 years did not reduce dementia (HR 1·0, 95% CI 0·8–1·2), death, physical disability, or cardiovascular disease over a period of 4·7 years.”

    From Dementia prevention, intervention, and care: 2020 report of the Lancet Commission (2020) · cites this paper as [87]

    The Abstract (Methods and Results; page unavailable) supports the 100 mg aspirin–placebo comparison, 19,114 participants, median 4.7-year follow-up, and no substantial reduction in dementia, death, or persistent physical disability. The Methods (Trial End Points; page unavailable) says cardiovascular disease was a secondary outcome analyzed in an accompanying article, not reported as a result in this paper. The age description is also broader than the eligibility criteria: participants were generally at least 70, with a threshold of 65 for Black and Hispanic participants in the United States. (LLM, conf=0.88)

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  1. [7]Whitlock EP, Williams SB, Burda BU, Feightner A, Beil T. Aspirin use in adults: cancer, all-cause mortality, and harms: a systematic evidence review for the U.S. Preventive Services Task Force Evidence syntheses no. 132. Rockville, MD: Agency for Healthcare Research and Quality, 2015 (https://www.ncbi.nlm.nih.gov/books/NBK321643/). 26491756

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Authors
McNeil, J. J., Woods, R. L., Nelson, M. R., Reid, C. M., Kirpach, B., Wolfe, R., Storey, E., Shah, R. C., Lockery, J. E., Tonkin, A. M., Newman, A. B., Williamson, J. D., Margolis, K. L., Ernst, M. E., Abhayaratna, W. P., Stocks, N., Fitzgerald, S. M., Orchard, S. G., Trevaks, R. E., Beilin, L. J., Donnan, G. A., Gibbs, P., Johnston, C. I., Ryan, J., Radziszewska, B., Grimm, R., & Murray, A. M.
Affiliations
  • Baker Heart and Diabetes Institute (AU)
  • University of Tasmania (AU)
  • Rush University Medical Center (US)
  • University of Iowa (US)
  • Australian National University (AU)
  • National Institutes of Health (US)
  • University of Minnesota (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2018-10-18
Volume
379
Issue
16
Pages
1499-1508
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1800722
PMC
PMC6426126
OpenAlex
W2891412296
Cited by
590
References
35
Citations by year
2026: 44 · 2025: 69 · 2024: 64 · 2023: 85 · 2022: 67 · 2021: 91 · 2020: 72 · 2019: 79 · 2018: 19
FWCI
49.37
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • UWA Profiles and Research Repository (UWA) (publishedVersion, other-oa)
  • PubMed (publishedVersion)
  • UTAS Research Repository (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • Digital Commons-TMC (Texas Medical Center) (submittedVersion)
  • eCite Digital Repository (University of Tasmania) (submittedVersion)
  • eSpace (Curtin University) (submittedVersion)
  • Figshare (submittedVersion, cc-by)
  • ANU Open Research (Australian National University) (submittedVersion)
Funders
  • Victorian Cancer Agency, Australia
  • National Health and Medical Research Council of Australia (334047, 1127060)
  • Monash University, Australia
  • National Institutes of Health (U01AG029824)
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 › Public Health, Environmental and Occupational Health › Aging, Health, and Disability
Keywords
aspirin, healthy older adults, disability-free survival, dementia, physical disability, mortality, major bleeding, bleeding risk, community-dwelling older adults, trial termination, medication adherence, enteric-coated aspirin, cardiovascular disease prevention, cognitive function
MeSH terms
Administration, Oral, Aged, Aged, 80 and over, Aspirin, Australia, Dementia, Double-Blind Method, Female, Follow-Up Studies, Persons with Disabilities, Disabled Persons, Hemorrhage, Humans, Male, Mortality, Platelet Aggregation Inhibitors, United States, Incidence, Treatment Failure, Disease-Free Survival, Independent Living

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