Effect of Aspirin on All-Cause Mortality in the Healthy Elderly

John J. McNeil(Walter and Eliza Hall Institute of Medical Research), Mark Nelson(University of Tasmania), Robyn L. Woods(Walter and Eliza Hall Institute of Medical Research), Jessica E. Lockery(Walter and Eliza Hall Institute of Medical Research), Rory Wolfe(Walter and Eliza Hall Institute of Medical Research), Christopher M. Reid(Walter and Eliza Hall Institute of Medical Research), Brenda Kirpach(Walter and Eliza Hall Institute of Medical Research), Raj C. Shah(Rush University Medical Center), Diane G. Ives(University of Pittsburgh), Elsdon Storey(Walter and Eliza Hall Institute of Medical Research), Joanne Ryan(Walter and Eliza Hall Institute of Medical Research), Andrew Tonkin(Walter and Eliza Hall Institute of Medical Research), Anne B. Newman(University of Pittsburgh), Jeff D. Williamson(Walter and Eliza Hall Institute of Medical Research), Karen L. Margolis(Walter and Eliza Hall Institute of Medical Research), Michael E. Ernst(University of Iowa), Walter P. Abhayaratna(Australian National University), Nigel Stocks(Walter and Eliza Hall Institute of Medical Research), Sharyn M. Fitzgerald(Walter and Eliza Hall Institute of Medical Research), Suzanne G. Orchard(Walter and Eliza Hall Institute of Medical Research), Ruth E. Trevaks(Walter and Eliza Hall Institute of Medical Research), Lawrence J. Beilin(The University of Western Australia), Geoffrey A. Donnan(The University of Melbourne), Peter Gibbs(Walter and Eliza Hall Institute of Medical Research), Colin I. Johnston(Baker Heart and Diabetes Institute), Barbara Radziszewska(Walter and Eliza Hall Institute of Medical Research), Richard H. Grimm(Walter and Eliza Hall Institute of Medical Research), Anne M. Murray(Walter and Eliza Hall Institute of Medical Research)
New England Journal of Medicine
September 16, 2018
10.1056/nejmoa1803955
Cited by 808Open Access
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Abstract

BACKGROUND: In the primary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, now published in the Journal, we report that the daily use of aspirin did not provide a benefit with regard to the primary end point of disability-free survival among older adults. A numerically higher rate of the secondary end point of death from any cause was observed with aspirin than with placebo. 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 disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. Deaths were classified according to the underlying cause by adjudicators who were unaware of trial-group assignments. Hazard ratios were calculated to compare mortality between the aspirin group and the placebo group, and post hoc exploratory analyses of specific causes of death were performed. RESULTS: Of the 19,114 persons who were enrolled, 9525 were assigned to receive aspirin and 9589 to receive placebo. A total of 1052 deaths occurred during a median of 4.7 years of follow-up. The risk of death from any cause was 12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group (hazard ratio, 1.14; 95% confidence interval [CI], 1.01 to 1.29). Cancer was the major contributor to the higher mortality in the aspirin group, accounting for 1.6 excess deaths per 1000 person-years. Cancer-related death occurred in 3.1% of the participants in the aspirin group and in 2.3% of those in the placebo group (hazard ratio, 1.31; 95% CI, 1.10 to 1.56). CONCLUSIONS: Higher all-cause mortality was observed among apparently healthy older adults who received daily aspirin than among those who received placebo and was attributed primarily to cancer-related death. In the context of previous studies, this result was unexpected and should be interpreted with caution. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).

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