Dataset Information

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

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 .).

SUBMITTER: McNeil JJ

PROVIDER: S-EPMC6433466 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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

McNeil John J JJ Nelson Mark R MR Woods Robyn L RL Lockery Jessica E JE Wolfe Rory R Reid Christopher M CM Kirpach Brenda B Shah Raj C RC Ives Diane G DG Storey Elsdon E Ryan Joanne J Tonkin Andrew M AM Newman Anne B AB Williamson Jeff D JD Margolis Karen L KL Ernst Michael E ME Abhayaratna Walter P WP Stocks Nigel N Fitzgerald Sharyn M SM Orchard Suzanne G SG Trevaks Ruth E RE Beilin Lawrence J LJ Donnan Geoffrey A GA Gibbs Peter P Johnston Colin I CI Radziszewska Barbara B Grimm Richard R Murray Anne M AM

The New England journal of medicine 20180916 16

<h4>Background</h4>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.<h4>Methods</h4>From 2010 through 2014, we enrolled community-dwelling persons in Australi ...[more]

PMID: 30221595

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Project description: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 .).

Dataset Information

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

Publications

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

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