McNeil, JJ and Woods, RL and Nelson, MR and Reid, CM and Kirpach, B and Wolfe, R and Storey, E and Shah, RC and Lockery, JE and Tonkin, AM and Newman, AB and Williamson, JD and Margolis, KL and Ernst, ME and Abhayaratna, WP and Stocks, N and Fitzgerald, SM and Orchard, SG and Trevaks, RE and Beilin, LJ and Donnan, GA and Gibbs, P and Johnston, CI and Ryan, J and Radziszewska, B and Grimm, R and Murray, AM, for the ASPREE Investigator Group, Effect of aspirin on disability-free survival in the healthy elderly, New England Journal of Medicine, 379, (16) pp. 1499-1508. ISSN 0028-4793 (2018) [Refereed Article]
Copyright 2018 Massachusetts Medical Society
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.
|Item Type:||Refereed Article|
|Keywords:||aspirin, healthy elderly, disability-free survival|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Cardiovascular medicine and haematology|
|Research Field:||Cardiology (incl. cardiovascular diseases)|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Nelson, MR (Professor Mark Nelson)|
|Web of Science® Times Cited:||194|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||154 View Download Statistics|
Repository Staff Only: item control page