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

Authors

• John J McNeil
• Mark R Nelson
• Robyn L Woods
• Jessica E Lockery
• Rory Wolfe
• Christopher M Reid
• Brenda Kirpach
• Raj C Shah
• Diane G Ives
• Elsdon Storey
• Joanne Ryan
• Andrew M Tonkin
• Anne B Newman
• Jeff D Williamson
• Karen L Margolis
• Michael E Ernst
• Walter P Abhayaratna
• Nigel Stocks
• Sharyn M Fitzgerald
• Suzanne G Orchard
• Ruth E Trevaks
• Lawrence J Beilin
• Geoffrey A Donnan
• Peter Gibbs
• Colin I Johnston
• Barbara Radziszewska
• Richard Grimm
• Anne M Murray

Publication/Presentation Date

10-18-2018

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 .).

Volume

379

Issue

16

First Page

1519

Last Page

1528

ISSN

1533-4406

Published In/Presented At

McNeil, J. J., Nelson, M. R., Woods, R. L., Lockery, J. E., Wolfe, R., Reid, C. M., Kirpach, B., Shah, R. C., Ives, D. G., Storey, E., Ryan, J., 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., … ASPREE Investigator Group (2018). Effect of Aspirin on All-Cause Mortality in the Healthy Elderly. The New England journal of medicine, 379(16), 1519–1528. https://doi.org/10.1056/NEJMoa1803955

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

30221595

Department(s)

Administration and Leadership

Document Type

Article