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

N Engl J Med 2018 10 16;379(16):1519-1528. Epub 2018 Sep 16.

From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., M.R.N., R.L.W., J.E.L., R.W., C.M.R., E.S., J.R., A.M.T., S.M.F., S.G.O., R.E.T., C.I.J.), Walter and Eliza Hall Institute of Medical Research (P.G.), and Baker Heart and Diabetes Institute (C.I.J.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, College of Medicine, Biology, and Environment, Australian National University, Canberra, ACT (W.P.A.), and Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (B.K., R.G., A.M.M.), and the Division of Geriatrics, Department of Medicine (A.M.M.), Hennepin Healthcare, HealthPartners Institute (K.L.M.), and the University of Minnesota (A.M.M.) - all in Minneapolis; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); the Center for Aging and Population Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh (D.G.I., A.B.N.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); and the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.).

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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http://dx.doi.org/10.1056/NEJMoa1803955DOI Listing
October 2018
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