John J McNeil1, Robyn L Woods1, Mark R Nelson1, Christopher M Reid1, Brenda Kirpach1, Rory Wolfe1, Elsdon Storey1, Raj C Shah1, Jessica E Lockery1, Andrew M Tonkin1, Anne B Newman1, Jeff D Williamson1, Karen L Margolis1, Michael E Ernst1, Walter P Abhayaratna1, Nigel Stocks1, Sharyn M Fitzgerald1, Suzanne G Orchard1, Ruth E Trevaks1, Lawrence J Beilin1, Geoffrey A Donnan1, Peter Gibbs1, Colin I Johnston1, Joanne Ryan1, Barbara Radziszewska1, Richard Grimm1, Anne M Murray1. 1. From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.L.W., M.R.N., C.M.R., R.W., E.S., J.E.L., A.M.T., S.M.F., S.G.O., R.E.T., C.I.J., J.R.), the Walter and Eliza Hall Institute of Medical Research (P.G.), and the Baker Heart and Diabetes Institute (C.I.J.), Melbourne, and the 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, the 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, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, 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, University of Pittsburgh, Pittsburgh (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 the 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.).
Abstract
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 .).
RCT Entities:
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 .).
Authors: B Winblad; A Wimo; K Engedal; H Soininen; F Verhey; G Waldemar; A-L Wetterholm; A Haglund; R Zhang; R Schindler Journal: Dement Geriatr Cogn Disord Date: 2006-02-27 Impact factor: 2.959
Authors: Paul M Ridker; Nancy R Cook; I-Min Lee; David Gordon; J Michael Gaziano; Joann E Manson; Charles H Hennekens; Julie E Buring Journal: N Engl J Med Date: 2005-03-07 Impact factor: 91.245
Authors: Mark R Nelson; Christopher M Reid; David A Ames; Lawrence J Beilin; Geoffrey A Donnan; Peter Gibbs; Colin I Johnston; Henry Krum; Elsdon Storey; Andrew Tonkin; Rory Wolfe; Robyn Woods; John J McNeil Journal: Med J Aust Date: 2008-07-21 Impact factor: 7.738
Authors: Colin Baigent; Lisa Blackwell; Rory Collins; Jonathan Emberson; Jon Godwin; Richard Peto; Julie Buring; Charles Hennekens; Patricia Kearney; Tom Meade; Carlo Patrono; Maria Carla Roncaglioni; Alberto Zanchetti Journal: Lancet Date: 2009-05-30 Impact factor: 79.321
Authors: Jill Belch; Angus MacCuish; Iain Campbell; Stuart Cobbe; Roy Taylor; Robin Prescott; Robert Lee; Jean Bancroft; Shirley MacEwan; James Shepherd; Peter Macfarlane; Andrew Morris; Roland Jung; Christopher Kelly; Alan Connacher; Norman Peden; Andrew Jamieson; David Matthews; Graeme Leese; John McKnight; Iain O'Brien; Colin Semple; John Petrie; Derek Gordon; Stuart Pringle; Ron MacWalter Journal: BMJ Date: 2008-10-16
Authors: John J McNeil; Robyn L Woods; Stephanie A Ward; Carlene J Britt; Jessica E Lockery; Lawrence J Beilin; Alice J Owen Journal: Int J Epidemiol Date: 2019-08-01 Impact factor: 7.196
Authors: Michael Berk; Robyn L Woods; Mark R Nelson; Raj C Shah; Christopher M Reid; Elsdon Storey; Sharyn Fitzgerald; Jessica E Lockery; Rory Wolfe; Mohammadreza Mohebbi; Seetal Dodd; Anne M Murray; Nigel Stocks; Paul B Fitzgerald; Catherine Mazza; Bruno Agustini; John J McNeil Journal: JAMA Psychiatry Date: 2020-10-01 Impact factor: 21.596
Authors: Suzanne G Orchard; Jessica E Lockery; Peter Gibbs; Galina Polekhina; Rory Wolfe; John Zalcberg; Andrew Haydon; John J McNeil; Mark R Nelson; Christopher M Reid; Brenda Kirpach; Anne M Murray; Robyn L Woods Journal: Contemp Clin Trials Date: 2020-07-31 Impact factor: 2.226
Authors: Jessica E Lockery; Taya A Collyer; Walter P Abhayaratna; Sharyn M Fitzgerald; John J McNeil; Mark R Nelson; Suzanne G Orchard; Christopher Reid; Nigel P Stocks; Ruth E Trevaks; Robyn Woods Journal: Med J Aust Date: 2018-12-21 Impact factor: 7.738