John J McNeil1, Mark R Nelson1, Robyn L Woods1, Jessica E Lockery1, Rory Wolfe1, Christopher M Reid1, Brenda Kirpach1, Raj C Shah1, Diane G Ives1, Elsdon Storey1, Joanne Ryan1, 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, Barbara Radziszewska1, Richard Grimm1, Anne M Murray1. 1. 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.).
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 receiveaspirin 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 .).
RCT Entities:
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 .).
Authors: F Gerald R Fowkes; Jacqueline F Price; Marlene C W Stewart; Isabella Butcher; Gillian C Leng; Alistair C H Pell; Peter A G Sandercock; Keith A A Fox; Gordon D O Lowe; Gordon D Murray Journal: JAMA Date: 2010-03-03 Impact factor: 56.272
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: Peter M Rothwell; Michelle Wilson; Jacqueline F Price; Jill F F Belch; Tom W Meade; Ziyah Mehta Journal: Lancet Date: 2012-03-21 Impact factor: 79.321
Authors: Peter M Rothwell; F Gerald R Fowkes; Jill F F Belch; Hisao Ogawa; Charles P Warlow; Tom W Meade Journal: Lancet Date: 2010-12-06 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: Adam de Havenon; Chelsea Meyer; J Scott McNally; Matthew Alexander; Lee Chung Journal: Curr Atheroscler Rep Date: 2019-07-27 Impact factor: 5.113
Authors: Danielle Perry; Samantha Moe; Christina Korownyk; Adrienne J Lindblad; Michael R Kolber; Betsy Thomas; Joey Ton; Scott Garrison; G Michael Allan Journal: Can Fam Physician Date: 2019-04 Impact factor: 3.275
Authors: Danielle Perry; Samantha Moe; Christina Korownyk; Adrienne J Lindblad; Michael R Kolber; Betsy Thomas; Joey Ton; Scott Garrison; G Michael Allan Journal: Can Fam Physician Date: 2019-04 Impact factor: 3.275
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