Effect of aspirin on all-cause mortality in the healthy elderly

J. J. McNeil, M. R. Nelson, R. L. Woods, J. E. Lockery, R. Wolfe, C. M. Reid, B. R. Kirpach, R. C. Shah, D. G. Ives, E. Storey, J. Ryan, A.M. Tonkin, A. B. Newman, J. D. Williamson, K. L. Margolis, M. E. Ernst, W. P. Abhayaratna, N. Stocks, S. M. Fitzgerald, S. G. Orchard & 9 others R. E. Trevaks, L. J. Beilin, G. A. Donnan, P. Gibbs, C. I. Johnston, B. Radziszewska, R. Grimm, A. M. Murray, for the ASPREE Investigator Group

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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.

Original languageEnglish
Pages (from-to)1519-1528
Number of pages10
JournalNew England Journal of Medicine
Volume379
Issue number16
DOIs
Publication statusPublished - 18 Oct 2018

Cite this

McNeil, J. J. ; Nelson, M. R. ; Woods, R. L. ; Lockery, J. E. ; Wolfe, R. ; Reid, C. M. ; Kirpach, B. R. ; 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. ; Trevaks, R. E. ; Beilin, L. J. ; Donnan, G. A. ; Gibbs, P. ; Johnston, C. I. ; Radziszewska, B. ; Grimm, R. ; Murray, A. M. ; for the ASPREE Investigator Group. / Effect of aspirin on all-cause mortality in the healthy elderly. In: New England Journal of Medicine. 2018 ; Vol. 379, No. 16. pp. 1519-1528.
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title = "Effect of aspirin on all-cause mortality in the healthy elderly",
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.",
author = "McNeil, {J. J.} and Nelson, {M. R.} and Woods, {R. L.} and Lockery, {J. E.} and R. Wolfe and Reid, {C. M.} and Kirpach, {B. R.} and Shah, {R. C.} and Ives, {D. G.} and E. Storey and J. Ryan and A.M. Tonkin and Newman, {A. B.} and Williamson, {J. D.} and Margolis, {K. L.} and Ernst, {M. E.} and Abhayaratna, {W. P.} and N. Stocks and Fitzgerald, {S. M.} and Orchard, {S. G.} and Trevaks, {R. E.} and Beilin, {L. J.} and Donnan, {G. A.} and P. Gibbs and Johnston, {C. I.} and B. Radziszewska and R. Grimm and Murray, {A. M.} and {for the ASPREE Investigator Group}",
year = "2018",
month = "10",
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doi = "10.1056/NEJMoa1803955",
language = "English",
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journal = "New England Journal of Medicine",
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McNeil, JJ, Nelson, MR, Woods, RL, Lockery, JE, Wolfe, R, Reid, CM, Kirpach, BR, Shah, RC, Ives, DG, Storey, E, Ryan, J, Tonkin, AM, Newman, AB, Williamson, JD, Margolis, KL, Ernst, ME, Abhayaratna, WP, Stocks, N, Fitzgerald, SM, Orchard, SG, Trevaks, RE, Beilin, LJ, Donnan, GA, Gibbs, P, Johnston, CI, Radziszewska, B, Grimm, R, Murray, AM & for the ASPREE Investigator Group 2018, 'Effect of aspirin on all-cause mortality in the healthy elderly', New England Journal of Medicine, vol. 379, no. 16, pp. 1519-1528. https://doi.org/10.1056/NEJMoa1803955

Effect of aspirin on all-cause mortality in the healthy elderly. / McNeil, J. J.; Nelson, M. R.; Woods, R. L.; Lockery, J. E.; Wolfe, R.; Reid, C. M.; Kirpach, B. R.; 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.; Trevaks, R. E.; Beilin, L. J.; Donnan, G. A.; Gibbs, P.; Johnston, C. I.; Radziszewska, B.; Grimm, R.; Murray, A. M.; for the ASPREE Investigator Group.

In: New England Journal of Medicine, Vol. 379, No. 16, 18.10.2018, p. 1519-1528.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Effect of aspirin on all-cause mortality in the healthy elderly

AU - McNeil, J. J.

AU - Nelson, M. R.

AU - Woods, R. L.

AU - Lockery, J. E.

AU - Wolfe, R.

AU - Reid, C. M.

AU - Kirpach, B. R.

AU - Shah, R. C.

AU - Ives, D. G.

AU - Storey, E.

AU - Ryan, J.

AU - Tonkin, A.M.

AU - Newman, A. B.

AU - Williamson, J. D.

AU - Margolis, K. L.

AU - Ernst, M. E.

AU - Abhayaratna, W. P.

AU - Stocks, N.

AU - Fitzgerald, S. M.

AU - Orchard, S. G.

AU - Trevaks, R. E.

AU - Beilin, L. J.

AU - Donnan, G. A.

AU - Gibbs, P.

AU - Johnston, C. I.

AU - Radziszewska, B.

AU - Grimm, R.

AU - Murray, A. M.

AU - for the ASPREE Investigator Group

PY - 2018/10/18

Y1 - 2018/10/18

N2 - 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.

AB - 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.

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U2 - 10.1056/NEJMoa1803955

DO - 10.1056/NEJMoa1803955

M3 - Article

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SP - 1519

EP - 1528

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 16

ER -