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

New England Journal of Medicine Sep 20, 2018

McNeil JJ, et al. - Focusing on specific causes of death, researchers analyzed the higher mortality in the aspirin group of the Aspirin in Reducing Events in the Elderly (ASPREE) trial involving men and women from Australia and the United States who were 70 years of age or older. They found that higher all-cause mortality was noted among apparently healthy older adults who received daily aspirin vs those who received placebo and was attributed primarily to cancer-related death.

Methods

  • From 2010 through 2014, researchers enrolled 19,114 community-dwelling men and women in Australia and the United States (US) aged ≥ 70 years (or aged ≥65 years among black and Hispanic individuals in the US) who did not have cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure), dementia, or disability.
  • Study participants were randomized to receive 100-mg enteric-coated aspirin (n=9,525) or placebo (n=9,589).
  • Deaths were classified according to the underlying cause by adjudicators who were unaware of trial-group assignments.
  • Hazar ratios (HRs) were calculated to compare mortality between the aspirin group and the placebo group.
  • Post hoc exploratory analyses of specific causes of death were performed.

Results

  • During a median of 4.7 years of follow-up, 1,052 deaths occurred.
  • The risk of death from any cause was 12.7 events/1,000 person-years (PYs) in the aspirin group.
  • The risk of death from any cause was 11.1 events/1,000 PYs in the placebo group (HR: 1.14; 95% confidence interval [CI]: 1.01-1.29).
  • Cancer was the major contributor to the higher mortality in the aspirin group, accounting for 1.6 excess deaths/1,000 PYs.
  • Cancer-related death occurred in 3.1% of the participants in the aspirin group and in 2.3% of those in the placebo group (HR: 1.31; 95% CI: 1.10-1.56).
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