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ASPREE

"Aspirin Use for the Primary Prevention of Cardiovascular Disease and Colorectal Cancer in the Elderly." The New England Journal of Medicine. 2018.

Clinical Question

Does daily low-dose aspirin therapy extend disability-free life in healthy seniors?

Bottom Line

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.

Major Points

Guidelines

No new guidelines have been directly impacted by the results of this study, as the focus is on healthy elderly individuals without cardiovascular disease, a group for which guidelines regarding aspirin use for primary prevention are not well-established.

Design

Multicenter, double-blind, placebo-controlled randomized trial.
N=19,114 participants aged ≥70 years (or ≥65 years among blacks and Hispanics in the U.S.).
Participants were randomized to receive 100 mg of enteric-coated aspirin daily (n=9525) or matching placebo (n=9589).
Median follow-up: 4.7 years.

Population

Inclusion Criteria: Individuals aged 70 years or older (or ≥65 years among blacks and Hispanics in the U.S.), without cardiovascular disease, dementia, or physical disability.
Exclusion Criteria: Chronic illness limiting survival to <5 years, documented cardiovascular or cerebrovascular disease, clinical diagnosis of dementia, high risk of bleeding, contraindication to aspirin, and significant physical disability.

Interventions

Random assignment to a 100-mg tablet of enteric-coated aspirin or matching placebo daily.

Outcomes

Primary Outcome: Composite of death, dementia, or persistent physical disability. The rate was 21.5 events per 1000 person-years in the aspirin group versus 21.2 per 1000 person-years in the placebo group (hazard ratio, 1.01; 95% CI, 0.92 to 1.11; P=0.79).
Secondary Outcomes: Individual components of the primary end point and major hemorrhage; 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).

Criticisms

- The relatively short duration of the intervention may have been insufficient to detect potential long-term benefits of aspirin in preventing conditions with long latency, such as Alzheimer’s disease and some cancers.
- The trial does not address whether elderly persons who have been using aspirin for primary prevention should continue or discontinue its use.
- Due to the trial's predominant ethnicity being white, the applicability of the trial findings to other racial and ethnic groups is unclear.

Funding

Supported by a grant from the National Institute on Aging and the National Cancer Institute at the National Institutes of Health, grants from the National Health and Medical Research Council of Australia, Monash University, and the Victorian Cancer Agency.