McNeil JJ, et al. - Researchers investigated the effect of daily low-dose aspirin therapy on disability-free life in healthy seniors. Outcomes revealed that healthy older individuals gained no benefit with aspirin treatment in term of prolonged disability-free survival but showed a higher rate of major hemorrhage compared with those receiving placebo.

Methods

• From 2010 through 2014, researchers enrolled 19,114 community-dwelling men and women (median age: 74 years; 56.4% were women; 8.7% were nonwhite; 11.0% reported previous regular aspirin use) 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 once-daily 100-mg enteric-coated aspirin (n=9,525) or placebo (n-9,589) orally.
• A composite of death, dementia, or persistent physical disability was assessed as the primary end point.
• The individual components of the primary end point and major hemorrhage were assessed as the secondary end points.

Results

• Researchers terminated the trial at a median of 4.7 years of follow-up, after they identified no utility of continued aspirin use with regard to the primary end point.
• In the aspirin group, the rate of the composite of death, dementia, or persistent physical disability was 21.5 events/1,000 person-years (PYs) and, in the placebo group, the respective value was 21.2 events/1,000 PYs (hazard ratio [HR]: 1.01; 95% confidence interval [CI]: 0.92-1.11; P=0.79).
• In the aspirin group and placebo group, the rate of adherence to the assigned intervention was 62.1% and 64.1%, respectively, in the in the final year of trial participation.
• No substantial differences were evident between the aspirin group and the placebo group with regard to the secondary individual end points of death from any cause (12.7 events/1,000 PYs in the aspirin group and 11.1 events/1,000 PYs in the placebo group), dementia, or persistent physical disability.
• The aspirin group displayed a higher rate of major hemorrhage than the placebo group (3.8% vs 2.8%, respectively; HR: 1.38; 95% CI: 1.18-1.62; P < 0.001).