ASPREE (Aspirin in Reducing Events in the Elderly)

Design

19,114 healthy adults ≥70 (or ≥65 if African American / Hispanic) in Australia/US randomised to low-dose aspirin (100 mg/day) or placebo, median follow-up 4.7 years.

Findings

• Primary endpoint (disability-free survival): no benefit.
• Cardiovascular events: no reduction.
• Major bleeding: 38% relative increase.
• All-cause mortality: 14% relative increase in aspirin arm (unexpected).
• Cancer mortality: 31% relative increase in aspirin arm (unexpected; possibly chance, possibly real).
• Dementia incidence: no effect.

Impact

ASPREE essentially ended routine aspirin for primary cardiovascular prevention in healthy older adults. USPSTF (2022) downgraded aspirin recommendations to selective use in 40–59-year-olds with elevated cardiovascular risk, after individualised discussion. Aspirin for secondary prevention (after established cardiovascular events) remains clearly beneficial.

Caveats

• The cancer-mortality signal is debated; some suggest the trial just caught more cancers earlier in the placebo arm. Long-term follow-up ongoing.
• ASPREE didn’t test the cancer-prevention benefit of long-term aspirin shown in colorectal trials — that benefit takes 10+ years to emerge.

Related entries

Low-dose aspirin, Cancer, Cardiovascular disease.