- Question
- To determine whether daily aspirin prevents first cardiovascular events in people with diabetes and no evident cardiovascular disease, and at what cost in bleeding.
- Design
- Randomized, double-blind, placebo-controlled trial with a 2x2 factorial design (aspirin vs. placebo and omega-3 vs. placebo), enrolling 15480 participants with a mean follow-up of 7.4 years.
- Population
- Adults with diabetes mellitus and no evident cardiovascular disease at trial entry.
- Intervention
- Aspirin 100 mg daily.
- Control
- Matching placebo for aspirin.
- Primary outcome
- Efficacy: first serious vascular event (myocardial infarction, stroke or TIA, or death from any vascular cause, excluding confirmed intracranial hemorrhage). Safety: first major bleeding event (intracranial hemorrhage, sight-threatening eye bleeding, gastrointestinal bleeding, or other serious bleeding).
- Results
- Serious vascular events were less frequent with aspirin (658 participants [8.5%] vs. 743 [9.6%]; rate ratio 0.88; 95% CI 0.79 to 0.97; P=0.01). There was no difference in gastrointestinal tract cancer (157 [2.0%] vs. 158 [2.0%]).
- Safety
- Major bleeding was more frequent with aspirin (314 participants [4.1%] vs. 245 [3.2%]; rate ratio 1.29; 95% CI 1.09 to 1.52; P=0.003), mostly gastrointestinal and other extracranial bleeding.
- Conclusion
- Aspirin prevented serious vascular events in people with diabetes and no prior cardiovascular disease, but it caused major bleeding that largely counterbalanced the absolute benefit.
- Why it matters
- It showed that in primary prevention in diabetes, the benefit of aspirin comes with a comparable bleeding risk, so routine use should be individualized rather than assumed.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026