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Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus
RCT in 15,480 adults with diabetes without evident CVD: aspirin 100 mg/day reduced first serious vascular events (rate ratio 0.88) but increased major bleeding (rate ratio 1.29) over mean 7.4 years versus placebo.
Design
- Population: 15,480 adults with diabetes and no evident CVD at baseline
- Arms: aspirin 100 mg daily vs matching placebo
- Co-primary style outcomes: serious vascular events (efficacy) and major bleeding (safety)
Results (mean follow-up 7.4 y)
- Serious vascular events: 658 (8.5%) (aspirin) vs 743 (9.6%) (placebo); rate ratio 0.88 (95% CI 0.79–0.97; P = 0.01)
- Major bleeding: 314 (4.1%) vs 245 (3.2%); rate ratio 1.29 (95% CI 1.09–1.52; P = 0.003)
Cancer endpoints (null at this follow-up)
- GI tract cancers and all cancers did not differ significantly between groups in the primary report (longer follow-up planned)
Evidence hygiene
This is pharmacologic primary prevention, not a diet pattern trial—use for aspirin benefit/bleeding balance in diabetes, not as DASH/Mediterranean evidence.
Publication
ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, et al. N Engl J Med. 2018 Oct 18;379(16):1529-1539. PMID 30146931.
Outcomes
- First serious vascular event: rate ratio 0.88 (95% CI 0.79–0.97; P=0.01) for aspirin 100 mg/day vs placebo (ASCEND; mean follow-up 7.4 years).
- First major bleeding event: rate ratio 1.29 (95% CI 1.09–1.52; P=0.003) for aspirin vs placebo (ASCEND).