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Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus
Factorial RCT component in 15,480 adults with diabetes without known ASCVD: 1 g/day n-3 capsules did not reduce first serious vascular events versus olive-oil placebo (689 vs 712 events; rate ratio 0.97; 95% CI 0.87–1.08; P=0.55) over mean 7.4 years.
Design
- Population: 15,480 UK adults with diabetes, no known atherosclerotic CVD
- Intervention: 1 g/day n-3 fatty acid capsules vs olive-oil placebo (trial also randomised aspirin separately)
- Primary outcome: first serious vascular event (nonfatal MI or stroke/TIA, or vascular death, excluding confirmed intracranial haemorrhage)
Primary result
- Serious vascular events: 689 (8.9%) (n-3) vs 712 (9.2%) (placebo)
- Rate ratio 0.97 (95% CI 0.87–1.08; P = 0.55)
Secondary composites (abstract)
- Serious vascular event or revascularisation: 11.4% vs 11.5% (RR 1.00, 95% CI 0.91–1.09)
- All-cause mortality: 9.7% vs 10.2% (RR 0.95, 95% CI 0.86–1.05)
Evidence hygiene
Primary-prevention null for routine mixed n-3 capsules in diabetes—do not equate with high-dose prescription EPA outcome trials (REDUCE-IT).
Publication
ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, et al. N Engl J Med. 2018 Oct 18;379(16):1540-1550. PMID 30146932.
Outcomes
- Primary serious vascular events: rate ratio 0.97 (95% CI 0.87–1.08; P=0.55) for n-3 fatty acid 1 g/day vs olive-oil placebo over mean 7.4 years (689 vs 712 events; ASCEND n-3 arm).
- All-cause mortality: rate ratio 0.95 (95% CI 0.86–1.05) for n-3 fatty acid vs placebo (ASCEND n-3 arm abstract).