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Randomized Controlled Trial
. 2018 Oct 18;379(16):1540-1550.
doi: 10.1056/NEJMoa1804989. Epub 2018 Aug 26.

Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus

ASCEND Study Collaborative Group; Louise Bowman, Marion Mafham, Karl Wallendszus, Will Stevens, Georgina Buck, Jill Barton, Kevin Murphy, Theingi Aung, Richard Haynes, Jolyon Cox, Aleksandra Murawska, Allen Young, Michael Lay, Fang Chen, Emily Sammons, Emma Waters, Amanda Adler, Jonathan Bodansky, Andrew Farmer, Roger McPherson, Andrew Neil, David Simpson, Richard Peto, Colin Baigent, Rory Collins, Sarah Parish, Jane Armitage
Collaborators
Free article
Randomized Controlled Trial

Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus

ASCEND Study Collaborative Group et al. N Engl J Med. .
Free article

Abstract

Background: Increased intake of n-3 fatty acids has been associated with a reduced risk of cardiovascular disease in observational studies, but this finding has not been confirmed in randomized trials. It remains unclear whether n-3 (also called omega-3) fatty acid supplementation has cardiovascular benefit in patients with diabetes mellitus.

Methods: We randomly assigned 15,480 patients with diabetes but without evidence of atherosclerotic cardiovascular disease to receive 1-g capsules containing either n-3 fatty acids (fatty acid group) or matching placebo (olive oil) daily. The primary outcome was a first serious vascular event (i.e., nonfatal myocardial infarction or stroke, transient ischemic attack, or vascular death, excluding confirmed intracranial hemorrhage). The secondary outcome was a first serious vascular event or any arterial revascularization.

Results: During a mean follow-up of 7.4 years (adherence rate, 76%), a serious vascular event occurred in 689 patients (8.9%) in the fatty acid group and in 712 (9.2%) in the placebo group (rate ratio, 0.97; 95% confidence interval [CI], 0.87 to 1.08; P=0.55). The composite outcome of a serious vascular event or revascularization occurred in 882 patients (11.4%) and 887 patients (11.5%), respectively (rate ratio, 1.00; 95% CI, 0.91 to 1.09). Death from any cause occurred in 752 patients (9.7%) in the fatty acid group and in 788 (10.2%) in the placebo group (rate ratio, 0.95; 95% CI, 0.86 to 1.05). There were no significant between-group differences in the rates of nonfatal serious adverse events.

Conclusions: Among patients with diabetes without evidence of cardiovascular disease, there was no significant difference in the risk of serious vascular events between those who were assigned to receive n-3 fatty acid supplementation and those who were assigned to receive placebo. (Funded by the British Heart Foundation and others; Current Controlled Trials number, ISRCTN60635500 ; ClinicalTrials.gov number, NCT00135226 .).

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