Effects of n−3 Fatty
Acid Supplements in Diabetes Mellitus
·
The ASCEND Study Collaborative Group
Abstract NEW ENGLAND JOURNAL OF MEDICINE
AUGUST 26, 2018
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.)