ASCEND (A Study of Cardiovascular Events in Diabetes)

Summary

15,480 diabetics without any sign of existing cardiovascular disease were randomly assigned to receive a daily 1 g capsule of omega-3 fatty acids (840 mg of EPA+DHA) or a placebo.
Participants were followed for an average of 7.4 years, and as a primary outcome, the study found no difference between the two groups in the rate of major cardiovascular events, but there was a statistically significant 19% reduction in the risk of vascular death.
Diabetics are at a much higher risk of cardiovascular events than the general population, and this study is the first interventional trial to evaluate the effect of omega-3s on this high-risk population.

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.

Source: https://www.ncbi.nlm.nih.gov/pubmed/30146932