n–3 Fatty Acids and Cardiovascular Outcomes in Patients with Dysglycemia

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This article (10.1056/NEJMoa1203859) was published on June 11, 2012, at NEJM.org.

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Background
The use of n–3 fatty acids may prevent cardiovascular events in patients with recent
myocardial infarction or heart failure. Their effects in patients with (or at risk for)
type 2 diabetes mellitus are unknown.
Methods
In this double-blind study with a 2-by-2 factorial design, we randomly assigned
12,536 patients who were at high risk for cardiovascular events and had impaired
fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule
containing at least 900 mg (90% or more) of ethyl esters of n–3 fatty acids or placebo
daily and to receive either insulin glargine or standard care. The primary
outcome was death from cardiovascular causes. The results of the comparison between
n–3 fatty acids and placebo are reported here.
Results
During a median follow up of 6.2 years, the incidence of the primary outcome was
not significantly decreased among patients receiving n–3 fatty acids, as compared
with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard
ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n–3 fatty
acids also had no significant effect on the rates of major vascular events (1034 patients
[16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10;
P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95%
CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%];
hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by
14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n–3 fatty
acids than among those receiving placebo (P<0.001), without a significant effect on
other lipids. Adverse effects were similar in the two groups.

Conclusions

Daily supplementation with 1 g of n–3 fatty acids did not reduce the rate of cardiovascular
events in patients at high risk for cardiovascular events.
(Funded by Sanofi;ORIGIN ClinicalTrials.gov number, NCT00069784.)