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

ORIGIN Trial , Study (2012) n–3 Fatty Acids and Cardiovascular Outcomes in Patients with Dysglycemia. New England Journal of Medicine, 367 (4). p. 309. ISSN 0028-4793

[img]PDF
Restricted to MDRF users only. Others may ->

674Kb

Abstract

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.)

Item Type:Article
Official URL/DOI:http://dx.doi.org/10.1056/NEJMoa1203859
Uncontrolled Keywords:ORIGIN Trial Investigators; Fatty Acids; Cardiovascular
Subjects:Diabetes Clinical Trials
Diabetology > Cardiovascular Diabetology
Divisions:Department of Clinical Trials
ID Code:727
Deposited By:surendar radha
Deposited On:14 Oct 2013 13:09
Last Modified:14 Oct 2013 13:09

Repository Staff Only: item control page