Effects of n-3 fatty acids on long-term outcomes of high risk patients with type 2 diabetes mellitus or IGF/IGT with a recent myocardial infarction

Purpose: The ORIGIN trial showed that daily supplementation with 1 g of n–3 fatty acids did not reduce the rate of Cardiovascular (CV) events in high risk patients with type 2 Diabetes Mellitus (DM) or IFG/IGT. This ancillary analysis of the trial is aimed to evaluate the effect of this treatment in the subgroup of patients with a recent Myocardial Infarction (MI) in whom the use of n–3 fatty acids has been previously demonstrated to be able to prevent CV events in patients within 3 months of a MI. Methods: The ORIGIN study randomly assigned patients to receive a 1g capsule containing at least 900 mg (90% or more) of ethyl esters of n–3 fatty acids or placebo daily. Long term outcomes were compared between n–3 fatty acids and placebo in the subgroup of patients with a recent MI (<6 months). Estimates of the hazard ratios and two-sided 95% confidence intervals were calculated with the use of a Cox regression model stratified according to study treatments, baseline metabolic status and a history of CV disease. Results: Of the 12,536 patients entered in ORIGIN, 931 suffered a MI in the 6 months prior to randomization. Mean age was 62 years, female gender accounted for 23% of the cases. The incidences of the primary outcome of the study (CV death) and of other relevant CV event during a median follow-up period of 6.2 years are reported in the Table. Outcome Omega 3 (n=439) Placebo (n=492) Adjusted HR (95% CI) CV death, % 11.8 10.0 1.19 (0.80–1.75) All-cause death, % 17.3 14.8 1.16 (0.84–1.60) Non fatal MI, % 8.7 9.1 0.95 (0.62–1.46) Non fatal stroke, % 2.1 4.3 0.47 (0.22–1.04) CV death, MI, stroke, % 19.8 20.3 0.96 (0.72–1.29) All-cause death, MI, stroke, % 25.1 25.2 0.98 (0.76–1.27) Conclusions: As in the overall population of the study of high risk patients with a recent diagnosis of DM or IGT/IGF, a daily supplementation with 1 g of n–3 fatty acids did not reduce the rate of CV events even in those with a recent MI.