Incremental effects of eicosapentaenoic acid on cardiovascular events in statin-treated patients with coronary artery disease

Circ J. 2009 Jul;73(7):1283-90. doi: 10.1253/circj.cj-08-1197. Epub 2009 May 8.

Abstract

Background: Results from JELIS (Japan EPA Lipid Intervention Study) demonstrated the efficacy of pure eicosapentaenoic acid (EPA) in preventing coronary artery disease (CAD) in hypercholesterolemic patients under statin treatment. The present study examined in detail whether EPA is effective for the secondary prevention of CAD.

Methods and results: Patients with established CAD and a total cholesterol level > or =250 mg/dl were observed with a mean follow-up of 4.6 years. They were randomly assigned to receive either 1,800 mg of EPA + statin (EPA group) or statin alone (control group). The incidence of major coronary events (MCE) were compared in the 2 groups. The incidence of MCE was significantly lower in the EPA group (8.7% vs 10.7%, adjusted hazard ratio =0.77, 95% confidence interval (CI) 0.63-0.96, P=0.017, number needed to treat (NNT) =49). Among 1,050 patients with prior myocardial infarction (MI), the incidence of MCE in the EPA group (15.0%) was significantly lower than that in the control group (20.1%, adjusted hazard ratio =0.73, 95%CI 0.54-0.98, P=0.033, NNT =19).

Conclusions: EPA is effective for secondary prevention of CAD, especially in individuals with prior MI, and should be added to conventional treatment.

Trial registration: ClinicalTrials.gov NCT00231738.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Cardiovascular Diseases / epidemiology
  • Cardiovascular Diseases / etiology
  • Cardiovascular Diseases / prevention & control*
  • Cholesterol, LDL / blood
  • Coronary Artery Disease / epidemiology
  • Coronary Artery Disease / etiology
  • Coronary Artery Disease / prevention & control*
  • Drug Therapy, Combination
  • Eicosapentaenoic Acid / therapeutic use*
  • Female
  • Follow-Up Studies
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hypercholesterolemia / blood
  • Hypercholesterolemia / complications
  • Hypercholesterolemia / drug therapy*
  • Incidence
  • Japan / epidemiology
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Triglycerides / blood

Substances

  • Cholesterol, LDL
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Triglycerides
  • Eicosapentaenoic Acid

Associated data

  • ClinicalTrials.gov/NCT00231738