Effects of eicosapentaenoic acid [EPA fish oil] on major coronary events in hypercholesterolemic patients (JELIS): A randomized open-label, blinded endpoint analysis

[Note: eicosapentaenoic acid (EPA) is an omega 3 fatty acid obtained in the human diet by eating oily fish or fish oil. It is also found in human breast milk. Hypercholesterolemic patients are tested to have an "excessive quantity of cholesterol in the blood and tissues." Statins are drugs prescribed to improve cholesterol levels.]

Journal: Lancet, 2007; 369(9567): 1090-1098.

Authors and affiliation: Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Saito Y, Ishikawa Y, Oikawa S, Sasaki J, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K. Japan EPA lipid intervention study (JELIS) Investigators, Kobe University, Kobe, Japan [E-mail: yokoyama@med.kobe-u.ac.jp ]

PMID: 17398308

Background: Epidemiological and clinical evidence suggests that an increased intake of long-chain omega-3 fatty acids protects against mortality from coronary artery disease. We aimed to test the hypothesis that long-term use of eicosapentaenoic acid (EPA) is effective for prevention of major coronary events in hypercholesterolemic patients in Japan who consume a large amount of fish.

Methods: 18,645 patients with a total cholesterol of 6.5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999.

Patients were randomly assigned to receive either 1800 mg of EPA daily with statin (EPA group; number=9,326) or statin only (controls; number=9,319) with a 5-year follow-up. The primary endpoint was any major coronary event, including sudden cardiac death, fatal and non-fatal myocardial infarction, and other non-fatal events including unstable angina pectoris, angioplasty, stenting, or coronary artery bypass grafting.

Analysis was by intention-to-treat. The study was registered at ClinicalTrials.gov, number NCT00231738.

Findings: n At mean follow-up of 4.6 years, we detected the primary endpoint in 262 (2.8%) patients in the EPA group and 324 (3.5%) in controls – a 19% relative reduction in major coronary events (p=0.011). n Post-treatment LDL [“bad”] cholesterol concentrations decreased 25%, from 4.7 mmol/L in both groups. Serum LDL cholesterol was not a significant factor in a reduction of risk for major coronary events. n Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group. n Sudden cardiac death and coronary death did not differ between groups. n In patients with a history of coronary artery disease who were given EPA treatment, major coronary events were reduced by 19% (secondary prevention subgroup: 158 [8.7%] in the EPA group vs 197 [10.7%] in the control group; p=0.048). n In patients with no history of coronary artery disease, EPA treatment reduced major coronary events by 18%, but this finding was not significant (104 [1.4%] in the EPA group vs 127 [1.7%] in the control group; p=0.132).

Interpretation: EPA is a promising treatment for prevention of major coronary events, and especially non-fatal coronary events, in Japanese hypercholesterolemic patients.

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