Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis - PubMed (original) (raw)
Randomized Controlled Trial
. 2007 Mar 31;369(9567):1090-8.
doi: 10.1016/S0140-6736(07)60527-3.
Hideki Origasa, Masunori Matsuzaki, Yuji Matsuzawa, Yasushi Saito, Yuichi Ishikawa, Shinichi Oikawa, Jun Sasaki, Hitoshi Hishida, Hiroshige Itakura, Toru Kita, Akira Kitabatake, Noriaki Nakaya, Toshiie Sakata, Kazuyuki Shimada, Kunio Shirato; Japan EPA lipid intervention study (JELIS) Investigators
Affiliations
- PMID: 17398308
- DOI: 10.1016/S0140-6736(07)60527-3
Randomized Controlled Trial
Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis
Mitsuhiro Yokoyama et al. Lancet. 2007.
Erratum in
- Lancet. 2007 Jul 21;370(9583):220
Abstract
Background: Epidemiological and clinical evidence suggests that an increased intake of long-chain n-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 hypercholesterolaemic 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; n=9326) or statin only (controls; n=9319) 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: 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). Post-treatment LDL 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. Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group. Sudden cardiac death and coronary death did not differ between groups. 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). 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 hypercholesterolaemic patients.
Comment in
- JELIS, fish oil, and cardiac events.
Mozaffarian D. Mozaffarian D. Lancet. 2007 Mar 31;369(9567):1062-3. doi: 10.1016/S0140-6736(07)60504-2. Lancet. 2007. PMID: 17398290 No abstract available. - Eicosapentaenoic acid for prevention of major coronary events.
Galli C, Risé P, Sirtori C. Galli C, et al. Lancet. 2007 Jul 21;370(9583):215. doi: 10.1016/S0140-6736(07)61113-1. Lancet. 2007. PMID: 17658383 No abstract available. - Eicosapentaenoic acid for prevention of major coronary events.
Colhoun HM. Colhoun HM. Lancet. 2007 Jul 21;370(9583):215. doi: 10.1016/S0140-6736(07)61112-X. Lancet. 2007. PMID: 17658384 No abstract available. - Does treatment with eicosapentaenoic acid prevent major coronary events in patients with hypercholesterolemia?
Harris WS. Harris WS. Nat Clin Pract Cardiovasc Med. 2007 Oct;4(10):532-3. doi: 10.1038/ncpcardio0967. Epub 2007 Aug 14. Nat Clin Pract Cardiovasc Med. 2007. PMID: 17700546 No abstract available. - Long term use of eicosapentaenoic acid reduced major coronary events in hypercholesterolaemia.
Newby LK. Newby LK. Evid Based Med. 2007 Oct;12(5):136. doi: 10.1136/ebm.12.5.136. Evid Based Med. 2007. PMID: 17909227 No abstract available.
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