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JELIS
Japan EPA Lipid Intervention Study
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Author(s) |
(a) Yokoyama M, Origasa H
(b) 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
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Title(s) |
(a) Effects of eicosapentaenoic acid on cardiovascular events in Japanese patients with hypercholesterolemia: Rationale, design, and baseline characteristics of the Japan EPA Lipid Intervention Study (JELIS)
(b) Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis
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Reference(s) |
(a) Am Heart J 2003;146:613–20
(b) Lancet 2007;369:1090–8
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Disease |
Hypercholesterolaemia |
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Purpose |
To investigate whether long-term treatment with eicosapentaenoic acid (EPA), in addition to statin therapy, is effective in the prevention of cardiovascular events in patients with hypercholesterolaemia |
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Study design |
Randomised, open, blinded endpoint
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Follow-up |
Mean 4.6 ± 1.1 years
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Patients |
Primary prevention: 14,981 patients (7503 EPA, 7478 control), mean age 61 years, with total cholesterol ≥ 6.5 mmol/l and LDL cholesterol ≥ 4.4 mmol/l
Secondary prevention: 3664 patients (1823 EPA, 1841 control), mean age 61 years, with total cholesterol ≥ 6.5 mmol/l, LDL cholesterol ≥ 4.4 mmol/l and clinical evidence of atherosclerotic coronary artery disease
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Treatment regimen |
EPA, 600 mg tid, or not |
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Concomitant therapy |
Pravastatin, 10–20 mg/day, or simvastatin, 5–10 mg/day |
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Results |
Among both arms combined, the primary endpoint of any major coronary event, including sudden cardiac death, fatal and nonfatal MI and other nonfatal events (including unstable angina pectoris, angioplasty, stenting or CABG) occurred in 2.8% of patients in the EPA group and 3.5% of patients in the control group (relative risk reduction 19%; p = 0.011). In the primary prevention arm, there was no significant difference between the EPA and control groups in the incidence of the primary endpoint (1.4% vs 1.7%, hazard ratio 0.82, 95% CI 0.63–1.06; p = 0.132). In the secondary prevention arm, 8.7% of patients taking EPA reached the primary endpoint compared to 10.7% of control patients (hazard ratio 0.81, 95% CI 0.66–1.00; p = 0.048)
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Comments |
Data comparing the incidence of coronary artery disease in patients with impaired glucose metabolism vs patients with normoglycaemia have been published in Atherosclerosis 2009;206:535–9
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