Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease Clinical Trial
Official title:
Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS)
The purpose of this study was to test the hypothesis that the long-term use of highly (＞98%) purified EPA, in addition to HMG-CoA reductase inhibitor (statin), would be more effective than statin alone in preventing cardiovascular events in Japanese patients with hypercholesterolemia.
Epidemiological studies from many countries including Finland, Italy, Japan, and The
Netherlands have suggested that an increased intake of dietary fish or fish oil rich in the
long-chain polyunsaturated n-3 fatty acids (PUFAs), eicosapentaenoic acid (EPA) and
docosahexaenoic acid (DHA), is inversely related to the risk of atherothrombotic diseases,
in particular coronary artery disease (CAD).
Results of many prospective observational cohort studies have found that diets rich in
marine PUFAs may be protective against major cardiovascular events, including mortality from
CAD, total cardiovascular death, all-cause mortality, and nonfatal myocardial infarction. To
date, only a few studies have examined the effects of purified n-3 PUFA preparations in
human subjects for short observation periods. The principle aim of the current study is to
test the hypothesis that the long-term use of highly purified EPA(eicosapentaenoic acid:
1800mg/day), in addition to HMG-CoA reductase inhibitor, is effective in preventing
cardiovascular events in Japanese patients with hypercholesterolemia.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention