Protective Effect of EPA on Cardiovascular Events
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.
Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease
Drug: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS)|
- Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)
- All-cause mortality
- Peripheral artery disease; and
|Study Start Date:||November 1996|
|Estimated Study Completion Date:||November 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231738
|Kobe University Graduate School of Medicine Cardiovascular and Respiratory Medicine Division, Department of Internal Medicine|
|Kobe, Hyogo-prefecture, Japan, 650-0017|
|Principal Investigator:||Mitsuhiro Yokoyama, MD, PhD.|