Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease
Conditions
Keywords
Eicosapentaenoic acid, Coronary artery disease
Brief summary
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.
Detailed description
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.
Interventions
DRUGEicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)
Sponsors
Mochida Pharmaceutical Company, Ltd.
Kobe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Eligible participants had a total cholesterol level of ≧250mg/dL(6.5m mol/L) at baseline. * Hyperlipidemic patients with serum total cholesterol of 250mg/dL or more. (Measurement of serum total cholesterol) * Serum total cholesterol should be measured twice at interval of 2-4weeks. A single measurement is acceptable if the cholesterol is measured by blood collection at fasting under strict compliance with dietary advice after withdrawal of the antihyperlipemic drug. * (Wash Out) The wash out period of 4weeks (8 weeks for probucol) is necessary in patients under treatment with antihyperlipemic drug. However, if treatment with the antihyperlipemic drug was started within 6 months of the initiation of the study, the patient can participate in the study without the washout period.
Exclusion criteria
* Acute myocardial infarction occurring within last 6 months * Unstable angina pectoris * A history or complication of serious heart disease(severe arrhythmia, heart failure, cardiac myopathy, valvular disease, congenital disease, etc.) * Receiving cardiovascular reconstruction within last 6 months * Cerebrovascular disorders occurring within last 6 months * Complication of serious hepatic disease or renal disease * Malignant tumor * Uncontrollable diabetes * Hyperlipidemia arising from the following disease: Nephrotic syndrome, hypothyroidism, Cushing's syndrome, secondary hyperlipidemia due to other disease * Hyperlipidemia due to some drugs such as steroid hormone * Hemorrhage(hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.) * Hemorrhagic diathesis * Hypersensitivity to the study drug formulation * Patients intending to undergo surgery * Patients judged to be inappropriate by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | — |
| Stroke | — |
| Peripheral artery disease; and | — |
| Cancer | — |
Countries
Japan
Outcome results
None listed