Protective Effect of EPA on Cardiovascular Events

Kobe University

Status and phase

Completed

Phase 4

Conditions

Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease

Treatments

Drug: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00231738

MYokoyama - 001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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