Protective Effect of EPA on Cardiovascular Events

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kobe University
• Collaborator: Mochida Pharmaceutical Company, Ltd.
• Treatments: Eicosapentaenoic acid ethyl ester

Criteria

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