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Effects of eicosapentaenoic acid on cardiovascular events in Japanese patients with hypercholesterolemia: rationale, design, and baseline characteristics of the Japan EPA Lipid Intervention Study (JELIS).
Am Heart J. 2003 Oct; 146(4):613-20.AH

Abstract

HYPOTHESIS

The principle aim of the current study is to test the hypothesis that the long-term use of highly purified EPA (eicosapentaenoic acid: 1800 mg/day), in addition to HMG-CoA reductase inhibitor, is effective in preventing cardiovascular events in Japanese patients with hypercholesterolemia.

BACKGROUND

Epidemiological and clinical evidence suggest that intake of long-chain polyunsaturated n-3 fatty acids (PUFAs), which are abundant in fish, might have a significant role in the prevention of coronary artery disease, as marine PUFAs have multiple biological functions through lipid-dependent and lipid-independent mechanisms.

METHODS

The Japan EPA Lipid Intervention Study (JELIS) is a prospective, randomized, open-label, blinded end point trial including both primary and secondary prevention strata, with a maximum follow-up of 5 years. Its main purpose is to examine the clinical effectiveness of EPA oil given as an additional treatment to patients taking HMG-CoA reductase inhibitors for hypercholesterolemia. A primary end point is major coronary events: sudden cardiac death, fatal and nonfatal myocardial infarction, and unstable angina pectoris including hospitalization for documented ischemic episodes, and events of angioplasty/stenting or coronary artery bypass grafting. Secondary end points include all-cause mortality, stroke, peripheral artery disease, and cancer. Baseline study composition comprises 15,000 participants (4204 men and 10,796 women) in the primary prevention stratum and 3645 (1656 men and 1989 women) in the secondary stratum. The minimum age is 40 years for men, women are required to be postmenopausal, and all patients must be < or =75 years of age. The mean age of participants is 61 years, and 69% are female. The schedule for plasma fatty acid composition measurement is as follows: at baseline, at 6 month, and yearly thereafter. The mean baseline total and low-density lipoprotein cholesterol levels were 275 mg/dL (7.1 mmol/L) and 180 mg/dL (4.6 mmol/L).

RESULTS

Results are expected in 2005.

CONCLUSION

JELIS is a large clinical trial that will evaluate whether EPA can make an additional improvement in mortality and morbidity of coronary artery disease beyond that of HMG-CoA reductase inhibitor treatment.

Authors+Show Affiliations

Division of Cardiovascular and Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. yokoyama@med.kobe-u.ac.jpNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14564313

Citation

Yokoyama, Mitsuhiro, et al. "Effects of Eicosapentaenoic Acid On Cardiovascular Events in Japanese Patients With Hypercholesterolemia: Rationale, Design, and Baseline Characteristics of the Japan EPA Lipid Intervention Study (JELIS)." American Heart Journal, vol. 146, no. 4, 2003, pp. 613-20.
Yokoyama M, Origasa H, JELIS Investigators. Effects of eicosapentaenoic acid on cardiovascular events in Japanese patients with hypercholesterolemia: rationale, design, and baseline characteristics of the Japan EPA Lipid Intervention Study (JELIS). Am Heart J. 2003;146(4):613-20.
Yokoyama, M., & Origasa, H. (2003). Effects of eicosapentaenoic acid on cardiovascular events in Japanese patients with hypercholesterolemia: rationale, design, and baseline characteristics of the Japan EPA Lipid Intervention Study (JELIS). American Heart Journal, 146(4), 613-20.
Yokoyama M, Origasa H, JELIS Investigators. Effects of Eicosapentaenoic Acid On Cardiovascular Events in Japanese Patients With Hypercholesterolemia: Rationale, Design, and Baseline Characteristics of the Japan EPA Lipid Intervention Study (JELIS). Am Heart J. 2003;146(4):613-20. PubMed PMID: 14564313.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of eicosapentaenoic acid on cardiovascular events in Japanese patients with hypercholesterolemia: rationale, design, and baseline characteristics of the Japan EPA Lipid Intervention Study (JELIS). AU - Yokoyama,Mitsuhiro, AU - Origasa,Hideki, AU - ,, PY - 2003/10/18/pubmed PY - 2003/11/5/medline PY - 2003/10/18/entrez SP - 613 EP - 20 JF - American heart journal JO - Am. Heart J. VL - 146 IS - 4 N2 - HYPOTHESIS: The principle aim of the current study is to test the hypothesis that the long-term use of highly purified EPA (eicosapentaenoic acid: 1800 mg/day), in addition to HMG-CoA reductase inhibitor, is effective in preventing cardiovascular events in Japanese patients with hypercholesterolemia. BACKGROUND: Epidemiological and clinical evidence suggest that intake of long-chain polyunsaturated n-3 fatty acids (PUFAs), which are abundant in fish, might have a significant role in the prevention of coronary artery disease, as marine PUFAs have multiple biological functions through lipid-dependent and lipid-independent mechanisms. METHODS: The Japan EPA Lipid Intervention Study (JELIS) is a prospective, randomized, open-label, blinded end point trial including both primary and secondary prevention strata, with a maximum follow-up of 5 years. Its main purpose is to examine the clinical effectiveness of EPA oil given as an additional treatment to patients taking HMG-CoA reductase inhibitors for hypercholesterolemia. A primary end point is major coronary events: sudden cardiac death, fatal and nonfatal myocardial infarction, and unstable angina pectoris including hospitalization for documented ischemic episodes, and events of angioplasty/stenting or coronary artery bypass grafting. Secondary end points include all-cause mortality, stroke, peripheral artery disease, and cancer. Baseline study composition comprises 15,000 participants (4204 men and 10,796 women) in the primary prevention stratum and 3645 (1656 men and 1989 women) in the secondary stratum. The minimum age is 40 years for men, women are required to be postmenopausal, and all patients must be < or =75 years of age. The mean age of participants is 61 years, and 69% are female. The schedule for plasma fatty acid composition measurement is as follows: at baseline, at 6 month, and yearly thereafter. The mean baseline total and low-density lipoprotein cholesterol levels were 275 mg/dL (7.1 mmol/L) and 180 mg/dL (4.6 mmol/L). RESULTS: Results are expected in 2005. CONCLUSION: JELIS is a large clinical trial that will evaluate whether EPA can make an additional improvement in mortality and morbidity of coronary artery disease beyond that of HMG-CoA reductase inhibitor treatment. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/14564313/Effects_of_eicosapentaenoic_acid_on_cardiovascular_events_in_Japanese_patients_with_hypercholesterolemia:_rationale_design_and_baseline_characteristics_of_the_Japan_EPA_Lipid_Intervention_Study__JELIS__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002870303003673 DB - PRIME DP - Unbound Medicine ER -