Financiado en parte por Mochida Pharmaceutical Company
Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis
Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Saito Y, Ishikawa Y, Oikawa S, Sasaki J, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K, Japan EPA lipid intervention study (JELIS) Investigators
Lancet (London, England) · 1,751 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Organización sin fines de lucro
- American Heart Association
- Empresa
- Mochida Pharmaceutical Company
Según 2 financiadores declarados.
Publicación
- Publicado
- 2007-03-01 · Lancet · vol. 369 · número 9567 · págs. 1090–1098
- Editorial
- Elsevier BV
- Citado
- 2,518 citas · más que el 100% de estudios similares · 108.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 50 trabajos
- Acceso
- De pago
- Áreas de investigación
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Nutritional Studies and Diet
- Palabras clave
- eicosapentaenoic acid, omega-3 fatty acids, hypercholesterolemia, major coronary events, secondary prevention, statins, LDL cholesterol, sudden cardiac death, myocardial infarction, unstable angina, coronary artery disease, fish consumption, cardiovascular risk reduction, Japanese patients, n-3 long-chain polyunsaturated fatty acids, coronary angioplasty
- MeSH
- humans, coronary disease, hypercholesterolemia, eicosapentaenoic acid, diet, adult, aged, middle aged, japan, female, male
16 autores
- Mitsuhiro Yokoyama🇯🇵 · autor de correspondenciaKobe University
- Hideki Origasa🇯🇵University of Toyama
- Masunori Matsuzaki🇯🇵Yamaguchi University
- Yūji Matsuzawa🇯🇵Sumitomo Hospital
- Yasushi Saitō🇯🇵Chiba University
- Yuichi Ishikawa🇯🇵Kobe University
- Shinichi Oikawa🇯🇵Nippon Medical School
- Junichi Sasaki🇯🇵International University of Health and Welfare
- Hitoshi Hishida🇯🇵Fujita Health University
- Hiroshige Itakura🇯🇵Ibaraki Christian University
- Toru Kita🇯🇵Kyoto University
- Akira Kitabatake
- Noriaki Nakaya
- Toshiie Sakata🇯🇵Nakamura Gakuen University
- Kazuyuki Shimada🇯🇵Jichi Medical University
- Kunio Shirato
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 fatty acids protects against mortality from coronary artery disease. We aimed to test the hypothesis that long-term use of eicosapentaenoic acid (EPA) is effective for prevention of major coronary events in hypercholesterolaemic patients in Japan who consume a large amount of fish.
Methods
18 645 patients with a total cholesterol of 6.5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999. Patients were randomly assigned to receive either 1800 mg of EPA daily with statin (EPA group; n=9326) or statin only (controls; n=9319) with a 5-year follow-up. The primary endpoint was any major coronary event, including sudden cardiac death, fatal and non-fatal myocardial infarction, and other non-fatal events including unstable angina pectoris, angioplasty, stenting, or coronary artery bypass grafting. Analysis was by intention-to-treat. The study was registered at ClinicalTrials.gov, number NCT00231738.
Findings
At mean follow-up of 4.6 years, we detected the primary endpoint in 262 (2.8%) patients in the EPA group and 324 (3.5%) in controls-a 19% relative reduction in major coronary events (p=0.011). Post-treatment LDL cholesterol concentrations decreased 25%, from 4.7 mmol/L in both groups. Serum LDL cholesterol was not a significant factor in a reduction of risk for major coronary events. Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group. Sudden cardiac death and coronary death did not differ between groups. In patients with a history of coronary artery disease who were given EPA treatment, major coronary events were reduced by 19% (secondary prevention subgroup: 158 [8.7%] in the EPA group vs 197 [10.7%] in the control group; p=0.048). In patients with no history of coronary artery disease, EPA treatment reduced major coronary events by 18%, but this finding was not significant (104 [1.4%] in the EPA group vs 127 [1.7%] in the control group; p=0.132).
Interpretation
EPA is a promising treatment for prevention of major coronary events, and especially non-fatal coronary events, in Japanese hypercholesterolaemic patients.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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