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(Stroke. 2008;39:2052.)
© 2008 American Heart Association, Inc.

Original Contributions

Reduction in the Recurrence of Stroke by Eicosapentaenoic Acid for Hypercholesterolemic Patients

Subanalysis of the JELIS Trial

Kortaro Tanaka, MD; Yuichi Ishikawa, MD; Mitsuhiro Yokoyama, MD; Hideki Origasa, PhD; Masunori Matsuzaki, MD; Yasushi Saito, MD; Yuji Matsuzawa, MD; Jun Sasaki, MD; Shinichi Oikawa, MD; Hitoshi Hishida, MD; Hiroshige Itakura, MD; Toru Kita, MD; Akira Kitabatake, MD; Noriaki Nakaya, MD; Toshiie Sakata, MD; Kazuyuki Shimada, MD; Kunio Shirato, MD for the JELIS Investigators, Japan

From the Department of Neurology (K.T.), Toyama University Hospital, Toyama, Japan; Faculty of Health Sciences (Y.I.), Kobe University School of Medicine, Kobe, Japan; Division of Cardiovascular and Respiratory Medicine, Department of Internal Medicine (M.Y.), Kobe University Graduate School of Medicine, Kobe, Japan; Division of Biostatistics and Clinical Epidemiology (H.O.), University of Toyama, Toyama, Japan; Division of Cardiology, Department of Medicine and Clinical Science (M.M.), Yamaguchi University Graduate School of Medicine, Ube, Japan; Department of Clinical Cell Biology (Y.S.), Graduate School of Medicine, Chiba University, Chiba, Japan; Sumitomo Hospital (Y.M.), Osaka, Japan; International University of Health and Welfare Graduate School of Public Health Medicine (J.S.), Fukuoka, Japan; Division of Endocrinology and Metabolism (S.O.), Department of Medicine, Nippon Medical School, Tokyo, Japan; Division of Cardiology, Department of Internal Medicine (H.H.), Fujita Health University School of Medicine, Toyoake, Japan; Department of Food Science (H.I.), Ibaraki Christian University, College of Life Science, Hitachi, Japan; Department of Cardiovascular Medicine (T.K.), Kyoto University Graduate School of Medicine, Kyoto, Japan; Kano General Hospital (A.K.), Osaka, Japan; Nakaya Clinic (N.N.), Tokyo, Japan; Department of Nutritional Sciences, Faculty of Nutritional Science (T.S.), Nakamura Gakuen University, Fukuoka, Japan; Division of Cardiovascular Medicine, Department of Medicine (K.S.), Jichi Medical School, Tochigi, Japan; and Saito Hospital (K.S.), Ishinomaki, Japan.

Correspondence to Kortaro Tanaka, MD, Department of Neurology, Toyama University Hospital, 2630 Sugitani, Toyama, Toyama, 930-0194, Japan. E-mail kortaro{at}med.u-toyama.ac.jp

Background and Purpose— The JELIS trial examined the preventive effect of eicosapentaenoic acid (EPA) against coronary artery diseases. Hypercholesterolemic patients received statin only (no EPA group: n=9319) or statin with EPA (EPA group: n=9326) for around 5 years. EPA significantly suppressed the incidence of coronary events in previous analysis. Herein, we investigated the effects of EPA on the primary and secondary prevention of stroke.

Methods— We conducted a subanalysis of JELIS with respect to stroke incidence in the primary and secondary prevention subgroups defined as those without and with a prior history of stroke using Cox proportional hazard ratios, adjusted for baseline risk factor levels.

Results— As for primary prevention of stroke, this occurred in 114 (1.3%) of 8862 no EPA group and in 133 (1.5%) of 8841 EPA group. No statistically significant difference in total stroke incidence (Hazard Ratio, 1.08; 95% confidence interval, 0.95 to 1.22) was observed between the no EPA and the EPA groups. In the secondary prevention subgroup, stroke occurred in 48 (10.5%) of 457 no EPA group and in 33 (6.8%) of 485 EPA group, showing a 20% relative reduction in recurrent stroke in the EPA group (Hazard Ratio, 0.80; 95% confidence interval, 0.64 to 0.997).

Conclusions— Administration of highly purified EPA appeared to reduce the risk of recurrent stroke in a Japanese population of hypercholesterolemic patients receiving low-dose statin therapy. Further research is needed to determine whether similar benefits are found in other populations with lower levels of fish intake. The trial is registered at ClinicalTrials.gov (number NCT00231738).

Key Words: JELIS • EPA • stroke • clinical trial • prevention

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