JELIS - Japan Eicosapentaenoic acid (EPA) Lipid Intervention Study Written by Linda Brookes, MSc Presenter: Mitsuhiro Yokoyama, MD, PhD (Kobe University Graduate School of Medicine, Japan) The first large-scale, prospective, randomized trial of combined treatment with a statin and an omega-3 fatty acid originally derived from fish, eicosapentaenoic acid (EPA), has shown that the addition of EPA to statin therapy provides additional benefit in preventing major coronary events, apparently through lipid-independent mechanisms. [1] The Japan eicosapentaenoic acid (EPA) Lipid Intervention Study (JELIS) tested the effects of long-term use of EPA 1800 mg/day in addition to a statin in Japanese patients with hypercholesterolemia. The results add support to previous evidence of the beneficial effect of omega-3 fatty acids in patients with known coronary heart disease, and show that that effect can extend the benefit of statins, the JELIS investigators believe. Men aged 40-75 years and postmenopausal women aged ¡Ý75 years with serum total cholesterol ¡Ý250 mg/dL were eligible for the study. A total of 18,645 subjects (mean age, 61 years; 31% male) were recruited. About 36% of the subjects were hypertensive, 15% had diabetes, and 20% had coronary artery disease (CAD). All were randomized to pravastatin 10 mg/day or simvastatin 5 mg/day (control group) or the same statin doses with EPA 1800 mg/day. The EPA formulation used in the trial was Epadel (Mochida; Tokyo, Japan), an ethical drug containing highly purified (>98%) fish-derived ethyl EPA, which is currently indicated in Japan for the treatment of arteriosclerosis and hyperlipidemia. A higher incidence of adverse events, especially gastrointestinal disorders, skin disorders, and abnormal liver function tests, was recorded in the EPA group than in the control group (25.3% vs 21.7%, P < .0001) . Most of these adverse events were mild. In the EPA group, the 11.7% who experienced an adverse event stopped treatment, compared with 7.2% in the controls. American Heart Association conference, 2005 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.