News Releases
The Results of a major clinical trial ("JELIS") to investigate the efficacy of "Epadel" were presented in a meeting of the American Heart Association (AHA)
(Tokyo, November 15, 2005) - Mochida Pharmaceutical Co., Ltd. (President: Naoyuki Mochida) announced on March 22 that a major clinical trial "the Japan EPA Lipid Intervention Study (JELIS)" had completed its investigations on whether "Epadel", a therapeutic agent for the treatment of hyperlipidemia and arteriosclerosis obliterans, is able to reduce the incidence of ischemic heart disease.
On November 14, the test results by JELIS investigators were presented in a Late-Breaking Clinical Trial Session at the American Heart Association (AHA)'s Scientific Sessions 2005 in Dallas, Texas, by the principal investigator, Mitsuhiro Yokoyama, MD, PhD, Kobe University Graduate School of Medicine, Japan.
Objectives and Abstract
This study is the first large-scale randomized trial to examine the efficacy of highly purified EPA (eicosapentaenoic acid), in addition to HMG-CoA reducatase inhibitor, in patients with hyperlipidemia. The primary endpoint was suppression of onset of coronary events including sudden cardiac death and fatal and nonfatal myocardial infarction.
A total enrollment of 18,645 patients was randomly placed into either the control group or the EPA group: the control group (9,319 patients) was treated only with HMG-CoA reductase inhibitor (pravastatin or simvastatin), the EPA group (9,326 patients) with concomitant administration of statin and Epadel 1,800 mg/day. Of the enrolled patients, 14,981 were categorized as primary prevention (no history of coronary artery disease) and 3,664 patients were secondary prevention (stable ischemic cardiac diseases).
Results
Analysis for all enrolled patients showed that incidence of major coronary events in the EPA group was 2.8%, significantly lower than the 3.5% occurring in the control, a 19% lower relative risk in the EPA group.
For secondary prevention, also, the incidence of major coronary events significantly decreased in the EPA group (8.7%) versus control (10.7%) with a 19% relative risk reduction. For primary prevention, the relative risk reduction was 18%, although this was not statistically significant.
Also, 5 years after the start of administration, both groups exhibited a 26% decrease in LDL-cholesterol levels and no change in HDL-cholesterol levels.
Conclusions
According to Prof. Yokoyama, these results indicate that no obvious differences were found in change in cholesterol levels between the two groups because patients in both groups were treated with statins. Therefore, the 19% decrease in the incidence of cardiac events in the EPA group may largely be attributed to a mechanism independent of cholesterol levels, leading to the expectation that the concomitant use of EPA and statins may prove beneficial.