News Releases
Mochida Announces Completion of "JELIS" Major Clinical Trial for "Epadel"
Hyperlipidemia and Arteriosclerosis Obliterans Therapeutic Treatment
(Tokyo, March 22, 2005) - Mochida Pharmaceutical Co., Ltd. (President: Naoyuki Mochida) has announced the recent completion of its major clinical trial "the Japan EPA Lipid Intervention Study (JELIS)" as conducted by JELIS investigators, and has proposed a schedule for reporting the results. "Epadel", the study drug used, is a therapeutic agent for the treatment of hyperlipidemia and arteriosclerosis obliterans and was provided by Mochida.
Major clinical trials for HMG-CoA reductase inhibitors (statins), broadly used for hyperlipidemia therapy in Japan, have proved in the US and Europe that there is a causal relationship between ischemic cardiac events and hyperlipidemia. Since mortality among ischemic cardiac disease sufferers in Japan is estimated about one third to one tenth of those in the US and Europe, much attention has been paid to the prominence of fish in the Japanese diet.
This study was designed to evaluate whether a long-term administration of Epadel, in conjunction with statins treatment, could suppress the incidence of ischemic cardiac disease in patients with hyperlipidemia, assuming a 25% lower incidence of ischemic cardiac disease as a primary endpoint in the Epadel treatment group as opposed to the control group treated with only statins. Details on the study design, including a background analysis of enrolled patients, were reported in the American Heart Journal (146(4) 613-620, 2003).
This study suggests that the Epadel group showed efficacy in the reduction of the incidence of ischemic cardiac disease. The details are to be presented at an international conference this fall, in expectation of an academic assessment.
<JELIS in brief>
| Study Title: | Japan EPA Lipid Intervention Study (JELIS) |
|---|---|
| Study Group: | JELIS study group (Principal Investigator: Prof. Mitsuhiro Yokoyama, Kobe University Graduate School of Medicine) |
| Administration Period: | 5 years |
| Study Period: | 1996/11-2005/03 |
| Study Size: | Participating centers about 2,900 Participating doctors about 4,900 Enrolled patients 18,645 |
| Study Subjects: | Patients with hyperlipidemia with total cholesterol level of 250 mg/dL and above (age range: 40 to 75 males and postmenopause to 75 females) |
| Study Design: | Randomized unblinded trial between an HMG-CoA reductase inhibitors with eicosapentaenoic acid and HMG-CoA reductase inhibitors only group. |