News Releases
Epadel Reduces Risk of Stroke Recurrence
New Results of JELIS Major Clinical Trial
(Tokyo, November 13, 2006) - Epadel (eicosapentaenoic acid ethyl ester, EPA-E), a therapeutic agent for the treatment of hyperlipidemia and arteriosclerosis obliterans, can significantly reduce the risk of recurrent stroke. These newly analyzed findings from the JELIS trial were presented by Professor Kotaro Tanaka, University of Toyama, at the 18th annual meeting of the Japanese Society of Cerebral Blood Flow and Metabolism held on November 11th and 12th in Tokyo's Chiyoda ward.
While there was no difference in the incidence of first stroke between EPA and control groups during the five-year JELIS trial - the extensive clinical trial for Epadel -, the incidence of stroke recurrence was significantly lower in the EPA group at 6.8% (33/485) versus control group at 10.5% (48/457), a reduction of 20%.
Further, while there was no difference in the incidence of recurrent hemorrhagic cerebral events between the two groups, EPA was effective in reducing the recurrence of ischemic cerebral vascular events such as cerebral infarction.
Subsequent findings for JELIS will be provided as soon as they become available, and are expected to reveal further evidence of the effectiveness of Epadel.
<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. |
A total of 18,645 hypercholesterolemic subjects enrolled in the JELIS study were randomized to receive either an HMG-CoA reductase inhibitor (pravastatin or simvastatin) and Epadel 1,800 mg/day (EPA group, n=9,326) or the inhibitor alone (control group, n=9,319) for a five-year observation period.
According to the results published last year, for all treated subjects the incidence of major coronary events was significantly lower in the EPA group than control (2.8% vs. 3.5%). This is a 19% decrease in relative risk.