News Releases
Epadel Inhibits Coronary Heart Disease and Reduces Recurrence
New Findings from the JELIS Large Scale Clinical Study
(Tokyo, November 15, 2006) - Two new findings from JELIS were presented at the American Heart Association’s ‘Scientific Sessions 2006’ on November 14 (Nov. 15 JST) in Chicago, IL. These indicated that Epadel was effective at inhibiting the development of coronary disease in persons with no prior coronary disease history and reducing recurrence in patients with a history of coronary disease.
JELIS was a large clinical trial using Epadel (eicosapentaenoic acid ethyl ester, EPA-E), a therapeutic agent for the treatment of hyperlipidemia and arteriosclerosis obliterans.
Presenter: Professor Yasushi Saito, Chiba University (Analysis of primary prevention group)
- Epadel decreased coronary events in the primary prevention group (no prior coronary disease history) who had hypercholesterolemia and combinations of multiple risk factors (such as obesity, hypertriglyceridemia and/or low-HDL cholesterolemia, diabetes, hypertension).
- Epadel demonstrated a statistically significant 53% risk reduction in coronary events in the patient sub-group with both hypertriglyceridemia (≥ 150 mg/dL) and low-HDL cholesterolemia (< 40 mg/dL).
Epadel may thus be effective in treating metabolic syndrome.
Presenter: Professor Masunori Matsuzaki, Yamaguchi University (Analysis of secondary prevention group)
- Epadel achieved a decrease in coronary events with the secondary prevention group (history of ischemic heart disease), in particular a statistically significant 27% risk reduction in the subgroup with a history of myocardial infarction.
- A higher serum EPA/arachidonic (AA) acid ratio may contribute to reducing coronary events as the occurrence of sudden cardiac death and myocardial infarction was significantly less frequent in the high-EPA/AA ratio subgroup.
- Professor Matsuzaki strongly recommended that Epadel should be combined with standard lipid-lowering therapy for secondary prevention treatment of coronary events.
Subsequent findings for JELIS will be provided as soon as they become available, and are expected to reveal new evidence on 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.