Cardiovascular outcome trial · Lancet 2007
JELIS trial
Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis.
The bottom line
Adding EPA to statin therapy modestly reduced major coronary events, mainly non-fatal events, in hypercholesterolaemic Japanese patients, without a significant effect on sudden cardiac or coronary death.
BenefitUS status: Not US-approved (Japan)
At a glance
- Medicine
- 1800 mg of EPA daily with statin (EPA group; n=9326)
- Compared with
- statin only (controls; n=9319)
- People
- 18,645
- Who took part
- Japanese patients with total cholesterol of 6.5 mmol/L or greater (hypercholesterolaemic), recruited 1996-1999
- Design
- randomised open-label, blinded endpoint analysis
- Follow-up
- mean follow-up of 4.6 years (5-year follow-up planned)
- Main question
- Any major coronary event, including sudden cardiac death, fatal and non-fatal myocardial infarction, and other non-fatal events including unstable angina pectoris, angioplasty, stenting, or coronary artery bypass grafting
Main result
262 (2.8%) patients in the EPA group and 324 (3.5%) in controls-a 19% relative reduction in major coronary events (p=0.011)
Effect on LDL cholesterol
Post-treatment LDL cholesterol concentrations decreased 25%, from 4.7 mmol/L in both groups
Other results
Sudden cardiac death and coronary death did not differ between groups; unstable angina and non-fatal coronary events were significantly reduced in the EPA group; secondary prevention subgroup: 158 [8.7%] EPA vs 197 [10.7%] control, p=0.048; primary prevention subgroup: 104 [1.4%] EPA vs 127 [1.7%] control, p=0.132
Safety
''
In the trial's own words
“At mean follow-up of 4.6 years, we detected the primary endpoint in 262 (2.8%) patients in the EPA group and 324 (3.5%) in controls-a 19% relative reduction in major coronary events (p=0.011).”
Quoted from the abstract of Lancet 2007, checked word for word against PubMed. PubMed 17398308 · Full paper (DOI)
Common questions
What did the JELIS trial find?
Adding EPA to statin therapy modestly reduced major coronary events, mainly non-fatal events, in hypercholesterolaemic Japanese patients, without a significant effect on sudden cardiac or coronary death.
Who was in JELIS?
18,645 people. Japanese patients with total cholesterol of 6.5 mmol/L or greater (hypercholesterolaemic), recruited 1996-1999.
What was JELIS's main result?
262 (2.8%) patients in the EPA group and 324 (3.5%) in controls-a 19% relative reduction in major coronary events (p=0.011)
How much did LDL cholesterol change in JELIS?
Post-treatment LDL cholesterol concentrations decreased 25%, from 4.7 mmol/L in both groups
Related trials
- FIELD (2005)In patients with type 2 diabetes not on statins, fenofibrate did not significantly reduce coronary events but did reduce total cardiovascular events, driven by fewer nonfatal heart attacks and revascularizations, with a small increase in pancreatitis and pulmonary embolism.
- ACCORD Lipid (2010)Adding fenofibrate to simvastatin did not reduce cardiovascular events or death compared with simvastatin alone in high-risk patients with type 2 diabetes, so routine combination therapy is not supported.
- AIM-HIGH (2011)In statin-treated patients with established cardiovascular disease and already-low LDL, adding extended-release niacin raised HDL and lowered triglycerides but did not reduce cardiovascular events compared with placebo.
- HPS2-THRIVE (2014)Adding extended-release niacin-laropiprant to statin therapy in patients with vascular disease did not reduce major vascular events and increased serious adverse effects, including new-onset diabetes, infection, and bleeding.
Get your LDL treated to a goal
Preval Health's protocols follow trials like this one. Licensed clinicians set your goal, prescribe and recheck until you reach it.
Get startedEducation only, not medical advice. Results describe the people in this trial and can differ for you. Talk with your clinician before starting or stopping any medicine. Back to all 106 trials.