JELIS
(2007)Objective
Evaluate whether adding eicosapentaenoic acid (EPA) to statin therapy reduces major coronary events in patients with hypercholesterolemia.
Study Summary
• In Japanese patients with hypercholesterolemia, EPA 1,800 mg/day added to low-dose statin therapy significantly reduced major coronary events over 4.6 years compared to statin alone. Benefit was driven by reductions in unstable angina and seen mainly in secondary prevention.
Intervention
EPA 1,800 mg/day + statin (pravastatin 10 mg or simvastatin 5 mg) vs. statin alone. Open-label randomized trial with 18,645 patients. Mean follow-up 4.6 years.
Study Design
Arms: Array
Outcome
• MACE — 2.8% (EPA + statin) vs. 3.5% (statin); HR 0.81; p=0.011
• Unstable angina — 1.6% vs. 2.1%; HR 0.76; p=0.014
• Nonfatal MI — 0.7% vs. 0.9%; p=0.086
• Revascularization — 2.1% vs. 2.4%; p=0.135
• Sudden cardiac death — 0.2% in both groups
• Secondary prevention subgroup — 8.7% vs. 10.7%; HR 0.81; p=0.048
• Primary prevention subgroup — 1.4% vs. 1.7%; HR 0.82; p=0.132
• Adverse events — 25.3% vs. 21.7%; p<0.0001 (notably GI disorders: 3.8% vs. 1.7%)
• Unstable angina — 1.6% vs. 2.1%; HR 0.76; p=0.014
• Nonfatal MI — 0.7% vs. 0.9%; p=0.086
• Revascularization — 2.1% vs. 2.4%; p=0.135
• Sudden cardiac death — 0.2% in both groups
• Secondary prevention subgroup — 8.7% vs. 10.7%; HR 0.81; p=0.048
• Primary prevention subgroup — 1.4% vs. 1.7%; HR 0.82; p=0.132
• Adverse events — 25.3% vs. 21.7%; p<0.0001 (notably GI disorders: 3.8% vs. 1.7%)