Key result
EPA added to statin therapy cuts major coronary events ~19% compared to statins alone.
Why the study?
Epidemiological and clinical evidence suggested that increased intake of long-chain n-3 fatty acids may protect against coronary artery disease mortality, but the effect of long-term EPA use on major coronary events in hypercholesterolaemic patients consuming high fish amounts was untested.
Does eicosapentaenoic acid reduce major coronary events in hypercholesterolaemic patients receiving statin therapy?
RCT (n=18,645)
Open-label, blinded endpoint
Randomly assigned
Yes
Does eicosapentaenoic acid reduce major coronary events in hypercholesterolaemic patients receiving statin therapy?
Effect estimate: 19% relative reduction
Absolute Event Rate: 2.8% vs 3.5%
p-value: p=0.011
Adding 1800 mg daily of EPA to statin therapy significantly reduces the risk of major coronary events, primarily driven by a reduction in non-fatal events, in Japanese hypercholesterolaemic patients.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“We are excited to enter into a collaboration with Mochida given our common mission to create preventative healthcare solutions on a worldwide basis, and our mutual commitment to continued innovation in the EPA research and development area. This collaboration seeks to leverage the decades of successful research and development experience at Amarin and Mochida towards expediting the development of new products and indications.”
Supports adding EPA to statins in hypercholesterolemic patients; extends epidemiological data to randomized evidence of coronary event reduction.
BACKGROUND: Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 fatty acids protects against mortality from coronary artery disease. We aimed to test the hypothesis that long-term use of eicosapentaenoic acid (EPA) is effective for prevention of major coronary events in hypercholesterolaemic patients in Japan who consume a large amount of fish. METHODS: 18 645 patients with a total cholesterol of 6.5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999. Patients were randomly assigned to receive either 1800 mg of EPA daily with statin (EPA group; n=9326) or statin only (controls; n=9319) with a 5-year follow-up. The primary endpoint was 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. Analysis was by intention-to-treat. The study was registered at ClinicalTrials.gov, number NCT00231738. FINDINGS: 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). Post-treatment LDL cholesterol concentrations decreased 25%, from 4.7 mmol/L in both groups. Serum LDL cholesterol was not a significant factor in a reduction of risk for major coronary events. Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group. Sudden cardiac death and coronary death did not differ between groups. In patients with a history of coronary artery disease who were given EPA treatment, major coronary events were reduced by 19% (secondary prevention subgroup: 158 [8.7%] in the EPA group vs 197 [10.7%] in the control group; p=0.048). In patients with no history of coronary artery disease, EPA treatment reduced major coronary events by 18%, but this finding was not significant (104 [1.4%] in the EPA group vs 127 [1.7%] in the control group; p=0.132). INTERPRETATION: EPA is a promising treatment for prevention of major coronary events, and especially non-fatal coronary events, in Japanese hypercholesterolaemic patients.
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Yokoyama et al. (2007) conducted an RCT in Hypercholesterolaemia (n=18,645). Eicosapentaenoic acid (EPA) with statin vs. Statin only was evaluated on 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 (19% relative reduction, p=0.011). Eicosapentaenoic acid (1800 mg daily) added to a statin significantly reduced major coronary events by 19% compared to statin therapy alone (2.8% vs 3.5%; P=0.011) over a mean 4.6 years.
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