Omega 3

Fish Oil Supplement plus a Statin?



Journal Watch Cardiology



May 2007, Page 39



Epidemiologic studies and clinical trials have demonstrated that intake of long-chain Omega-3 polyunsaturated fatty acids (PUFAs) is inversely associated with coronary heart disease. Now, researchers in Japan have conducted a prospective, open-label trial, involving 18,645 hypercholesterolemic patients, to examine the incremental effectiveness of adding a supplement containing elcosapentaenoic acid (EPA) -- a PUFA found in fatty fish -- to statin therapy. The supplement manufacturer funded the study. Mean follow-up was 4.6 years.



Patients, stratified by need for primary or secondary prevention, were randomized to receive either 1800 mg/day of EPA plus a strain (prevastatin 10 mg/day or simvastatin 5 mg/day) or the statin alone. Mean baseline levels of total cholesterol (275 mg/dL [7.1 mmol/Lj and LDL cholesterol (180 mg/dL [4.7 mmol/Lj) decreased by about 19% and 25% respectively, in both the EPA/statin and statin-alone groups by study's end. Mean triglyceride levels decreased by 10% with combined therapy and 5% with a statin alone.



Incidence of the blindly adjudicated primary endpoint of major adverse coronary events (MACE) was significantly lower with combination therapy than with a statin alone (2.8% vs. 3.5%), an effect largely driven by a reduction in unstable angina (1.6% vs. 2.1%). EPA showed no incremental advantage in preventing either sudden death or coronary death. Combination therapy's advantage over statin-only therapy was significant for secondary prevention of MACE (8.7% vs. 10.7%; P=0.048) but not for primary prevention (1.4% vs. 1.7%; P=0.13).



Comment:



It's unclear whether these results of high-dose EPA supplementation in a population with extremely high fish consumption are applicable to populations with lower fish consumption or to people with lower LDL levels. The population characteristics might account for the lack of reduction in cardiac-mortality endpoints in this large, long-term trial.



For now, clinicians should be guided by the AHA statement about fish consumption and fish oil (Circulation 2004; 110:637). It supports initially increasing diestary intake of Omega-3 fatty acids and then, if required, using a high-quality contaminant-free supplement.



--JoAnne M. Foody, MD



Yokoyama M et al, for the JELIS Investigators. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): A randomised open-label, blinded endpoint analysis. Lancet 2007 Mar 31; 369:1090-8.



Mozaffarian D. JELIS, fish oil, and cardiac events. Lancet 2007 Mar 31; 369:1062-3.