An omega-3 polyunsaturated fatty acid concentrate administered for one year decreased triglycerides in simvastatin treated patients with coronary heart disease and persisting hypertriglyceridaemia

Background-Omega-3 fatty acids, such as those present in fish oil, have bee n reported to prolong life in myocardial infarction survivors. These fatty acids can decrease serum triglyceride concentrations, but so far the doses used in trials examining their effects on coronary end points have had only minimal triglyceride lowering effects. Objective-To examine the triglyceride lowering effectiveness, safety, and t olerability of Omacor, a concentrate of omega-3, long chain, polyunsaturate d fatty acids from fish oil (84% of the total as opposed to an average of 3 5% in fish oil) over one year in patients with established coronary heart d isease (CHD) and persisting hypertriglyceridaemia, despite receiving simvas tatin in doses similar to those employed in the Scandinavian simvastatin su rvival study. Subjects and methods-59 patients with CHD, receiving simvastatin 10-40 mg d aily with serum triglycerides > 2.3 mmol/l, were randomised to receive Omac or 2 g twice a day or placebo for 24 weeks in a double blind trial. Forty s ix patients accepted the offer of active treatment for a further 24 weeks i n an open phase of the trial. Results-There was a sustained significant decrease in serum triglycerides b y 20-30% (p < 0.005) and in very low density lipoprotein (VLDL) cholesterol by 30-40% (p < 0.005) in patients receiving active Omacor at three, six, a nd 12 months compared either to baseline or placebo. Omacor did not have an y deleterious effect on low density or high density lipoprotein cholesterol or on biochemical and haematological safety tests. There was no adverse ef fect on glycaemic control in patients with diabetes, who showed a decrease in serum triglyceride, which was at least as great as in non-diabetic patie nts. One patient receiving placebo died of acute myocardial infarction. Thr ee patients withdrew from the trial (two on placebo and one on active treat ment). Omacor was generally well tolerated. Conclusion-Omacor was found to be a safe and effective means of lowering se rum triglycerides over one year in patients with CHD and combined hyperlipi daemia, whose triglycerides remained elevated despite simvastatin treatment .