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Abstract
Omacor® is a highly purified fish oil preparation whose main ingredients are the omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid in the form of ethyl esters. Omacor decreases serum triglyceride and very low-density lipoprotein cholesterol levels predominantly by its action on the liver, where its component fatty acids form a poor substrate for triglyceride synthesis. Omacor is useful in the treatment of mild-to-moderate hypertriglyceridemia. It has little effect on high-density lipoprotein cholesterol concentrations and in some patients there can be a small rise in low-density lipoprotein, but this rise is not in the more atherogenic small dense variety. Omacor is effective as monotherapy, but its effect is potentiated when used in conjunction with 3-hydroxy-3- methylglutaryl coenzyme A reductase inhibitors. A dose of 4 g/day has the optimal triglyceride-lowering effect. There is little interaction with other drugs, although a small increase in bleeding time may be seen with anticoagulants. Side effects are rare, and related to the gastrointestinal tract. In Europe, Omacor 1 g/day is currently licensed for the prevention of sudden death post-myocardial infarction. Omacor is being evaluated in an extensive clinical development program. Studies in progress include several large clinical outcome trials designed to evaluate the impact of Omacor on death and major morbid events in patients with heart failure (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico [GISSI]-Heart Failure trial), diabetes (Avosentan on Doubling of Serum Creatinine End Stage Renal Disease and Death in Diabetic Nephropathy [ASCEND] and Outcome Reduction with Initial Glargine Intervention [ORIGIN]), and in patients with a high risk for the development of cardiovascular disease (GISSI Risk and Prevention Trial). Studies are ongoing to examine the role of Omacor in preventing the development of atrial fibrillation after coronary artery bypass grafting in the treatment of immunoglobulin A nephropathy and in rheumatoid arthritis. Its effects on endothelial function and inflammatory markers are also being investigated.