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Severe hypertriglyceridemia is a risk factor for acute pancreatitis, therefore decreasing serum triglyceride concentrations is an important component of risk management. Omega-3 fatty acids are well known hypotriglyceridemic agents, but their efficacy in severe forms of the disorder is not well documented. Our objective was to examine the effects of Omacor, a drug composed of 85% omega-3 fatty acid ethyl estersForty-two patients with triglyceride concentrations between 5.65 and 22.60 mmol/l (500 and 2000mg/dl) were studied in a prospective, double-blind, placebo-controlled trial of Omacor (4 g/day for 4 months)Compared with baseline values, Omacor significantly reduced mean triglyceride concentrations by 45% (P< 0.00001), cholesterol by 15% (P< 0.001), verylow- density lipoprotein cholesterol by 32% (P< 0.0001) and cholesterol: high density lipoprotein (HDL) cholesterol ratio by 20% (P= 0.0013), and increased HDL cholesterol by 13% (P= 0.014) and low-density lipoprotein cholesterol by 31% (P= 0.0014). The placebo had no effect on these parameters. Omacor was well tolerated and no patient discontinued medication because of side effects.Four capsules of Omacor per day markedly decreased triglyceride concentrations in patients with severe hypertriglyceridemia. The availability of a potent and safe omega-3 fatty acid preparation for this patient population should diminish the risk for acute pancreatitis, and may also reduce the long-term risk for cardiovascular disease.