Safety and efficacy of Omacor in severe hypertriglyceridemia

William S. Harris, Henry N. Ginsberg, Narin Arunakul, Neil S. Shachter, Sheryl L. Windsor, Marian Adams, Lars Berglund, Karin Osmundsen

Research output: Contribution to journalArticlepeer-review

295 Scopus citations


Background: 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 esters. Methods: Forty-two patients with triglyceride concentrations between 5.65 and 22.60 mmol/l (500 and 2000 mg/dl) were studied in a prospective, double-blind, placebo-controlled trial of Omacor (4 g/day for 4 months). Results: Compared with baseline values, Omacor significantly reduced mean triglyceride concentrations by 45% (P<0.00001), cholesterol by 15% (P<0.001), very-low- 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)385-391
Number of pages7
JournalJournal of Cardiovascular Risk
Issue number5-6
StatePublished - 1997
Externally publishedYes


  • Docosahexaenoic acid
  • Eicosapentaenoic acid
  • Fish oil
  • Hypertriglyceridemia
  • Pancreatitis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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