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

314 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 2000mg/dl) were studied in a prospective, double-blind, placebo-controlled trial of Omacor (4g/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
StatePublished - 1997
Externally publishedYes


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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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