title: Safety and efficacy of Omacor in severe hypertriglyceridemia.
abstract: 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.
authors.affiliation: Department of Medicine, University of Kansas Medical Center, Kansas City, USA.
authors.forename: W S
authors.initials: WS
authors.lastname: Harris
authors.forename: H N
authors.initials: HN
authors.lastname: Ginsberg
authors.forename: N
authors.initials: N
authors.lastname: Arunakul
authors.forename: N S
authors.initials: NS
authors.lastname: Shachter
authors.forename: S L
authors.initials: SL
authors.lastname: Windsor
authors.forename: M
authors.initials: M
authors.lastname: Adams
authors.forename: L
authors.initials: L
authors.lastname: Berglund
authors.forename: K
authors.initials: K
authors.lastname: Osmundsen
mesh_terms: D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015228:Hypertriglyceridemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014280:Triglycerides / Q000097:blood
chemical_list: D015525:Fatty Acids, Omega-3; D014280:Triglycerides; D002784:Cholesterol