title: Icosapent ethyl for treatment of elevated triglyceride levels.
abstract: OBJECTIVE
  To review the pharmacology, pharmacokinetics, clinical trial data, adverse effects, and formulary considerations of icosapent ethyl for the treatment of high triglyceride (TG) levels.
  
  
  METHODS
  A literature search with keywords Vascepa, icosapent ethyl, AMR101, and eicosapentaenoic acid of articles up to July 2013, along with the package insert for Vascepa and current guidelines for hypertriglyceridemia.
  
  
  METHODS
  Two phase-III, placebo-controlled, randomized, double-blind, 12-week clinical trials were included in this review: the MARINE trial and ANCHOR study. The MARINE trial consisted of mainly overweight Caucasian men with fasting TG ≥500 and ≤2000 mg/dL taking 4 g/day icosapent ethyl, 2 g/day, or placebo. The ANCHOR study consisted of mainly overweight Caucasians with type-2 diabetes mellitus on statin therapy, with fasting TG ≥200 and <500 mg/dL taking 4 g/day icosapent ethyl, 2 g/day, or placebo.
  
  
  RESULTS
  The MARINE trial showed a placebo-corrected median decrease in TG of 33.1% for patients receiving 4 g/day icosapent ethyl, with no significant change in low-density lipoprotein cholesterol (LDL-C) levels. TG was reduced by 19.7% in those taking 2 g/day. The ANCHOR study showed a placebo-corrected decrease in TG of 21.5% with a 6.3% decrease in LDL-C for patients taking 4 g/day icosapent ethyl as add-on to statin therapy. TG was reduced by 10.1% in those taking 2 g/day. The main adverse effect observed was joint pain (2.3%).
  
  
  CONCLUSIONS
  Icosapent ethyl is effective in reducing TG levels without increasing LDL-C, and has efficacy similar to other TG-lowering therapies with fewer adverse effects or interactions.
authors.affiliation: University of Utah College of Pharmacy, Salt Lake City, UT, USA.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Nelson
authors.forename: Mark A
authors.initials: MA
authors.lastname: Munger
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D015118:Eicosapentaenoic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use; D006801:Humans; D015228:Hypertriglyceridemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood*
chemical_list: D000960:Hypolipidemic Agents; D014280:Triglycerides; C035276:eicosapentaenoic acid ethyl ester; D015118:Eicosapentaenoic Acid
keywords: eicosapentaenoic acid; icosapent ethyl; triglycerides