Icosapent Ethyl for Treatment of Elevated Triglyceride Levels. (November 2013)

• Record Type: Journal Article
• Authors: Nelson, Scott D.; Munger, Mark A.
• Is Part Of: Annals of pharmacotherapy. Volume 47:Number 11(2013)
• Page Start: 1517
• Page End: 1523
• Publication Date: 2013-11
• Subjects: icosapent ethyl -- triglycerides -- eicosapentaenoic acid; Chemotherapy -- Periodicals; Pharmacology -- Periodicals; 615.5805
• DOI: 10.1177/1060028013504079
• Languages: English
• ISSNs: 1060-0280

Abstract

Objectives: To review the pharmacology, pharmacokinetics, clinical trial data, adverse effects, and formulary considerations of icosapent ethyl for the treatment of high triglyceride (TG) levels.Data Sources: 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.Study Selection/Data Extraction: 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.Data Synthesis: 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.