Key result
Icosapent ethyl reduces triglycerides ~33% vs placebo without increasing LDL-C.
Why the study?
A comprehensive review of icosapent ethyl's pharmacology, clinical trial data, adverse effects, and formulary considerations for treating high triglyceride levels was needed.
Does icosapent ethyl reduce triglyceride levels in patients with hypertriglyceridemia?
Does icosapent ethyl reduce triglyceride levels in patients with hypertriglyceridemia?
Icosapent ethyl is effective in reducing triglyceride levels without increasing LDL-C, with a favorable safety profile.
May aid triglyceride management without LDL-C rise; leaves open cardiovascular outcome confirmation in larger trials.
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.
No takes yet. Share an insight, caveat, or question.
Nelson et al. (2013) conducted a review in high triglyceride levels. Icosapent ethyl vs. placebo was evaluated on placebo-corrected median decrease in triglycerides. Icosapent ethyl 4 g/day provided a placebo-corrected median decrease in triglycerides of 33.1% in the MARINE trial and 21.5% in the ANCHOR trial, without increasing LDL-C.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: