Epanova® for Lowering Very High Triglycerides

Summary

The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.

Timeline

Start

2011-01

Primary completion

2012-03

Completion

2012-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); Olive Oil (Placebo) vs Epanova 2 g; p = 0.005; Placebo adjusted % change from baseline -21.68 (95% CI -40.70 to -2.89) NCT01242527 ↗

paper CONCLUSIONS: OM3-FFA achieved the primary end point for TG lowering and secondary end point of non-HDL-C lowering at 2, 3, and 4 g/d PMID 24528690 ↗

Publications

• Kastelein JJ, Maki KC, Susekov A, Ezhov M, Nordestgaard BG, Machielse BN, Kling D, Davidson MH. Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial. J Clin Lipidol. 2014 Jan-Feb;8(1):94-106. doi: 10.1016/j.jacl.2013.10.003. Epub 2013 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	omefas	Unknown	2 g	—
Subject	omefas	Unknown	3 g	—
Subject	omefas	Unknown	4 g	—

Indications

No indication recorded.