Abstract 16374: Title: Dose Response of a Novel Free-Fatty Acid Formulation of Omega-3 For the Management of Dyslipidemia in Patients with Severe Hypertriglyceridemia - EpanoVa fOr Lowering Very High TriglycErides (The EVOLVE Trial)

Abstract

Background: At least 4 grams of prescription omega-3 ethyl esters (EE) are required to lower triglycerides (TG) in patients with hypertriglyceridemia (HTG). Omega-3 EE require hydrolysis to the free-fatty acid (FFA) form by pancreatic lipases for adequate absorption. Epanova, a novel omega-3 already in the FFA form does not require hydrolysis, is directly absorbed and has been shown to have up to 5-fold greater bioavailability than the EE form. The EVOLVE trial evaluated a low 2 g/d dosage as well as 3 and 4 g/d of Epanova compared to olive oil (OO) in patients with severe HTG.

Methods: A total of 399 diet-stable patients with fasting TG ≥500 mg/dl and <2000 mg/dl (with or without background statin or statin/ezetimibe therapy) were randomized to Epanova 2, 3 or 4 g/d or OO in this 12 week double-blind study. The primary efficacy end point for each arm was the percent change in TG levels from baseline to end-of-treatment.

Results: See table for efficacy results. Withdrawals related to treatment emergent adverse events were between 5-7% in the active arms compared to none in the OO arm.

Conclusion: Omega-3 FFA at dosages of 2-4 g/d are effective and well tolerated for lowering of TG, non-HDL-C, TC/HDL-C, and VLDL-C in patients with severe HTG.