Novel Omega-3 Free Fatty Acid Formulation Reduces Non-HDL-C in High-Risk Patients on Statins

SAN FRANCISCO, CA—A novel formulation of omega-3 free fatty acids (OM3-FFA) at a dosage as low as 2g/d was effective and well tolerated in lowering non-high density lipoprotein cholesterol (non-HDL-C), triglycerides (TG), and other markers of cardiovascular risk—including Apo CIII and Lp-PLA2—in patients with persistent hypertriglyceridemia on statin therapy, according to a study presented at ACC.13, the American College of Cardiology’s 62nd Annual Scientific Session.

Reduction of non-HDL-C in patients on statin therapy with TG between 200–499mg/dL require a 4mg dose of omega-3 ethyl esters (EE). The OM3-FFA Epanova does not require hydrolysis and has a greater bioavailability than the EE form. This improvement in bioavailability may lead to a lower daily dosage compared with EE formulations, reported Kevin C. Maki, PhD, from Biofortis Clinical Research in Addison, IL, and colleagues.

In the ESPRIT Trial, the investigators evaluated the efficacy of adding Epanova 2g/day or 4g/day to statin therapy—compared with olive oil—for lowering non-HDL-C and TG and raising HDL-C in patients with persistent hypertriglyceridemia at high risk of cardiovascular disease. The primary end point was percent change in non-HDL from baseline to end-of-treatment for each arm.

In this 6-week, double-blind, randomized study conducted at 96 U.S. sites, 647 diet-stable patients with a fasting triglyceride ≥200mg/dL and <500mg/dL, on a maximum tolerated dose of statin or statin and ezetimibe therapy were enrolled. Participants were randomized to either Epanova 2g/day, 4g/day, or the olive oil group.

Results showed that the non-HDL at median baseline was 135mg/dL, 140mg/dL, and 139mg/dL in the olive oil, 2g/day, and 4g/day groups, respectively (P=0.0373). At end-of-treatment, these results were 136mg/dL, 136mg/dL, and 132mg/dL, respectively; least squares geometric mean percent changes from baseline were -0.9, -7.3, and -6.9, respectively.

Non-HDL-C reduction was greater in patients on high potency statins compared to low potency statins and in patients with a higher baseline non-HDL-C, TG, and/or Apo CIII levels.

Dr. Maki concluded that “increasing the dose to 4g/d provided incremental benefit.”