Abstract 14232: Effects of AMR101, a Pure Ethyl Eicosapentaenoic Acid Omega-3 Fatty Acid, on Lipoprotein Particle Concentration and Size in Patients with Very High Triglycerides (the MARINE Study)
Objective: AMR101 is an omega-3 fatty acid agent containing ≥96% pure icosapent ethyl, the ethyl ester of eicosapentaenoic acid (EPA). The MARINE trial evaluated the efficacy and safety of AMR101 in patients with very high triglycerides (TG) (≥500 mg/dL; baseline TG: 680 mg/dL), and previously demonstrated significant reductions in TG levels (AMR101 4 g/day: -33.1%; P<0.0001) and other lipid parameters. This current analysis reports AMR101 effects on lipoprotein particle concentration and size.
Methods: The MARINE study was a phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week study. Patients (N=229) were randomized to 3 treatment arms: AMR101 4 g/day, AMR101 2 g/day or placebo. Lipoprotein particle concentrations and size were measured with nuclear magnetic resonance spectroscopy.
Results: AMR101 4 g/day significantly reduced median placebo-corrected concentrations of large VLDL (-27.9%; P=0.0211), total LDL (-16.3%; P=0.0006), small LDL (-25.6%; P<0.0001), and total HDL (-7.4%; P=0.0063) particles (Table), and VLDL particle size (-8.6%; P=0.0017). Reductions in atherogenic particle concentrations are consistent with previously reported reductions in apolipoprotein B (-8.5%; P=0.0019; baseline 121 mg/dL).
Conclusions: In this study of patients with TG ≥500 mg/dl, AMR101 4 g/day for 12 weeks significantly reduced large VLDL, total LDL, small LDL, and total HDL particle concentrations and VLDL particle size. Changes in VLDL particle concentration and size are reflective of mechanisms by which EPA lowers TG levels. The reduction in LDL particle concentration with AMR101 is novel among omega-3 therapies and consistent with AMR101's previously reported reduction in apolipoprotein B and lack of LDL-C increase in patients with very high TG.
- © 2011 by American Heart Association, Inc.