Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Patients With Very High Triglyceride Levels (From the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] Trial)
Does AMR101, an omega-3 fatty acid agent containing >96% eicosapentaenoic acid ethyl ester and no docosahexaenoic acid, reduce triglyceride levels without raising low-density lipoprotein (LDL) cholesterol levels?
The multicenter, placebo-controlled, randomized, double-blind, 12-week study with an open-label extension (MARINE) was a phase III study conducted in the United States, South Africa, India, Russia, Ukraine, Finland, Germany, Italy, and the Netherlands. Entry criteria included triglyceride levels >500 mg/dl and <2000 mg/dl (with or without background statin therapy). Patients were randomized to AMR101 4 g/day, AMR101 2 g/day, or placebo. The primary endpoint was the placebo-corrected median percentage of change in triglyceride from baseline to week 12.
A total of 229 diet-stable patients were included in this study. Baseline triglyceride levels were 680, 657, and 703 mg/dl for the groups randomized to AMR101 4 g/day, AMR101 2 g/day, and placebo, respectively. AMR101 4 g/day reduced the placebo-corrected triglyceride levels by 33.1% (p < 0.0001) and AMR101 2 g/day by 19.7% (p = 0.0051). For baseline triglyceride levels >750 mg/dl, AMR101 4 g/day reduced the placebo-corrected triglyceride levels by 45.4% (p = 0.0001) and AMR101 2 g/day by 32.9% (p = 0.0016). AMR101 did not significantly increase the placebo-corrected median LDL cholesterol levels at 4 g/day or 2 g/day (both p = NS). AMR101 significantly reduced non–high-density lipoprotein cholesterol, apolipoprotein B, lipoprotein-associated phospholipase A2, very LDL cholesterol, and total cholesterol.
The investigators concluded that AMR101 significantly reduced the TG levels without significantly increasing the LDL cholesterol levels.
This study demonstrates that AMR101 shows promise in the management of patients with elevated triglycerides. Larger (and longer-term) studies are warranted.
Keywords: Cholesterol, LDL, South Africa, Hypertriglyceridemia, Russia, Finland, Germany, Eicosapentaenoic Acid, Ukraine, Italy, Lipoproteins, LDL, Docosahexaenoic Acids, Fatty Acids, Omega-3, India, Netherlands, Diet, Triglycerides, United States
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