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)

Study Questions:

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?

Methods:

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.

Results:

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.

Conclusions:

The investigators concluded that AMR101 significantly reduced the TG levels without significantly increasing the LDL cholesterol levels.

Perspective:

This study demonstrates that AMR101 shows promise in the management of patients with elevated triglycerides. Larger (and longer-term) studies are warranted.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Hypertriglyceridemia, Lipid Metabolism, Nonstatins, Diet

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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