Effects of MAT9001 containing eicosapentaenoic acid and docosapentaenoic acid, compared to eicosapentaenoic acid ethyl esters, on triglycerides, lipoprotein cholesterol, and related variables

BACKGROUND: Long-chain omega-3 fatty acid concentrate pharmaceuticals are used in the United States for treatment of severe hypertriglyceridemia (>= 500 mg/dL) and are under investigation as adjuncts to statins for lowering cardiovascular risk in patients with high triglycerides (TGs; 200-499 mg/dL). OBJECTIVE: To evaluate MAT9001, an investigational prescription-only omega-3 fatty acid agent containing predominantly eicosapentaenoic acid (EPA) and docosapentaenoic acid, in 42 men and women with fasting TG 200 to 400 mg/dL. METHODS: In this open-label, crossover trial, subjects received MAT9001 and EPA ethyl esters (EPA-EE) in random order. They were housed in a clinical research unit for 2 14-day treatment periods, separated by a >= 35-day washout. Lipoprotein lipids, apolipoproteins (Apos) and proprotein convertase subtilisin kexin type 9 levels were measured before and at the end of each treatment period. RESULTS: MAT9001, compared with EPA-EE, resulted in significantly (P < .05) larger reductions from pretreatment levels for TG (-33.2% vs-10.5%), total cholesterol (-9.0% vs-6.2%), non high-density lipoprotein cholesterol (-8.8% vs-4.6%), very low density lipoprotein cholesterol (-32.5% vs-8.1%), Apo C3 (-25.5% vs 5.0%), and proprotein convertase subtilisin kexin type 9 (-12.3% vs +8.8%). MAT9001 also produced a significantly (P =.003) larger reduction in Apo Al (-15.3% vs-10.2%), but responses for high-density lipoprotein cholesterol (-11.3% vs 11.1%), low-density lipoprotein cholesterol (-2.4% vs-4.3%), and Apo B (-3.8% vs 0.7%), respectively, were not significantly different relative to EPA-EE. CONCLUSIONS: MAT9001 produced significantly larger reductions than EPA-EE in several lipoprotein-related variables that would be expected to favorably alter cardiovascular disease risk in men and women with hypertriglyceridemia. (C) 2016 National Lipid Association. All rights reserved.