Efficacy and safety of omega‐3‐acid ethyl acetate 90 capsules in severe hypertriglyceridemia: A randomized, controlled, multicenter study

Omega‐3‐acid ethyl acetate 90 capsules (containing 465 mg of eicosapentaenoic acid and 375 mg docosahexaenoic acid) is composed of highly purified omega‐3 polyunsaturated fatty acid (PUFA) ethyl esters, whose lipid‐lowering effect for severe hypertriglyceridemia (HTG) treatment is unclear. This study aimed to evaluate the efficacy and safety of omega‐3‐acid ethyl acetate 90 capsules in patients with severe HTG. In this randomized, double‐blind, placebo‐controlled, multicenter study, 239 patients with severe HTG were enrolled and randomized (1:1) into omega‐3 group (N = 122) and placebo group (N = 117) to receive 12‐week corresponding treatments. Lipid‐related indexes were obtained at treatment initiation (W0), 4 weeks (W4), W8, and W12 after treatment. Adverse events and adverse drug reactions were recorded. Triacylglycerols (TAG), total cholesterol (TC), non‐high‐density lipoprotein cholesterol (non‐HDL‐C), very‐low‐density lipoprotein cholesterol (VLDL‐C), and apolipoprotein C‐III (Apo C‐III) at W4, W8, and W12 were decreased in the omega‐3 group versus the placebo group (all p 0.05). Omega‐3‐acid ethyl acetate 90 capsules exhibit satisfied lipid‐lowering effect with tolerable safety profile in patients with severe HTG.