A randomized,double-blind,placebo-controlled clinical trial to assess the efficacy and safety of ethyl-ester omega-3 fatty acid in Taiwanese hypertriglyceridemic patients

Aim: information regarding the effects of omega-3 fatty acid on hypertriglyceridemic patients in chinese is still limited. this study aimed to investigate the efficacy and safety of omacor ®,a prescription ethyl-ester omega-3 fatty acid for the treatment of hypertriglyceridemia,administered at doses of 2 g/day and 4 g/day to taiwanese hypertriglyceridemic patients. methods: a multicenter,randomized,double-blind,placebo-controlled,parallel study in adults with hypertriglyceridemia was conducted. after a five-week diet lead in period patients with triglycerides =200–1000 mg/dl were randomized to receive omacor ®,a concentrated preparation of omega-3 eicosapentaenoic acid (epa) plus docosahexaenoic acid (dha) in a dose of 1 g twice daily (2 g omacor ®),2 g twice daily (4 g omacor ®) or placebo,for eight weeks. the primary endpoint was the percentage change in triglyceride serum levels from baseline to the end of treatment. results: a total of 253 taiwanese patients were randomized,of which 65.6% (166) were men. at the end of the treatment,the percentage change in triglyceride serum levels in both the omacor ® 4 g/ day (－32.1%) and 2 g/day (－29.7%) groups was larger than in the placebo group (－5.4%) (p＜ 0.001). the incidence of drug-related adverse events was as follows: 0.0%,1.2%,and 0.0% in omacor ® 4 g/day,omacor ® 2 g/day,and placebo groups,respectively. no drug-related serious adverse events were reported during the study. conclusions: omacor ® may be a feasible option to treat hypertriglyceridemia in taiwanese patients. © 2017 japan atherosclerosis society.