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.
RCT Entities:
AIM: Information regarding the effects of omega-3 fatty acid on hypertriglyceridemicpatients 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 hypertriglyceridemicpatients. 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.
Authors: W S Harris; H N Ginsberg; N Arunakul; N S Shachter; S L Windsor; M Adams; L Berglund; K Osmundsen Journal: J Cardiovasc Risk Date: 1997 Oct-Dec
Authors: Elizabeth C Leigh-Firbank; Anne M Minihane; David S Leake; John W Wright; Margaret C Murphy; Bruce A Griffin; Christine M Williams Journal: Br J Nutr Date: 2002-05 Impact factor: 3.718
Authors: Michael H Davidson; Evan A Stein; Harold E Bays; Kevin C Maki; Ralph T Doyle; Robert A Shalwitz; Christie M Ballantyne; Henry N Ginsberg Journal: Clin Ther Date: 2007-07 Impact factor: 3.393
Authors: M John Chapman; Henry N Ginsberg; Pierre Amarenco; Felicita Andreotti; Jan Borén; Alberico L Catapano; Olivier S Descamps; Edward Fisher; Petri T Kovanen; Jan Albert Kuivenhoven; Philippe Lesnik; Luis Masana; Børge G Nordestgaard; Kausik K Ray; Zeljko Reiner; Marja-Riitta Taskinen; Lale Tokgözoglu; Anne Tybjærg-Hansen; Gerald F Watts Journal: Eur Heart J Date: 2011-04-29 Impact factor: 29.983