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 dose...

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Published inJournal of Atherosclerosis and Thrombosis Vol. 24; no. 3; pp. 275 - 289
Main Authors Chiang, Fu-Tien, Hwang, Juey-Jen, Huang, Kuo-Chin, Wang, Kuo-Yang, Su, Ta-Chen, Lin, Lian-Yu, Olivar, José Emilio Ruiz, Tsai, Wei-Chuan, Chien, Kuo-Liong, Charng, Min-Ji, Vige, Runar, Tseng, Chuen-Den
Format Journal Article
LanguageEnglish
Published Japan Japan Atherosclerosis Society 01.01.2017
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ISSN1340-3478
1880-3873
1880-3873
DOI10.5551/jat.34231

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Summary: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.
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ISSN:1340-3478
1880-3873
1880-3873
DOI:10.5551/jat.34231