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

Ta-Chen Su, Juey-Jen Hwang, Kuo-Chin Huang, Fu-Tien Chiang, Kuo-Liong Chien, Kuo-Yang Wang, Min-Ji Charng, Wei-Chuan Tsai, Lian-Yu Lin, Runar Vige, José Emilio Ruiz Olivar, Chuen-Den Tseng, Ta-Chen Su, Juey-Jen Hwang, Kuo-Chin Huang, Fu-Tien Chiang, Kuo-Liong Chien, Kuo-Yang Wang, Min-Ji Charng, Wei-Chuan Tsai, Lian-Yu Lin, Runar Vige, José Emilio Ruiz Olivar, Chuen-Den Tseng

Abstract

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.

Figures

Fig. 1.
Fig. 1.
Flowchart of Subject Disposition in Trial
Fig. 2.
Fig. 2.
Time-course of percent change in triglyceride levels (ITT population)

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Source: PubMed

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