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.
OBJECTIVE
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.
Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital.
Ta-Chen
TC
Su
Juey-Jen
JJ
Hwang
Kuo-Chin
KC
Huang
Fu-Tien
FT
Chiang
Kuo-Liong
KL
Chien
Kuo-Yang
KY
Wang
Min-Ji
MJ
Charng
Wei-Chuan
WC
Tsai
Lian-Yu
LY
Lin
Runar
R
Vige
José Emilio Ruiz
JE
Olivar
Chuen-Den
CD
Tseng
D000328:Adult; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid / Q000627:therapeutic use*; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D015228:Hypertriglyceridemia / Q000188:drug therapy* / Q000473:pathology; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008019:Life Style; D008297:Male; D008875:Middle Aged; D012449:Safety; D012720:Severity of Illness Index; D013624:Taiwan; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D004338:Drug Combinations; D015525:Fatty Acids, Omega-3; D000960:Hypolipidemic Agents; D014280:Triglycerides; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; C405603:Omacor