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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Online AccessGet full text
ISSN1340-3478
1880-3873
1880-3873
DOI10.5551/jat.34231

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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.
AbstractList 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.
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. 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. 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. Omacor may be a feasible option to treat hypertriglyceridemia in Taiwanese 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(R), 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(R), a concentrated preparation of omega-3 eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) in a dose of 1 g twice daily (2 g Omacor(R)), 2 g twice daily (4 g Omacor(R)) 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(R) 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(R) 4 g/day, Omacor(R) 2 g/day, and placebo groups, respectively. No drug-related serious adverse events were reported during the study. Conclusions: Omacor(R) may be a feasible option to treat hypertriglyceridemia in Taiwanese 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.
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.AIMInformation 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.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.METHODSA 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.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.RESULTSA 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.Omacor® may be a feasible option to treat hypertriglyceridemia in Taiwanese patients.CONCLUSIONSOmacor® may be a feasible option to treat hypertriglyceridemia in Taiwanese patients.
Author Tsai, Wei-Chuan
Charng, Min-Ji
Su, Ta-Chen
Hwang, Juey-Jen
Huang, Kuo-Chin
Chiang, Fu-Tien
Wang, Kuo-Yang
Lin, Lian-Yu
Tseng, Chuen-Den
Chien, Kuo-Liong
Vige, Runar
Olivar, José Emilio Ruiz
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  fullname: Tseng, Chuen-Den
  organization: Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
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National Taiwan University
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Snippet Aim: Information regarding the effects of omega-3 fatty acid on hypertriglyceridemic patients in Chinese is still limited. This study aimed to investigate the...
Information regarding the effects of omega-3 fatty acid on hypertriglyceridemic patients in Chinese is still limited. This study aimed to investigate the...
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StartPage 275
SubjectTerms Adult
Dietary Supplements
Docosahexaenoic acid
Docosahexaenoic Acids - therapeutic use
Double-Blind Method
Drug Combinations
Eicosapentaenoic acid
Eicosapentaenoic Acid - therapeutic use
Ethnic chinese
Fatty Acids, Omega-3 - administration & dosage
Female
Humans
Hypertriglyceridemia
Hypertriglyceridemia - drug therapy
Hypertriglyceridemia - pathology
Hypolipidemic Agents - therapeutic use
Life Style
Male
Middle Aged
Omacor
Omega-3 fatty acids
Original
Safety
Severity of Illness Index
Taiwan
Treatment Outcome
Triglycerides - blood
Title 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
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https://www.ncbi.nlm.nih.gov/pubmed/27600795
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https://pubmed.ncbi.nlm.nih.gov/PMC5383544
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