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 in | Journal of Atherosclerosis and Thrombosis Vol. 24; no. 3; pp. 275 - 289 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Japan
Japan Atherosclerosis Society
01.01.2017
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Subjects | |
Online Access | Get full text |
ISSN | 1340-3478 1880-3873 1880-3873 |
DOI | 10.5551/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. |
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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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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27600795$$D View this record in MEDLINE/PubMed |
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CitedBy_id | crossref_primary_10_1016_j_ajcnut_2023_03_025 crossref_primary_10_1016_j_advnut_2023_08_003 crossref_primary_10_1038_s41598_020_72686_0 crossref_primary_10_3390_nu14051104 crossref_primary_10_3390_nu10101460 crossref_primary_10_1038_s41430_020_00709_0 crossref_primary_10_1515_jpem_2018_0409 crossref_primary_10_5551_jat_ED063 crossref_primary_10_1016_j_plefa_2018_01_001 crossref_primary_10_3389_fnut_2022_1039056 crossref_primary_10_1161_JAHA_123_029512 crossref_primary_10_3390_nu15051088 |
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Copyright | 2017 This article is distributed under the terms of the latest version of CC BY-NC-SA defined by the Creative Commons Attribution License. 2017 Japan Atherosclerosis Society 2017 |
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CorporateAuthor | National Taiwan University Hospital Taichung Veterans General Hospital National Taiwan University Department of Internal Medicine National Cheng Kung University Hospital Department of Medicine Internal Medicine National Taiwan University College of Public Health Department of Family Medicine Institute of Epidemiology and Preventive Medicine College of Public Health Institute of Occupational Medicine and Industrial Hygiene Division of Cardiology Taipei Veterans General Hospital Ferrer Group Shin Kong Wu Ho-Su Memorial Hospital Cardiovascular Center and Department of Anesthesiology Pronova Biopharma Norge AS |
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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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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 |
URI | https://www.jstage.jst.go.jp/article/jat/24/3/24_34231/_article/-char/en http://mol.medicalonline.jp/en/journal/download?GoodsID=ex7domya/2017/002403/009&name=0275-0289e https://www.ncbi.nlm.nih.gov/pubmed/27600795 https://www.proquest.com/docview/1859727062 https://pubmed.ncbi.nlm.nih.gov/PMC5383544 https://www.jstage.jst.go.jp/article/jat/24/3/24_34231/_pdf |
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