Dataset Information

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.

ABSTRACT: 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.

SUBMITTER: Su TC

PROVIDER: S-EPMC5383544 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Publications

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.

Su Ta-Chen TC Hwang Juey-Jen JJ Huang Kuo-Chin KC Chiang Fu-Tien FT Chien Kuo-Liong KL Wang Kuo-Yang KY Charng Min-Ji MJ Tsai Wei-Chuan WC Lin Lian-Yu LY Vige Runar R Olivar José Emilio Ruiz JE Tseng Chuen-Den CD

Journal of atherosclerosis and thrombosis 20160906 3

<h4>Aim</h4>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<sup>®</sup>, 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.<h4>Methods</h4>A multicenter, randomized, double-blind, placebo-controlled, parallel study in adults with hypertr ...[more]

PMID: 27600795

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Project description:Endothelial cells are thought to play a central role in the pathogenesis of antiphospholipid syndrome (APS). Omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation has been shown to improve endothelial function in a number of diseases; thus, it could be of high clinical relevance in APS. The aim of this study was to evaluate the efficacy of n-3 PUFA supplementation on endothelial function (primary outcome) of patients with primary APS (PAPS). A 16-week randomized clinical trial was conducted with 22 adult women with PAPS. Patients were randomly assigned (1:1) to receive placebo (PL, n?=?11) or n-3 PUFA (?-3, n?=?11) supplementation. Before (pre) and after (post) 16?weeks of the intervention, patients were assessed for endothelial function (peripheral artery tonometry) (primary outcome). Patients were also assessed for systemic markers of endothelial cell activation, inflammatory markers, dietary intake, international normalized ratio (INR), and adverse effects. At post, ?-3 group presented significant increases in endothelial function estimates reactive hyperemia index (RHI) and logarithmic transformation of RHI (LnRHI) when compared with PL (+13 vs. -12%, p?=?0.06, ES?=?0.9; and +23 vs. -22%, p?=?0.02, ES?=?1.0). No changes were observed for e-selectin, vascular adhesion molecule-1, and fibrinogen levels (p?>?0.05). In addition, ?-3 group showed decreased circulating levels of interleukin-10 (-4 vs. +45%, p?=?0.04, ES?=?-0.9) and tumor necrosis factor (-13 vs. +0.3%, p?=?0.04, ES?=?-0.95) and a tendency toward a lower intercellular adhesion molecule-1 response (+3 vs. +48%, p?=?0.1, ES?=?-0.7) at post when compared with PL. No changes in dietary intake, INR, or self-reported adverse effects were observed. In conclusion, 16?weeks of n-3 PUFA supplementation improved endothelial function in patients with well-controlled PAPS. These results support a role of n-3 PUFA supplementation as an adjuvant therapy in APS. Registered at http://ClinicalTrials.gov as NCT01956188.

Dataset Information

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.

Publications

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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