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 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.

Supplements of L-arginine attenuate the effects of high-fat meal on endothelial function and oxidative stress.

BACKGROUND: Postprandial hypertriglyceridemia is known to cause endothelial dysfunction and increased oxidative stress. Oral supplements of l-arginine have been found to improve endothelial function. However, the effects of supplements of l-arginine on the influences of postprandial hypertriglyceridemia were not studied before. METHODS: Forty young healthy men without any risk factors were equally divided into two groups. l-arginine group (age 22+/-1 years, body mass index 23.5+/-1.2 kg/m(2)) received a standard high-fat meal with 15 g oral l-arginine. Control group (age 22+/-1 years, body mass index 23.8+/-0.9 kg/m(2)) received a standard high-fat meal with placebo. A standard high-fat meal consisted of 900 kcal and 50 g of fat. Flow-mediated vasodilation (FMD), von Willebrand factor (vWF), p-Selectin, and glutathione peroxidase (GSH-Px) were measured before and 2 h after the high-fat meal. RESULTS: Serum triglyceride levels were significantly increased 2 h after the high-fat meal in both groups. In the control group, FMD (10.5+/-1.2% vs. 6.8+/-1.4%, p<0.001) and GSH-Px (23.5+/-6.2 vs. 21.9+/-5.0 mug/ml, p=0.029) were significantly decreased after the high-fat meal. P-Selectin (20.0+/-7.7 vs. 25.9+/-10.5 mg/l, p=0.025) and vWF (731.2+/-131.5 vs. 934.9+/-133.8 mU/ml, p<0.001) were significantly increased after the high-fat meal. In the l-arginine group, FMD (10.3+/-1.3 vs. 9.3+/-0.9%, p<0.001) was slightly but significantly decreased after the high-fat meal but not GSH-Px (23.6+/-3.6 vs. 23.0+/-4.8%, p=0.468). P-Selectin (20.1+/-5.9 vs. 25.7+/-10.2 mg/l, p=0.001) and vWF (793.2+/-146.0 vs. 944.4+/-136.8 mU/ml, p<0.001) were significantly increased after the high-fat meal. Degree of FMD attenuation following the high-fat meal was significantly less in the l-arginine group (1.0+/-0.9 vs. 3.8+/-1.5%, p<0.001). CONCLUSIONS: Concomitant supplements of l-arginine improved endothelial dysfunction and oxidative stress induced by postprandial hypertriglyceridemia. However, changes of p-Selectin and vWF were not affected by supplements of l-arginine with the high-fat meal.