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Efficacy and safety of omega-3-acid ethyl acetate 90 capsules in severe hypertriglyceridemia: A randomized, controlled, multicenter study.
Zhao, Wang; Wang, Yangang; Li, Jin; Chen, Tao; Yin, Delu; Dai, Hailong; Yao, Zhuhua; Zhao, Shuiping.
Afiliación
  • Zhao W; Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Wang Y; Department of Endocrinology and Metabolism, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
  • Li J; Department of Cardiology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
  • Chen T; Department of Endocrinology and Metabolism, Adrenal Center, West China Hospital of SiChuan University, Chengdu, Sichuan, China.
  • Yin D; Department of Cardiology, The First People's Hospital of Lianyungang, The First Affiliated Hospital of Kangda College of Nanjing Medical University, Lianyungang, China.
  • Dai H; Department of Cardiology, Yan'an Affiliated Hospital of Kunming Medical University, Yunnan Cardiovascular Hospital, Kunming, Yunnan, China.
  • Yao Z; Department of Cardiology, Tianjin Union Medical Center, Tianjin, China.
  • Zhao S; Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.
Lipids ; 2024 Jun 03.
Article en En | MEDLINE | ID: mdl-38830807
ABSTRACT
Omega-3-acid ethyl acetate 90 capsules (containing 465 mg of eicosapentaenoic acid and 375 mg docosahexaenoic acid) is composed of highly purified omega-3 polyunsaturated fatty acid (PUFA) ethyl esters, whose lipid-lowering effect for severe hypertriglyceridemia (HTG) treatment is unclear. This study aimed to evaluate the efficacy and safety of omega-3-acid ethyl acetate 90 capsules in patients with severe HTG. In this randomized, double-blind, placebo-controlled, multicenter study, 239 patients with severe HTG were enrolled and randomized (11) into omega-3 group (N = 122) and placebo group (N = 117) to receive 12-week corresponding treatments. Lipid-related indexes were obtained at treatment initiation (W0), 4 weeks (W4), W8, and W12 after treatment. Adverse events and adverse drug reactions were recorded. Triacylglycerols (TAG), total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and apolipoprotein C-III (Apo C-III) at W4, W8, and W12 were decreased in the omega-3 group versus the placebo group (all p < 0.05). Moreover, the percentage changes of TAG, TC, non-HDL-C, and VLDL-C from W0 to W4, W8, and W12, and the percentage change of Apo C-III from W0 to W4 and W8, were more obvious in the omega-3 group compared with the placebo group (all p < 0.05). However, no difference was observed in the percentage changes of HDL-C, low-density lipoprotein cholesterol (LDL-C), and LDL-C/HDL-C ratio during follow-up between groups (all p > 0.05). Additionally, there was no discrepancy in adverse events and adverse drug reactions between groups (all p > 0.05). Omega-3-acid ethyl acetate 90 capsules exhibit satisfied lipid-lowering effect with tolerable safety profile in patients with severe HTG.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Lipids Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Lipids Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos