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Icosapent ethyl therapy for very high triglyceride levels: a 12-week, multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial in China.

Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. Department of Cardiac Function, The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China. Department of Cardiology, Yuncheng Central Hospital, Yuncheng, Shanxi, China. Department of Cardiology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China. Department of Cardiology, Chinese PLA General Hospital, Beijing, China. Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. Department of Cardiology, Tianjin Union Medical Center, Tianjin, China. Department of Cardiology, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, China. Department of Cardiology, Liaocheng People's Hospital and Liaocheng Clinical School of Taishan Medical University, Liaocheng, Shandong, China. Department of Cardiology, Jinzhou Central Hospital, Jinzhou, Liaoning, China. Department of Cardiology, Chifeng Municipal Hospital, Chifeng, Inner Mongolia, China. Department of Cardiology, Inner Mongolia People's Hospital, Huhhot, China. Department of Cardiology, General Hospital of Ningxia Medical University, Yinchuan, China. Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China. Department of Cardiology, Jilin Central General Hospital, Jilin, China. Department of Cardiology, Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Departments of Cardiology, Suzhou Kowloon Hospital, School of Medicine Shanghai Jiaotong University, Suzhou, Jiangsu, China. Department of Cardiology, Jingzhou Central Hospital, Jingzhou, Hubei, China. Department of Cardiology, Shanxi Provincial People's Hospital, Taiyuan, China. Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. ge.junbo2@zs-hospital.sh.cn.

Lipids in health and disease. 2023;(1):71
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Abstract

OBJECTIVES Eicosapentaenoic acid in its ethyl ester form is the single active component of icosapent ethyl (IPE). This study was a phase III, multi-center trial assessing the safety and efficiency of IPE for treating very high triglyceride (TG) in a Chinese cohort. METHODS Patients having TG levels (5.6-22.6 mmol/L) were enrolled and randomly assigned to receive a treatment of oral intake of 4 g or 2 g/day of IPE, or placebo. Before and after 12 weeks of treatment, TG levels were assessed and the median was calculated to determine the change between the baseline and week 12. In addition to examining TG levels, the impact of such treatments on other lipid changes was also investigated. The official Drug Clinical Trial Information Management Platform has registered this study (CTR20170362). RESULTS Random assignments were performed on 373 patients (mean age 48.9 years; 75.1% male). IPE (4 g/day) lowered TG levels by an average of 28.4% from baseline and by an average of 19.9% after correction for placebo (95% CI: 29.8%-10.0%, P < 0.001). In addition, plasma concentration of non-high-density lipoprotein cholesterol (non-HDL-C), very low-density lipoprotein (VLDL) cholesterol, and VLDL-TG remarkedly reduced after IPE (4 g/day) treatment by a median of 14.6%, 27.9%, and 25.2%, respectively compared with participants in placebo group. Compared to the placebo, neither 4 nor 2 g of IPE daily elevated LDL-C levels with statistical significance. IPE was well tolerated by all the treatment groups. CONCLUSIONS IPE at 4 g/day dramatically lowered other atherogenic lipids without a noticeable increase in LDL-C, thereby decreasing TG levels in an exceptionally high-TG Chinese population.

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