Treatment of Chinese Patients with Hypertriglyceridemia with a Pharmaceutical-Grade Preparation of Highly Purified Omega-3 Polyunsaturated Fatty Acid Ethyl Esters: Main Results of a Randomized, Double-Blind, Controlled Trial

• Main Authors: Qi L, Zhang Q, Zheng Z, Pei Z, Mao H, Jiang T, Kazei D, Kahler E, Huo Y
• Format: Article
• Language: English
• Published: Dove Medical Press 2021-09-01
• Series: Vascular Health and Risk Management
• Subjects: omega-3pufas; hypertriglyceridemia; triglycerides; clinical trial; china; statin.
• Online Access: https://www.dovepress.com/treatment-of-chinese-patients-with-hypertriglyceridemia-with-a-pharmac-peer-reviewed-fulltext-article-VHRM
• ISSN: 1178-2048

Litong Qi,1 Qiuling Zhang,2 Zeqi Zheng,3 Zhaohui Pei,4 Hong Mao,5 Tingbo Jiang,6 Dmitri Kazei,7 Elke Kahler,8 Yong Huo1 1Peking University First Hospital, Beijing, 100034, People’s Republic of China; 2The Affiliated Hospital of Hangzhou Normal University, Hangzhou City, Zhejiang, 310015, People’s Republic of China; 3The First Affiliated Hospital of Nanchang University, Nanchang City, Jiangxi, 330000, People’s Republic of China; 4The Third Hospital of Nanchang, Nanchang City, Jiangxi, 330000, People’s Republic of China; 5The Central Hospital of Wuhan, Wuhan City, Hubei, 430014, People’s Republic of China; 6The First Affiliated Hospital of Soochow University, Suzhou City, Jiangsu, 215006, People’s Republic of China; 7Abbott Healthcare Products BV, Weesp, 1381 CT, The Netherlands; 8Abbott Laboratories GmbH, Hannover, 30173, GermanyCorrespondence: Yong HuoDepartment of Cardiology, Peking University First Hospital, No. 8 Xishiku St. Xicheng District, Beijing, 100034, People’s Republic of ChinaTel [phone]Email [e-mail]: The lipid-modifying potential of omega-3 polyunsaturated fatty acids in Chinese patients is under-researched. We conducted a multicenter, randomized, placebo-controlled, double-blind, parallel-group study of twice-daily treatment with OMACOR (OM3EE), a prescription-only formulation of highly purified ethyl esters of omega-3 polyunsaturated fatty acids in Chinese adult patients (≥ 18 years) who had elevated baseline fasting serum triglycerides (TG).Methods: Patients were stratified according to the severity of their hypertriglyceridemia (severe HTG, with baseline TG ≥ 500 and < 1000 mg/dL or moderate HTG, with baseline TG > 200 and < 500 mg/dL) or use of statins. Patients randomized to OM3EE therapy received 2 g/day for 4 weeks, then 4 g/day for 8 weeks. The primary efficacy endpoint was the percentage change in fasting serum TG between baseline and the end of treatment in patients with severe HTG. The study was concluded after a planned interim analysis demonstrated a significant TG-lowering effect of OM3EE in that contingent (p=0.0019).Results: The mean TG end-of-treatment effect of OM3EE was – 29.46% (standard deviation 40.60%) in the severe HTG contingent compared with +0.26% (standard deviation 54.68%) in the placebo group. Corresponding changes were – 12.12% and – 23.25% in the moderate HTG and combination cohorts (vs +55.45% and +6.24% in relevant placebo groups). A dose-dependent reduction in TG was evident in all patient contingents. Safety and tolerability of OM3EE were in line with previous experience.Discussion: These data indicate that OMACOR therapy at a dose of 2– 4 g/day is an effective treatment for Chinese patients with raised TG levels and is well tolerated.Keywords: omega-3 PUFAs, hypertriglyceridemia, triglycerides, clinical trial, China, statin