Vascular Health and Risk Management (Sep 2021)
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
Abstract
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 +86 139 01333060Email [email protected]: 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 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
