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

Introduction

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

Data Sharing Statement

All relevant data are within the paper and its Supplementary Materials.

Acknowledgments

The investigators express their appreciation to the patients who agreed to participate in this study, which was supported by Abbott Products Operations AG, Allschwil, Switzerland. Hughes associates, Oxford, UK, provided editorial assistance in the preparation of this report.

Disclosure

L.Q., Q.Z., Z.Z., Z.P., H.M., T.J. and Y.H. report no conflicts of interest in this work. E.K. is an employee of Abbott Laboratories GmbH, Hannover, Germany and owns shares of Abbott. D.K. is an employee of Abbott Healthcare Products B.V., Weesp, The Netherlands and owns shares of Abbott. The authors report no other conflicts of interest in this work.