The metabolic effects of omega-3 plant sterol esters in mixed hyperlipidemic subjects

Rafael Bitzur*, Hofit Cohen, Tzafra Cohen, Tali W. Dror, Yael Herzog, Yael Lifshitz, Tamar Lubish, Dror Harats, Ardon Rubinstein

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: The aim of the current study was to evaluate the therapeutic effects of omega-3 plant sterol esters (n-3-PSE) on lipid profile and other coronary heart disease risk factors in subjects with mixed hyperlipidemia. Methods: Ninety-one patients with mixed hyperlipidemia were randomized in a double blind fashion to receive either placebo (corn oil) or n-3-PSE. Twenty four patients dropped out or were excluded from the efficacy analysis due to protocol violation. The primary efficacy endpoint was mean change in plasma low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment. Other efficacy measures included plasma lipids, lipoproteins, and high-sensitivity C-reactive protein (hsCRP) levels. Participants who completed the double-blind study were given the option to continue into an open-label, 12-weeks follow up phase. Results: n-3-PSE treatment did not result in a significant change in LDL-C levels. Triglyceride levels were reduced significantly by 19% (51 mg/dL, p<0.0001) in the n-3-PSE group in comparison with the placebo group (p=0.025). Diastolic blood pressure and hsCRP were reduced by 7% (5.9 mmHg) and 7.8% (0.6 mg/L), respectively, and were significantly different from the placebo group (p=0.036 and p=0.018, respectively). Conclusions: In patients with mixed hyperlipidemia, n-3-PSE treatment may offer a safe and effective therapy for triglyceride level reduction while avoiding the typical increase in LDL-C levels associated with n-3 fatty acid treatment. The observed reduction in blood pressure and inflammation markers warrants further evaluation. The positive effect of n-3-PSE treatment was preserved at the end of the follow up phase.

Original languageEnglish
Pages (from-to)429-437
Number of pages9
JournalCardiovascular Drugs and Therapy
Volume24
Issue number5-6
DOIs
StatePublished - Dec 2010
Externally publishedYes

Funding

FundersFunder number
Enzymotec Ltd.
Migdal HaEmeq, Israel

    Keywords

    • Dyslipidemia
    • High-sensitivity C-reactive protein (hsCRP)
    • Hypertriglyceridemia
    • Plant sterol esters
    • n-3 fatty acids

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