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The Metabolic Effects of Omega-3 Plant Sterol Esters in Mixed Hyperlipidemic Subjects

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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.

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Acknowledgements

We thank Prof Harold Lebovitz for the help in the study design and results analysis.

WRB, DH, AR, TC, YH, and TWD designed the trial; TL coordinated the study; RB, HC and AR were responsible for patient recruitment and management; TL conducted the laboratory analyses. RB, DH, AR, HC, YL and TWD interpreted the data, and wrote the draft of the manuscript; and all authors participated in the critical review of the manuscript and approved the final version.

Conflict of interest statement

The study was supported by Enzymotec Ltd., Migdal HaEmeq, Israel. TC, TWD, YH, and YL are employees of Enzymotec Ltd. None of the other authors have any personal or financial conflict of interest.

Author information

Authors and Affiliations

  1. The Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer, Israel

    Rafael Bitzur, Hofit Cohen, Tamar Lubish & Dror Harats

  2. Metabolic Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

    Ardon Rubinstein

  3. R&D Department, Enzymotec Ltd, Migdal HaEmeq, Israel

    Tzafra Cohen, Tali W. Dror, Yael Herzog & Yael Lifshitz

Authors
  1. Rafael Bitzur
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  2. Hofit Cohen
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  6. Yael Lifshitz
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  7. Tamar Lubish
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  9. Ardon Rubinstein
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Corresponding author

Correspondence to Rafael Bitzur.

Additional information

ClinicalTrials.gov.identifier: NCT00441480

The study was supported by Enzymotec Ltd., Migdal HaEmeq, Israel.

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Bitzur, R., Cohen, H., Cohen, T. et al. The Metabolic Effects of Omega-3 Plant Sterol Esters in Mixed Hyperlipidemic Subjects. Cardiovasc Drugs Ther 24, 429–437 (2010). https://doi.org/10.1007/s10557-010-6249-5

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