Cardiovascular Drugs and Therapy

, Volume 24, Issue 5–6, pp 429–437 | Cite as

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
Article

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.

Key words

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

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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Rafael Bitzur
    • 1
  • Hofit Cohen
    • 1
  • Tzafra Cohen
    • 3
  • Tali W. Dror
    • 3
  • Yael Herzog
    • 3
  • Yael Lifshitz
    • 3
  • Tamar Lubish
    • 1
  • Dror Harats
    • 1
  • Ardon Rubinstein
    • 2
  1. 1.The Bert W. Strassburger Lipid CenterSheba Medical CenterTel HashomerIsrael
  2. 2.Metabolic InstituteTel Aviv Sourasky Medical CenterTel AvivIsrael
  3. 3.R&D DepartmentEnzymotec LtdMigdal HaEmeqIsrael

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