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Cardiovasc Drugs Ther. 2010 Dec;24(5-6):429-37. doi: 10.1007/s10557-010-6249-5.

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

Author information

1
The Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer, Israel. Rafael.Bitzur@sheba.health.gov.il

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00441480.

PMID:
20617456
DOI:
10.1007/s10557-010-6249-5
[Indexed for MEDLINE]

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