The metabolic effects of omega-3 plant sterol esters in mixed hyperlipidemic subjects.
OBJECTIVE
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.
Bitzur
Rafael
R
The Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer, Israel. Rafael.Bitzur@sheba.health.gov.il
Cohen
Hofit
H
Cohen
Tzafra
T
Dror
Tali W
TW
Herzog
Yael
Y
Lifshitz
Yael
Y
Lubish
Tamar
T
Harats
Dror
D
Rubinstein
Ardon
A
D001794:Blood Pressure / Q000187:drug effects; D002097:C-Reactive Protein / Q000378:metabolism; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D004952:Esters / Q000009:adverse effects / Q000627:therapeutic use; D015525:Fatty Acids, Omega-3 / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood* / Q000188:drug therapy* / Q000503:physiopathology; D008055:Lipids / Q000097:blood; D008074:Lipoproteins / Q000097:blood; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D014280:Triglycerides / Q000097:blood
D008078:Cholesterol, LDL; D004952:Esters; D015525:Fatty Acids, Omega-3; D008055:Lipids; D008074:Lipoproteins; D010840:Phytosterols; D010919:Placebos; D014280:Triglycerides; D002097:C-Reactive Protein