Submitted on June 20, 2005
Revised on September 1, 2005
Accepted on September 8, 2005
Inhibition of cholesterol absorption by the combination of dietary plant sterols and ezetimibe: Effects on plasma lipid levels
Lily Jakulj, Mieke D. Trip, Thomas Sudhop, Klaus von Bergmann, John J. P. Kastelein, and Maud N. Vissers
Department of Vascular Medicine, Academic Medical Center, Amsterdam 1105
Corresponding Author: m.n.vissers{at}amc.uva.nl
The consumption of plant sterols as well as treatment with ezetimibe both reduce cholesterol absorption in the intestine. The mechanism of action of both treatment modalities is not similar and the consequences of combination treatment are unknown. Therefore, we performed a double-blind placebo controlled cross-over study for the plant sterol component with open-label ezetimibe treatment to determine the individual consequences of plant sterol intake and ezetimibe as well as their combined effects on safety and plasma lipid levels. Forty mildly hypercholesterolemic subjects were randomized to the following treatments for four weeks each: 10 mg/d ezetimibe in combination with 25 g/d of control spread; 10 mg/d ezetimibe in combination with 25 g/d of spread containing 2.0 g of plant sterols; 25 g/d of spread containing 2.0 g of plant sterols; and placebo treatment consisting of 25 g/d of control spread. Combination treatment of plant sterols and ezetimibe reduced LDL-C by 25.2% or 1.06 mmol/L (p<0.001) as compared to 4.7% or 0.23 mmol/L (p=0.006) by plant sterols and to 22.2% or 0.94 mmol/L (p<0.001) by ezetimibe monotherapy. LDL-C reduction conferred by the combination treatment did not differ significantly from ezetimibe monotherapy (-3.5% or -0.12 mmol/L; p=0.13). In addition, the ratio of the cholesterol precursor lathosterol to cholesterol increased with all treatments. The ratios of sitosterol and campesterol to cholesterol increased after plant sterol treatment, and decreased upon ezetimibe and combination therapy. No differences were observed for liver transaminases and creatine phosphokinase between treatments. Our results demonstrate that the combination of plant sterols and ezetimibe has no therapeutic benefit over ezetimibe monotherapy in subjects with mild hypercholesterolemia.
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