Phytosterols, Ezetimibe, and Cholesterol Metabolism

Summary

Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action. The investigators' hypothesis is that phytosterols and ezetimibe given together will block cholesterol absorption in an additive fashion. In a randomized, placebo-controlled crossover trial the effects of placebo, ezetimibe treatment and ezetimibe plus phytosterol treatment will be measured.

Timeline

Start

2009-06

Primary completion

2009-10

Completion

2010-02

Outcome

Met primary endpoint

paper Fecal cholesterol excretion was significantly greater (P<0.0001) with combined treatment PMID 21768544 ↗

paper The combined treatment resulted in significantly lower intestinal cholesterol absorption (598 mg/d; 95% confidence interval [CI], 368 to 828) PMID 21768544 ↗

registry analysis (equivalence test); Phytosterol-Deficient Diet vs Phytosterol-Deficient Diet Plus Ezetimibe Plus Phytosterols; p <0.01; Mean Difference (Final Values) 28; ANOVA; note: Adjusted for multiple comparisons. NCT00863265 ↗

Publications

• Results Lin X, Racette SB, Lefevre M, Ma L, Spearie CA, Steger-May K, Ostlund RE Jr. Combined effects of ezetimibe and phytosterols on cholesterol metabolism: a randomized, controlled feeding study in humans. Circulation. 2011 Aug 2;124(5):596-601. doi: 10.1161/CIRCULATIONAHA.110.006692. Epub 2011 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezetimibe	Unknown	10 mg	—

Indications