Effect of Simvastatin and Ezetimibe on Lipid and Inflammation
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
Ezetimibe specifically blocks the absorption of dietary and biliary cholesterol and plant
sterols. Synergism of ezetimibe-statin therapy on LDL-cholesterol has been demonstrated, but
data concerning the pleiotropic effects of this combination are controversial. We tested the
hypothesis that the combination of simvastatin and ezetimibe would induce improvement in
inflammatory status, as reflected by leukocyte count and CRP, IL-6 and TNF-a levels. This
open-label trial evaluated whether this combination results in a synergistic effect the
pro-inflammatory status of pre-diabetic subjects. Fifty pre-diabetic subjects were randomly
assigned to one of 2 groups, one receiving ezetimibe (10 mg/d), the other, simvastatin (20
mg/d) for 12 weeks, followed by an additional 12-week period of combined therapy.