drugset / Trial / NCT01103648

Effect of Simvastatin and Ezetimibe on Lipid and Inflammation

NCT01103648

Completed 50 enrolled Federal University of São Paulo
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-06
Primary completion
2006-05
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ezetimibe Unknown 10 mg Oral
Comparator Simvastatin Small molecule 20 mg Oral