Ezetimibe and Simvastatin in Dyslipidemia of Diabetes
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
Diabetes mellitus is becoming a global epidemic burden. Its chronic cardiovascular
complications, myocardial infarction and stroke, are the main causes of death in diabetic
patients. It was found that low density lipoprotein (LDL) cholesterol concentration is
related to the increased coronary disease risk that could be successfully reduced by
cholesterol-lowering therapy. Furthermore, preliminary evidence suggests that ameliorating
dyslipidemia may be renoprotective in diabetic patients with proteinuria.
Ezetimibe is the first selective inhibitor of cholesterol absorption and it has demonstrated
a high efficacy in lowering cholesterol concentration and an excellent safety profile.
Preliminary data suggest that ezetimibe, combined with a drug that blocks the cholesterol
synthesis (statins), could be even more effective in decreasing cholesterol concentration.
The aim of this study is to evaluate whether ezetimibe-simvastatin combined therapy is
superior to simvastatin monotherapy in ameliorating the lipid profile and albuminuria in type
2 diabetic patients.
Phase:
Phase 2
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research