Ezetimibe and Simvastatin in Dyslipidemia of Diabetes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
|Official Title:||A Randomized, Prospective, Double-Blind Study to Evaluate the Effects on Lipid Profile of Combined Ezetimibe and Simvastatin Therapy as Compared to Simvastatin Alone in People With Type 2 Diabetes|
- LDL-cholesterol, at 16 weeks of treatment. LDL-cholesterol is measured at -4, 0, 8, 12 and 16 weeks.
- Total cholesterol, apolipoprotein A1 and B, lipoprotein and triglycerides, at -4, 0, 8, 12 and 16 weeks
- Urinary albumin excretion, at -4, 0, 8 and 16 weeks
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||December 2006|
|ASl of Ponte San Pietro - Diabetologic Unit|
|Ponte San Pietro, Bergamo, Italy, 24036|
|Clinical Research Center for Rare Diseases|
|Ranica, Bergamo, Italy, 24020|
|Hospital "Treviglio Caravaggio " - Diabetologic Unit|
|Treviglio, Bergamo, Italy, 24047|
|Hospital "Ospedali Riuniti di Bergamo" - Diabetologic Unit|
|Bergamo, Italy, 24128|
|Principal Investigator:||Piero Ruggenenti, MD||Mario Negri Institute|