Ezetimibe and Simvastatin in Dyslipidemia of Diabetes
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.
Timeline
- Start
- 2005-01
- Primary completion
- —
- Completion
- 2006-12
Outcome
Met primary endpoint
paper Unlike placebo, ezetimibe decreased LDL cholesterol from 99 +/- 31 to 66 +/- 22 mg/dl PMID 20566677 ↗
paper P < 0.0001 for all changes versus placebo PMID 20566677 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Background | Simvastatin | Small molecule | 40 mg | — |