Ezetimibe and Simvastatin in Dyslipidemia of Diabetes

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Treatments: Ezetimibe; Simvastatin

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus with stable antidiabetic treatment since at least three months

• Total cholesterol concentrations >135mg/dl and/or concomitant lipid lowering therapy with HMGCoA inhibitors

• Serum creatinine ≤1.5mg/dl

• Urinary albumin excretion rate < 200μg/min

• Written informed consent

Exclusion Criteria:

• History of myocardial infarction, stroke or hospital admission for angina within the previous 6 months

• History of percutaneous transluminal coronary angioplasty or coronary artery bypass grafting

• Clinically manifest heart failure (grade III or above according to New York Heart Association criteria)

• Poor glycemic control (HbA1C >11%)

• Primary hyperlipidemia

• Uncontrolled thyroid diseases

• Infectious disease within 4 weeks of starting

• Acute liver disease or hepatic dysfunction

• Inflammatory muscle disease or evidence of muscle problems

• Concurrent treatment with systemic steroids, androgens, cyclosporin and other immunosuppressive drugs, fibrates, high-dose niacin or cholestyramine

• Pregnancy or lactating

• Women of childbearing potential without following a scientifically accepted form of contraception

• Life-threatening conditions or terminal concomitant diseases other than diabetes

• Specific contraindications or history of hypersensitivity to the study drugs or other statins

• Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial

• Evidence of an uncooperative attitude

• Any evidence that patient will not be able to complete the trial follow-up