Patients with type 2 diabetes without manifest cadiovascular disease.
Conditions
Interventions
Cerivastatin 0.4 mg (Bayer BV, Mijdrecht, the Netherlands) daily or placebo for 2 years.
After the withdrawal of cerivastatin from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin (
Sponsors
The trial was ïnvestigator driven (see scientific contact).
The trial was supported by Bayer BV(Mijdrecht, the Netherlands). After the withdrawal of cerivastatin from the market, Merck, Sharp and Dome (Haarlem, the Netherlands) supplied the simvastatin/placebo tablets for the remaining study period.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes for at least 1 year; 2. Age 30-80 years; 3. Written informed consent; 4. With no prior cardiovascular disease; 5. Total cholesterol 4.0-6.9 mmol/l triglycerides < 6.0 mmol/l.
Exclusion criteria
Exclusion criteria: 1. Prior cardiovascular disease; 2. current/recent use of lipid lowering drugs; 3. Impaired renal function ( 3 ULN; 5. Uncontrolled thyroid disease; 6. Liver disease or ALAT > 2 ULN; 7. Inadequate contraception, pregnancy or lactation; 8. Life expectancy <2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean intima-media thickness (IMT) of the common carotid artery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in: 1. Mean IMT of the carotid bifurcation, internal carotid artery, common femoral artery and superficial femoral artery; 2. Distensibility of the common carotid artery; 3. Flow mediated vasodilation (FMD) of the brachial artery as a parameter for endothelial function; 4. 48 ambulatory ECG as a parameter for silent myocardial ischemia; 5. -hs-CRP and other blood parameters for vascular inflammation, hemostatis, fibrinolysis, platelet activation, endothelial function. | — |
Contacts
Public ContactE.D. Beishuizen
't Lange Land Hospital PO box 3015
Outcome results
None listed