Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.
Ezetimibe, a cholesterol-absorption inhibitor, significantly lowers low-density lipoprotein cholesterol (LDL-C) when administered in addition to statin treatment. The effect of ezetimibe on the incidence and progression of vascular disease is elusive. Therefore, our objective was to examine the effects of fluvastatin and fluvastatin plus ezetimibe on lipoprotein subfractions in patients with diabetes mellitus and/or coronary heart disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
80 mg MR, 12 weeks
fluvastatin 80 mg MR plus ezetimibe 10 mg
Depart. of Internal Medicine, Medical University of Graz
Graz, Austria
Reduction in Low density lipoprotein cholesterol (LDL-C)
Time frame: week 6 and 12
Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP
Time frame: week 6 and 12
adverse events, CK elevation, liver enzyme elevation
Time frame: week 6, 12
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