Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: fluvastatin
* Drug: Fluvastatin plus ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CHD or CHD equivalent with LDL 100-160 mg/dl Male or female sex Normal values of CK, AST and ALT Normal kidney function Exclusion Criteria: CHD Stage III-IV St. p. myocardial infarction or coronary artery bypass grafting Pregnancy or breastfeeding Premenopausal women without certain contraception Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluvastatin<br>Fluvastatin 80 mg MR | Drug: fluvastatin<br>* 80 mg MR, 12 weeks<br>* Other names: Lescol;|
| Active Comparator: Fluvastatin + Ezetimibe<br>Fluvastatin MR 80 mg plus Ezetimibe 10 mg | Drug: Fluvastatin plus ezetimibe<br>* fluvastatin 80 mg MR plus ezetimibe 10 mg<br>* Other names: Lescol, Ezetrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Low density lipoprotein cholesterol (LDL-C) |  | week 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP |  | week 6 and 12 | 
| adverse events, CK elevation, liver enzyme elevation |  | week 6, 12 |