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

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Fluvastatin plus ezetimibe; Drug: fluvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00814723

2004-002535-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Fluvastatin

Active Comparator group

Description:

Fluvastatin 80 mg MR

Treatment:

Drug: fluvastatin

Fluvastatin + Ezetimibe

Active Comparator group

Description:

Fluvastatin MR 80 mg plus Ezetimibe 10 mg

Treatment:

Drug: Fluvastatin plus ezetimibe