Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: fluvastatin Drug: Fluvastatin plus ezetimibe	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Fluvastatin Fluvastatin sodium Ezetimibe

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:

Reduction in Low density lipoprotein cholesterol (LDL-C) [ Time Frame: week 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP [ Time Frame: week 6 and 12 ] [ Designated as safety issue: No ]
adverse events, CK elevation, liver enzyme elevation [ Time Frame: week 6, 12 ] [ Designated as safety issue: Yes ]


Enrollment:	90
Study Start Date:	September 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Fluvastatin Fluvastatin 80 mg MR	Drug: fluvastatin 80 mg MR, 12 weeks Other Name: Lescol
Active Comparator: Fluvastatin + Ezetimibe Fluvastatin MR 80 mg plus Ezetimibe 10 mg	Drug: Fluvastatin plus ezetimibe fluvastatin 80 mg MR plus ezetimibe 10 mg Other Name: Lescol, Ezetrol

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00814723

Locations


Austria
Depart. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036

Sponsors and Collaborators

Medical University of Graz

Investigators


Principal Investigator:	Winfried März, Prof. , M.D.	Medical University of Graz, Synlab Medizinisches Versorgungszentrum für Labordiagnostik Heidelberg

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stojakovic T, de Campo A, Scharnagl H, Sourij H, Schmölzer I, Wascher TC, März W. Differential effects of fluvastatin alone or in combination with ezetimibe on lipoprotein subfractions in patients at high risk of coronary events. Eur J Clin Invest. 2010 Mar;40(3):187-94. doi: 10.1111/j.1365-2362.2009.02249.x. Epub 2010 Jan 7.


Responsible Party:	Prof. Dr. Winfried März, Medical University of Graz
ClinicalTrials.gov Identifier:	NCT00814723 History of Changes
Other Study ID Numbers:	2004-002535-12
Study First Received:	December 24, 2008
Last Updated:	December 24, 2008
Health Authority:	Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:


Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Ezetimibe Fluvastatin	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016