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Comparison of ezetimibe plus simvastatin versus simvastatin monotherapy on atherosclerosis progression in familial hypercholesterolemia. Design and rationale of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial.
- Source :
-
American heart journal [Am Heart J] 2005 Feb; Vol. 149 (2), pp. 234-9. - Publication Year :
- 2005
-
Abstract
- Background: Lipid lowering through statin therapy significantly reduces the risk of cardiovascular events. The ENHANCE study is an international 2-year, randomized, double-blind, controlled trial designed to test the hypothesis that treatment of hypercholesterolemia by use of 2 complementary agents, ezetimibe (a specific cholesterol absorption inhibitor) and simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor), will result in larger beneficial effects on carotid artery intima-media thickness (CA IMT) than simvastatin monotherapy.<br />Methods: The study will recruit 725 men and women with heterozygous familial hypercholesterolemia. After a placebo washout period, participants are randomized to receive daily administration of either simvastatin 80 mg and ezetimibe 10 mg or simvastatin 80 mg and placebo. The ENHANCE trial uses novel state-of-the-art single-frame digital image acquisition and rigorous quality assurance and control.<br />Results: The primary end point is mean change from baseline to 2 years in CA IMT, using composite measures from the right and left far wall common carotid artery, carotid bulb, and internal carotid artery. Secondary end points include (1) the proportion of participants who exhibit reductions in CA IMT, (2) the change in maximum far wall IMT, (3) the proportion of participants who develop new carotid artery plaques, and (4) the changes in carotid plus common femoral artery IMT.<br />Conclusions: This study addresses the question of whether a regimen that uses drugs with different mechanisms of action will be of further benefit in terms of atherosclerosis reduction compared to statin monotherapy.
- Subjects :
- Adult
Aged
Carotid Arteries diagnostic imaging
Carotid Arteries pathology
Double-Blind Method
Drug Therapy, Combination
Ezetimibe
Female
Humans
Male
Middle Aged
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Research Design
Tunica Intima pathology
Tunica Media pathology
Ultrasonography
Anticholesteremic Agents therapeutic use
Azetidines therapeutic use
Hyperlipoproteinemia Type II drug therapy
Simvastatin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6744
- Volume :
- 149
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- American heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 15846260
- Full Text :
- https://doi.org/10.1016/j.ahj.2004.06.024