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ENHANCE
Ezetimibe and Simvastatin in Hypercholesterolemia Enhances atherosclerosis regression
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Author(s) |
(a) Kastelein JJP, Sager PT, de Groot E, Veltri E
(b) Kastelein JJP, Akdim F, Stroes ESG, Zwinderman AH, Bots ML, Stalenhoef AFH, Visseren FLJ, Sijbrands EJG, Trip MD, Stein EA, Gaudet D, Duivenvoorden R, Veltri EP, Marais AD, de Groot E |
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Title(s) |
(a) 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
(b) Simvastatin with or without ezetimibe in familial hypercholesterolemia |
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Reference(s) |
(a) Am Heart J 2005;149:234–9
(b) N Engl J Med 2008;358:1431–43 |
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Disease |
Hypercholesterolaemia |
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Purpose |
To evaluate the effects of simvastatin with or without ezetimibe on atherosclerosis in patients with familial hypercholesterolaemia |
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Study design |
Randomised, double-blind, controlled |
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Follow-up |
24 months |
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Patients |
720 patients (357 simvastatin plus ezetimibe, 363 simvastatin plus placebo), aged 30–75 years, with heterozygous familial hypercholesterolaemia and LDL cholesterol > 5.43 mmol/l (> 210 mg/dl) |
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Treatment regimen |
Simvastatin, 80 mg/day, plus either ezetimibe, 10 mg/day, or placebo |
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Results |
642 patients (322 simvastatin plus ezetimibe, 320 simvastatin plus placebo) were included in the intention-to-treat analysis. The primary outcome of the mean change from baseline in the carotid artery intima-media thickness was 0.0111 ± 0.0038 mm in the simvastatin plus ezetimibe group and 0.0058 ± 0.0037 mm in the simvastatin plus placebo group (p = 0.29) |
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Comments |
The results of a post-hoc analysis on the influence of baseline cholesterol absorption on the response to therapy have been published in J Lipid Res 2010;51:755–62 |
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