Simvastatin with or without ezetimibe in familial hypercholesterolemia
Kastelein JJ, Akdim F, Stroes ES, Zwinderman AH, Bots ML, Stalenhoef AF, Visseren FL, Sijbrands EJ, Trip MD, Stein EA, Gaudet D, Duivenvoorden R, Veltri EP, Marais AD, de Groot E, ENHANCE Investigators
The New England journal of medicine · 826 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2008-03-30 · N Engl J Med · vol. 358 · número 14 · págs. 1431–1443
- Editorial
- Massachusetts Medical Society
- Citado
- 1,240 citas · más que el 100% de estudios similares · 193.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 34 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Cardiovascular Health and Disease Prevention · Cholesterol and Lipid Metabolism
- Palabras clave
- simvastatin, ezetimibe, familial hypercholesterolemia, LDL cholesterol lowering, atherosclerosis progression, carotid intima-media thickness, femoral artery, cholesterol absorption inhibition, triglycerides, C-reactive protein, statin combination therapy, lipid-lowering therapy, atherosclerotic plaque regression
- MeSH
- tunica media, carotid arteries, femoral artery, tunica intima, humans, azetidines, simvastatin, cholesterol, triglycerides, anticholesteremic agents, ultrasonography, treatment outcome, drug therapy, combination, double-blind method, adult, middle aged, female, male, hyperlipoproteinemia type ii, cholesterol, ldl, ezetimibe
15 autores
- John J.P. Kastelein🇳🇱Amsterdam UMC Location University of Amsterdam
- Fatima Akdim🇳🇱Amsterdam UMC Location University of Amsterdam
- Erik S.G. Stroes🇳🇱Amsterdam UMC Location University of Amsterdam
- Aeilko Having Zwinderman🇳🇱Amsterdam UMC Location University of Amsterdam
- Michiel L. Bots🇳🇱University Medical Center Utrecht
- Anton F. H. Stalenhoef🇳🇱Radboud University Nijmegen; Radboud University Medical Center
- Frank L.J. Visseren🇳🇱University Medical Center Utrecht
- Eric J.G. Sijbrands🇳🇱Erasmus MC
- Mieke D. Trip🇳🇱Amsterdam UMC Location University of Amsterdam
- Evan A. Stein
- Daniel Gaudet
- Raphaël Duivenvoorden🇳🇱Amsterdam UMC Location University of Amsterdam
- Enrico P. Veltri
- Adéle Marais
- Eric de Groot🇳🇱Amsterdam UMC Location University of Amsterdam
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Ezetimibe, a cholesterol-absorption inhibitor, reduces levels of low-density lipoprotein (LDL) cholesterol when added to statin treatment. However, the effect of ezetimibe on the progression of atherosclerosis remains unknown.
Methods
We conducted a double-blind, randomized, 24-month trial comparing the effects of daily therapy with 80 mg of simvastatin either with placebo or with 10 mg of ezetimibe in 720 patients with familial hypercholesterolemia. Patients underwent B-mode ultrasonography to assess the intima-media thickness of the walls of the carotid and femoral arteries. The primary outcome measure was the change in the mean carotid-artery intima-media thickness, which was defined as the average of the means of the far-wall intima-media thickness of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries.
Results
The primary outcome, the mean (+/-SE) change in the carotid-artery intima-media thickness, was 0.0058+/-0.0037 mm in the simvastatin-only group and 0.0111+/-0.0038 mm in the simvastatin-plus-ezetimibe (combined-therapy) group (P=0.29). Secondary outcomes (consisting of other variables regarding the intima-media thickness of the carotid and femoral arteries) did not differ significantly between the two groups. At the end of the study, the mean (+/-SD) LDL cholesterol level was 192.7+/-60.3 mg per deciliter (4.98+/-1.56 mmol per liter) in the simvastatin group and 141.3+/-52.6 mg per deciliter (3.65+/-1.36 mmol per liter) in the combined-therapy group (a between-group difference of 16.5%, P<0.01). The differences between the two groups in reductions in levels of triglycerides and C-reactive protein were 6.6% and 25.7%, respectively, with greater reductions in the combined-therapy group (P<0.01 for both comparisons). Side-effect and safety profiles were similar in the two groups.
Conclusions
In patients with familial hypercholesterolemia, combined therapy with ezetimibe and simvastatin did not result in a significant difference in changes in intima-media thickness, as compared with simvastatin alone, despite decreases in levels of LDL cholesterol and C-reactive protein. (ClinicalTrials.gov number, NCT00552097 [ClinicalTrials.gov].).
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