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Simvastatin with or without ezetimibe in familial hypercholesterolemia.
- Source :
-
The New England journal of medicine [N Engl J Med] 2008 Apr 03; Vol. 358 (14), pp. 1431-43. Date of Electronic Publication: 2008 Mar 30. - Publication Year :
- 2008
-
Abstract
- 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.<br />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.<br />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.<br />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].).<br /> (Copyright 2008 Massachusetts Medical Society.)
- Subjects :
- Adult
Anticholesteremic Agents adverse effects
Azetidines adverse effects
Carotid Arteries diagnostic imaging
Carotid Arteries pathology
Cholesterol blood
Double-Blind Method
Drug Therapy, Combination
Ezetimibe
Female
Femoral Artery diagnostic imaging
Femoral Artery pathology
Humans
Hyperlipoproteinemia Type II pathology
Male
Middle Aged
Simvastatin adverse effects
Treatment Outcome
Triglycerides blood
Tunica Intima diagnostic imaging
Tunica Intima pathology
Tunica Media diagnostic imaging
Tunica Media pathology
Ultrasonography
Anticholesteremic Agents therapeutic use
Azetidines therapeutic use
Cholesterol, LDL blood
Hyperlipoproteinemia Type II drug therapy
Simvastatin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 358
- Issue :
- 14
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 18376000
- Full Text :
- https://doi.org/10.1056/NEJMoa0800742