| Title: |
Simvastatin with or without ezetimibe in familial hypercholesterolemia |
| Authors: |
Kastelein, JJP; Akdim, F; Stroes, ESG; Zwinderman, AH; Bots, ML (Michiel); Stalenhoef, AFH; Visseren, FLJ; Sijbrands, E.J.G.; Trip, MD; Stein, EA; Gaudet, D; Duivenvoorden, R; Veltri, EP; Marais, AD; de Groot, E (Eric) |
| Source: |
Kastelein, JJP, Akdim, F, Stroes, ESG, Zwinderman, AH, Bots, ML, Stalenhoef, AFH, Visseren, FLJ, Sijbrands, E J G, Trip, MD, Stein, EA, Gaudet, D, Duivenvoorden, R, Veltri, EP, Marais, AD & de Groot, E 2008, 'Simvastatin with or without ezetimibe in familial hypercholesterolemia', New England Journal of Medicine, vol. 358, no. 14, pp. 1431-1443. https://doi.org/10.1056/NEJMoa0800742 |
| Publication Year: |
2008 |
| Description: |
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 |
| Document Type: |
article in journal/newspaper |
| Language: |
unknown |
| ISSN: |
0028-4793; 1533-4406 |
| Relation: |
info:eu-repo/semantics/altIdentifier/pissn/0028-4793; info:eu-repo/semantics/altIdentifier/eissn/1533-4406 |
| DOI: |
10.1056/NEJMoa0800742 |
| Availability: |
https://pure.eur.nl/en/publications/9fbd3b8c-5b69-4d49-ba70-d7e40a32a4d2; https://doi.org/10.1056/NEJMoa0800742; https://hdl.handle.net/1765/32431 |
| Rights: |
info:eu-repo/semantics/closedAccess |
| Accession Number: |
edsbas.3B5D3D07 |
| Database: |
BASE |