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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Colesevelam Hydrochloride: Efficacy and Safety in Pediatric Subjects with Heterozygous Familial Hypercholesterolemia
Journal of Pediatrics, Volume 156, No. 2, Year 2010
Notification
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Description
Objective: Evaluate the efficacy and safety of colesevelam hydrochloride in children with heterozygous familial hypercholesterolemia (heFH). Study design: This was a randomized, double-blind, 41-site study in 194 children aged 10 to 17 years (inclusive) with heFH (statin-naïve or on a stable statin regimen). After a 4-week stabilization period (period I), subjects were randomized 1:1:1 to placebo, colesevelam 1.875 g/d, or colesevelam 3.75 g/d for 8 weeks (period II). All then received open-label colesevelam 3.75 g/d for 18 weeks (period III), with follow-up 2 weeks later. The primary endpoint was percent change in low-density lipoprotein (LDL)-cholesterol from baseline to week 8. Secondary endpoints included percent change in other lipoprotein variables, including non-high-density lipoprotein (non-HDL)-cholesterol. Adverse events were also evaluated. Results: At week 8, a significant difference from baseline in LDL-cholesterol was reported with colesevelam 1.875 g/d (-6.3%; P = .031) and colesevelam 3.75 g/d (-12.5%; P < .001) compared with placebo. Significant treatment effects were also reported for total cholesterol (-7.4%), non-HDL-cholesterol (-10.9%), HDL-cholesterol (+6.1%), apolipoprotein A-I (+6.9%), and apolipoprotein B (-8.3%) and a nonsignificant effect for triglycerides (+5.1%) with colesevelam 3.75 g/d compared with placebo at week 8. These treatment effects were maintained during period III. Conclusions: Colesevelam significantly lowered LDL-cholesterol levels in children with heFH. © 2010 Mosby, Inc. All rights reserved.
Authors & Co-Authors
Stein, Evan A.
United States, Cincinnati
Metabolic and Atherosclerosis Research Center
Marais, Adrian David
South Africa, Cape Town
Faculty of Health Sciences
Szamosi, Tamas
Hungary, Budapest
Ii. No. Pediatric Clinic
Raal, Frederick Johan
South Africa, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Schurr, Daniel
Israel, Jerusalem
Hadassah University Medical Centre
Urbina, Elaine M.
United States, Cincinnati
Cincinnati Children's Hospital Medical Center
Hopkins, Paul Nathan
United States, Salt Lake City
The University of Utah
Karki, Sulekha
United States, Basking Ridge
Daiichi Sankyo, Inc.
Xu, Jianbo
United States, Basking Ridge
Daiichi Sankyo, Inc.
Misir, Soamnauth
United States, Basking Ridge
Daiichi Sankyo, Inc.
Melino, Michael
United States, Basking Ridge
Daiichi Sankyo, Inc.
Statistics
Citations: 72
Authors: 11
Affiliations: 8
Identifiers
Doi:
10.1016/j.jpeds.2009.08.037
ISSN:
00223476
Research Areas
Disability
Genetics And Genomics
Maternal And Child Health
Study Design
Cohort Study