Document Detail


Colesevelam: in pediatric patients with heterozygous familial hypercholesterolemia.
MedLine Citation:
PMID:  20218749     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Colesevelam hydrochloride (colesevelam), a non-absorbed, synthetic, lipid-lowering polymer, is a bile acid sequestrant. Colesevelam binds with high affinity to bile acids within the gastrointestinal tract, thereby inhibiting the reabsorption of bile acids, resulting in decreases in serum low-density lipoprotein cholesterol (LDL-C) levels. Colesevelam is available as tablets and as powder for oral suspension. At dosages of 3.75 g once daily or 1.875 g twice daily, colesevelam is approved in the US for the treatment of pediatric patients aged 10-17 years with heterozygous familial hypercholesterolemia. Colesevelam may be administered as monotherapy or in combination with an HMG-CoA reductase inhibitor (statin). A 32-week trial was conducted and consisted of a stablilization period ( approximately 4 weeks), a randomized period (8 weeks), an open-label period (18 weeks), and a 2-week follow-up period. In the 8-week, randomized, double-blind, placebo-controlled period of the trial, colesevelam (tablets), as monotherapy or with a statin, was an effective treatment for pediatric patients with heterozygous familial hypercholesterolemia. At week 8, recipients of colesevelam 3.75 g/day had significant percentage reductions from baseline in mean LDL-C levels (primary endpoint) compared with placebo recipients. Significant beneficial treatment effects for colesevelam 3.75 g/day versus placebo were also reported for several other lipid/lipoprotein parameters at week 8 of the study. The reported treatment effects on lipid/lipoprotein parameters were maintained over a subsequent 18-week, open-label, noncomparative period, when all patients received colesevelam 3.75 g/day. Colesevelam 3.75 g/day was generally well tolerated for up to 26 weeks by pediatric patients with heterozygous familial hypercholesterolemia.
Authors:
Caroline M Perry
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Paediatric drugs     Volume:  12     ISSN:  1179-2019     ISO Abbreviation:  Paediatr Drugs     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-03-11     Completed Date:  2010-06-04     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883685     Medline TA:  Paediatr Drugs     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  133-40     Citation Subset:  IM    
Affiliation:
Adis, a Wolters Kluwer Business, North Shore 0754, Auckland, New Zealand. demail@adis.co.nz
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MeSH Terms
Descriptor/Qualifier:
Allylamine / adverse effects,  analogs & derivatives*,  pharmacology,  therapeutic use
Anticholesteremic Agents / adverse effects,  pharmacology,  therapeutic use*
Bile Acids and Salts / metabolism
Child
Cholesterol, LDL / blood,  drug effects
Drug Therapy, Combination
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
Hyperlipoproteinemia Type II / drug therapy*,  physiopathology
Randomized Controlled Trials as Topic
Chemical
Reg. No./Substance:
0/Anticholesteremic Agents; 0/Bile Acids and Salts; 0/Cholesterol, LDL; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 107-11-9/Allylamine; 182815-44-7/colesevelam

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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