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Review
. 2010 Aug 4:1:53-60.
doi: 10.2147/AHMT.S9272. eCollection 2010.

Role of colesevelam in managing heterozygous familial hypercholesterolemia in adolescents and children

Travis Sonnett  1 , Jennifer Robinson  1 , Paul Milani  1 , R Keith Campbell  1
Affiliations
Review

Role of colesevelam in managing heterozygous familial hypercholesterolemia in adolescents and children

Travis Sonnett et al. Adolesc Health Med Ther. .

Abstract

Background: Colesevelam hydrochloride is a synthetic, nonsystemically absorbed polymer that functions as a bile acid sequestrant for the treatment of hypercholesterolemia. Recently, colesevelam was investigated for the treatment of heterozygous familial hypercholesterolemia (HeFH) in the pediatric/adolescent population aged 10-17 years.

Objective: The purpose of this article is to review the disease state of HeFH in children and adolescents, review the pharmacologic mechanism of action, kinetics, and safety profile of colesevelam, analyze the results of a recent clinical trial of colesevelam in the pediatric/adolescent HeFH population, and discuss the role of colesevelam as a viable treatment option for HeFH.

Methods: A literature search using Medline (1966-03 May 2010), PubMed (1950-03 May 2010), Science Direct (1994-03 May 2010), and International Pharmaceutical Abstracts (2004-2010) was performed using the search term colesevelam. English language, original research, and review articles were examined, and citations from these articles were also assessed. The manufacturer's prescribing information and the Food and Drug Administration review of the new drug application for the powder formulation were also examined.

Results: A 32-week trial was performed investigating the efficacy of colesevelam as monotherapy or combination therapy with a stable statin regimen. Upon completion of the trial, significant benefits were found in regard to the treatment of HeFH and the lowering of low-density lipoprotein cholesterol, total cholesterol, and other secondary measures. Safety and tolerability were also examined throughout the duration of the clinical trial, with adverse drug reactions considered mild in severity.

Conclusion: Colesevelam has been shown to reduce low-density lipoprotein cholesterol levels significantly in pediatric/adolescent patients with HeFH, while maintaining a mild side effect profile. Although further research would be beneficial for long-term effects in this population, colesevelam should be considered when developing a treatment regimen for HeFH in the pediatric/adolescent population.

Keywords: bile acid sequestrant; colesevelam; heterozygous familial hypercholesterolemia; hyperlipidemia; pediatric.

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Figures

Figure 1
Figure 1
Chemical structure of colesevelam hydrochloride.
Figure 2
Figure 2
Subject randomization and completion from baseline to Period III completion. Adapted with permission from Stein et al.
See this image and copyright information in PMC

References

    1. Cox E, Halloran D, Homan S, Welliver S, Mager D. Trends in the prevalence of chronic medication use in children: 2002–2005. Pediatrics. 2008;122(5):e1053–e1061. - PubMed
    1. McGill H, McMahan C, Zieske A, et al. Associations of coronary heart disease risk factors with the intermediate lesion of atherosclerosis in youth. The Pathobiological Determinants of Atherosclerosis in Youth Research Group. Arterioscler Thromb Vasc Biol. 2000;20:1998–2004. - PubMed
    1. Berenson G, Srinivasan S, Newman W, Tracy R, Wattigney W. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998;338(23):1650–1656. - PubMed
    1. Daniels S, Greer F, Committee on Nutrition Lipid screening and cardiovascular health in childhood. Pediatrics. 2008;122:198–208. - PubMed
    1. Raitakari O, Juonala M, Kahonen M, et al. Cardiovascular risk factors in childhood and carotid artery intima-media thickness in adulthood: The cardiovascular risk in young Finns study. JAMA. 2003;290(17):2277–2283. - PubMed

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