The efficacy of colesevelam HCL in the treatment of heterozygous familial hypercholesterolemia in pediatric and adult patients

Clinical Therapeutics

Volumn 35, Issue 8, 2013, Pages 1247-1252

  Davidson, Michael ^a  

^a UNIVERSITY OF CHICAGO   (United States)

Author keywords

Adolescents; Children; Colesevelam; Familial hypercholesterolemia; LDL C

Indexed keywords

COLESEVELAM; EZETIMIBE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO;

ADOLESCENT; CHILD; CHOLESTEROL BLOOD LEVEL; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FAMILIAL HYPERCHOLESTEROLEMIA; FEMALE; FOLLOW UP; HUMAN; HYPERCHOLESTEROLEMIA; MALE; MEDLINE; MULTICENTER STUDY; PHASE 4 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; SCHOOL CHILD; TREATMENT DURATION;

ADOLESCENTS; CHILDREN; COLESEVELAM; FAMILIAL HYPERCHOLESTEROLEMIA; LDL-C;

ADOLESCENT; ADULT; AGED; ALLYLAMINE; ANTICHOLESTEREMIC AGENTS; AZETIDINES; CHOLESTEROL, LDL; CORONARY ARTERY DISEASE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERLIPOPROTEINEMIA TYPE II; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 84882880623     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2013.06.014     Document Type: Review

References (29)

1. Scriver C.R., Vogelstein B., Kinzler K.W., et al. The Metabolic & Molecular Bases of Inherited Disease 2001, The McGraw-Hill Companies, New York, NY. 8th ed.
2. Civeira F. International Panel on Management of Familial Hypercholesterolemia. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis 2004, 173:55-68.
3. Gylling H., Aalto-Setala K., Kontula K., Miettinen T.A. Serum low density lipoprotein cholesterol level and cholesterol absorption efficiency are influenced by apolipoprotein B and E polymorphism and by the FH-Helsinki mutation of the low density lipoprotein receptor gene in familial hypercholesterolemia. Arterioscler Thromb 1991, 11:1368-1375.
4. Kotze M.J., De Villiers W.J., Steyn K., et al. Phenotypic variation among familial hypercholesterolemics heterozygous for either one of two Afrikaner founder LDL receptor mutations. Arterioscler Thromb 1993, 13:1460-1468.
5. Moorjani S., Roy M., Gagné C., et al. Homozygous familial hypercholesterolemia among French Canadians in Québec province. Arteriosclerosis 1989, 9:211-216.
6. Raal F., Scott R., Somaratne R., et al. Low-density lipoprotein cholesterol-lowering effects of AMG 145, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease in patients with heterozygous familial hypercholesterolemia: the Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD) randomized trial. Circulation 2012, 126:2408-2417.
7. Neil A., Cooper J., Betteridge J., et al. Reductions in all-cause, cancer, and coronary mortality in statin-treated patients with heterozygous familial hypercholesterolaemia: a prospective registry study. Eur Heart J 2008, 29:2625-2633.
8. Wiegman A., Rodenburg J., de Jongh S., et al. Family history and cardiovascular risk in familial hypercholesterolemia: data in more than 1000 children. Circulation 2003, 107:1473-1478.
9. Tonstad S., Joakimsen O., Stensland-Bugge E., et al. Risk factors related to carotid intima-media thickness and plaque in children with familial hypercholesterolemia and control subjects. Arterioscler Thromb Vasc Biol 1996, 16:984-991.
10. Goldberg A.C., Hopkins P.N., Toth P.P., et al. Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol 2011, 5(Suppl 3):S1-S8.
11. Harada-Shiba M., Arai H., Oikawa S., et al. Guidelines for the management of familial hypercholesterolemia. J Atheroscler Thromb 2012, 19:1043-1060.
12. Watts G.F., Sullivan D.R., van Bockxmeer F.M., et al. A new model of care for familial hypercholesterolaemia: what is the role of cardiology?. Heart Lung Circ 2012, 21:543-550.
13. Huijgen R., Abbink E.J., Bruckert E., et al. Colesevelam added to combination therapy with a statin and ezetimibe in patients with familial hypercholesterolemia: a 12-week, multicenter, randomized, double-blind, controlled trial. Clin Ther 2010, 32:615-625.
14. Stein E.A., Marais A.D., Szamosi T., et al. Colesevelam hydrochloride: efficacy and safety in pediatric subjects with heterozygous familial hypercholesterolemia. J Pediatr 2010, 156(231-236):e1-e3.
15. Huijgen R., Vissers M.N., Defesche J.C., et al. Familial hypercholesterolemia: current treatment and advances in management. Expert Rev Cardiovasc Ther 2008, 6:567-581.
16. Lee W.P., Datta B.N., Ong B.B., et al. Defining the role of lipoprotein apheresis in the management of familial hypercholesterolemia. Am J Cardiovasc Drugs 2011, 11:363-370.
17. Colestid, Flavored Colestid (colestipol hydrochloride for oral suspension) [prescribing information]. New York, NY: Pfizer Inc; revised June 2006.
18. Cholestyramine for oral suspension, USP [US prescribing information]. Minneapolis, MN: Upsher-Smith Laboratories Inc; revised September 2011.
19. Mordasini R., Twelsiek F., Oster P., et al. Abnormal low density lipoproteins in children with familial hypercholesterolemia-effect of polyanion exchange resins. Klin Wochenschr 1978, 56:805-808.
20. Welchol (colesevelam HCl) [US prescribing information]. Parsippany, NJ: Daiichi Sankyo Inc; revised June 2012.
21. Daniels S.R., Gidding S.S., de Ferranti S.D. National Lipid Association Expert Panel on Familial Hypercholesterolemia. Pediatric aspects of familial hypercholesterolemias: recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol 2011, 5(Suppl 3):S30-S37.
22. Abrahamsson A., Gustafsson U., Ellis E., et al. Feedback regulation of bile acid synthesis in human liver: importance of HNF-4α for regulation of CYP7A1. Biochem Biophys Res Commun 2005, 330:395-399.
23. Kim I., Ahn S.H., Inagaki T., et al. Differential regulation of bile acid homeostasis by the farnesoid X receptor in liver and intestine. J Lipid Res 2007, 48:2664-2672.
24. Beysen C., Murphy E.J., Deines K., et al. Effect of bile acid sequestrants on glucose metabolism, hepatic de novo lipogenesis, and cholesterol and bile acid kinetics in type 2 diabetes: a randomised controlled study. Diabetologia 2012, 55:432-442.
25. Smushkin G., Sathananthan M., Piccinini F., et al. The effect of a bile acid sequestrant on glucose metabolism in subjects with type 2 diabetes. Diabetes 2013, 62:1094-1101.
26. Standards of medical care in diabetes-2013. Diabetes Care. 2013, 36(Suppl 1):S11-S66. American Diabetes Association.
27. Lambert M., Lupien P.J., Gagné C., et al. Treatment of familial hypercholesterolemia in children and adolescents: effect of lovastatin. Canadian Lovastatin in Children Study Group. Pediatrics 1996, 97:619-628.
28. Jacobson T.A., Armani A., McKenney J.M., Guyton J.R. Safety considerations with gastrointestinally active lipid-lowering drugs. Am J Cardiol 2007, 99:47C-55C.
29. Hanus M., Zhorov E. Bile acid salt binding with colesevelam HCl is not affected by suspension in common beverages. J Pharm Sci 2006, 95:2751-2759.