title: Colesevelam: in pediatric patients with heterozygous familial hypercholesterolemia.
abstract: 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.affiliation: Adis, a Wolters Kluwer Business, North Shore 0754, Auckland, New Zealand. demail@adis.co.nz
authors.forename: Caroline M
authors.initials: CM
authors.lastname: Perry
mesh_terms: D000499:Allylamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001647:Bile Acids and Salts / Q000378:metabolism; D002648:Child; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D000069472:Colesevelam Hydrochloride; D004359:Drug Therapy, Combination; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D006938:Hyperlipoproteinemia Type II / Q000188:drug therapy* / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic
chemical_list: D000924:Anticholesteremic Agents; D001647:Bile Acids and Salts; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000499:Allylamine; D000069472:Colesevelam Hydrochloride