Colesevelam HCl Lowered LDL Cholesterol in Pediatric Patients With Heterozygous Familial Hyperchole...(indicated as an adjunct to diet and exer...),Health

Date:11/11/2008

indicated as an adjunct to diet and exercise to improve both glycemic control in adults with type 2 diabetes mellitus, and to reduce elevated LDL cholesterol in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (a statin). Welchol should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis. Welchol has not been studied in type 2 diabetes as monotherapy or in combination with a DPP-4 inhibitor and has not been extensively studied in combination with thiazolidinediones. Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. Welchol is not currently approved for use in pediatric patients and has not been studied in children nine years of age and younger or in pre-menarchal girls.

About the Study

The study was a 32 week, multi-center, controlled study, conducted with boys and post-menarchal girls 10-17 years of age, who were either treatment naive or on stable background statin therapy. The primary efficacy measurement was percent change in LDL cholesterol from baseline (beginning of double-blind period) to week eight (end double-blind period). There was an initial four-week, single-blind, placebo run-in, to measure compliance, followed by an eight-week, double-blind period in which patients were randomized to either placebo (n=65), colesevelam HCl 1.875 g/day (n=65) or colesevelam HCl 3.75 g/day (n=64). The eight-week, double-blind period was followed by an 18-week open-label treatment to goal (LDL cholesterol <110 mg/dL) in which all patients received colesevelam HCl 3.75 g/day (and were eligible to receive a statin), concluding with a two-week follow-up period.

The most common adverse reactions in the eight-week, doubleblind period were: nasopharyngitis (6.2 percent), headache (4.7 percent), fatigue (3.9 percent), vomiting (2.3 percent), rhinitis (2.3 percent) and creatine phosphokinase in
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SOURCE Daiichi Sankyo, Inc. (DSI) Copyright©2008 PR Newswire. All rights reserved

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