Colesevelam HCl Lowered LDL Cholesterol in Pediatric Patients With Heterozygous Familial Hyperchole...((HDL) or good cholesterol (p0.01). Thes...),Health

Date:11/11/2008

(HDL) or "good" cholesterol (p<0.01). These study arm findings also produced statistically significant placebo-corrected reductions from baseline in total cholesterol (7 percent; p<0.01), apolipoprotein B (8 percent; p<0.01) and non-HDL cholesterol (11 percent; p less than or equal to 0.0001) as well as an increase in apolipoprotein A-I (7 percent; p<0.01). There was a non-significant, placebo-adjusted, 5.1 percent median increase in triglyceride levels. Compliance rates for patients receiving colesevelam HCl 3.75 g/day in the study at the completion of the double-blind period was 87 percent.

"Treatment with colesevelam HCl in pediatric patients with inherited high cholesterol significantly reduced their LDL or 'bad' cholesterol and increased the HDL or 'good' cholesterol. This was seen in children who received colesevelam HCl alone or combined with a statin, demonstrating the additive effect on LDL-cholesterol reduction that is offered by colesevelam HCl therapy," said Evan A Stein MD PhD, Director, Metabolic & Atherosclerosis Research Center, Cincinnati, OH. "Current guidelines support the need for and benefits of lowering LDL cholesterol in children with heterozygous familial hypercholesterolemia."

According to the American Academy of Pediatrics (AAP), high cholesterol is a growing problem among children in the United States. In the AAP's Child and Adolescent Trial for Cardiovascular Health, 13.3 percent of children in the fourth grade had total cholesterol concentrations of greater than 200 mg/dL.(4) The current NCEP guidelines for total cholesterol in children ages 2 to 18 years of age is less than 170 mg/dL, with high cholesterol identified as greater than 200 mg/dL.(5) The AAP also recently published a statement recommending that cholesterol lowering medications should be considered for children who are more than eight years old and have high LDL concentrations.(6)

Colesevelam HCl, marketed as Welchol(R), is the first and only medication
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SOURCE Daiichi Sankyo, Inc. (DSI) Copyright©2008 PR Newswire. All rights reserved

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