Colesevelam HCl Lowered LDL Cholesterol in Pediatric Patients With Heterozygous Familial Hyperchole...( First Presentation of Pivotal Stu...),Health

First Presentation of Pivotal Study Data in Pediatric Patients Presented at the American Heart Association's Annual Scientific Sessions 2008

PARSIPPANY, N.J., Nov. 11 /PRNewswire-FirstCall/ -- Daiichi Sankyo, Inc. (DSI), announced today that results from the pivotal study supporting the use of colesevelam HCl in pediatric patients with heterozygous familial hypercholesterolemia (heFH), were presented for the first time at the American Heart Association's (AHA) Annual Scientific Sessions 2008. According to the findings, colesevelam HCl was well-tolerated and produced a significant reduction in low density lipoprotein (LDL) or "bad" cholesterol when used as monotherapy or in combination with a statin.

Familial hypercholesterolemia (FH) is a genetic disorder resulting in elevated LDL cholesterol and increased risk of cardiovascular disease (CVD).(1) There are 10 million people with FH worldwide, the majority of whom have heterozygous FH.(2) Early identification of FH is critical, as is proper diet, exercise and medication to help lower LDL cholesterol.(3)

The efficacy of colesevelam HCl 3.75 g/day as monotherapy or in combination with a statin was evaluated in an eight-week, multi-center, randomized, double-blind, placebo-controlled study of pediatric patients with heFH, followed by an 18-week, open-label treatment period. At week eight, patients with heFH who were given colesevelam HCl 3.75 g/day showed a significant, placebo-adjusted mean reduction of 13 percent in LDL cholesterol (p less than or equal to 0.0001). The reductions in LDL cholesterol in pediatric patients who received colesevelam HCl 3.75 g/day during the double-blind period were maintained through the 18-week open-label treatment period. Additional findings from the eight-week study showed that patients in the colesevelam HCl 3.75 g/day study group demonstrated a clinically and statistically significant, placebo-adjusted mean six percent increase in high density lipoprotein
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