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Title: Colesevelam Safe, Effective in Lowering Cholesterol in Children With Familial Hypercholesterolaemia: Presented at AHA

"Colesevelam Safe, Effective in Lowering Cholesterol in Children With Familial Hypercholesterolaemia: Presented at AHA"

By Ed Susman NEW ORLEANS -- November 12, 2008 -- Children with heterozygous familial hypercholesterolaemia can be safely and effectively treated with the bile-acid sequestrant colesevelam, researchers said here at the American Heart Association (AHA) Scientific Sessions. "No clinically meaningful changes in growth, sexual maturation, chemistry, haematology, hormones, fat-soluble vitamins, or clotting factors occurred" with treatment of colesevelam, said investigator Evan Stein, MD, PhD, Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio. "The use of colesevelam may improve the management of low-density lipoprotein [LDL] -cholesterol abnormalities in paediatric patients with heterozygous familial hypercholesterolaemia," said Dr. Stein at his poster presentation on November 11. "This may also be applicable to the management of LDL cholesterol levels in the general paediatric population with primary hypercholesterolaemia." Dr. Stein and colleagues enrolled 191 patients aged 10 to 17 years with heterozygous familial hypercholesterolaemia and average LDL cholesterol levels of about 200 mg/dL. Participants first took placebo for 4 weeks to evaluate compliance and then were randomised in a double-blind fashion to 1 of the 3 groups: 65 received placebo; 63 received colesevelam 1.875 g/day; 63 received colesevelam 3.75 g/day. After 8 weeks, all subjects were switched to open-label colesevelam 3.75 g/day for 18 weeks and then were evaluated for 2 weeks. Patients were[eligible to receive statin therapy throughout the study. Approximately 25% were on a statin at entry into the double-blind period, anda further 10% added a statin during the open-label period.

At week 8, patients who were given colesevelam 3.75 g/day showed a significant placebo-adjusted mean reduction of 13% in LDL cholesterol (P < .0001). The reductions in LDL cholesterol in patients who received colesevelam 3.75 g/day during the double-blind period were maintained through the 18-week open-label period, Dr. Stein reported.

Colesevelam 3.75 g/day study group achieved a clinically and statistically significant, placebo-adjusted mean 6% increase in high-density lipoprotein (HDL) cholesterol (P < .01).

Compliance rates for patients receiving colesevelam 3.75 g/day in the study at the completion of the double-blind period were 87%.

"Treatment with colesevelam HCl in paediatric 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 therapy," Dr. Stein said.

Adverse events in the study were as expected, according to the researchers, and treatment was well tolerated.

"Current guidelines support the need for and benefits of lowering LDL cholesterol in children with heterozygous familial hypercholesterolaemia," he said.

Funding for this study was provided by Daiichi Sankyo Inc., a subsidiary of Tokyo-based Daiichi Sankyo Co., Ltd.

[Presentation title: Efficacy and Safety of Colesevelam HCl in Pediatric Patients With Heterozygous Familial Hypercholesterolemia. Abstract 3699]

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