This double-blind, randomized "TRIPLE" study will involve 80 patients with FH enrolled in six European centers (including in the UK, Netherlands, Sweden and France) and preliminary results are expected in Q3 2008.
"Patients with genetic conditions like familial hypercholesterolemia are at particularly high risk of early coronary heart disease," said Dr. Anthony Wierzbicki, from London's St. Thomas' Hospital and a board member and chairman of the Medical Scientific and Research Committee of FH patient association 'Heart UK'. "Patients have to take multiple cholesterol-lowering therapies and yet still often require further cholesterol reduction to reach target lipid levels recommended for patients at risk of cardiovascular events. New non-systemic agents are a welcome addition for these patients to help them achieve these targets."
Unlike most other cholesterol-lowering treatments, Cholestagel is non- systemic, and therefore is not absorbed into the bloodstream. Cholestagel binds bile acids in the intestine, impeding their reabsorption. This process -- called bile acid sequestration -- results in an increased clearance of LDL cholesterol from the blood. Cholestagel is also well tolerated, with minimal gastrointestinal side effects similar to those seen in placebo, and has limited drug-interaction.
Colesevelam has been approved for use in the United States since 2000, where it is marketed by Daiichi Sankyo Inc. under the trade name WelChol(R). Genzyme plans to launch Cholestagel in the United Kingdom, the Netherlands and the Scandinavian region this quarter, and in additional European countries next year. Genzyme also intends to pursue regulatory approvals for Cholestagel in Latin America, Canada, and the Asia Pacific region.
|SOURCE Genzyme Corp.|
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