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Published on 4/21/2006 in the Prospect News Biotech Daily.

Shire says Fosrenol reduces tablet burden, improves satisfaction for renal disease patients

By Elaine Rigoli

Tampa, Fla., April 21 - Shire plc released new trial data showing that conversion to the non-calcium phosphate binder Fosrenol (lanthanum carbonate) from other phosphate binder therapies controlled the level of phosphorus found in the blood of end-stage renal disease patients with hyperphosphatemia and significantly reduced their daily dose and tablet burden.

This phase 4, open-label, multi-center trial was designed to evaluate efficacy, patient and physician satisfaction and daily dose and tablet burden compared with previous phosphate binder therapy.

In addition to reducing tablet burden, changing to Fosrenol from other therapies resulted in significant improvements in both patient and physician satisfaction with phosphate binder therapy, according to a company news release.

Both patients and physicians preferred Fosrenol over sevelamer hydrochloride and calcium-based phosphate binders, the company said.

At baseline, 52% of physicians expressed overall satisfaction with their phosphate binder therapies compared with 84% following 12 weeks of treatment with Fosrenol.

Among patients who completed 12 weeks of treatment, satisfaction increased to 84% from 67% at baseline.

This study showed a 30% to 40% reduction in tablet burden overall and up to a 56% reduction in tablet burden compared with combination therapy, the company said.

Phosphorus, an element found in nearly all foods, is absorbed from the gastrointestinal tract into the bloodstream. When the kidneys fail, they no longer effectively remove phosphorus, even with the help of blood-cleansing dialysis machines.

Fosrenol works by binding to dietary phosphorus in the gastrointestinal tract. Once bound, the Fosrenol/phosphorus complex cannot pass into the bloodstream and is eliminated from the body, thereby decreasing mean serum phosphorus levels, according to the release.

This data was presented Friday at the National Kidney Foundation's 2006 clinical meeting in Chicago.

Shire is a London-based pharmaceutical company that develops drugs for conditions of the central nervous system and gastrointestinal disorders.


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