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FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease Patients With Hyperphosphatemia
Date:10/16/2007

toward positive bone health -- a treatment attribute that also may be of benefit to CKD Stage 4 patients."

Most CKD Stage 4 and 5 patients will develop chronic kidney disease- mineral and bone disorder (CKD-MBD) -- a systemic disorder of mineral and bone metabolism due to CKD. CKD-MBD often manifests as hyperphosphatemia, which causes bone disease characterized by bone pain, brittle bones, skeletal deformities and fractures, and vascular or other soft tissue calcification. Evidence also shows that hyperphosphatemia contributes to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients.

"Shire recently completed a multicenter, placebo-controlled study in patients with CKD Stages 3 and 4 with hyperphosphatemia. The results showed that FOSRENOL-treated patients had statistically significant reductions in serum phosphate levels compared to placebo after eight weeks of treatment. This study provided valuable insights into controlling hyperphosphatemia in CKD Stages 3 and 4 patients," said Ray Pratt, M.D., vice president, scientific leader, Renal Business Unit, Research and Development, Shire Pharmaceuticals. "We are committed to offering all patients the most effective phosphate binder therapy and will continue to invest in a clinical program that includes the development of additional FOSRENOL formulation options aimed at further simplifying treatment for all CKD patients."

Managing Hyperphosphatemia

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. While the normal adult range for phosphorus is 2.5 to 4.5 mg/dL, the blood phosphorus levels of many patients on dialysis often exceed 6.5 mg/dL. Such levels have been linked to a significantly higher morbidity and mortality risk for patients who have undergone at least one year of dialysis. Research has shown that for each mg/dL i
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SOURCE Shire plc
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