The new studies – which will focus on reaching target serum phosphate levels as defined by the K/DOQI guidelines (Kidney Disease Outcomes Quality initiative)1 – will strengthen FOSRENOL's position as the most extensively studied modern phosphate binder.
The trials will build on earlier phase III studies with FOSRENOL, reviewed today at the ERA-EDTA2 Congress in Lisbon, which demonstrated that patients with end stage renal disease (ESRD) treated with FOSRENOL can largely avoid the damaging consequences of hyperphosphataemia (excessively high phosphate levels in the blood) seen in as many as 80% of dialysis patients3.
"Effective management of hyperphosphataemia is a crucial part of management for patients on dialysis", commented Professor Jorge Cannata-Andia, of the Hospital Central de Asturias, Oviedo, Spain. "This silent condition has dangerous consequences as it disrupts the delicate interplay between the body's levels of calcium, parathyroid hormone and vitamin D, resulting in calcium deposits in the vasculature, which contribute to cardiovascular disease, and renal bone disease, which may give rise to skeletal deformities, pain and fractures."
Paradoxically, use of calcium-based phosphate binders – the current mainstay of treatment for hyperphosphataemia – can exacerbate vascular calcification by increasing blood calcium levels beyond acceptable levels (hypercalcaemia). In addition, calcium-based phosphate binders are associated with long-term bone problems of their own 4,5. In contrast, a much lower incidence of hypercalcaemia has been seen with FOSRENOL 6,7, which lowers serum phosphate to target levels within eight weeks and maintains this long-term 6,8 without increasing blood calcium levels.
Moreover, extensive bone biopsy studies have shown that 59% of patients treated with FOSRENOL moved towards normalisation of pre-existing bone disease compared with 21% on calcium carbonate. 9
"The data we have seen today at the ERA-EDTA Shire symposium represent a comprehensive package of safety and efficacy data for this new phosphate binder", commented Professor Jorge Cannata-Andia, who chaired the symposium. "Taken together, these data demonstrate that FOSRENOL lowers phosphate levels effectively and has the potential to reduce some of the most serious clinical consequences of hyperphosphataemia. We welcome Shire's initiative to continue research with FOSRENOL and look forward to the results from the new trials in Europe and North America."
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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