Vidyya Medical News Service
Volume 6 Issue 139 Published - 14:00 UTC 08:00 EST 18-May-2004 Next Update - 14:00 UTC 08:00 EST 19-May-2004
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On the edge: Are we at risk of an ESRD pandemic?

An analysis of demographic data collected on European and American patients participating in studies for a new non-calcium phosphate binder show striking differences between the causes of renal failure: 14% of European renal failure patients had diabetes as their primary diagnosis, whereas 34% of US patients had this diagnosis.2 If, as expected by many experts, the incidence of diabetes in Europe (estimated by the WHO to rise from 33 million in 2000 to over 48 million by 20303) grows to match that of the US, demand for renal replacement therapy in end stage renal disease (ESRD) could escalate sharply.

"Patient demographic data from studies are extremely useful in helping us understand the pattern of disease and the underlying causes of renal failure", commented lead investigator of the US study, Dr William F. Finn, Professor of Medicine, University of North Carolina School of Medicine. "The question we have to ask ourselves is whether Europe will follow the US, where increasing obesity is driving up the likelihood that diabetes numbers will increase, thereby increasing the incidence of diabetes-related renal failure."

The studies in which these renal failure patients were enrolled were set up to assess the efficacy and safety of FOSRENOL® (lanthanum carbonate), a new phosphate binding medication recently granted its first regulatory approval (in Sweden). Hyperphosphataemia (excessive levels of phosphate in the blood) develops in up to 80% of patients on dialysis4 and can lead to bone pain, skeletal deformities and fractures if left untreated. It is also associated, in conjunction with elevated calcium levels, with the development of cardiovascular disease, which accounts for nearly 50% of all deaths in dialysis patients.5,6

Baseline screening data from the new studies also illustrated the shortcomings of currently available hyperphosphataemia treatments. At entry to the studies, calcium-based phosphate binders were the most commonly used medication, both in the US (93%) and Europe (65%).2 However, serum phosphorus levels in these patients at study entry were markedly higher than the target levels (3.5 to 5.5 mg/dL) recommended by the new K/DOQI (Kidney Disease Outcomes Quality Initiative) guidelines7, with a mean level of 6.6 mg/dL in the European patients and 6.2 mg/dL in the US patients.2

In previous studies, FOSRENOL has been shown to be an effective and well tolerated phosphate binder, lowering serum phosphate to target levels within eight weeks and maintaining this long-term, with some patients treated for 36 months (three years) or more.8,9 FOSRENOL therefore represents a promising option for hyperphosphataemia management.

"There is no doubt that, with diabetes on the increase, end stage renal disease will increase as well. To help our patients stay well, for as long as possible while on dialysis, there is a pressing need for new and effective treatments like FOSRENOL to help us manage serious complications such as hyperphosphataemia", concluded Dr Alastair Hutchison, Manchester Institute of Nephrology & Transplantation, UK, who led the European study.

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