Public Release: 

On the edge: Are we at risk of an ESRD pandemic?

Worldwide increase in diabetes forecasts renal disease explosion

Resolute Communications

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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For further information please contact:

Onsite: Elizabeth Park, Resolute Communications 44-798-998-8440
Anna Korving, Resolute Communications 44-771-042-0523

In London: Ane Tobro, Resolute Communications 44-207-357-8187

References: 1. 41st Congress of the ERA/EDTA (European Renal Association/European Dialysis & Transplant Association), Lisbon, Portugal, 15-18 May, 2004
2. Finn W, Hutchison A. The Dialysis Population: Analysis of European and American Patients. Poster presented at the 41st ERA/EDTA Congress, Lisbon, Portugal 15-18 May 2004.
3. WHO www.who.int/ncd/dia/databases4.htm Accessed 15 March 2004.
4. Market Research, Insight International, Dec 01 / Jan 02
5. Salusky IB & Goodman WG. Cardiovascular calcification in end-stage renal disease. Nephrol Dial Transplant 2002; 17: 336-339
6. Norris KC. Toward a new treatment paradigm for hyperphosphatemia in chronic renal disease. Dial Transplant 1998; 27 (12): 767-773
7. Eknoyan G, Levin A, Levin NW. Bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003; 42 (4, Suppl 3): S62
8. Hutchison A, Webster I, Gill M, Schmieder R. Safety, Tolerability and Efficacy of Lanthanum Carbonate in Haemodialysis Patients: a 12 month study. (301). Poster presented a the 40th ERA-EDTA World Congress of Nerphrology, Berlin, Germany, 8-12 June 2003
9. Hutchison A, Webster I. Lanthanum Carbonate, a Novel, Non-Aluminium, Non-Calcium Phosphate Binder, is Effective and Well Tolerated in Hyperphosphatemia. (301) Poster presented at the 9th Asian Pacific Congress of Nephrology, Pattaya, Thailand, 16-20 February 2003
10. International Diabetes Federation website. Accessed 15 March 2004. http://www.idf.org/home/index.cfm?node=37
11. Reikes ST. Trends in end-stage renal disease. Epidemiology, morbidity, and mortality. Postgrad Med 2000; 108:124-42
12. Bakris G, Sowers J, Epstein M et al. Hypertension in patients with diabetes: why is aggressive treatment essential? Postgrad Med 2000; 107(2): 53-64.

NOTES TO EDITORS

Lanthanum carbonate (FOSRENOL®)
FOSRENOL works by binding to dietary phosphate in the GI tract; once bound, the FOSRENOL/phosphate complex cannot pass through the intestinal lining into the blood stream and is eliminated from the body. As a consequence, overall phosphate absorption from the diet is decreased significantly. Shire has conducted an extensive clinical research programme for FOSRENOL involving over 1750 patients, some of whom have been treated for 36 months or more. This programme has demonstrated that FOSRENOL is an effective phosphate binder with a proven safety profile for long-term use.

The diabetes epidemic
According to the World Health Organisation, there were 33 million people with diabetes in Europe in 2000 and numbers are anticipated to exceed 48 million by 2030,3 with a consequent increase in the number of patients with end stage renal disease. The latest estimates from the International Diabetes Foundation indicate that there are currently 194 million people diagnosed with type 2 diabetes worldwide and that figure is expected to top 333 million by 2025.10 Diabetes is the number one cause of kidney disease, responsible for about 40% of all kidney failure.11 In addition, there is a strong connection between hypertension and diabetes, although it is difficult to establish whether hypertension is a cause of diabetes or rather a result of the disease. Evidence shows that hypertension is twice as common in people who have diabetes as in those who do not.12 Indeed, patients with type 2 diabetes represent the majority of hypertensive patients.12

Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on Shire, please visit the Company's website: www.shire.com

The original language of this press release is English.

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