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Published on 1 May 2007

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New ESA “effectively stabilises haemoglobin levels in elderly dialysis patients”

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Data presented at the World Congress of Nephrology indicates thatonce-monthly methoxy polyethylene glycol-epoietin beta effectivelystabilises haemoglobin levels in patients over the age of 65, one ofthe fastest- growing group of patients with anaemia induced by chronickidney disease (CKD). Roche, manufacturer of this newerythropoietin-stimulating agent (ESA), has submitted information tothe EMEA and hopes for approval later this year. The licensed drugwould be known as Mircera®.

According to Roche,challenges with traditional ESAs include fluctuating haemoglobin levelsdue to variations in erythropoietic activity. A phase III analysis of1,245 patients across Europe showed that elderly patients can besuccessfully switched from frequent-dosing ESAs to Roche’s long-actingESA with both intravenous and subcutaneous administration. Theonce-monthly ESA maintained stable haemoglobin levels from theinitiation of treatment and was found to be well tolerated.

DrRichard Fluck, of Derby City General Hospital in the UK, commented:”These results demonstrate that this ESA can be used effectively totreat anaemia in the older person with CKD. Elderly people arepotentially fragile with a poorer prognosis because of the interactionbetween anaemia and other coexisting diseases. Renal anaemia worsensquality of life and has adverse outcomes. Sustainable treatment ofrenal anaemia using an effective ESA is vital in the management ofthese patients.”

In the UK, the prevalence of CKD patients on dialysis is a growing burden:

•    One-tenth of the population may have CKD, with as many as 90% (100,000) affected by renal anaemia.

•   More than 50% of patients on dialysis are over 60 years of age, andthis figure is rising due to the ageing population and the currentdiabetes epidemic.

•    The prevalence of CKD patients ondialysis is projected to grow by 7% every year, and it is estimatedthat by 2010 there will be more than two million people on dialysisworldwide.

Catherine Johnson, newly elected president ofthe UK’s Anaemia Nurse Specialist Association, commented: “With moreelderly people requiring dialysis in the UK, doctors need effectivemedications that can improve the way we manage renal anaemia.”

Theanalysis was based on data from two phase III clinical trials, MAXIMAand PROTOS, part of the largest-ever clinical development programme fora renal anaemia treatment. In total, 1,245 dialysis patients wererandomised to remain on their current epoietin treatment administeredup to three times a week or to be switched directly to Roche’slong-acting ESA, administered by IV and SC either once every two orfour weeks. The results showed minimal changes from baseline toevaluation in mean haemoglobin (Hb) levels in patients <65 and>65 years (-0.18 vs -0.34g/dl) as well as minimal changes with maleand female patients (-0.21 vs -0.30g/dl). The study drug was welltolerated with a safety profile characteristic of the patientpopulation.

Press release, Virgo Health PR, 23/4/2007



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