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Low-Dose Epoetin Beta Offers Improved Renal Anaemia Management for Haemodialysis Patients: Presented at ASN

By Maria Bishop

PHILADELPHIA, PA -- November 11, 2005 -- Switching stable haemodialysis patients to a relatively low dose of NeoRecormon (epoetin beta) from epoetin alfa or darbepoetin alfa improves the efficacy of renal anaemia therapy, with more patients attaining target haemoglobin levels.

European researchers reported interim data on 1005 patients from the Gain Effectiveness in Anemia Treatment with NeoRecormon (GAIN) trial here on November 10^th at the 38^th Annual Meeting and Scientific Exposition of the American Society of Nephrologists (ASN).

The ongoing GAIN trial is comparing NeoRecormon, epoetin alfa and darbepoetin alfa in more than 4500 stable haemodialysis patients from 217 centres in 13 European countries.

Study subjects were of mean age 60.9 years (56.4% male) at baseline, with normal blood pressure. Diabetic nephropathy (22.9%) and glomerulonephritis (27.0%) were the top two reasons for patients requiring haemodialysis.

The percentage of haemodialysis patients achieving the European Best Practice Guideline (EBPG) target hemoglobin (>11g/dL) increased by 9% during the observational phase of this study, when 79% of patients were switched to NeoRecormon from either intravenous epoetin alfa or darbepoetin alfa. The switch also required a mean dose reduction of 1450 units (adjusted for baseline dose and haemoglobin, and earlier treatment, both P < .0001) -- a potential 24% dose-saving relative to a typical clinical dose (6000 IU/30 mcg/week).

All patients were previously treated with epoetin for 12 or more weeks in the retrospective phase, receiving epoetin alfa (69.9%), NeoRecormon (20.9%) or darbepoetin alfa (9.2%). The intravenous:subcutaneous ratio was about 5:1 in that retrospective phase.

During the 6-month observational phase, all patients received NeoRecormon, either intravenously or subcutaneously (1:1 ratio).Target haemoglobin level was achieved with a lower dose of NeoRecormon administered subcutaneously compared with intravenously.

Patients were well maintained in terms of haemoglobin stability following the 6-month treatment, regardless of dosing route and across a range of intervals, noted study leader Petar Kes, MD, Department of Dialysis, University Hospital Centre, Zagreb, Croatia.

Safety assessments were unremarkable, Dr. Kes noted. Rate of subject discontinuation was less than 10%.

Long-term follow-up will provide insight as the trial continues across Europe.

Trial leaders said they received grant/research support from Hoffmann-La Roche and Pfizer. Frezenius Medical of Germany acts as a consultant.


[Presentation title: GAIN Effectiveness in Anemia Treatment with Neorecormo (GAIN). Use in Europe in 2004: An Interim Analysis. Abstract 816]

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