Extended dosing of darbepoetin alfa in peritoneal dialysis patients
1 Reparto di Nefrologia e Dialisi, Ospedale dell'Angelo, Via Pacagnella, 30174 Mestre, Italy
2 Department of Nephrology & Dialysis, AZ, Nikolaas, Moerlandstraat 1, 9100 Sint-Niklaas, Belgium
3 Director, Department of Renal Medicine, Eastern Health, c/- Arnold Street, Box Hill 3128, Victoria, Australia
4 Dialysis Unit, Centre Suzanne Levy, Paris 75011, France
5 Biostatistics, Amgen Ltd, 240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD, UK
6 Clinical Development, Amgen (Europe) GmbH, Dammstrasse 23, 6300 Zug, Switzerland
7 Department of Internal Medicine, Hemodialysis, Barmherzige Brüder Eisenstadt, Esterhazystrasse 26, A-7000 Eisenstadt, Austria
BMC Nephrology 2011, 12:13 doi:10.1186/1471-2369-12-13Published: 24 March 2011
Anemia is common among peritoneal dialysis (PD) patients, and most patients require erythropoiesis-stimulating agents (ESA) to maintain their hemoglobin concentrations within current guideline recommendations. Darbepoetin alfa is an ESA with a 3-fold longer half-life and greater in vivo biological activity than recombinant human erythropoietin, allowing less frequent dosing that may simplify anemia management in these patients, providing benefits to patients, care givers and health care providers. Clinical studies have confirmed the efficacy and safety of darbepoetin alfa administered at extended dosing intervals. However, there are limited data on the management of anemia with ESAs in PD patients in routine clinical practice. The aim of this multicenter observational study in European and Australian dialysis patients was to evaluate darbepoetin alfa administered once every 2 weeks (Q2W) in routine clinical practice for 12 months.
PD patients ≥18 years old and converting to treatment with darbepoetin alfa Q2W were eligible for enrollment regardless of previous or current ESA use. Patients enrolled in the study were treated according to local usual clinical practice. Data were collected up to 6 months prior to and 12 months after conversion to darbepoetin alfa Q2W. The primary endpoint was hemoglobin concentration 12 months after conversion to darbepoetin alfa Q2W.
Of the 741 eligible PD patients (mean age, 61 years; male, 57%), 640 (86%) completed the study. Mean hemoglobin concentration (g/dL) was 11.69 (95% CI, 11.53-11.86) 6 months before the conversion, 12.25 (95% CI, 12.13-12.38) at conversion, and 11.88 (95% CI, 11.74-12.02) 12 months after conversion to darbepoetin alfa Q2W. The weekly equivalent ESA dose (μg/wk) was a geometric mean of 25.24 (95% CI, 23.46-27.15) 6 months before conversion, 20.90 (95% CI, 19.13-22.83) immediately before conversion, 18.89 (95% CI, 18.13-19.68) at conversion and 19.04 (95% CI, 17.69-20.49) 12 months after conversion. Twelve months after conversion, 70% of patients were receiving darbepoetin alfa Q2W and 73% had hemoglobin concentrations >11.0 g/dL.
In this large observational study, PD patients were able to maintain mean hemoglobin concentrations >11.0 g/dL after conversion to extended dosing of darbepoetin alfa Q2W, with no mean dose increase.