title: [Darbepoetin-alfa treatment of anemia secondary to chronic renal failure in dialysis patients: Results of a French multicenter study].
abstract: Darbepoetin alfa is a unique genetically engineered glycoprotein with a three-fold longer terminal half-life than recombinant human erythropoietin (rHuEPO). The objective of this study was to determine if darbepoetin alfa administered at a reduced dosing frequency relative to the prior rHuEpo regimen is an effective and safe alternative for treating renal anemia in patients undergoing dialysis. A total of 1,008 French hemodialysis and peritoneal dialysis patients receiving stable rHuEPO therapy by either the intravenous (i.v., N = 217) or subcutaneous (s.c., N = 791) route were switched to darbepoetin alfa given by the same route of administration at a reduced dosing frequency. Patients receiving rHuEPO once weekly (N = 248, 25%) were switched to darbepoetin alfa every two weeks, and those receiving rHuEPO two or three times weekly (N = 760, 75%) were switched to darbepoetin alfa once weekly. The doses of darbepoetin alfa were titrated to maintain hemoglobin concentration in the target range of 10.0 to 13.0 g/dl for up to 24 weeks. The primary endpoint was the change in hemoglobin between baseline and the evaluation period (weeks 21-24). Adjusted (for covariates that might influence hemoglobin response) mean change in hemoglobin from baseline to the evaluation period was not clinically significant: +0.11 g/dl (95% CI: -0.30; 0.52). An i.v./s.c. dose ratio of 0.96 (95% CI: 0.86; 1.06) at evaluation confirms previous findings that darbepoetin alfa dose requirements were not different for the s.c. and i.v. routes. At the end of the evaluation period, more than 98% of patients successfully maintained hemoglobin within the target range and at their darbepoetin alfa assigned dosing frequency. Darbepoetin alfa was well tolerated with a safety profile consistent with that observed in previous darbepoetin alfa studies. Darbepoetin alfa administered at a reduced dosing frequency relative to the prior rHuEpo regimen effectively maintains hemoglobin in the target range in dialysis patients with renal anemia.
authors.affiliation: Service de néphrologie, CHU de Nancy-Brabois, 8, rue du Morvan, 54511 Vandoeuvre-Lès-Nancy cedex, France. m.kessler@chu-nancy.fr
authors.forename: Michèle
authors.initials: M
authors.lastname: Kessler
authors.forename: Thierry
authors.initials: T
authors.lastname: Hannedouche
authors.forename: Henry
authors.initials: H
authors.lastname: Fitte
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Cayotte
authors.forename: Pablo
authors.initials: P
authors.lastname: Urena
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Réglier
mesh_terms: D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D005260:Female; D005602:France; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D006435:Renal Dialysis / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa