title: An observational study of the effectiveness of darbepoetin alpha administered in dialysis patients once every 2 weeks for 12 months.
abstract: OBJECTIVE
  Erythropoiesis-stimulating agents (ESAs) are recommended for managing renal anemia. ALTERNATE is an observational study in European and Australian dialysis patients evaluating darbepoetin a (DA) once every 2 weeks (Q2W) in clinical practice.
  
  
  METHODS
  Adult dialysis patients initiating treatment with DA Q2W were eligible regardless of previous/current ESA use. Data were collected 6 months before and 12 months after Q2W initiation. The primary endpoint was hemoglobin (Hb) concentration 12 months after initiation.
  
  
  RESULTS
  A total of 6,112 patients were enrolled; 6,104 were eligible (87% hemodialysis, 12% peritoneal dialysis). Before initiation, 77.3%, 8.8%, and 7.8% of patients were receiving DA, epoetin beta, and epoetin alpha, respectively; 6% were ESA naïve. Mean (95% CI) Hb (g/dl) was 11.68 (11.63-11.72) 6 months before initiation, 12.00 (11.97-12.04) at initiation, and 11.62 (11.58-11.66) 12 months after initiation. Geometric mean (95% CI) weekly ESA dose (µg/wk) was 27.27 (26.62-27.93) immediately before initiation, 23.69 (23.28 - 24.10) at initiation, and 26.80 (26.12-27.49) 12 months after initiation. At month 12, 77.3% of patients were receiving DA Q2W.
  
  
  CONCLUSIONS
  This large observational study demonstrates that Hb concentrations can be effectively maintained over 12 months in a general dialysis population with DA Q2W without an increase in ESA dose.
authors.affiliation: Centre Suzanne Levy, Diaverum Group, Clinique du Mont Louis, Paris, France. jacques.rottembourg@wanadoo.fr
authors.forename: J B
authors.initials: JB
authors.lastname: Rottembourg
authors.forename: I
authors.initials: I
authors.lastname: Bridges
authors.forename: W
authors.initials: W
authors.lastname: Pronai
authors.forename: M
authors.initials: M
authors.lastname: Feriani
authors.forename: L P
authors.initials: LP
authors.lastname: McMahon
authors.forename: J M J
authors.initials: JM
authors.lastname: De Meester
authors.forename: M
authors.initials: M
authors.lastname: Farouk
authors.forename: B
authors.initials: B
authors.lastname: Molemans
mesh_terms: D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D001315:Australia; D015415:Biomarkers / Q000097:blood; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005060:Europe; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006760:Hospitalization; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000009:adverse effects; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa