title: Effect of darbepoetin alfa administered once monthly on maintaining hemoglobin levels in older patients with chronic kidney disease.
abstract: BACKGROUND
  The anemia of chronic kidney disease (CKD) is associated with increased hospitalizations, increased cardiovascular morbidity and mortality, and diminished quality of life in the elderly. Darbepoetin alfa is an erythropoiesis-stimulating agent that has been shown to be effective in treating anemia in patients with CKD (but not on dialysis) when administered using extended-dosing regimens.
  
  
  OBJECTIVE
  The purpose of this post hoc analysis was to examine the efficacy and safety profile of once-monthly (QM) darbepoetin alfa in study patients stratified according to age (ie, <65, 65-74, and > or =75 years).
  
  
  METHODS
  Patients with CKD but not on dialysis, receiving darbepoetin alfa every other week (Q2W), and with stable hemoglobin (Hb) levels between 11 and 13 g/dL, inclusive, were enrolled in this 33-week, multicenter, open-label, single-arm study. The study was carried out at 36 US centers and consisted of a 24-week QM darbepoetin alfa dose-titration period followed by an 8-week evaluation period. Hb levels were measured Q2W. Study results were stratified according to patient age (<65, 65-74, and > or =75 years).
  
  
  RESULTS
  A total of 152 patients (79 women, 73 men) were enrolled; 55 patients (36%) were <65 years of age, 46 (30%) were 65 to 74 years of age, and 51 (34%) were > or =75 years of age. In patients who received > or =1 dose of darbepoetin alfa, Hb levels > or =11 g/dL were maintained in 76%, 80%, and 71% of patients aged <65, 65 to 74, and > or =75 years, respectively. For patients who completed the study, the proportions who maintained Hb levels > or =11 g/dL were 83%, 88%, and 85%, respectively, for the 3 age groups. The safety profile of QM darbepoetin alfa in this study was consistent with that expected in patients with CKD not receiving dialysis.
  
  
  CONCLUSIONS
  Darbepoetin alfa administered QM maintained Hb levels > or =11 g/dL in patients with CKD (not on dialysis) aged <65, 65 to 74, and > or =75 years. This treatment regimen may help optimize anemia management for older community-dwelling and long-term care patients.
authors.affiliation: Division of Nephrology and Hypertension, Case Western Reserve University School of Medicine at Metro Health Medical Center, Cleveland, Ohio 44109-1998, USA. msilver51@gmail.com
authors.forename: Marcia R
authors.initials: MR
authors.lastname: Silver
authors.forename: Anil
authors.initials: A
authors.lastname: Agarwal
authors.forename: Michelle
authors.initials: M
authors.lastname: Krause
authors.forename: Lei
authors.initials: L
authors.lastname: Lei
authors.forename: Catherine
authors.initials: C
authors.lastname: Stehman-Breen
mesh_terms: D000367:Age Factors; D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D012111:Residence Characteristics
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa