title: Once-monthly darbepoetin alfa for maintaining hemoglobin levels in older patients with chronic kidney disease.
abstract: OBJECTIVE
  To evaluate the efficacy of once-monthly darbepoetin alfa in maintaining hemoglobin (Hb) levels between 10 and 12 g/dL in older subjects receiving darbepoetin alfa every 2 weeks.
  
  
  METHODS
  A secondary analysis of a 29-week multicenter, open-label, single-arm study with an initial 2-week screening/baseline period, followed by a 20-week once-monthly darbepoetin alfa dose titration period and an 8-week evaluation period.
  
  
  METHODS
  Twenty treatment centers in the United States.
  
  
  METHODS
  Subjects with CKD who were not receiving dialysis and whose hemoglobin levels were > or =10 g/dL with darbepoetin alfa every 2 weeks.
  
  
  METHODS
  Darbepoetin alfa administered once monthly and titrated to maintain Hb level between 10 and 12 g/dL, inclusive.
  
  
  METHODS
  The proportion of subjects maintaining a mean Hb concentration of 10 to 12 g/dL, inclusive, while receiving once-monthly darbepoetin alfa during the evaluation period (weeks 21 to 29); the mean change in Hb levels and darbepoetin alfa doses between baseline and the evaluation period; and the treatment relationship, frequency, severity, and outcomes of all adverse events. Analyses were stratified by age (<65, > or =65, and > or =75 years).
  
  
  RESULTS
  Seventy-nine percent of subjects aged > or =65 years and 80% of subjects aged > or =75 years maintained their Hb levels within the specified target range, compared with 80% of subjects aged <65 years who maintained their Hb levels within the specified target range. Hemoglobin levels and darbepoetin alfa doses did not change significantly from baseline to the evaluation period. Darbepoetin alfa administered once monthly was well tolerated in all age groups.
  
  
  CONCLUSIONS
  Darbepoetin alfa administered once monthly effectively maintained target Hb levels in older subjects with CKD (not receiving dialysis) who were maintained previously with an every 2 weeks darbepoetin alfa regimen.
authors.affiliation: The Ohio State University Medical Center, Columbus, OH 43210, USA. Anil.Agarwal@osumc.edu
authors.forename: Anil
authors.initials: A
authors.lastname: Agarwal
authors.forename: Marcia R
authors.initials: MR
authors.lastname: Silver
authors.forename: Michael
authors.initials: M
authors.lastname: Walczyk
authors.forename: Wei
authors.initials: W
authors.lastname: Liu
authors.forename: Paul
authors.initials: P
authors.lastname: Audhya
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D004921:Erythropoietin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005853:Geriatrics; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000453:epidemiology; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D012449:Safety; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa