title: Effect of Epoetin alfa dose changes on hemoglobin and mortality in hemodialysis patients with hemoglobin levels persistently below 11 g/dL.
abstract: OBJECTIVE
  The mortality risk associated with attempting to raise hemoglobin (Hb) levels by increasing Epoetin alfa (EPO) doses in hemodialysis patients with persistently low Hb remains poorly understood. Design, setting, participants, & measurements. We included hemodialysis patients from a large dialysis provider between July 2000 and June 2001 who had EPO dose and Hb data for 6 consecutive months, and a mean Hb <11 g/dl in months 4 to 6 (sub-11 period). We identify predictors of EPO dose changes during the sub-11 period; evaluate the proportion of patients achieving a Hb >or=11 g/dl after the sub-11 period by dose-change categories; and evaluate the association between EPO dose changes and mortality risk.
  
  
  RESULTS
  Patients were more likely to receive greater EPO dose increases if they had lower EPO doses, higher Hb levels, or were recently hospitalized. Greater EPO dose increases elevated the likelihood of achieving an Hb >or=11 g/dl in the subsequent 3 mo. Larger EPO dose changes over the sub-11 period were not associated with an elevated mortality risk, but having an Hb <9 g/dl at the end of that period independent of dose change was associated with mortality risk. We found that patients receiving larger dose changes and whose resulting Hb level remained <9.5 g/dl at the end of the 3 mo were at elevated mortality risk.
  
  
  CONCLUSIONS
  In patients with persistently low Hb levels, mortality risk was strongly associated with the patient's ability to achieve a hematopoietic response rather than the magnitude of EPO dose titrations.
authors.affiliation: Department of Biostatistics and Epidemiology, Amgen, Inc, Thousand Oaks, California 41984, USA. bradbury@amgen.com
authors.forename: Brian D
authors.initials: BD
authors.lastname: Bradbury
authors.forename: Mark D
authors.initials: MD
authors.lastname: Danese
authors.forename: Michelle
authors.initials: M
authors.lastname: Gleeson
authors.forename: Cathy W
authors.initials: CW
authors.lastname: Critchlow
mesh_terms: D000328:Adult; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D015415:Biomarkers / Q000097:blood; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage*; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D053208:Kaplan-Meier Estimate; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000401:mortality*; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa