title: Comparative short-term safety of bolus versus maintenance iron dosing in hemodialysis patients: a replication study.
abstract: BACKGROUND
  Recent research has reported that patients receiving bolus (frequent large doses to achieve iron repletion) versus maintenance dosing of iron have an increased short-term risk of infection, but a similar risk of cardiovascular events. We sought to determine whether these findings could be replicated using the same methods and a different data source.
  
  
  METHODS
  Clinical data from 6,605 patients of a small U.S. dialysis provider merged with Medicare claims data were examined. Iron dosing patterns (bolus, maintenance, no iron) were identified during 1-month exposure periods and cardiovascular and infection-related outcomes were assessed during 3-month follow-up periods. The effects of bolus versus maintenance dosing were assessed using Cox proportional hazards regression analyses to estimate hazard ratios and semiparametric additive risk models to estimate hazard rate differences, controlling for demographic and clinical characteristics, laboratory values and medications, and comorbidities.
  
  
  RESULTS
  48,050 exposure/follow-up periods were examined. 13.9 percent of the exposure periods were bolus dosing, 49.3 percent were maintenance dosing, and the remainder were no iron use. All of the adjusted hazard ratios were >1.00 for the infection-related outcomes, suggesting that bolus dosing increases the risk of these events. The effects were greatest for hospitalized for infection of any major organ system (hazard ratio 1.13 (1.03, 1.24)) and use of intravenous antibiotics (hazard ratio 1.08 (1.02, 1.15). When examining the subgroup of individuals with catheters, the hazard ratios for the infection-related outcomes were generally greater than in the overall sample. There was little association between type of dosing practice and cardiovascular outcomes.
  
  
  CONCLUSIONS
  Results of this study provide further evidence of the association between bolus dosing and increased infection risk, particularly in the subgroup of patients with a catheter, and of the lack of an association between dosing practices and cardiovascular outcomes.
authors.affiliation: Cecil G, Sheps Center for Health Services Research, University of North Carolina, 725 Martin Luther King, Jr, Blvd,, CB# 7590, Chapel Hill, NC 27599-7590, North Carolina. janet_freburger@unc.edu.
authors.forename: Janet K
authors.initials: JK
authors.lastname: Freburger
authors.forename: Alan R
authors.initials: AR
authors.lastname: Ellis
authors.forename: Abhijit V
authors.initials: AV
authors.lastname: Kshirsagar
authors.forename: Lily
authors.initials: L
authors.lastname: Wang
authors.forename: M Alan
authors.initials: MA
authors.lastname: Brookhart
mesh_terms: D000368:Aged; D055499:Catheter-Related Infections / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D002408:Catheters, Indwelling / Q000009:adverse effects / Q000382:microbiology; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000009:adverse effects* / Q000379:methods; D012189:Retrospective Studies; D013997:Time Factors
chemical_list: D007501:Iron