title: Comparative Short-term Safety of Sodium Ferric Gluconate Versus Iron Sucrose in Hemodialysis Patients.
abstract: BACKGROUND
  Despite different pharmacologic properties, little is known about the comparative safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients.
  
  
  METHODS
  Retrospective cohort study using the clinical database of a large dialysis provider (2004-2005) merged with administrative data from the US Renal Data System.
  
  
  METHODS
  66,207 patients with Medicare coverage who received center-based hemodialysis.
  
  
  METHODS
  Iron formulation use assessed during repeated 1-month exposure periods (n=278,357).
  
  
  RESULTS
  All-cause mortality, infection-related hospitalizations and mortality, and cardiovascular-related hospitalizations and mortality occurring during a 3-month follow-up period.
  
  
  METHODS
  For all outcomes, we estimated 90-day risk differences between the formulations using propensity score weighting of Kaplan-Meier functions, which controlled for a wide range of demographic, clinical, and laboratory variables. Risk differences were also estimated within various clinically important subgroups.
  
  
  RESULTS
  Ferric gluconate was administered in 11.4%; iron sucrose, in 48.9%; and no iron in 39.7% of the periods. Risks for most study outcomes did not differ between ferric gluconate and iron sucrose; however, among patients with a hemodialysis catheter, use of ferric gluconate was associated with a slightly decreased risk for both infection-related death (risk difference, -0.3%; 95% CI, -0.5% to 0.0%) and infection-related hospitalization (risk difference, -1.5%; 95% CI, -2.3% to -0.6%). Bolus dosing was associated with an increase in infection-related events among both ferric gluconate and iron sucrose users.
  
  
  CONCLUSIONS
  Residual confounding and outcome measurement error.
  
  
  CONCLUSIONS
  Overall, the 2 iron formulations studied exhibited similar safety profiles; however, ferric gluconate was associated with a slightly decreased risk for infection-related outcomes compared to iron sucrose among patients with a hemodialysis catheter. These associations should be explored further using other data or study designs.
authors.affiliation: Department of Epidemiology, UNC Gillings School of Global Public Health UNC Chapel Hill, Chapel Hill, NC; Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC. Electronic address: mabrook@email.unc.edu.
authors.forename: M Alan
authors.initials: MA
authors.lastname: Brookhart
authors.affiliation: Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC.
authors.forename: Janet K
authors.initials: JK
authors.lastname: Freburger
authors.affiliation: Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Ellis
authors.affiliation: Selzman Institute for Kidney Health, Section of Nephrology, Department of Medicine, Baylor College of Medicine, Houston, TX.
authors.forename: Wolfgang C
authors.initials: WC
authors.lastname: Winkelmayer
authors.affiliation: Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC.
authors.forename: Lily
authors.initials: L
authors.lastname: Wang
authors.affiliation: University of North Carolina Kidney Center, UNC School of Medicine, Chapel Hill, NC.
authors.forename: Abhijit V
authors.initials: AV
authors.lastname: Kshirsagar
mesh_terms: D018798:Anemia, Iron-Deficiency / Q000188:drug therapy*; D015331:Cohort Studies; D005260:Female; D005290:Ferric Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid / Q000009:adverse effects / Q000627:therapeutic use*; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D012189:Retrospective Studies; D013997:Time Factors
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; C035552:ferric gluconate
keywords: Anemia; cardiovascular events; chronic kidney disease (CKD); end-stage renal disease (ESRD); hemodialysis (HD); hospitalization; infection; intravenous iron formulations; iron sucrose; mortality; safety; sodium ferric gluconate