title: Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study.
abstract: BACKGROUND
  Intravenous iron therapy is a treatment option for iron deficient patients who are intolerant to oral iron or where oral iron is ineffective, but with possible adverse effects. Currently, prospective studies comparing different intravenous iron formulations are needed to determine safety and efficacy of these agents.
  
  
  METHODS
  We conducted a prospective, double-blind, randomized controlled trial (RCT) to assess the feasibility of a trial comparing the safety of high molecular weight intravenous iron dextran, Infufer®, with intravenous iron sucrose, Venofer®, in non-hemodialysis adult outpatients. Primary outcome was the occurrence of immediate severe drug reactions.
  
  
  RESULTS
  We enrolled 143 patients in a one-year period. Overall, 45/143 (31.5 %) patients (20 iron dextran, 25 iron sucrose) developed 48 infusion reactions (14 immediate, 28 delayed, and 3 both). The risk of an immediate reaction was similar in both groups, 9/73 (12.3 %) iron dextran versus 8/70 (11.4 %) iron sucrose, RR = 0.93 (95 % CI; 0.38 to 2.27). The risk of a delayed reaction was significantly higher in the iron sucrose group 22/70 (31.4 %) versus the iron dextran group 9/73 (12.3 %), RR = 2.55 (95 % CI; 1.26 to 5.15; p = 0.0078).
  
  
  CONCLUSIONS
  In this limited feasibility study, no major differences in immediate reactions were seen, but a significantly higher number of delayed reactions were seen in the iron sucrose group. Further, under our assumptions and design a full RCT to evaluate the safety of different intravenous iron preparations is not feasible. Future studies should consider modifying the clinical outcomes, utilize multiple centers, and consider other emerging parenteral iron formulations. (ClinicalTrials.gov NCT005936197 January 3, 2008).
authors.affiliation: Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada.
authors.forename: Martha L
authors.initials: ML
authors.lastname: Louzada
authors.affiliation: Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada ; London Health Sciences Centre, Department of Medicine, Division of Hematology. Rm E6-219A, Victoria Hospital, 800 Commissioners Road E., London, ON N6A 5W9 Canada.
authors.forename: Cyrus C
authors.initials: CC
authors.lastname: Hsia
authors.affiliation: University of Western Ontario, London, ON Canada.
authors.forename: Fatimah
authors.initials: F
authors.lastname: Al-Ani
authors.affiliation: University of Western Ontario, London, ON Canada ; Department of Anesthesia and Perioperative Medicine, London, ON Canada.
authors.forename: Fiona
authors.initials: F
authors.lastname: Ralley
authors.affiliation: Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada.
authors.forename: Anargyros
authors.initials: A
authors.lastname: Xenocostas
authors.affiliation: University of Western Ontario, London, ON Canada ; Department of Pharmacy, London Health Sciences Centre, London, ON Canada.
authors.forename: Janet
authors.initials: J
authors.lastname: Martin
authors.affiliation: University of Western Ontario, London, ON Canada ; Department of Pharmacy, London Health Sciences Centre, London, ON Canada.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Connelly
authors.affiliation: Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada.
authors.forename: Ian H
authors.initials: IH
authors.lastname: Chin-Yee
authors.affiliation: Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada.
authors.forename: Leonard
authors.initials: L
authors.lastname: Minuk
authors.affiliation: Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada ; Department of Epidemiology & Biostatistics, London, ON Canada.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Lazo-Langner
keywords: Feasibility; Intravenous iron; Iron dextran; Iron sucrose; Randomized controlled trial; Safety