Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study

Affiliations

¹ Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada.
² 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.
³ University of Western Ontario, London, ON Canada.
⁴ University of Western Ontario, London, ON Canada ; Department of Anesthesia and Perioperative Medicine, London, ON Canada.
⁵ University of Western Ontario, London, ON Canada ; Department of Pharmacy, London Health Sciences Centre, London, ON Canada.
⁶ Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada ; Department of Epidemiology & Biostatistics, London, ON Canada.

PMID: 26973791
PMCID: PMC4788943
DOI: 10.1186/s12878-016-0046-8

Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study

Martha L Louzada et al. BMC Hematol. 2016.

. 2016 Mar 11:16:7.

doi: 10.1186/s12878-016-0046-8. eCollection 2016.

Authors

Affiliations

¹ Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada.
² 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.
³ University of Western Ontario, London, ON Canada.
⁴ University of Western Ontario, London, ON Canada ; Department of Anesthesia and Perioperative Medicine, London, ON Canada.
⁵ University of Western Ontario, London, ON Canada ; Department of Pharmacy, London Health Sciences Centre, London, ON Canada.
⁶ Department of Medicine, Division of Hematology, London, ON Canada ; University of Western Ontario, London, ON Canada ; Department of Epidemiology & Biostatistics, London, ON Canada.

PMID: 26973791
PMCID: PMC4788943
DOI: 10.1186/s12878-016-0046-8

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).

Conclusion: 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).

Keywords: Feasibility; Intravenous iron; Iron dextran; Iron sucrose; Randomized controlled trial; Safety.

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Figures

**Fig. 1**
Study flow diagram. *Reaction assessment performed during infusion (immediate reaction) and at 24 h post infusion

See this image and copyright information in PMC

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Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study

Affiliations

Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study

Authors

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Abstract

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