Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia

Several intravenous iron complexes are available for the treatment of iron deficiency anemia (IDA). Iron dextran (DEX) is associated with an elevated risk of potentially serious anaphylactic reactions, whereas others must be administered in several small infusions to avoid labile iron reactions. Fer...

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Main Authors: Iftikhar Hussain, Jessica Bhoyroo, Angelia Butcher, Todd A. Koch, Andy He, David B. Bregman
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:Anemia
Online Access:http://dx.doi.org/10.1155/2013/169107
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author Iftikhar Hussain
Jessica Bhoyroo
Angelia Butcher
Todd A. Koch
Andy He
David B. Bregman
author_facet Iftikhar Hussain
Jessica Bhoyroo
Angelia Butcher
Todd A. Koch
Andy He
David B. Bregman
author_sort Iftikhar Hussain
collection DOAJ
description Several intravenous iron complexes are available for the treatment of iron deficiency anemia (IDA). Iron dextran (DEX) is associated with an elevated risk of potentially serious anaphylactic reactions, whereas others must be administered in several small infusions to avoid labile iron reactions. Ferric carboxymaltose (FCM) is a nondextran intravenous iron which can be administered in high single doses. A randomized, open label, and multicenter comparison of FCM to DEX in adults with IDA and baseline hemoglobin of ≤11.0 g/dL was conducted. A total of 160 patients were in the safety population (FCM n=82; DEX n=78). Adverse events, including immune system disorders (0% in FCM versus 10.3% in DEX, P=0.003) and skin disorders (7.3% in FCM versus 24.4% in DEX, P=0.004), were less frequently observed in the FCM group. A greater portion of patients in the FCM group experienced a transient, asymptomatic decrease in phosphate compared to patients in the DEX group (8.5% in FCM versus 0% in DEX, P=0.014). In the FCM arm, the change in hemoglobin from baseline to the highest observed level was 2.8 g/dL, whereas the DEX arm displayed a change of 2.4 g/dL (P=0.20). Treatment of IDA with FCM resulted in fewer hypersensitivity-related reactions than DEX.
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spelling doaj-art-3036d86128514b1cbea6f7823496a4252025-02-03T01:09:10ZengWileyAnemia2090-12672090-12752013-01-01201310.1155/2013/169107169107Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency AnemiaIftikhar Hussain0Jessica Bhoyroo1Angelia Butcher2Todd A. Koch3Andy He4David B. Bregman5Vital Prospects Clinical Research Institute, PC, Tulsa, OK 74136, USAVital Prospects Clinical Research Institute, PC, Tulsa, OK 74136, USALuitpold Pharmaceuticals, Inc., Norristown, PA 19403, USALuitpold Pharmaceuticals, Inc., Norristown, PA 19403, USALuitpold Pharmaceuticals, Inc., Norristown, PA 19403, USALuitpold Pharmaceuticals, Inc., Norristown, PA 19403, USASeveral intravenous iron complexes are available for the treatment of iron deficiency anemia (IDA). Iron dextran (DEX) is associated with an elevated risk of potentially serious anaphylactic reactions, whereas others must be administered in several small infusions to avoid labile iron reactions. Ferric carboxymaltose (FCM) is a nondextran intravenous iron which can be administered in high single doses. A randomized, open label, and multicenter comparison of FCM to DEX in adults with IDA and baseline hemoglobin of ≤11.0 g/dL was conducted. A total of 160 patients were in the safety population (FCM n=82; DEX n=78). Adverse events, including immune system disorders (0% in FCM versus 10.3% in DEX, P=0.003) and skin disorders (7.3% in FCM versus 24.4% in DEX, P=0.004), were less frequently observed in the FCM group. A greater portion of patients in the FCM group experienced a transient, asymptomatic decrease in phosphate compared to patients in the DEX group (8.5% in FCM versus 0% in DEX, P=0.014). In the FCM arm, the change in hemoglobin from baseline to the highest observed level was 2.8 g/dL, whereas the DEX arm displayed a change of 2.4 g/dL (P=0.20). Treatment of IDA with FCM resulted in fewer hypersensitivity-related reactions than DEX.http://dx.doi.org/10.1155/2013/169107
spellingShingle Iftikhar Hussain
Jessica Bhoyroo
Angelia Butcher
Todd A. Koch
Andy He
David B. Bregman
Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia
Anemia
title Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia
title_full Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia
title_fullStr Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia
title_full_unstemmed Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia
title_short Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia
title_sort direct comparison of the safety and efficacy of ferric carboxymaltose versus iron dextran in patients with iron deficiency anemia
url http://dx.doi.org/10.1155/2013/169107
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