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. 2013:2013:169107.
doi: 10.1155/2013/169107. Epub 2013 Aug 29.

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

Iftikhar Hussain  1 , Jessica Bhoyroo, Angelia Butcher, Todd A Koch, Andy He, David B Bregman
Affiliations

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

Iftikhar Hussain et al. Anemia. 2013.

Abstract

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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Figures

Figure 1
Figure 1
Flowchart of the study. aAll subjects treated with FCM or DEX were included in the safety population. bmITT: all subjects in the safety population with 2 baseline hemoglobin values (with <1 g/dL difference between the 2 values) and at least 1 postbaseline hemoglobin value on or before Day 49 or intervention date, whichever came first.
Figure 2
Figure 2
Mean phosphorus values for FCM and DEX patients.
Figure 3
Figure 3
Mean hemoglobin values for FCM and DEX patients.
See this image and copyright information in PMC

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