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Clinical Trial
. 2018 May;93(5):683-690.
doi: 10.1002/ajh.25060. Epub 2018 Feb 24.

Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial

N Franklin Adkinson  1 , William E Strauss  2 , Iain C Macdougall  3 , Kristine E Bernard  2 , Michael Auerbach  4   5 , Robert F Kaper  2 , Glenn M Chertow  6 , Julie S Krop  2
Affiliations
Clinical Trial

Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial

N Franklin Adkinson et al. Am J Hematol. 2018 May.

Abstract

Few trials have examined rates of hypersensitivity reactions (HSRs) with intravenous iron formulations used to treat iron deficiency anemia (IDA). This randomized, multicenter, double-blind clinical trial compared the safety, and efficacy of ferumoxytol versus ferric carboxymaltose (FCM), focusing on rates of HSRs and hypotension as the primary end point. Patients with IDA of any etiology in whom oral iron was unsatisfactory or intolerable received ferumoxytol (n = 997) or FCM (n = 1000) intravenously over ≥15 minutes on days 1 and 8 or 9 for total respective doses of 1.02 g and 1.50 g. Composite incidences of moderate-to-severe HSRs, including anaphylaxis, or moderate-to-severe hypotension from baseline to week 5 (primary safety end point) were 0.6% and 0.7% in the ferumoxytol and FCM groups, respectively, with ferumoxytol noninferior to FCM. No anaphylaxis was reported in either group. The secondary safety end point of incidences of moderate-to-severe HSRs, including anaphylaxis, serious cardiovascular events, and death from baseline to week 5 were 1.3% and 2.0% in the ferumoxytol and FCM groups, respectively (noninferiority test P < .0001). Least-squares mean changes in hemoglobin at week 5 were 1.4 g/dL and 1.6 g/dL in the ferumoxytol and FCM groups, respectively (noninferiority test P < .0001). Incidence of hypophosphatemia was 0.4% for ferumoxytol and 38.7% for FCM.

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Figures

Figure 1
Figure 1
Changes in Hb from baseline. (A) Least‐squares mean changes in Hb from baseline to week 5. (B) Changes in Hb from baseline to week 5 per gram of iron administered (intention‐to‐treat population). Results were from an analysis of covariance model adjusting for BL value. Error bars show the standard error. BL, baseline; CI, confidence interval; Hb, hemoglobin
Figure 2
Figure 2
Measures of phosphate. Mean values for (A) serum phosphate and (B) fractional excretion of phosphate by visit. Shading indicates the normal range.15 Error bars show the standard deviation. *P < .0001. † P ≤ .005. ǂ P < .05. To convert serum phosphate to mmol/L, multiply by 0.323
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References

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