Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia

A randomized trial

N Franklin Adkinson, William E. Strauss, Iain C. Macdougall, Kristine E. Bernard, Michael Auerbach, Robert F. Kaper, Glenn M. Chertow, Julie S. Krop

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalAmerican Journal of Hematology
DOIs
StateAccepted/In press - Jan 1 2018

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Ferrosoferric Oxide
Iron-Deficiency Anemias
Safety
Hypersensitivity
Anaphylaxis
Hypotension
Incidence
Iron
Hypophosphatemia
ferric carboxymaltose
Least-Squares Analysis
Hemoglobins
Clinical Trials

ASJC Scopus subject areas

  • Hematology

Cite this

Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia : A randomized trial. / Adkinson, N Franklin; Strauss, William E.; Macdougall, Iain C.; Bernard, Kristine E.; Auerbach, Michael; Kaper, Robert F.; Chertow, Glenn M.; Krop, Julie S.

In: American Journal of Hematology, 01.01.2018.

Research output: Contribution to journalArticle

Adkinson, N Franklin ; Strauss, William E. ; Macdougall, Iain C. ; Bernard, Kristine E. ; Auerbach, Michael ; Kaper, Robert F. ; Chertow, Glenn M. ; Krop, Julie S. / Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia : A randomized trial. In: American Journal of Hematology. 2018.
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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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