TY - JOUR
T1 - Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia
T2 - A randomized trial
AU - Adkinson, N. Franklin
AU - Strauss, William E.
AU - Macdougall, Iain C.
AU - Bernard, Kristine E.
AU - Auerbach, Michael
AU - Kaper, Robert F.
AU - Chertow, Glenn M.
AU - Krop, Julie S.
N1 - Publisher Copyright:
© 2018 The Authors American Journal of Hematology Published by Wiley Periodicals, Inc.
PY - 2018/5
Y1 - 2018/5
N2 - 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.
AB - 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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U2 - 10.1002/ajh.25060
DO - 10.1002/ajh.25060
M3 - Article
C2 - 29417614
AN - SCOPUS:85042412026
SN - 0361-8609
VL - 93
SP - 683
EP - 690
JO - American journal of hematology
JF - American journal of hematology
IS - 5
ER -