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

被引:110
作者
Adkinson, N. Franklin [1 ]
Strauss, William E. [2 ]
Macdougall, Iain C. [3 ]
Bernard, Kristine E. [2 ]
Auerbach, Michael [4 ,5 ]
Kaper, Robert F. [2 ]
Chertow, Glenn M. [6 ]
Krop, Julie S. [2 ]
机构
[1] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
[2] AMAG Pharmaceut Inc, 1100 Winter St, Waltham, MA 02451 USA
[3] Kings Coll Hosp London, Dept Renal Med, London, England
[4] Auerbach Hematol & Oncol, Baltimore, MD USA
[5] Georgetown Univ, Sch Med, Washington, DC USA
[6] Stanford Univ, Stanford, CA 94305 USA
关键词
CHRONIC KIDNEY-DISEASE; HYPERSENSITIVITY REACTIONS; SEVERE HYPOPHOSPHATEMIA; ORAL IRON; EFFICACY; OUTCOMES; SUCROSE; RISK;
D O I
10.1002/ajh.25060
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:683 / 690
页数:8
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