Оценка безопасности в/в пр-тов железа (монофер против феринджекта) на примере лечения 2 тысяч пациенток - гипофосфатемия развивалась у каждой третьей на фоне феринджекта:
This randomized, multicenter, double-blind clinical trial compared the safety and efficacy of ferumoxytol versus ferric carboxymaltose (FCM), focusing on rates of hypersensitivity reactions and hypotension as the primary end point. Patients with iron deficiency anemia 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 hypersensitivity reactions, 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 hypersensitivity reactions, 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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Am J Hematol. 2018 Feb 8.
Comparative safety of intravenous ferumoxytol vs ferric carboxymaltose in iron deficiency anemia: A randomized trial.
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