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Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for the treatment of preoperative anemia in patients with menorrhagia: An open‐label, multicenter, randomized study
Author(s) -
Lee Sanghoon,
Ryu KiJin,
Lee Eun Sil,
Lee Keun Ho,
Lee Jeong Jae,
Kim Tak
Publication year - 2019
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/jog.13893
Subject(s) - medicine , iron sucrose , anemia , randomized controlled trial , clinical endpoint , quality of life (healthcare) , intravenous iron , hemoglobin , gastroenterology , open label , iron deficiency anemia , multicenter study , surgery , iron deficiency , nursing
Aim To compare ferric carboxymaltose (FCM) with iron sucrose (IS) for the effective and timely treatment of preoperative iron deficiency anemia (IDA) in women with menorrhagia. Methods This open‐label, multicenter, two‐arm study randomized patients to receive either a single dose of FCM or multiple doses of IS. The primary endpoint was the proportion of patients who achieved hemoglobin (Hb) levels ≥10 g/dL within 2 weeks after the first administration. Secondary endpoints included mean Hb levels, time to reach Hb ≥10 g/dL and quality of life (QoL). Results In total, 101 patients (FCM n = 52; IS n = 49) were randomized to the study treatments. FCM was as effective as IS in achieving Hb ≥10 g/dL within 2 weeks after the first administration (78.8% vs 72.3%). The time to reach Hb ≥10 g/dL was significantly shorter in the FCM group than in the IS group (7.7 days vs 10.5 days). Mean Hb levels were higher in the FCM‐treated patients than in the IS‐treated patients with borderline significance. QoL scores did not differ between the two groups. Conclusion Ferric carboxymaltose is as effective as IS in correcting preoperative IDA among patients with menorrhagia. The added benefits of FCM over IS included significant rapid correction of IDA, replenishment of iron stores and reduced hospital visits.