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

Sanghoon Lee, Ki Jin Ryu, Eun Sil Lee, Keun Ho Lee, Jeong Jae Lee, Tak Kim

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1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)858-864
Number of pages7
JournalJournal of Obstetrics and Gynaecology Research
Volume45
Issue number4
DOIs
Publication statusPublished - 2019 Apr 1

Fingerprint

saccharated ferric oxide
Menorrhagia
Multicenter Studies
Anemia
Safety
Hemoglobins
Iron-Deficiency Anemias
Therapeutics
Quality of Life
ferric carboxymaltose

Keywords

  • ferric carboxymaltose
  • iron deficiency anemia
  • iron sucrose
  • menorrhagia
  • preoperative

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

@article{79f22758349e4cd184ee757e05140975,
title = "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",
abstract = "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.",
keywords = "ferric carboxymaltose, iron deficiency anemia, iron sucrose, menorrhagia, preoperative",
author = "Sanghoon Lee and Ryu, {Ki Jin} and Lee, {Eun Sil} and Lee, {Keun Ho} and Lee, {Jeong Jae} and Tak Kim",
year = "2019",
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doi = "10.1111/jog.13893",
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TY - JOUR

T1 - Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for the treatment of preoperative anemia in patients with menorrhagia

T2 - An open-label, multicenter, randomized study

AU - Lee, Sanghoon

AU - Ryu, Ki Jin

AU - Lee, Eun Sil

AU - Lee, Keun Ho

AU - Lee, Jeong Jae

AU - Kim, Tak

PY - 2019/4/1

Y1 - 2019/4/1

N2 - 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.

AB - 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.

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