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Efficacy and safety of ferric carboxymaltose versus ferrous sulfate for iron deficiency anemia during pregnancy: subgroup analysis of Korean women

Cited 5 time in Web of Science Cited 4 time in Scopus
Authors
Shim, Jae-Yoon; Kim, Moon Young; Kim, Young Ju; Lee, Young; Lee, Jeong Jae; Jun, Jong Kwan; Shin, Jong Chul; Cho, Yong Kyoon; Lee, Keun Young; Kim, Ahm; Song, Tae-Bok
Issue Date
2018-08-28
Publisher
BioMed Central
Citation
BMC Pregnancy and Childbirth, 18(1):349
Keywords
Intravenous ironIron deficiencyAnemiaPregnancyKoreaFerric carboxymaltoseClinical trial
Abstract
Background
We performed a post-hoc subgroup analysis in Korean women who participated in the Phase III FER-ASAP (FERric carboxymaltose-Assessment of SAfety and efficacy in Pregnancy) study to compare the efficacy and safety of ferric carboxymaltose (FCM) with oral ferrous sulfate (FS).

Methods
Pregnant Korean women (gestational weeks 16–33) with iron-deficiency anemia (IDA) were randomized 1:1 to FCM (n = 46; 1000–1500 mg iron) or FS (n = 44; 200 mg iron/day) group for 12 weeks. The primary objective was to compare the mean hemoglobin (Hb) increase at week 3; secondary objectives included change in iron parameters, quality of life (QoL), and safety.

Results
Baseline characteristics of the Korean subgroup were consistent with those of non-Korean FER-ASAP population except for lower body-mass index and higher maternal age. Hb level increases were comparable between the two treatment groups in Korean women at week 3 (FCM 1.23 ± 0.89 g/dL vs FS 1.14 ± 1.72 g/dL). Iron parameters improved over time as secondary endpoints were significantly in favor of FCM. In terms of QoL, FCM treatment significantly improved the mental and physical components as well as vitality prior to delivery. Both treatments were well tolerated.

Conclusions
FCM provided significantly greater improvements in iron parameters and QoL compared to FS in the Korean subgroup. FCM may be a preferable alternative to currently available treatments for IDA during pregnancy.
ISSN
1471-2393
Language
English
URI
http://hdl.handle.net/10371/143544
DOI
https://doi.org/10.1186/s12884-018-1817-y
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College of Medicine/School of Medicine (의과대학/대학원)Obstetrics & Gynecology (산부인과전공)Journal Papers (저널논문_산부인과학전공)
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