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

Title
Efficacy and safety of ferric carboxymaltose versus ferrous sulfate for iron deficiency anemia during pregnancy: subgroup analysis of Korean women
Authors
Shim, Jae-YoonKim, Moon YoungKim, Young JuLee, YoungLee, Jeong JaeJun, Jong KwanShin, Jong ChulCho, Yong KyoonLee, Keun YoungKim, AhmSong, Tae-Bok
Ewha Authors
김영주
SCOPUS Author ID
김영주scopus
Issue Date
2018
Journal Title
BMC PREGNANCY AND CHILDBIRTH
ISSN
1471-2393JCR Link
Citation
BMC PREGNANCY AND CHILDBIRTH vol. 18
Keywords
Intravenous ironIron deficiencyAnemiaPregnancyKoreaFerric carboxymaltoseClinical trial
Publisher
BMC
Indexed
SCIE; SCOPUS WOS scopus
Document Type
Article
Abstract
Background: We performed a post-hoc subgroup analysis in Korean women who participated in the Phase III FERASAP (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.
DOI
10.1186/s12884-018-1817-y
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의과대학 > 의학과 > Journal papers
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