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

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dc.contributor.authorShim, Jae-Yoon-
dc.contributor.authorKim, Moon Young-
dc.contributor.authorKim, Young Ju-
dc.contributor.authorLee, Young-
dc.contributor.authorLee, Jeong Jae-
dc.contributor.authorJun, Jong Kwan-
dc.contributor.authorShin, Jong Chul-
dc.contributor.authorCho, Yong Kyoon-
dc.contributor.authorLee, Keun Young-
dc.contributor.authorKim, Ahm-
dc.contributor.authorSong, Tae-Bok-
dc.date.accessioned2018-11-14T07:11:14Z-
dc.date.available2018-11-14T16:12:20Z-
dc.date.issued2018-08-28-
dc.identifier.citationBMC Pregnancy and Childbirth, 18(1):349ko_KR
dc.identifier.issn1471-2393-
dc.identifier.urihttps://hdl.handle.net/10371/143544-
dc.description.abstractBackground
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.
ko_KR
dc.description.sponsorshipThis study was funded by Vifor Pharma, which had no role in the design of the study, in collection, analysis, and interpretation of the data, and in writing the manuscript.ko_KR
dc.language.isoenko_KR
dc.publisherBioMed Centralko_KR
dc.subjectIntravenous ironko_KR
dc.subjectIron deficiencyko_KR
dc.subjectAnemiako_KR
dc.subjectPregnancyko_KR
dc.subjectKoreako_KR
dc.subjectFerric carboxymaltoseko_KR
dc.subjectClinical trialko_KR
dc.titleEfficacy and safety of ferric carboxymaltose versus ferrous sulfate for iron deficiency anemia during pregnancy: subgroup analysis of Korean womenko_KR
dc.typeArticleko_KR
dc.contributor.AlternativeAuthor심재윤-
dc.contributor.AlternativeAuthor김문영-
dc.contributor.AlternativeAuthor김영주-
dc.contributor.AlternativeAuthor이영-
dc.contributor.AlternativeAuthor이정재-
dc.contributor.AlternativeAuthor전종관-
dc.contributor.AlternativeAuthor신종철-
dc.contributor.AlternativeAuthor조용균-
dc.contributor.AlternativeAuthor이근영-
dc.contributor.AlternativeAuthor김암-
dc.contributor.AlternativeAuthor송태복-
dc.identifier.doi10.1186/s12884-018-1817-y-
dc.language.rfc3066en-
dc.rights.holderThe Author(s).-
dc.date.updated2018-09-02T03:19:58Z-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Obstetrics & Gynecology (산부인과전공)Journal Papers (저널논문_산부인과학전공)
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