Efficacy and safety of ferric carboxymaltose versus ferrous sulfate for iron deficiency anemia during pregnancy: subgroup analysis of Korean women
- 주제(키워드) Intravenous iron , Iron deficiency , Anemia , Pregnancy , Korea , Ferric carboxymaltose , Clinical trial
- 주제(기타) Obstetrics & Gynecology
- 설명문(일반) [Shim, Jae-Yoon; Kim, Ahm] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Obstet & Gynecol, 88 Olymp Ro,43 Gil, Seoul 05505, South Korea; [Kim, Moon Young] Dankook Univ, Coll Med, Cheil Gen Hosp, Dept Obstet & Gynecol, Seoul, South Korea; [Kim, Moon Young] Dankook Univ, Coll Med, Womens Healthcare Ctr, Seoul, South Korea; [Kim, Young Ju] Ewha Womans Univ, Sch Med, Dept Obstet & Gynecol, Seoul, South Korea; [Lee, Young; Shin, Jong Chul] Catholic Univ Korea, Coll Med, Seoul St Marys Hosp, Dept Obstet & Gynecol, Seoul, South Korea; [Lee, Jeong Jae] Soonchunhyang Univ, Coll Med, Seoul Hosp, Dept Obstet & Gynecol, Seoul, South Korea; [Jun, Jong Kwan] Seoul Natl Univ, Coll Med, Dept Obstet & Gynecol, Seoul, South Korea; [Cho, Yong Kyoon] Inje Univ, Coll Med, Sanggyepaik Hosp, Dept Obstet & Gynecol, Seoul, South Korea; [Lee, Keun Young] Hallym Univ, Coll Med, Kangnam Sacred Heart Hosp, Dept Obstet & Gynecol, Seoul, South Korea; [Song, Tae-Bok] Chonnam Natl Univ, Med Sch, Dept Obstet & Gynecol, Gwangju, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 BMC
- 발행년도 2018
- URI http://www.dcollection.net/handler/ewha/000000155783
- 본문언어 영어
- Published As http://dx.doi.org/10.1186/s12884-018-1817-y
초록/요약
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.
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