Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnancy: A Subgroup Analysis of a Multicenter Real-World Study Involving 1191 Pregnant Women.

IF 1.6 Q3 OBSTETRICS & GYNECOLOGY
Prakash Trivedi, S Chitra, Suma Natarajan, Vandana Amin, Shilpi Sud, Priti Vyas, Meenakshi Singla, Ajinkya Rodge, Onkar C Swami
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引用次数: 2

Abstract

Background: Real-world evidence of the efficacy and safety of ferric carboxymaltose (FCM) infusion in Indian pregnant women with iron deficiency anemia (IDA) is lacking.

Objective: To assess the efficacy and safety of intravenous (IV) FCM in Indian pregnant women with IDA in 4 weeks in a real-life scenario.

Methods: This is a subgroup analysis of our previously conducted retrospective, multicenter, observational, real-world PROMISE study. Data on demographic and hematological parameters, patient-reported adverse events, and physicians' clinical impressions of efficacy and safety were analysed at 4 ± 1 week.

Results: This subgroup analysis included 1191 pregnant women in whom IV FCM resulted in a significant increase in hemoglobin (Hb) by 2.8 g/dL and serum ferritin by 30.03 μg/L at 4 weeks (P < 0.001 for both). In 103 pregnant women with severe IDA, there was a significant increase in Hb by 3.6 g/dL (P < 0.001), and serum ferritin by 16.96 μg/L (P=0.12). In 978 pregnant women with moderate IDA, significant improvement in Hb by 2.74 g/dL and serum ferritin by 33 μg/L (P < 0.001 for both) was noted. Similarly, there was a significant increase in red blood cell count, hematocrit, mean corpuscular volume, and mean corpuscular hemoglobin (P < 0.001 for all). In pregnant women with mild IDA (n = 26), Hb increased significantly by 1.99 g/dL (P < 0.001). Adverse effects were reported in 8.6% of pregnant women. No new safety signals or serious adverse effects were observed. Based on physicians' global assessment, good to very good efficacy and safety of IV FCM was noted in 99.2% and 98.6% of pregnant women, respectively.

Conclusions: IV FCM rapidly corrected anemia in a short period of 4 weeks with favorable safety in the second and third trimester of pregnancy with all severities of IDA (severe, moderate, and mild). The physicians' favorable global assessment of FCM's efficacy and safety in pregnant women with IDA supports its use in daily clinical practice. This trial is registered with CTRI/2021/12/039065.

Abstract Image

羧基麦芽糖铁治疗妊娠期缺铁性贫血:一项涉及1191名孕妇的多中心真实世界研究的亚组分析
背景:印度孕妇缺铁性贫血(IDA)缺乏羧基麦芽糖铁(FCM)输注的有效性和安全性的实际证据。目的:在真实情况下评估印度妊娠4周内静脉(IV) FCM的有效性和安全性。方法:这是我们之前进行的回顾性、多中心、观察性、真实世界PROMISE研究的亚组分析。在4±1周时,对人口统计学和血液学参数、患者报告的不良事件以及医生对疗效和安全性的临床印象进行分析。结果:该亚组分析包括1191名孕妇,IV FCM导致血红蛋白(Hb)在4周时显著增加2.8 g/dL,血清铁蛋白增加30.03 μg/L(两者均P < 0.001)。103例重度IDA孕妇Hb升高3.6 g/dL (P < 0.001),血清铁蛋白升高16.96 g/L (P=0.12)。在978例中度IDA孕妇中,Hb显著改善2.74 g/dL,血清铁蛋白显著改善33 g/L(两者均P < 0.001)。同样,红细胞计数、红细胞压积、平均红细胞体积和平均红细胞血红蛋白均显著增加(P < 0.001)。在轻度IDA的孕妇中(n = 26), Hb显著增加1.99 g/dL (P < 0.001)。8.6%的孕妇报告了不良反应。未观察到新的安全信号或严重的不良反应。根据医生的整体评估,99.2%和98.6%的孕妇认为IV FCM的疗效好到非常好,安全性好。结论:在妊娠中晚期(重度、中度和轻度),静脉流式细胞术可在短时间内快速纠正贫血,且安全性较好。医生对FCM在IDA孕妇中的有效性和安全性的总体评价支持其在日常临床实践中的使用。该试验注册号为CTRI/2021/12/039065。
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来源期刊
Obstetrics and Gynecology International
Obstetrics and Gynecology International OBSTETRICS & GYNECOLOGY-
CiteScore
3.60
自引率
0.00%
发文量
26
审稿时长
19 weeks
期刊介绍: Obstetrics and Gynecology International is a peer-reviewed, Open Access journal that aims to provide a forum for scientists and clinical professionals working in obstetrics and gynecology. The journal publishes original research articles, review articles, and clinical studies related to obstetrics, maternal-fetal medicine, general gynecology, gynecologic oncology, uro-gynecology, reproductive medicine and infertility, reproductive endocrinology, and sexual medicine.
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