Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India

Charmila, Ayyavoo; Natarajan, Suma; Chitra, Thevoor Venkatesan; Pawar, Nivedita; Kinjawadekar, Sucheta; Firke, Yogini; Murugesan, Umaiyal; Yadav, Poonam; Ohri, Neelam; Modgil, Vidhu; Rodge, Ajinkya; Swami, Onkar C

doi:10.2147/jbm.s361210

Cited by 6 publications

(16 citation statements)

References 36 publications

(40 reference statements)

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“…This is a subgroup analysis of a multi-center, retrospective, observational, data collection study (PROMISE) across 269 centers in India in a real-world scenario [ 31 ]. Pregnant women with IDA (hemoglobin (Hb) level between 4 and <12 g/dL), who provided informed consent for future use of their medical records for research and received IV FCM were included in the PROMISE study.…”

Section: Methodsmentioning

confidence: 99%

“…RWEs are important because they substantiate the clinical trial evidence in real-world scenarios [ 30 ]. The previously reported PROMISE study is a retrospective, observational, real-world study of 1800 patients with IDA that assessed the efficacy and safety of intravenous (IV) FCM in adolescents and adults with IDA [ 31 ]. Herewith, we represent the efficacy and safety of IV FCM for correcting anemia in a subgroup of 1191 pregnant Indian women with IDA.…”

Section: Introductionmentioning

confidence: 99%

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

Trivedi

Chitra²,

Natarajan

et al. 2022

Obstetrics and Gynecology International

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Trivedi

Chitra²,

Natarajan

et al. 2022

Obstetrics and Gynecology International

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“…Oral interventions prove inadequate in cases of moderate to severe anemia, necessitating prompt elevation of hemoglobin levels and rapid iron store replenishment. Instead, expedited remedies like parenteral therapies become imperative (11). Notably, parenteral options, including intravenous iron preparations, facilitate swifter iron restoration compared to oral methods, and their tolerability during pregnancy is notable.…”

Section: Introductionmentioning

confidence: 99%

Effect of IV ferric carboxy maltose for moderate/severe anemia: a systematic review and meta-analysis

Khatib,

Sinha,

Gaidhane

et al. 2024

Front. Med.

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IntroductionAnemia remains a prevalent global health issue with varying severity. Intravenous iron supplementation, particularly with ferric carboxymaltose (FCM), has appeared as a possible therapeutic intervention for individuals with moderate to severe anemia. The study aimed to assess the efficacy and safety of ferric carboxymaltose (FCM) in reducing anemia.MethodsWe searched electronic databases, registries, websites, e-libraries, reference lists of reviews, citations, etc. We included randomized control trials (RCTs), non-RCTs, and single-arm studies, while observational studies, case series, and case studies were excluded. Two reviewers independently screened the studies and extracted the data. We included studies of moderate-to-severely anemic Indians and excluded Indians with other comorbidities. We assessed the risk of bias and the overall quality of evidence (QoE) using GRADE GDT.ResultWe identified 255 studies and included 14 studies (11 RCT, one non-RCT, and two single-arm studies) with 1,972 participants for qualitative analysis and 10 studies in the meta-analysis. All the included studies detailed the use of FCM for anemia. The primary outcomes assessed in the included studies were anemia, hemoglobin, and adverse events. The outcomes assessed ranged from 2 weeks to 12 weeks. The risk of bias varied across different studies with different outcomes. FCM is consistent with a fewer number of adverse events as compared to other interventions and provides “moderate” to “very low” QoE.ConclusionA slow single infusion of 1 gram of FCM is well-tolerated, safe, and effective in treating iron deficiency anemia (IDA) and surpasses other interventions (Iron Sucrose Complex (ISC), Iron sucrose, and ferrous ascorbate) in elevating hemoglobin levels and replenishing iron stores.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=459363, CRD42023459363.

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“…Anaemia stands as a pervasive global public health concern, impacting around one-third (22.8%) of the global population in the year 2019. 1 The 2019-2020 National Family Health Survey (NFHS-5) data reveals a significant prevalence of anaemia in India, where 57% of women and 25% of men between the ages of 15 and 49 exhibit this health condition. 1 These statistics emphasising the urgency of targeted interventions and public health initiatives to address this critical health issue.…”

Section: Introductionmentioning

confidence: 99%

“…1 The 2019-2020 National Family Health Survey (NFHS-5) data reveals a significant prevalence of anaemia in India, where 57% of women and 25% of men between the ages of 15 and 49 exhibit this health condition. 1 These statistics emphasising the urgency of targeted interventions and public health initiatives to address this critical health issue. 1 Moreover, the persistence of severe anaemia remains a significant challenge, delineated by haemoglobin (Hb) levels falling below 7 g/dL, despite the existence of Indian guidelines and dedicated efforts aimed at eradicating anaemia.…”

Section: Introductionmentioning

confidence: 99%

Safety and Efficacy of FCM in the Management of Iron Deficiency Anaemia: a Multi-centre Cohort-based Study

et al. 2023

IJFMR

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This study investigated the efficacy and safety of ferric carboxymaltose (FCM) in the treatment of iron deficiency anaemia (IDA) in a cohort of 100 patients across four locations in West Bengal, India. The results demonstrated significant improvements in various hematological parameters, including a substantial increase in haemoglobin levels, following FCM administration. The study also highlighted the absence of adverse events, showcasing a favorable safety profile of FCM in this population. The use of FCM, a third-generation parenteral iron formulation, proved effective in addressing moderate-to-severe IDA, aligning with existing evidence supporting its efficacy and safety. The rapid and substantial improvement in haemoglobin levels observed within four weeks of FCM administration emphasizes its efficiency in iron repletion, particularly in cases where oral preparations may be insufficient. The absence of adverse effects further supports the tolerability of FCM, a crucial factor in its consideration for widespread use. The study contributes valuable real-world data, especially in the context of the high prevalence of anaemia in India. The findings underscore the potential of FCM as a cornerstone in the treatment of severe anaemia, advocating for its inclusion in targeted interventions and public health initiatives. Overall, this study adds to the growing body of evidence supporting FCM as a promising option in the management of iron deficiency anaemia.

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Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India

Cited by 6 publications

References 36 publications

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

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

Effect of IV ferric carboxy maltose for moderate/severe anemia: a systematic review and meta-analysis

Safety and Efficacy of FCM in the Management of Iron Deficiency Anaemia: a Multi-centre Cohort-based Study

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