REGAIN STUDY: Retrospective Study to Assess the Effectiveness, Tolerability, and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnant Women

Wani, Saleema; Noushad, Mariyam; Ashiq, Shabana

doi:10.1155/2019/4640635

Cited by 16 publications

(22 citation statements)

References 20 publications

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“…9,10 Over the last 8 years, substantial evidence has been developed for the usage of FCM in pregnancy across the world. [9][10][11][12][13][14][15][16][17][18][19] These studies highlighted the efficacy and safety of FCM up to 1500 mg dosage over 4 to 12 weeks' follow-up. A cumulatively massive increase of hemoglobin by 3 to 4 g/dL over 6 weeks was reported with replenishment of iron stores.…”

Section: Discussionmentioning

confidence: 96%

“…8 There is an extensive experience of FCM usage in patients of anemia associated with pregnancy. [9][10][11][12][13][14][15][16][17][18][19] However, there is limited clinical experience of FCM usage in Indian pregnant women with anemia. The objective of the present retrospective study was to assess the efficacy and safety of FCM injection in Indian pregnant women with moderate-to-severe anemia in the department of obstetrics and gynecology at tertiary care research institute in India.…”

Section: Introductionmentioning

confidence: 99%

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Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real‐life experience

Gupte¹,

Venkataraman²,

Shah³

et al. 2021

J of Obstet and Gynaecol

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Background: There is limited clinical evidence of ferric carboxymaltose injection (FCM) usage in Indian pregnant women. We assessed the efficacy and safety of FCM in Indian pregnant women with moderate-tosevere anemia. Methods: Single-center, retrospective, observational data collection was conducted at a tertiary care research institute. Data of pregnant women with anemia who received FCM in their second and third trimester was retrieved and analyzed for hematological parameters at baseline and at 4 AE 2 weeks. Neonatal outcomes were also assessed. Adverse events and other safety parameters were noted. Results: Data of 271 patients was retrieved and analyzed for safety and data for 168 patients analyzed for efficacy. A significant increase in hemoglobin was noted with FCM in 4 weeks (1.25 g/dL; p < 0.001). Patients with severe anemia reported an increase in hemoglobin of 4.23 g/dL (p = 0.01). Patients receiving FCM in the second trimester noted a significant increase in hemoglobin of 1.74 g/dL (p < 0.001). A significant increase in hemoglobin was noted as early as 20 days (p < 0.001) and also in patients receiving FCM after 34 weeks (p = 0.002). No adverse fetal or neonatal outcomes were observed. Adverse events noted in 4% of patients with itching and rash being most common. Continuous monitoring of blood pressure, heart rate, and oxygen saturation for 40 min during and after FCM administration reported no deterioration or negative safety signal. Conclusion: FCM corrects anemia in all subsets of Indian pregnant women and supports evidence of efficacy and safety. Continuous monitoring of vital parameters during FCM infusions supports its excellent safety.

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Section: Discussionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real‐life experience

Gupte¹,

Venkataraman²,

Shah³

et al. 2021

J of Obstet and Gynaecol

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“…17 A study conducted in UAE also demonstrate that IV FCM effectively increase hemoglobin in pregnant female with iron deficiency anemia. 18 Another study conducted in Turkey also document that intravenous carboxymaltose improve hemoglobin in short time. 19 Ferric carboxymaltose seems to be superior to other parentral iron formulations due to its high efficacy, safety and compliance revolutionizing the management of iron deficiency anemia during pregnancy.…”

Section: Discussionmentioning

confidence: 97%

Comparison of ferric carboxymaltose versus Iron Sucrose for treatment of iron deficiency anemia in pregnancy.

Jamal

Zafar

Naz

et al. 2021

TPMJ

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Objective: To compare the mean increase in hemoglobin level with ferric carboxymaltose injection and iron sucrose injection for the management of the pregnant females presenting with iron deficiency anemia. Study Design: Randomized Controlled Trial. Settings: Department of Obstetrics and Gynecology Madina Teaching Hospital affiliated with University medical and Dental College Faisalabad. Period: July 2019 to December 2019. Material & Method: A total number of 100 patients presented in OPD satisfying the selection criteria were enrolled in the study after permission from ethical committee. On enrollment, a detailed clinical history which include previous iron treatment including and chronic medical disorders was taken. Clinical examination was done. Investigations for anemia include hemoglobin, reticulocyte count, peripheral film and red cell indices, serum ferritin level and Hb electrophoresis if indicated. The patients were randomly divided in two groups. In group A, females were given ferric carboxymaltose and in group B, females were given iron sucrose. After calculating the total iron deficit, patients in group A were given intravenous FCM. Patients in group B were given IS. Follow up of the patient was done after 3 weeks of intravenous iron treatment. The baseline Hb and values after 3 weeks of intravenous iron treatment were compared between the FCM and IS groups and increase in Hb level calculated as mean and SD. Both groups were analyzed for rise in Hb level by using independent sample t test. P value < 0.05 was taken as significant. Results: A total 100 pregnant female were found eligible for study, and were randomized into two groups of 50 each. Mean increase in hemoglobin level with ferric carboxymaltose and iron sucrose was evaluated, it shows that baseline Hb was 8.84±0.68 in Group A and 8.78 ±0.76 in Group B, P value was 0.67, after treatment Hb was 12.02±0.89 in Group A and 10.92 ±0.99 in Group B. Mean increase was 3.18 ±0.60 in Group A and 2.14±0.81 in Group B. P value was 0.001. Conclusion: Ferric carboxymaltose significantly increase Hb level and restores the iron stores as compare to iron sucreose. FCM is safe and effective intravenous treatment for iron deficiency anemia in pregnancy. FCM has the advantages of single large dose administration and fewer hospital visit. FCM is most suitable drug for the treatment of patients with IDA who required quick replenishment of iron stores.

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“…14 All these properties make IV FCM an attractive alternative in terms of safety, efficacy, convenience, and resource utilization. 16 There are published literatures highlighting role of FCM for treatment of anemia in the postpartum period and other diseases with associated anemia.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of ferric carboxymaltose in Indian pregnant women with iron deficiency anemia

Bhat¹,

Kiran²,

Deshmukh³

et al. 2021

Int J Reprod Contracept Obstet Gynecol

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Background: Iron deficiency anemia (IDA) is a significant problem worldwide particularly in women. The aim of the study was to evaluate the effectiveness of intravenous ferric carboxymaltose (FCM) in in Indian pregnant women with anemia.Method: This was a single centre, prospective, observational, open label, clinical study at real life scenario with 4 weeks follow up. Fifty pregnant women with IDA and visiting to the Radhakrishna multispecialty hospital, Bangalore, for antenatal care were enrolled for the study. IV FCM was given as per the standard protocol. Change in the laboratory parameters such as hemoglobin, mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), packed cell volume (PCV) level at baseline and after 4 weeks of completion of parenteral iron therapy was recorded and fatigue score was assessed. The pregnant women were monitored for the adverse events. Results: All pregnant women received a single IV infusion of FCM 1000 mg. A significant increase in the hemoglobin of 2.37±0.51 g/dl (p<0.001) was noted at 4 weeks, MCV rise of 19.89±21.94 (p<0.001) was noted at 4 weeks, MCHC rise was of 2.56±5.65 and PCV rise was of 4.45±2.67 (p<0.011) at over 4 weeks. Significant improvement in fatigue score was observed at 4 weeks after single FCM infusion. No adverse effects were observed in any pregnant woman throughout the duration of the study.Conclusions: This real-life observational study highlights IV FCM is effective in management of IDA in pregnant women and well tolerated. Trial registration number: CTRI/2021/02/030874

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REGAIN STUDY: Retrospective Study to Assess the Effectiveness, Tolerability, and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnant Women

Cited by 16 publications

References 20 publications

Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real‐life experience

Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real‐life experience

Comparison of ferric carboxymaltose versus Iron Sucrose for treatment of iron deficiency anemia in pregnancy.

Efficacy and safety of ferric carboxymaltose in Indian pregnant women with iron deficiency anemia

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