The following is a summary of “Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnancy: A Subgroup Analysis of a Multicenter Real-World Study Involving 1191 Pregnant Women,” published in the November 2022 issue of Medicine by Trivedi, et al.
There was a dearth of clinical data supporting the effectiveness and safety of ferric carboxymaltose (FCM) infusion in pregnant Indian women with iron deficiency anemia (IDA). In a real-world setting, researchers, for a study, sought to evaluate the effectiveness and safety of intravenous (IV) FCM in Indian pregnant women with IDA in 4 weeks.
It was a subgroup analysis of the PROMISE trial, which was previously done retrospectively, multicenter, and in the real world. At 4±1 week, data on demographic and hematological characteristics, patient adverse event reports, and clinical assessments of effectiveness and safety made by doctors were also analyzed.
In the 1,191 pregnant women included in the subgroup study, IV FCM significantly raised hemoglobin (Hb) by 2.8 g/dL and serum ferritin by 30.03 μg/L at 4 weeks (P< 0.001 for both). Hb increased by 3.6 g/dL (P< 0.001) and serum ferritin by 16.96 μg/L (P = 0.12), all of which were statistically significant increases in 103 pregnant women with severe IDA. Significant increases in serum ferritin by 33 μg/L and Hb by 2.74 g/dL (P< 0.001 for both) were seen in 978 pregnant women with mild IDA. The mean corpuscular volume, mean corpuscular hemoglobin, hematocrit, and red blood cell count all increased significantly (P< 0.001 for all). Pregnant women with moderate IDA (n = 26) had a substantial rise in Hb of 1.99 g/dL (P< 0.001). 8.6% of pregnant women reported adverse effects. There were no brand-new warning signs of safety or alarming side effects. According to doctors’ overall assessments, 99.2% and 98.6% of pregnant women who received IV FCM with good to very good effectiveness and safety, respectively.
In the second and third trimesters of pregnancy, with all levels of IDA, IV FCM effectively treated anemia in a matter of 4 weeks with excellent safety. The use of FCM in routine clinical practice was supported by the physicians’ positive overall appraisal of its effectiveness and safety in pregnant women with IDA.