Comparative analysis of ferric carboxymaltose and iron sucrose in treating iron deficiency anemia in perimenopausal women with heavy menstrual bleeding: a randomized controlled trial
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Objective To evaluate the impact of intravenous ferric carboxymaltose (FCM) compared to iron sucrose (ISC) in perimenopausal women with heavy menstrual bleeding (HMB) and anemia. Methods This prospective, open-label, randomized controlled trial enrolled perimenopausal women (40-50 years) with HMB and hemoglobin levels between 6-10 g/dL, intolerant or non-compliant to oral iron therapy. The study compared FCM and ISC by assessing hematological parameters, including hemoglobin, ferritin, and iron levels, over a 12-week period. The patients were followed up at 3, 6, and 12 weeks after initiation. The adverse effects were also evaluated. Results The study included 60 perimenopausal women, with 30 in each group. The baseline patient characteristics were comparable. FCM demonstrated a statistically significant higher mean increase in hemoglobin (4.97 g/dL) than ISC (4.63 g/dL) over 12 weeks. The proportion of patients achieving correction of anemia (hemoglobin ≥12 g/dL) was higher in the FCM group (75.9% vs. 65.5%). Serum ferritin levels were significantly higher in the FCM group after 3 weeks. Adverse effects were minimal and comparable between the groups. Although the direct cost of FCM is high, its ability to be administered in larger doses may result in lower total costs. Conclusion In perimenopausal women with heavy menstrual bleeding and iron deficiency anemia, FCM and ISC show comparable efficacy in increasing hemoglobin levels with similar side effect profiles. This study highlights the potential benefits of FCM and calls for further exploration of these therapies in diverse patient populations.
Abstract
Objective To evaluate the impact of intravenous ferric carboxymaltose (FCM) compared to iron sucrose (ISC) in perimenopausal women with heavy menstrual bleeding (HMB) and anemia. Methods This prospective, open-label, randomized controlled trial enrolled perimenopausal women (40-50 years) with HMB and hemoglobin levels between 6-10 g/dL, intolerant or non-compliant to oral iron therapy. The study compared FCM and ISC by assessing hematological parameters, including hemoglobin, ferritin, and iron levels, over a 12-week period. The patients were followed up at 3, 6, and 12 weeks after initiation. The adverse effects were also evaluated. Results The study included 60 perimenopausal women, with 30 in each group. The baseline patient characteristics were comparable. FCM demonstrated a statistically significant higher mean increase in hemoglobin (4.97 g/dL) than ISC (4.63 g/dL) over 12 weeks. The proportion of patients achieving correction of anemia (hemoglobin ≥12 g/dL) was higher in the FCM group (75.9% vs. 65.5%). Serum ferritin levels were significantly higher in the FCM group after 3 weeks. Adverse effects were minimal and comparable between the groups. Although the direct cost of FCM is high, its ability to be administered in larger doses may result in lower total costs. Conclusion In perimenopausal women with heavy menstrual bleeding and iron deficiency anemia, FCM and ISC show comparable efficacy in increasing hemoglobin levels with similar side effect profiles. This study highlights the potential benefits of FCM and calls for further exploration of these therapies in diverse patient populations.
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