Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial

Abstract

Background Iron deficiency anaemia is of major concern in low-income settings, especially for women of childbearing age. Oral iron substitution efficacy is limited by poor compliance and iron depletion severity. We aimed to assess the efficacy and safety of intravenous ferric carboxymaltose versus oral iron substitution following childbirth in women with iron deficiency anaemia in Tanzania. Methods This parallel-group, open-label, randomised controlled phase 3 trial was done at Bagamoyo District Hospital and Mwananyamala Hospital, Tanzania. Eligible participants were close to delivery and had iron deficiency anaemia defined as a haemoglobin concentration of less than 110 g/L and a ferritin concentration of less than 50 μg/L measured within 14 days before childbirth. Participants were randomly assigned 1:1 to receive intravenous ferric carboxymaltose or oral iron, stratified by haemoglobin concentration and site. Intravenous ferric carboxymaltose was administered at a dose determined by the haemoglobin concentration and bodyweight (bodyweight 35 kg to <70 kg and haemoglobin ≥100 g/L: 1000 mg in one dose; bodyweight 35 kg to <70 kg and haemoglobin <100 g/L, or bodyweight ≥70 kg and haemoglobin ≥100 g/L: 1500 mg in two doses at least 7 days apart; bodyweight ≥70 kg and haemoglobin <100 g/L: 2000 mg in two doses at least 7 days apart). Oral iron treatment consisted of three dried ferrous sulphate tablets of 200 mg containing 60 mg of elementary iron and 5 mg of folic acid every morning. Oral treatment was to be taken for 3 months after haemoglobin normalisation. The primary outcome was haemoglobin normalisation (>115 g/L) at 6 weeks. Follow-up visits were at 6 weeks, and 3, 6, and 12 months. Analyses were done in the modified intention-totreat population of participants who had a 6-week haemoglobin concentration result, using logistic and linear regression models for binary and continuous outcomes, adjusted for baseline haemoglobin concentration and site. This trial is registered with ClinicalTrials.gov, NCT02541708.

Single Dose of Intravenous Ferric Carboxymaltose Prevents Anemia for 6 Months among Moderately or Severely Anemic Postpartum Women: A Case Study from India

“…These findings are similar to those in our study. A study conducted in Tanzania reported a substantial increase in hemoglobin and serum ferritin concentrations (358 ng/mL) after intravenous FCM, and reported a sustained increase in hemoglobin and a significant decline in serum ferritin concentrations from 6 to 52 wk, which is in line with the findings of our study ( 8 ). Long-term beneficial effects of FCM have also been reported among patients with pulmonary arterial hypertension ( 11 ).…”

“…Despite extensive review of the literature, only 2 studies were found that reported the long-term effect of FCM on hemoglobin and serum ferritin concentrations among postpartum women ( 7 , 8 ). Becuzzi et al ( 7 ) constructed a retrospective cohort of moderately anemic postpartum women (hemoglobin: 9.6–10.5 g/dL).…”

“…However, most of these studies have reported the findings up to 6 to 12 wk after administration of FCM ( 1 – 6 ). To the best of our knowledge, only 2 studies measured hemoglobin and serum ferritin concentrations among postpartum women, 6 mo after administration of intravenous FCM ( 7 , 8 ). Therefore, the question of whether, or when, to repeat FCM administration among women who had already received FCM remains largely unanswered.…”

Blood and blood treatments

“…In an open-label randomized, parallel-group controlled, phase 3 trial, hemoglobin normalization in postpartum women with hemoglobin levels < 110 g/L and ferritin levels < 50 μg/L was evaluated by Vanobberghen et al (2021) [C]. Between October 8, 2015, and March 14, 2017, 230 women who needed treatment for iron deficiency anemia were randomly assigned to two separate groups in two hospitals located in a resource-deficient area in Tanzania.…”

Protocol for a multicentre, parallel-group, open-label randomised controlled trial comparing ferric carboxymaltose with the standard of care in anaemic Malawian pregnant women: the REVAMP trial

“…18 Intravenous iron is increasingly recommended as a suitable first-line option for women with moderate or severe iron-deficiency anaemia beyond the first trimester of pregnancy. 19 Studies have evaluated the role of older forms of intravenous iron in pregnancy in low-income settings such as India, 20 21 while other studies have demonstrated the feasibility of using FCM in the postpartum period in sub-Saharan Africa 22 but modern formulations capable of delivering a rapid total-dose infusion have not yet been studied in women in pregnancy in low-income countries.…”