The REVAMP trial: key questions remain

We read the Article by Sant-Rayn Pasricha and colleagues1Pasricha S-R Mwangi MN Moya E et al.Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial.Lancet. 2023; 401: 1595-1609Summary Full Text Full Text PDF PubMed Scopus (17) Google Scholar with great interest. The authors showed that the use of ferric carboxymaltose in resource-poor contexts (in which the risk of infection is high) is feasible. However, they seem to have used a non-standard approach for administering ferric carboxymaltose in this clinical trial. According to the manufacturer, the use of ferric carboxymaltose follows a step-by-step approach of: first, determining the individual's iron requirements; second, calculating and applying the iron dosage; and third, evaluating the individual's anaemia status after iron supplementation. It is recommended that the dose of ferric carboxymaltose be calculated on the basis of the individual's haemoglobin concentration and bodyweight, rather than simply treating them with a single injection of 20 mg/kg ferric carboxymaltose (up to 1000 mg). In fact, another randomised controlled trial2Vanobberghen F Lweno O Kuemmerle A et al.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.Lancet Glob Health. 2021; 9: e189-e198Summary Full Text Full Text PDF PubMed Scopus (22) Google Scholar completed in sub-Saharan Africa with the standard administration method showed that ferric carboxymaltose yielded a better haemoglobin response than oral iron treatment. We are concerned that a simple single dose of ferric carboxymaltose could result in insufficient administration for some pregnant women, which could affect the evaluation of its efficacy as a treatment. Haemoglobin concentrations should also be reassessed within 4 weeks after administration of ferric carboxymaltose to establish whether further supplementation is necessary. The authors seem to have overlooked this point. We declare no competing interests. Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trialIn this malaria-endemic sub-Saharan African setting, treatment of anaemic pregnant women with ferric carboxymaltose was safe but did not reduce anaemia prevalence at 36 weeks' gestation or increase birthweight. Full-Text PDF Open AccessThe REVAMP trial: key questions remain – Authors' replyWe thank Bingwen Eugene Fan, Deku Liang and colleagues, Alizée Froeliger and colleagues, Tomohiko Sato and Ryu Yanagisawa, and Qin-Yu Cai and colleagues for their feedback on our Article on the REVAMP trial.1 Fan and Liang and colleagues note that a single dose of ferric carboxymaltose (20 mg/kg up to 1000 mg) might have been inadequate, especially for women with more profound iron deficiency at baseline. Use of the Ganzoni formula would generally have resulted in higher dosing (eg, up to 1500 mg, given over two doses). Full-Text PDF