Safety and efficacy of intravenous ferric carboxymaltose (750 mg) in the treatment of iron deficiency anemia: two randomized, controlled trials.

In this article, the authors present data from two phase 3, open-label, randomized, controlled, multicenter trials on the use of single (NCT00703937; n=735) or multiple (NCT00704353; n=703) 750 mg doses of ferric carboxymaltose (FCM) versus standard medical care (SMC: oral iron, IV iron, or no iron replacement) for treating iron deficiency anemia (IDA) in a host of clinical settings, including IBD, CKD, heavy uterine bleeding, postpartum anemia, etc. In the SMC cohort, IV iron consisted of iron sucrose, iron gluconate or iron dextran. Follow-up was 30-42 days. The main outcome variable was safety, and secondary endpoints were improvement in hemoglobin and iron indices.

Regarding overall safety, the FCM and SMC groups were similar in terms of incidence of adverse events and serious adverse events, including deaths (3.7% vs. 2.7%; only 1 death in the SMC group). The transient hypophosphatemia observed in the FCM groups (18% in single dose, 48% in multiple doses) was not associated with adverse events or clinical sequelae. Interestingly, a greater mean decrease in platelet concentration from baseline to Day 30 was observed in the FCM group compared to the SMC group (reduction of thrombotic risk).

Regarding efficacy, improvement in hemoglobin and iron indices in patients treated with FCM was comparable to other IV iron formulations, and better than with oral iron. To reach target iron levels, fewer infusions and of shorter duration were needed with FCM (1-3) compared to other IV iron formulations (1-6). These findings are in agreement with another comparison between FCM and iron sucrose in surgery (Br J Anaesth 2011;107:477-8).

In summary, data from these two trials add to the role of FCM as a safe option for treating IDA on an outpatient basis, thus reducing visits to the clinic and venipunctures and resulting in fewer disruptions to patients’ lifestyles and reduced administration costs. These advantages may be shared by other newer IV iron formulations (Ferumoxytol and iron isomaltoside 1000) but head-to-head comparisons are needed.

– Manuel Muñoz