Clinical experience with ferric carboxymaltose in the management of anemia in acute gastrointestinal bleeding

Abstract

ObjectiveThe aim of this study was to assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) following hospitalization for acute gastrointestinal bleeding (AGIB) in the context of a restrictive transfusion strategy.Patients and methodsA retrospective single-center study analyzed patients with AGIB (excluding AGIB secondary to portal hypertension) administered a single FCM dose with or without blood transfusion.ResultsEighty-six episodes in 84 patients were analyzed. Seventy-nine patients had upper AGIB. Nineteen episodes were associated with hemodynamic instability. FCM was administered during hospitalization as a single dose of 1000 mg iron in 84/86 episodes and as a single dose of 500 mg iron in two episodes, with blood transfusion in 60/86 (69.8%) episodes. The mean hemoglobin (Hb) was 9.0 g/dl at admission, 7.6 g/dl at the lowest in-hospital value, 9.4 g/dl at discharge, and 12.7 g/dl at follow-up (mean: 55 days postdischarge) (P<0.001 for follow-up vs. all other timepoints). The lowest mean in-hospital Hb value was 7.2 and 8.8 g/dl, respectively, in patients with transfusion+FCM versus FCM alone; the mean Hb was 12.4 versus 13.7 g/dl at follow-up. In patients administered FCM alone, the mean Hb at follow-up in the subpopulations aged older than or equal to 75 years (n=33), Charlson comorbidity index of at least 3 (n=48), and Hb of up to 10 g/dl at admission (n=47) were 12.6, 13.1, and 13.3 g/dl, respectively. No adverse effects were detected.ConclusionTreatment with FCM for AGIB is associated with a good erythropoietic response and anemia correction after hospitalization, even in severe episodes or when transfusion is needed. FCM is safe and well tolerated, and may support a restrictive transfusion policy.

Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding

“…Studies comparing iv FCM and oral FeSulf in other indications with acute and chronic blood loss (eg uterine bleeding, postpartum anaemia) using a similar study design as the study presented here showed superiority of FCM in the correction of both anaemia and iron deficiency 10,[28][29][30]. A recently published retrospective analysis reported data from patients with acute GIB who were treated with a single 1000 mg iron dose FCM either alone or combined with red blood cell transfusions (given in patients with Hb <7 g/dL or haemodynamic instability) 26. Patients in both the FCM + transfusion and the FCM alone group recovered from lowest in-hospital Hb levels of 7.2 and 8.8 g/ dL to 9.4 and 9.3 g/dL at discharge and to 12.4 and 13.7 g/dL at 2-month follow-up, suggesting that FCM therapy can facilitate a restrictive transfusion policy.…”

“…A recently published retrospective analysis reported data from patients with acute GIB who were treated with a single 1000 mg iron dose FCM either alone or combined with red blood cell transfusions (given in patients with Hb <7 g/dL or haemodynamic instability) . Patients in both the FCM + transfusion and the FCM alone group recovered from lowest in‐hospital Hb levels of 7.2 and 8.8 g/dL to 9.4 and 9.3 g/dL at discharge and to 12.4 and 13.7 g/dL at 2‐month follow‐up, suggesting that FCM therapy can facilitate a restrictive transfusion policy.…”

“…While the increase of haemoglobin (Hb) was independent of the iron administration route, the correction of iron deposits was more rapidly achieved by iv FCM than oral FeSulf . A recently published retrospective analysis of patients who were admitted with acute GIB and treated with FCM either alone or combined with red blood cell transfusions suggested effectiveness and safety of FCM in this population …”

“…25 A recently published retrospective analysis of patients who were admitted with acute GIB and treated with FCM either alone or combined with red blood cell transfusions suggested effectiveness and safety of FCM in this population. 26 The randomised study presented here compared the efficacy and safety of iv FCM given at weight-and Hb-adjusted doses according to the summary of product characteristics (SmPC) and oral FeSulf in patients with anaemia secondary to non-variceal acute GIB, aiming to improve the evidence base in lieu of established treatment protocols.…”

Efficacy and Safety of Treatment With Ferric Carboxymaltose in Patients With Cirrhosis and Gastrointestinal Bleeding

“…There are a few studies of the efficacy of i.v. FCM in acute or chronic GI bleeding anemia of different etiologies (13)(14)(15)(16)(17), but there are no data on its use in the treatment of anemia after acute or chronic GIB in patients with cirrhosis. Therefore, the objective of our study was to investigate the efficacy and safety of FCM treatment in cirrhotic patients with acute or chronic GIB.…”