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

Luis Ferrer-Barceló, Laura Sanchis Artero, Javier Sempere García-Argüelles, Pilar Canelles Gamir, Javier P Gisbert, Luis Manuel Ferrer-Arranz, Ana Monzó Gallego, Lydia Plana Campos, Jose Mª Huguet Malavés, Marisol Luján Sanchis, Lucía Ruiz Sánchez, Susana Barceló Cerdá, Enrique Medina Chuliá, Luis Ferrer-Barceló, Laura Sanchis Artero, Javier Sempere García-Argüelles, Pilar Canelles Gamir, Javier P Gisbert, Luis Manuel Ferrer-Arranz, Ana Monzó Gallego, Lydia Plana Campos, Jose Mª Huguet Malavés, Marisol Luján Sanchis, Lucía Ruiz Sánchez, Susana Barceló Cerdá, Enrique Medina Chuliá

Abstract

Background: Acute gastrointestinal bleeding is prevalent condition and iron deficiency anaemia is a common comorbidity, yet anaemia treatment guidelines for affected patients are lacking.

Aim: To compare efficacy and safety of intravenous ferric carboxymaltose (FCM) and oral ferrous sulphate (FeSulf) in patients with anaemia secondary to non-variceal gastrointestinal bleeding METHODS: A prospective 42-day study randomised 61 patients with haemoglobin <10 g/dL upon discharge (Day 0) to receive FCM (n = 29; Day 0: 1000 mg, Day 7: 500 or 1000 mg; per label) or FeSulf (n = 32; 325 mg/12 hours for 6 weeks). Outcome measures were assessed on Days 0 (baseline), 7, 21 and 42. The primary outcome was complete response (haemoglobin ≥12 g/dL [women], ≥13 g/dL [men]) after 6 weeks.

Results: A higher proportion of complete response was observed in the FCM vs the FeSulf group at Days 21 (85.7% vs 45.2%; P = 0.001) and 42 (100% vs 61.3%; P < 0.001). Additionally, the percentage of patients with partial response (haemoglobin increment ≥2 g/dL from baseline) was significantly higher in the FCM vs the FeSulf group (Day 21:100% vs 67.7%; P = 0.001, Day 42:100% vs 74.2%; P = 0.003). At Day 42, normalisation of transferrin saturation to 25% or greater was observed in 76.9% of FCM vs 24.1% of FeSulf-treated patients (P < 0.001). No patient in the FCM group reported any adverse event vs 10 patients in the FeSulf group.

Conclusion: FCM provided greater and faster Hb increase and iron repletion, and was better tolerated than FeSulf in patients with iron deficiency anaemia secondary to non-variceal acute gastrointestinal bleeding.

© 2019 The Authors. Alimentary Pharmacology & Therapeutics Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Patient flow CONSORT diagram. FCM, ferric carboxymaltose; FeSulf, ferrous sulphate
Figure 2
Figure 2
Complete (A) and partial (B) response of patients after iv FCM or oral FeSulf administration over the duration of the study. FCM, ferric carboxymaltose; FeSulf, ferrous sulphate
Figure 3
Figure 3
Mean Hb levels of patients treated with iv FCM or oral FeSulf. Lab measurements on Day 0 were done before treatments were administered. FCM, ferric carboxymaltose; FeSulf, ferrous sulphate; Hb, haemoglobin
Figure 4
Figure 4
Mean transferrin saturation index of patients treated with iv FCM or oral FeSulf. Lab measurements on Day 0 were done before treatments were administered. FCM, ferric carboxymaltose; FeSulf, ferrous sulphate; TSAT, transferrin saturation
Figure 5
Figure 5
Results of quality of life questionnaire EQ‐5D‐3L and EQ‐VAS. For EQ‐5D‐3L dimensions (mobility, self‐care, usual activities, anxiety/depression and pain/discomfort) higher percentages correspond to more patients with problems. For EQ‐VAS, higher scores correspond to better health status (quality of life). FCM, ferric carboxymaltose; FeSulf, ferrous sulphate

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