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

Abstract

[EN] 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.