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- Title
Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding.
- Authors
Ferrer‐Barceló, Luis; Sanchis Artero, Laura; Sempere García‐Argüelles, Javier; Canelles Gamir, Pilar; P. Gisbert, Javier; Ferrer‐Arranz, Luis Manuel; Monzó Gallego, Ana; Plana Campos, Lydia; Huguet Malavés, Jose Mª; Luján Sanchis, Marisol; Ruiz Sánchez, Lucía; Barceló Cerdá, Susana; Medina Chuliá, Enrique
- Abstract
Summary: 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.
- Subjects
IRON supplements; THERAPEUTICS; BLOOD coagulation factor XIII; ANEMIA; FERROUS sulfate; CLINICAL trials; IRON deficiency
- Publication
Alimentary Pharmacology & Therapeutics, 2019, Vol 50, Issue 3, p258
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.15327