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

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.

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

“…In this regard, i.v. iron allows the repletion of iron stores and erythropoiesis (15,23). For example, FCM can prevent recurrence of anemia in patients with inflammatory bowel disease, compared with placebo (24).…”

“…Furthermore, i.v. iron treatment usually contributes to faster iron recovery than oral treatments (10,15,22).…”

“…Ferrer-Barceló et al, in a RCT that compared i.v. FCM vs. oral ferrous sulfate in patients with anemia after acute non-variceal GIB, demonstrated that FCM offers a faster and more efficient normalization of s-Hb levels and iron repletion stores compared to oral iron therapy (15). Additionally, the administration of FCM is associated with few adverse events and improved patient quality of life, further contributing to an overall favorable risk-benefit profile (15).…”

“…FCM vs. oral ferrous sulfate in patients with anemia after acute non-variceal GIB, demonstrated that FCM offers a faster and more efficient normalization of s-Hb levels and iron repletion stores compared to oral iron therapy (15). Additionally, the administration of FCM is associated with few adverse events and improved patient quality of life, further contributing to an overall favorable risk-benefit profile (15). Overall, the results of the previous studies and the one presented here, provide clinical support for considering patients with anemia secondary to acute or chronic GIB regardless of its origin (cirrhotic or not), can benefit from FCM treatment and to include FCM into treatment schemes and guidelines.…”

“…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.…”