Randomized controlled trial of Intravenous ferric-carboxymaltose vs oral iron to treat iron deficiency anemia after variceal bleed in patients with cirrhosis.

OBJECTIVE:Limited evidence exists on the optimal strategy to correct iron deficiency anaemia(IDA) after variceal bleeding(VB) in cirrhosis. This trial compared the efficacy and safety of intravenous ferric-carboxymaltose (IV-FCM) with that of oral iron therapy in this cohort. DESIGN:In this open-label single center randomized controlled trial, eligible patients with hemoglobin <10 gm/dL and iron deficiency(Ferritin <100 ng/ml) after VB received either IV-FCM (1500-2000 mg) divided into two doses(n=48) or oral Carbonyl iron(100 mg elemental iron/day)(n=44) for 3 months. Primary outcome was change in hemoglobin at 3 months. Secondary outcomes included improvement in anemia(last hemoglobin>12gm/dL), normalization of iron stores(ferritin>100ng/ml), liver related adverse events, adverse drug reactions and changes in quality-of-life(CLDQOL questionnaire). RESULTS:Baseline characteristics, including median CTP score 7[IQR 6-9], MELD score 12[IQR 10-17], blood hemoglobin(8.25 ± 1.06 gm/dl) and ferritin[30.00 ng/ml (15.00, 66.50)] were comparable in both arms. The median increase in hemoglobin at 3 months in the IV and oral arm were 3.65 gm/dl(IQR2.55, 5.25) and 1.10 gm/dl[IQR 0.05, 2.90] gm/dl) (p<0.001) respectively. Iron stores normalized in 84.6% and 21% of the IV and oral arms, respectively(p<0.001). Anaemia improved in 50% and 21.9% in the IV and oral arms, respectively(p<0.009). Patients in IV arm showed a significant improvement in all domains of CLDQOL. Liver related adverse events were comparable in both arms. Transient mild/moderate hypophosphatemia developed in 43% of patients receiving IV-FCM. CONCLUSION:Intravenous iron replacement is efficacious and safe to treat IDA after VB in patients with cirrhosis.