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  • Tabish M
  • Agarwal S
  • Gopi S
  • Rana R
  • Ahmed S
  • et al.
Am J Gastroenterol. 2024 May 14; doi: 10.14309/ajg.0000000000002775.
POPULATION:

Patients with cirrhosis and iron deficiency anaemia following variceal bleed (n= 92).

INTERVENTION:

Intravenous ferric-carboxymaltose (IV-FCM) (n= 48).

COMPARISON:

Oral carbonyl iron (n= 44).

OUTCOME:

The primary outcome was change in haemoglobin at 3 months. The median increase in haemoglobin at 3 months in the intravenous and oral arm were 3.65 gm/dl (IQR= 2.55, 5.25) and 1.10 gm/dl (IQR= 0.05, 2.90) respectively. Iron stores normalized in 84.6% and 21% of the intravenous and oral arms, respectively. Anaemia improved in 50% and 21.9% in the intravenous and oral arms, respectively. Patients in the intravenous arm showed a significant improvement in all domains of chronic liver disease quality of life. Liver related adverse events were comparable in both arms. Transient mild/moderate hypophosphataemia developed in 43% of patients receiving IV-FCM.

INTRODUCTION:

Limited evidence exists on the optimal strategy to correct iron deficiency anemia after variceal bleeding (VB) in cirrhosis. This trial compared the efficacy and safety of intravenous ferric carboxymaltose (IV-FCM) with those of oral iron therapy in this cohort.

METHODS:

In this open-label, single-center, randomized controlled trial, eligible patients with hemoglobin <10 g/dL and iron deficiency (ferritin <100 ng/mL) after VB received either IV-FCM (1,500-2,000 mg) divided into 2 doses (n = 48) or oral carbonyl iron (100 mg elemental iron/day) (n = 44) for 3 months. The primary outcome was change in hemoglobin at 3 months. Secondary outcomes included improvement in anemia (last hemoglobin >12 g/dL), normalization of iron stores (ferritin >100 ng/mL), liver-related adverse events, adverse drug reactions, and changes in quality of life (CLDQOL questionnaire).

RESULTS:

Baseline characteristics, including median Child-Turcotte-Pugh score 7 (interquartile range [IQR] 6-9), Model for End-Stage Liver Disease score 12 (IQR 10-17), blood hemoglobin (8.25 ± 1.06 g/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 arms was 3.65 g/dL (IQR 2.55-5.25) and 1.10 g/dL (IQR 0.05-2.90 g/dL) ( P < 0.001), respectively. Iron stores normalized in 84.6% and 21% of the IV and oral arms, respectively ( P < 0.001). Anemia improved in 50% and 21.9% in the IV and oral arms, respectively ( P < 0.009). Patients in the 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.

DISCUSSION:

Intravenous iron replacement is efficacious and safe to treat iron deficiency anemia after VB in patients with cirrhosis.