IV iron appears safe, effective for bleeding-related iron-deficiency anemia in cirrhosis

Patients with cirrhosis who had iron-deficiency anemia after variceal bleeding had greater improvement in clinical outcomes at three months with IV iron versus oral iron therapy, a randomized trial in India found.

IV iron therapy appears safe and effective for managing iron-deficiency anemia after variceal bleeding in patients with cirrhosis, a trial found.

Researchers in India performed an open-label, single-center trial in which patients with cirrhosis who had iron-deficiency anemia after hospitalization for acute variceal bleeding were randomly assigned to receive IV ferric carboxymaltose, 1,500 to 2,000 mg divided into two doses, or oral carbonyl iron, 100 mg elemental iron/d, for three months. Patients were eligible for the trial if they had a hemoglobin level below 10 g/dL and a ferritin level below 100 ng/mL. Change in hemoglobin level at three months was the primary outcome, with improved anemia, normalization of iron stores, liver-related adverse events, adverse drug reactions, and changes in quality of life as secondary outcomes. The trial was conducted between March 2022 and January 2023 at a single tertiary care center. The results were published May 14 by the American Journal of Gastroenterology.

Forty-eight patients were assigned to the IV iron group and 44 were assigned to the oral iron group. Mean age was 46.3 years, and 87% were men. At baseline, median Child-Turcotte-Pugh score (7; interquartile range [IQR], 6 to 9), Model for End-Stage Liver Disease score (12; IQR, 10 to 17), hemoglobin level (8.25 ± 1.06 g/dL), and ferritin level (30.00 ng/mL; IQR, 15.00 to 66.50 ng/mL) were comparable between groups. Nine patients in the IV group and 10 in the oral group were lost to follow-up and excluded from per protocol analysis, while a modified intention-to-treat analysis for the primary outcome included all patients with last recorded hemoglobin values carried forward. At three months, the median increase in hemoglobin level was 3.65 g/dL (IQR, 2.55 to 5.25 mg/dL) in the IV group and 1.10 g/dL (IQR, 0.05 to 2.90 g/dL) in the oral group (P<0.001), with iron stores normalizing in 84.6% and 21% (P<0.001) and anemia improving in 50% and 21.9% (P<0.009), respectively. Liver-related adverse events were similar in both groups, while 43% of patients in the IV group had transient mild to moderate hypophosphatemia.

The trial was not blinded and follow-up was short, among other limitations, the authors noted. They called for future studies to validate their results in a broader group of patients and to evaluate whether IV iron is more effective in all patients with cirrhosis and iron-deficiency anemia, with or without variceal bleeding. "In conclusion, our study provides evidence that IV FCM [ferric carboxymaltose] is a safe and potentially superior treatment option compared with oral iron supplementation in patients with cirrhosis and [iron-deficiency anemia] following variceal bleed," they wrote. "The findings of our study support the potential inclusion of IV FCM in treatment regimens and guidelines for patients in this setting."