Ferric Maltol Is Effective in Correcting Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: Results from a Phase-3 Clinical Trial Program

Study answer

What this study found

Ferric maltol improved hemoglobin more than placebo and was generally well tolerated. In the ferric maltol group, mean hemoglobin increased from 11.00 to 13.20 g/dL by week 12, compared with 11.10 to 11.20 g/dL with placebo, and the primary endpoint difference was significant (P < 0.0001). The adjusted mean treatment difference versus placebo was 1.04 g/dL at week 4 and 1.73 g/dL at week 8; the odds ratio for hemoglobin increases of at least 1 g/dL was 41.8 (95% CI, 13.5-129.9), and the odds ratio for hemoglobin normalization was 15.3 (95% CI, 5.9-39.3). Median time to hemoglobin…

Study & population

Phase 3 randomized, double-blind, placebo-controlled trial in adults with ulcerative colitis or Crohn's disease in remission or with mild-to-moderate disease activity and mild-to-moderate iron deficiency anemia.

Intervention

Oral ferric maltol capsules were given at 231.5 mg per capsule, equivalent to 30 mg elemental iron, twice daily in the morning and at night on an empty stomach with water for 12 weeks.

Key limitation

The treatment period was short at 12 weeks, so longer-term efficacy and safety were not established.

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Original abstract