Absorption of ferric maltol, a novel ferric iron compound, in iron-deficient subjects

Ferric Maltol Is Effective in Correcting Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease

“…After oral ingestion, ferric iron is delivered to the intestinal mucosa in a biologically labile complex form that is believed to allow efficient uptake of elemental ferric iron into enterocytes 31–33. As a result, effective gastrointestinal iron uptake is achieved at a relatively low daily dose of elemental iron, which meets current recommendations for the use of oral iron in IBD 6,34–36. In addition, unlike unabsorbed ferrous iron, the ferric iron in iron–maltol complexes remains in a chelated form if it is not absorbed 32…”

“…Evaluation of ORs in the responder analysis in this study illustrated that it is more difficult to achieve a clinically significant improvement in Hb in patients with mild-to-moderate anemia than it is in patients with more severe anemia 34,35. Although inclusion of only patients with mild-to-moderate anemia was a prerequisite for the incorporation of a placebo control arm in this trial, it is tempting to speculate whether greater treatment effects could be achieved in patients with more severe anemia at baseline, as have been included in previous published studies assessing ferrous sulfate in IBD 17,47…”

“…After oral ingestion of ferric maltol, ferric iron reaches the intestinal mucosa in complex form, which is believed to allow more efficient uptake of elemental ferric iron into enterocytes compared with ferrous iron salts 31–33. In addition, iron uptake can be achieved at a relatively low daily oral iron dose 34–36. Early, experimental data indicate a clear potential for ferric maltol to provide effective oral iron treatment with a substantially reduced risk of gastrointestinal side effects compared with ferrous salts 31–33,37,38.…”

Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long‐term extension data from a Phase 3 study

“…Disease‐specific quality of life and general quality of life were assessed at randomisation, Week 12, and at 12‐weekly intervals thereafter during the long‐term extension using the IBDQ and the 36‐item Short‐Form (SF‐36) questionnaire, respectively.…”

“…This formulation allows ferric iron to reach the intestinal mucosa in complex form, with more efficient uptake of elemental iron into enterocytes at relatively low iron dose levels, which helps to meet current recommendations for the use of oral iron in inflammatory bowel disease. [21][22][23][24][25] A recent pivotal Phase 3 clinical trial program comprising two 12-week prospective, randomised, double-blind, placebo-controlled trials with ferric maltol in patients with ulcerative colitis and Crohn's disease demonstrated rapid, clinically meaningful improvements in haemoglobin over 4-12 weeks of treatment, with a high proportion of patients achieving clinically meaningful increases (+2 g/dL) and/or achievement of normal haemoglobin by study end. 26 Crucially, ferric maltol was associated with a low incidence of treatmentrelated gastrointestinal adverse events that was similar to placebo, irrespective of disease aetiology.…”