Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program.

Abstract

BACKGROUND:

Iron deficiency anemia (IDA) is frequently seen in inflammatory bowel disease. Traditionally, oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation. This multicenter phase-3 study tested the efficacy and safety of ferric maltol, a complex of ferric (Fe) iron with maltol (3-hydroxy-2-methyl-4-pyrone), as a novel oral iron therapy for IDA.

METHODS:

Adult patients with quiescent or mild-to-moderate ulcerative colitis or Crohn's disease, mild-to-moderate IDA (9.5-12.0 g/dL and 9.5-13.0 g/dL in females and males, respectively), and documented failure on previous oral ferrous products received oral ferric maltol capsules (30 mg twice a day) or identical placebo for 12 weeks according to a randomized, double-blind, placebo-controlled study design. The primary efficacy endpoint was change in hemoglobin (Hb) from baseline to week 12. Safety and tolerability were assessed.

RESULTS:

Of 329 patients screened, 128 received randomized therapy (64 ferric maltol-treated and 64 placebo-treated patients) and comprised the intent-to-treat efficacy analysis: 55 ferric maltol patients (86%) and 53 placebo patients (83%) completed the trial. Significant improvements in Hb were observed with ferric maltol versus placebo at weeks 4, 8, and 12: mean (SE) 1.04 (0.11) g/dL, 1.76 (0.15) g/dL, and 2.25 (0.19) g/dL, respectively (P < 0.0001 at all time-points; analysis of covariance). Hb was normalized in two-thirds of patients by week 12. The safety profile of ferric maltol was comparable with placebo, with no impact on inflammatory bowel disease severity.

CONCLUSIONS:

Ferric maltol provided rapid clinically meaningful improvements in Hb and showed a favorable safety profile, suggesting its possible use as an alternative to intravenous iron in IDA inflammatory bowel disease.

• Authors: Christoph Gasche, Tariq Ahmad, Zsolt Tulassay, Daniel C Baumgart, Bernd Bokemeyer, Carsten Büning, Stefanie Howaldt, Andreas Stallmach, AEGIS Study Group
• Journal: Inflammatory bowel diseases (Inflamm Bowel Dis) Vol. 21 Issue 3 Pg. 579-88 (Mar 2015) ISSN: 1536-4844 [Electronic] England
• PMID: 25545376 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Ferric Compounds
• Hemoglobins
• Pyrones
• ferric maltol

Topics

• Administration, Oral
• Adult
• Anemia, Iron-Deficiency (drug therapy, etiology)
• Colitis, Ulcerative (complications, pathology)
• Crohn Disease (complications, pathology)
• Double-Blind Method
• Female
• Ferric Compounds (therapeutic use)
• Hemoglobins (analysis)
• Humans
• Male
• Maximum Tolerated Dose
• Prognosis
• Pyrones (therapeutic use)
• Quality of Life