title: 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.affiliation: *Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria; †University of Exeter Medical School, Exeter, United Kingdom; ‡Department of Medicine, Semmelweis University of Medicine, Budapest, Hungary; §Division of Gastroenterology and Hepatology, Department of Medicine, Charité Medical School, Humboldt-University of Berlin, Germany; ‖Gastroenterology Practice, Minden, Germany; ¶Department of Hepatology and Gastroenterology, Charite, University of Medicine, Berlin, Germany; **Division of Inflammatory Bowel Disease, Hamburg Institute of Research, Hamburg, Germany; and ††Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), Jena University Hospital, Jena, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Gasche
authors.forename: Tariq
authors.initials: T
authors.lastname: Ahmad
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Tulassay
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Baumgart
authors.forename: Bernd
authors.initials: B
authors.lastname: Bokemeyer
authors.forename: Carsten
authors.initials: C
authors.lastname: Büning
authors.forename: Stefanie
authors.initials: S
authors.lastname: Howaldt
authors.forename: Andreas
authors.initials: A
authors.lastname: Stallmach
mesh_terms: D000284:Administration, Oral; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D003093:Colitis, Ulcerative / Q000150:complications* / Q000473:pathology; D003424:Crohn Disease / Q000150:complications* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D011379:Prognosis; D011753:Pyrones / Q000627:therapeutic use*; D011788:Quality of Life
chemical_list: D005290:Ferric Compounds; D006454:Hemoglobins; D011753:Pyrones; C062088:ferric maltol