title: Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a Phase 3 study.
abstract: Ferric maltol was effective and well-tolerated in iron deficiency anaemia patients with inflammatory bowel disease during a 12-week placebo-controlled trial.
  
  
  
  To perform a Phase 3 extension study evaluating long-term efficacy and safety with ferric maltol in inflammatory bowel disease patients in whom oral ferrous therapies had failed to correct iron deficiency anaemia.
  
  
  
  After 12 weeks of randomised, double-blind treatment, patients with iron deficiency anaemia and mild-to-moderate ulcerative colitis or Crohn's disease received open-label ferric maltol 30 mg b.d. for 52 weeks.
  
  
  
  111 patients completed randomised treatment and 97 entered the open-label ferric maltol extension. In patients randomised to ferric maltol ('continued'; n = 50), mean ± s.d. haemoglobin increased by 3.07 ± 1.46 g/dL between baseline and Week 64. In patients randomised to placebo ('switch'; n = 47), haemoglobin increased by 2.19 ± 1.61 g/dL. Normal haemoglobin was achieved in high proportions of both continued and switch patients (89% and 83% at Week 64, respectively). Serum ferritin increased from 8.9 μg/L (baseline) to 26.0 μg/L (Week 12) in ferric maltol-treated patients, and to 57.4 μg/L amongst all patients at Week 64. In total, 80% of patients reported ≥1 adverse event by Week 64. Adverse events considered related to ferric maltol were recorded in 27/111 (24%) patients: 8/18 discontinuations due to adverse events were treatment-related. One patient was withdrawn due to increased ulcerative colitis activity.
  
  
  
  Normal haemoglobin was observed in ≥80% of patients from weeks 20-64 of long-term ferric maltol treatment, with concomitant increases in iron storage parameters. Ferric maltol was well-tolerated throughout this 64-week study.
authors.affiliation: Clinic of Internal Medicine IV, Jena University Hospital, Jena, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Schmidt
authors.affiliation: University of Exeter Medical School, Exeter, UK.
authors.forename: T
authors.initials: T
authors.lastname: Ahmad
authors.affiliation: Department of Medicine, Semmelweis University of Medicine, Budapest, Hungary.
authors.forename: Z
authors.initials: Z
authors.lastname: Tulassay
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, Charité Medical School, Humboldt-University of Berlin, Berlin, Germany.
authors.forename: D C
authors.initials: DC
authors.lastname: Baumgart
authors.affiliation: Gastroenterology Practice, Minden, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Bokemeyer
authors.affiliation: Division of Inflammatory Bowel Disease, Hamburg Institute of Research, Hamburg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Howaldt
authors.affiliation: Clinic of Internal Medicine IV, Jena University Hospital, Jena, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Stallmach
authors.affiliation: Department of Internal Medicine, Hospital Waldfriede, Berlin, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Büning
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D003093:Colitis, Ulcerative / Q000097:blood / Q000150:complications / Q000188:drug therapy; D003424:Crohn Disease / Q000097:blood / Q000150:complications / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D006455:Hemoglobins, Abnormal / Q000378:metabolism; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D007501:Iron / Q000008:administration & dosage / Q000097:blood; D008297:Male; D008875:Middle Aged; D011753:Pyrones / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D005290:Ferric Compounds; D006455:Hemoglobins, Abnormal; D011753:Pyrones; C032001:hemoglobin D; D007501:Iron; C062088:ferric maltol