title: FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease.
abstract: OBJECTIVE
  Iron deficiency anemia (IDA) is common in chronic diseases and intravenous iron is an effective and recommended treatment. However, dose calculations and inconvenient administration may affect compliance and efficacy. We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen (FCM) with individually calculated iron sucrose (IS) doses in patients with inflammatory bowel disease (IBD) and IDA.
  
  
  METHODS
  This randomized, controlled, open-label, multicenter study included 485 patients with IDA (ferritin <100 μg/L, hemoglobin [Hb] 7-12 g/dL [female] or 7-13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries. Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron. Primary end point was Hb response (Hb increase ≥ 2 g/dL); secondary end points included anemia resolution and iron status normalization by week 12.
  
  
  RESULTS
  The results of 240 FCM-treated and 235 IS-treated patients were analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 118 [53.6%]; 12.2% difference, P = .004) or Hb normalization (166 [72.8%] vs 136 [61.8%]; 11.0% difference, P = .015). Both treatments improved quality of life scores by week 12. Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience. Deviations from scheduled total iron dosages were more frequent in the IS group.
  
  
  CONCLUSIONS
  The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen.
authors.affiliation: Department of Medicine 3, Division of Gastroenterology and Hepatology, Christian Doppler Laboratory for Molecular Cancer Chemoprevention, Medical University of Vienna, Vienna, Austria.
authors.forename: Rayko
authors.initials: R
authors.lastname: Evstatiev
authors.forename: Philippe
authors.initials: P
authors.lastname: Marteau
authors.forename: Tariq
authors.initials: T
authors.lastname: Iqbal
authors.forename: Igor L
authors.initials: IL
authors.lastname: Khalif
authors.forename: Jürgen
authors.initials: J
authors.lastname: Stein
authors.forename: Bernd
authors.initials: B
authors.lastname: Bokemeyer
authors.forename: Ivan V
authors.initials: IV
authors.lastname: Chopey
authors.forename: Florian S
authors.initials: FS
authors.lastname: Gutzwiller
authors.forename: Lise
authors.initials: L
authors.lastname: Riopel
authors.forename: Christoph
authors.initials: C
authors.lastname: Gasche
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology*; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology*; D007262:Infusions, Intravenous; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005290:Ferric Compounds; D006454:Hemoglobins; C522335:ferric carboxymaltose; D008320:Maltose; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid