title: A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial.
abstract: OBJECTIVE
  Anemia is a common complication of inflammatory bowel diseases (IBD) This multicenter study tested the noninferiority and safety of a new intravenous iron preparation, ferric carboxymaltose (FeCarb), in comparison with oral ferrous sulfate (FeSulf) in reducing iron deficiency anemia (IDA) in IBD.
  
  
  METHODS
  Two hundred patients were randomized in a 2:1 ratio (137 FeCarb:63 FeSulf) to receive FeCarb (maximum 1,000 mg iron per infusion) at 1-wk intervals until the patients' calculated total iron deficit was reached or FeSulf (100 mg b.i.d.) for 12 wk. The primary end point was change in hemoglobin (Hb) from baseline to week 12.
  
  
  RESULTS
  The median Hb improved from 8.7 to 12.3 g/dL in the FeCarb group and from 9.1 to 12.1 g/dL in the FeSulf group, demonstrating noninferiority (P= 0.6967). Response (defined as Hb increase of >2.0 g/dL) was higher for FeCarb at week 2 (P= 0.0051) and week 4 (P= 0.0346). Median ferritin increased from 5.0 to 323.5 mug/L at week 2, followed by a continuous decrease in the FeCarb group (43.5 mug/L at week 12). In the FeSulf group, a moderate increase from 6.5 to 28.5 mug/L at week 12 was observed. Treatment-related adverse events (AEs) occurred in 28.5% of the FeCarb and 22.2% of the FeSulf groups, with discontinuation of study medication due to AEs in 1.5% and 7.9%, respectively.
  
  
  CONCLUSIONS
  FeCarb is effective and safe in IBD-associated anemia. It is noninferior to FeSulf in terms of Hb change over 12 wk, and provides a fast Hb increase and a sufficient refill of iron stores.
authors: Division of Gastroenterology and Hepatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
authors: Stefanie
authors: S
authors: Kulnigg
authors: Simeon
authors: S
authors: Stoinov
authors: Vladimir
authors: V
authors: Simanenkov
authors: Larisa V
authors: LV
authors: Dudar
authors: Waldemar
authors: W
authors: Karnafel
authors: Luis Chaires
authors: LC
authors: Garcia
authors: Alicia M
authors: AM
authors: Sambuelli
authors: Geert
authors: G
authors: D'Haens
authors: Christoph
authors: C
authors: Gasche
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy*; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy*; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005293:Ferritins / Q000097:blood; D005296:Ferrous Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005858:Germany; D006452:Hemoglobinometry; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged
chemical_list: D005290:Ferric Compounds; D005296:Ferrous Compounds; C020748:ferrous sulfate; C522335:ferric carboxymaltose; D008320:Maltose; D005293:Ferritins