PMID- 18371137
OWN - NLM
STAT- MEDLINE
DCOM- 20080530
LR  - 20220408
IS  - 1572-0241 (Electronic)
IS  - 0002-9270 (Linking)
VI  - 103
IP  - 5
DP  - 2008 May
TI  - A novel intravenous iron formulation for treatment of anemia in inflammatory 
      bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial.
PG  - 1182-92
LID - 10.1111/j.1572-0241.2007.01744.x [doi]
AB  - BACKGROUND AIMS: 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.
FAU - Kulnigg, Stefanie
AU  - Kulnigg S
AD  - Division of Gastroenterology and Hepatology, Department of Medicine III, Medical 
      University of Vienna, Vienna, Austria.
FAU - Stoinov, Simeon
AU  - Stoinov S
FAU - Simanenkov, Vladimir
AU  - Simanenkov V
FAU - Dudar, Larisa V
AU  - Dudar LV
FAU - Karnafel, Waldemar
AU  - Karnafel W
FAU - Garcia, Luis Chaires
AU  - Garcia LC
FAU - Sambuelli, Alicia M
AU  - Sambuelli AM
FAU - D'Haens, Geert
AU  - D'Haens G
FAU - Gasche, Christoph
AU  - Gasche C
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080326
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Ferric Compounds)
RN  - 0 (Ferrous Compounds)
RN  - 39R4TAN1VT (ferrous sulfate)
RN  - 6897GXD6OE (ferric carboxymaltose)
RN  - 69-79-4 (Maltose)
RN  - 9007-73-2 (Ferritins)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Anemia, Iron-Deficiency/blood/*drug therapy
MH  - Cohort Studies
MH  - Colitis, Ulcerative/blood/*drug therapy
MH  - Crohn Disease/blood/*drug therapy
MH  - Female
MH  - Ferric Compounds/*administration & dosage/adverse effects
MH  - Ferritins/blood
MH  - Ferrous Compounds/*administration & dosage/adverse effects
MH  - Germany
MH  - Hemoglobinometry
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Maltose/administration & dosage/adverse effects/*analogs & derivatives
MH  - Middle Aged
EDAT- 2008/03/29 09:00
MHDA- 2008/05/31 09:00
CRDT- 2008/03/29 09:00
PHST- 2008/03/29 09:00 [pubmed]
PHST- 2008/05/31 09:00 [medline]
PHST- 2008/03/29 09:00 [entrez]
AID - AJG1744 [pii]
AID - 10.1111/j.1572-0241.2007.01744.x [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2008 May;103(5):1182-92. doi: 
      10.1111/j.1572-0241.2007.01744.x. Epub 2008 Mar 26.