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A Novel Intravenous Iron Formulation for Treatment of Anemia in Inflammatory Bowel Disease

The Ferric Carboxymaltose (FERINJECT®) Randomized Controlled Trial

Kulnigg, Stefanie, M.D.1; Stoinov, Simeon2; Simanenkov, Vladimir, M.D.3; Dudar, Larisa V., M.D.4; Karnafel, Waldemar, M.D.5; Garcia, Luis Chaires, M.D.6; Sambuelli, Alicia M., M.D.7; D'Haens, Geert, Ph.D.8; Gasche, Christoph, M.D.1

American Journal of Gastroenterology: May 2008 - Volume 103 - Issue 5 - p 1182–1192
ORIGINAL CONTRIBUTION: INFLAMMATORY BOWEL DISEASE
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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 μg/L at week 2, followed by a continuous decrease in the FeCarb group (43.5 μg/L at week 12). In the FeSulf group, a moderate increase from 6.5 to 28.5 μg/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.

1Division of Gastroenterology and Hepatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria; 2Multi-Profile Hospital for Active Treatment “Queen Joanna,” Sofia, Bulgaria; 3City Hospital N26, St Petersburg, Russian Federation; 4Crimean Medical University, Simferopo, Ukraine; 5Katedra i Klinika Gastroenterologii, Warsaw, Poland 6Hospital Central Dr. Ignacio Morones Prieto, Mexico City, Mexico; 7Hospital de Gastroenterologia “Dr Carlos Bonorino Udaondo,” Buenos Aires, Argentina; and 8Imeldaziekenhuis, Imeldalaan 9, Bonheiden, Belgium

Reprint requests and correspondence: Prof. Christoph Gasche, Abteilung für Gastroenterologie und Hepatologie, Währinger Gürtel 18–20, Vienna A-1090, Austria.

Received August 19, 2007; accepted November 5, 2007.

© The American College of Gastroenterology 2008. All Rights Reserved.
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