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Cited by 349

The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.

A Novel Intravenous Iron Formulation for Treatment of Anemia in Inflammatory Bowel Disease: The Ferric Carboxymaltose (FERINJECT®) Randomized Controlled Trial

Kulnigg, Stefanie, Stoinov, Simeon, Simanenkov, Vladimir, Dudar, Larisa V., Karnafel, Waldemar, Garcia, Luis Chaires, Sambuelli, Alicia M., D'Haens, Geert, Gasche, Christoph·2008·The American Journal of Gastroenterology
DOI 10.1111/j.1572-0241.2007.01744.x
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Abstract

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.

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Crossref · 10.1111/j.1572-0241.2007.01744.x

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Metadata

Authors
Kulnigg, S., Stoinov, S., Simanenkov, V., Dudar, L. V., Karnafel, W., Garcia, L. C., Sambuelli, A. M., D'Haens, G., & Gasche, C.
Venue
The American Journal of Gastroenterology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2008-05
Volume
103
Issue
5
Pages
1182-1192
ISSN
  • 0002-9270 (ISSN-L)
  • 1572-0241
DOI
10.1111/j.1572-0241.2007.01744.x
OpenAlex
W2102485252
Cited by
349
References
4
FWCI
11.64
Type
journal article
Language
en
Open access
closed

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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