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Intravenous Iron and Erythropoietin for Anemia Associated with Crohn Disease: A Randomized, Controlled Trial

Christoph Gasche, MD; Clemens Dejaco, MD; Thomas Waldhoer, PhD; Wolfgang Tillinger, MD; Walter Reinisch, MD; Gerhard F. Fueger, MD; Alfred Gangl, MD; and Herbert Lochs, MD
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From the University of Vienna, Vienna, Austria; and the University Hospital Graz, Graz, Austria. Grant Support: Study drugs were provided by Janssen & Cilag Pharma, Vienna, Austria. Acknowledgments: The authors thank Drs. Walter Horl, Wolfgang Petritsch, and Klaus G. Bernhard for their advice on study design and Silvia Bakos, Christa Barowitsch, Elizabeth Hacket, Cornelia Lichtenberger, and Babak Parsaei for their assistance. Requests for Reprints: Christoph Gasche, MD, Klinik fur Innere Medizin IV, Neues AKH, Wahringer Gurtel 18-20, A-1090 Vienna, Austria. Current Author Addresses: Drs. Gasche, Dejaco, Tillinger, Reinisch, and Gangl: Klinik fur Innere Medizin IV, Neues AKH, Wahringer Gurtel 18-20, A-1090 Vienna, Austria.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1997;126(10):782-787. doi:10.7326/0003-4819-126-10-199705150-00006
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Background: Anemia often complicates Crohn disease and affects quality of life.

Objective: To evaluate the efficacy of intravenous iron alone and in combination with erythropoietin for the treatment of anemia associated with Crohn disease.

Design: Double-blind, randomized, placebo-controlled trial with a subsequent open-label phase.

Setting: University-based gastroenterology outpatient clinic.

Patients: 40 patients with Crohn disease and a hemoglobin concentration of 10.5 g/dL or less.

Intervention: All patients received intravenous iron saccharate for 16 weeks. During the blinded phase of the trial, they received either erythropoietin or placebo. During the open phase, the erythropoietin dose was increased in nonresponders who had received erythropoietin and erythropoietin therapy was initiated in nonresponders who had received placebo.

Measurements: Response was defined as an increase in hemoglobin concentration of 2 g/dL or more.

Results: 15 of 20 patients in the placebo group (75% [95% CI, 51% to 91%]) and 18 of 19 patients in the erythropoietin group (95% [CI, 74% to 100%]) responded to intravenous iron (P = 0.20). The erythropoietin group had a higher cumulative response rate (P = 0.036) and a more pronounced mean increase in hemoglobin concentration (4.9 g/dL in the erythropoietin group compared with 3.3 g/dL in the placebo group, a difference of 1.6 g/dL [CI, 0.6 g/dL to 2.5 g/dL]; P = 0.004). In the open phase, all 6 previous nonresponders had a response. Hematologic response was associated with improved quality of life (P = 0.03).

Conclusions: Most patients who have anemia associated with Crohn disease respond to intravenous iron alone. Erythropoietin has additional effects on hemoglobin concentrations.


Grahic Jump Location
Figure 1.
Kaplan-Meier estimation of the cumulative response to erythropoietin and iron saccharate or placebo and iron saccharate.

Response was defined as an increase in hemoglobin concentration of 2 g/dL or more.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Mean hemoglobin concentrations in five nonresponders in the placebo group and one nonresponder in the erythropoietin group during the blinded and open phases of the study.leftright

Bars represent 95% Cls for the nonresponders in the placebo group. All patients had been treated without response for 8 weeks in the blinded phase of the trial ( ). In the open phase of the trial ( ), nonresponders in the placebo group received erythropoietin, 150 IU/kg of body weight, and the one nonresponder in the erythropoietin group received erythropoietin, 300 IU/kg. To convert g/dL to g/L, multiply by 10.

Grahic Jump Location




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