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Adverse events in clinical trials with azathioprine and mesalamine for prevention of postoperative recurrence of Crohn’s disease
  1. H Herfarth1,
  2. C Tjaden2,
  3. M Lukas3,
  4. F Obermeier4,
  5. K Dilger5,
  6. R Müller5,
  7. J Schölmerich6,
  8. A Z T-1 Study Group
  1. 1Department of Internal Medicine, University of Regensburg, Regensburg, Germany
  2. 2Department of Surgery, University of Heidelberg, Heidelberg, Germany
  3. 3IV Interni Klinika, Charles University, Praha, Czech Republic
  4. 4Department of Internal Medicine, University of Regensburg, Regensburg, Germany
  5. 5Dr Falk Pharma GmbH, Freiburg, Germany
  6. 6Department of Internal Medicine, University of Regensburg, Regensburg, Germany
  1. Correspondence to:
    Professor H Herfarth
    Division of Gastroenterology and Hepatology, CB#7080 Bioinformatics Bldg, University of North Carolina, Chapel Hill, 27599 North Carolina, USA; hherf{at}

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We read with great interest the study by Ardizzone and colleagues (Gut 2006;55:47–53) and the excellent review of Sands (Gut 2006;55:437–41) commenting on the efficacy and side effects of azathioprine (AZA) in the therapy of ulcerative colitis. Ardizzone et al observed in their investigator blinded study, which included patients with steroid dependent ulcerative colitis, more mild to moderate adverse events in azathioprine than in mesalamine (5-ASA) treated patients (26% v 6%; p = 0.046). However, only two of 36 patients on AZA were withdrawn from the study because of adverse events. We would like to comment on the side effects of AZA, which we observed in a double blind, double dummy, randomised, prospective, multicentre study on the efficacy and safety of AZA (2.0–2.5 mg/kg/day) and 5-ASA (4 g/day) for prevention of postoperative endoscopic recurrence in Crohn’s disease.

Seventy nine patients (AZA, 42; …

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  • Conflict of interest: None declared.

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