LETTER

Adverse events in clinical trials with azathioprine and mesalamine for prevention of postoperative recurrence of Crohn’s disease

H Herfarth¹, C Tjaden², M Lukas³, F Obermeier⁴, K Dilger⁵, R Müller⁵, J Schölmerich⁶ A Z T-1 Study Group

¹ Department of Internal Medicine, University of Regensburg, Regensburg, Germany
² Department of Surgery, University of Heidelberg, Heidelberg, Germany
³ IV Interni Klinika, Charles University, Praha, Czech Republic
⁴ Department of Internal Medicine, University of Regensburg, Regensburg, Germany
⁵ Dr Falk Pharma GmbH, Freiburg, Germany
⁶ Department of Internal Medicine, University of Regensburg, Regensburg, Germany

Correspondence to:
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@med.unc.edu

Keywords: azathioprine; mesalamine; postoperative recurrence; Crohn’s disease

The first 150 words of the full text of this article appear below.

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 However, only two of 36 patients on AZA were withdrawn from the study because of adverse events.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; 5-ASA, 37) . . . [Full text of this article]

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