Clinical-alimentary tractA Randomized, Double-Blind, Controlled Withdrawal Trial in Crohn’s Disease Patients in Long-term Remission on Azathioprine
Section snippets
Patients
The study was performed at 11 sites in France and 1 site in Belgium, all of which are members of the Groupe d’Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID). Recruitment of patients took place from October 1995 to November 1999.
Eligible patients were at least 18 years old and had Crohn’s disease according to established clinical, endoscopic, radiological, and histological criteria. Criteria for inclusion in the study were (1) continuous treatment with azathioprine
Baseline Characteristics of the Study Patients
Between October 1995 and November 1999, a total of 83 patients were enrolled; 43 patients were randomly assigned to receive placebo, and 40 were randomly assigned to receive azathioprine. Demographic and other baseline characteristics were similar in the 2 study groups (Table 1). One patient in the azathioprine group never took study medication. Five patients discontinued the study for reasons other than relapse. Three patients withdrew their consent, 2 at month 9 (1 patient in each treatment
Discussion
Controlled trials, 1, 2, 3 a meta-analysis, 25 and a Cochrane review 26 have shown that azathioprine and 6-mercaptopurine are effective in Crohn’s disease, both for maintaining remission and as steroid-sparing agents in chronic, active, steroid-dependent cases. However, there has been no consensus about the duration of the treatment once remission has been obtained. Because thiopurines only suppress disease activity, the issue of when to stop the drug is a difficult clinical decision and is
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Cited by (0)
This study was initiated, designed, and conducted by GETAID. It was funded by grant supports from the Société Nationale Française de Gastroentérologie and by the Association François Aupetit. Drugs were provided by GlaxoSmithKline. All data analysis and writing were performed independently by GETAID, without the involvement of representatives of GlaxoSmithKline.