Randomised, controlled trial, of azathioprine and 5- aminosalicylic acid for treatment of steroid-dependent ulcerative colitis

Sandro Ardizzone ^1*, Giovanni Maconi ¹, Antonio Russo ², Venerina Imbesi ¹, Elisabetta Colombo ¹ and Gabriele Bianchi Porro ¹

¹ Cattedra di Gastroenterologia - Ospedale, Italy
² Epidemiology Unit-Local Health Authority-Milan, Italy

^* To whom correspondence should be addressed. E-mail: samari1{at}tin.it.

Accepted 31 May 2005

Abstract

Background and aim: There are limited evidence- based data concerning the use of azathioprine in ulcerative colitis. We aimed to compare the efficacy of azathioprine and oral 5-aminosalicylic acid in inducing remission of steroid-dependent ulcerative colitis.

Methods: 72 patients with steroid-dependent ulcerative colitis were admitted to this investigator- blind study. Steroid-dependence was defined as a requirement for steroid therapy at 10 mg/day during the preceding 6 months, with at least two attempts to discontinue the medication. The disease had to be clinically and endoscopically active at study entry, and all patients were taking systemic prednisolone (40 mg/day). Patients were randomized to receive azathioprine 2 mg/kg/day or oral 5-aminosalicylic acid, 3.2 g/day, for a 6-month follow-up period. The outcome of the treatment was defined as (1) success, indicating induction of clinical and endoscopic remission and steroid discontinuation, (2) failure, indicating the need for at least one further cycle of systemic steroids to control symptoms, apart from the initial one, or colectomy.

Results: Significantly more patients in the azathioprine than in the 5-aminosalicylic acid group had clinical and endoscopic remission, and discontinued steroid therapy, both at the intention-to-treat [azathioprine vs 5-aminosalicylic acid: 19/36 patients (53%) vs 7/36 (21%), OR = 4.78, 95%CI 1.57-14.5], and per protocol analysis [azathioprine vs 5-aminosalicylic acid: 19/33 patients (58%) vs 7/34 (21%), OR = 5.26; 95% CI 1.59-18.1].

Conclusions: Azathioprine is significantly more effective than 5-aminosalicylic acid in inducing clinical and endoscopic remission and avoiding steroid requirement in the treatment of steroid-dependent ulcerative colitis.

Keywords: 5-aminosalicylic acid, azathioprine, steroid-dependent ulcerative colitis

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