Issue: 2007 > October > original article

Maintenance treatment with budesonide 6 mg versus 9 mg once daily in patients with Crohns disease in remission



ORIGINAL ARTICLE
D.J. de Jong, D.J. Bac, G. Tan, S.Y. de Boer, I.L.F. Grabowsky, J.B.M.J. Jansen, R. Greinwald, T.H.J. Naber
AbstractPDF

Abstract

Background: In previous trials, budesonide 6 mg/day
was able to prolong the time to relapse in patients with
quiescent Crohns disease and budesonide 9 mg/day was
effective in active disease with limited side effects. The
aim of this study was to compare the effectiveness of
budesonide 9 mg <i>vs</i> 6 mg once daily on the maintenance of remission and occurrence of adverse events.
Methods: Double-blind, randomised trial in patients with
Crohns disease in remission. Patients were randomised to receive 6 mg/day or 9 mg/day of budesonide (Budenofalk<sup>®</sup>) without concomitant treatment for Crohns disease. Endpoints were the time to relapse and relapse rates after one year.
Results: Seventy-six patients were randomised to 6 mg/day and 81 patients to 9 mg/day. Survival analysis showed no differences in the time to relapse. One-year relapse rates were not significantly different (6 mg group 24%; 9 mg group 19%). Any adverse event was reported in 61 and 68% of patients in the 6 mg and 9 mg groups, respectively; none of the 12 serious adverse events were drug related.
Conclusion: The one-year relapse rates were low and not
significantly different between the group of patients treated with budesonide 6 mg <i>vs</i> 9 mg/day. Also, time to relapse and the number of adverse events were similar in both treatment groups.