Issue: 2007 > October > original article

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

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


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.