Dr Hanauer and colleagues from Chicago, America undertook a study in order to assess the efficacy and safety of budesonide capsules.
The research team administered 6 mg daily and assessed prolongation of time to relapse and maintenance of remission in patients with Crohn's disease (CD) affecting the ileum and/or ascending colon.
The researchers designed a double-blind, placebo-controlled, multicenter trial including a total of 110 patients with CD.
The researchers enrolled patients who had previously achieved remission in a placebo-controlled trial of budesonide 9 mg daily.
The research team randomly assigned participants to receive either budesonide 6 mg once daily or placebo for 52 weeks.
|Median time to relapse was 360 days for budesonide patients; 169 days for placebo patients|
|Alimentary Pharmacology and Therapeutics|
The primary outcome measure was time to relapse [CD activity index (CDAI) of >150 plus an increase of at least 60 points from study entry or withdrawal due to clinical deterioration].
The researchers found that the median time to relapse was 360 days for budesonide patients; 169 days for placebo patients.
The research team noted that there were no significant differences between groups in relapse rates at 1 year.
Dr Hanauer concluded, "Budesonide was safe and well tolerated, with a similar adverse events profile to placebo."
"Patients treated with budesonide 6 mg once daily had a trend towards a prolonged time to relapse and lower Crohn's disease activity index scores compared with patients treated with placebo."
"However, relapse rates were not significantly different at the 1-year end point."