AI Article Synopsis
- The study evaluates the effectiveness and safety of oral budesonide for maintaining remission in patients with mild to moderately active Crohn's disease affecting the ileum and/or ascending colon.
- Four double-blind, placebo-controlled trials were combined, involving 380 patients who were randomly assigned to receive either budesonide (3 mg or 6 mg) or placebo daily for a year, with the main focus on how long it took for symptoms to return.
- Results showed that patients taking 6 mg of budesonide experienced a significantly longer time to relapse compared to those on lower doses or placebo, indicating its effectiveness, especially at the 3 and 6-month mark.
Article Abstract
Objectives: To evaluate the efficacy and safety of oral budesonide for maintenance of remission in patients with mild to moderately active Crohn's disease (CD) of the ileum and/or ascending colon.
Methods: Four double-blind, placebo-controlled trials with identical protocols were combined according to a predetermined analysis plan. Three hundred eighty patients with CD in medically induced remission (CD activity index [CDAI]< or =150) were randomized to receive oral budesonide 3 mg, 6 mg, or placebo daily for 12 months. The primary outcome measure was time to relapse (increase in CDAI of 60 points above baseline and >150).
Results: The median time to relapse was 268, 170, and 154 days for budesonide 6 mg, budesonide 3 mg, and placebo groups, respectively (p= 0.0072). The frequency of adverse events and glucocorticosteroid side effects were similar in all groups.
Conclusion: Budesonide 6 mg/day is effective for prolonging time to relapse and for significantly reducing rates of relapse at 3 and 6 months but not 12 months in patients with CD in medically induced remission.
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| http://dx.doi.org/10.1111/j.1572-0241.2005.41992.x | DOI Listing |
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