The effectiveness of budesonide therapy for Crohn's disease.

Abstract

AIM:

To assess the effectiveness and safety of budesonide in comparison to corticosteroids, 5-aminosalicylic acid (5-ASA), or placebo for inducing remission of active Crohn's disease and for maintaining remission.

STUDY SELECTION CRITERIA:

Randomized controlled trials comparing budesonide to corticosteroids, 5-ASA products or placebo were included. Trials had to report on the effectiveness of treatment (defined as decreasing or maintaining Crohn's Disease Activity Index, CDAI, scores < or = 150) or adverse events.

DATA ANALYSIS:

After assessing the validity of study design and independent, duplicate data extraction from selected trials, summary relative risks (RR) were calculated for each outcome. A test of heterogeneity was also calculated for each outcome using a random effects model.

RESULTS:

Budesonide was more likely to induce remission than placebo (RR=1.82, 95% CI: 1.15-2.88) or 5-ASA (RR=1.73, 95% CI: 1.26-2.39), although only one trial compared budesonide to 5-ASA products. Although budesonide induced remission less frequently than conventional corticosteroids (RR=0.87, 95% CI: 0.76-0.995), there was no significant difference between conventional corticosteroids and budesonide for inducing remission among patients with a low disease activity (initial CDAI=200-300). Budesonide was significantly less likely to cause corticosteroid-associated adverse events than conventional corticosteroids (RR=0.65, 95% CI: 0.53-0.80). No significant difference in total adverse events or corticosteroid-associated adverse events was demonstrated between budesonide and 5-ASA or placebo.

CONCLUSION:

Budesonide is significantly more effective than placebo or 5-ASA for inducing remission of active Crohn's disease. Although budesonide is 13% less effective for the induction of remission in active Crohn's disease than conventional corticosteroids, it is less likely to cause corticosteroid-related adverse effects. Budesonide is ineffective in maintaining remission.

• Authors: S V Kane, P Schoenfeld, W J Sandborn, W Tremaine, T Hofer, B G Feagan
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 16 Issue 8 Pg. 1509-17 (Aug 2002) ISSN: 0269-2813 [Print] England
• PMID: 12182751 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't, Review)

Chemical References

• Anti-Inflammatory Agents
• Anti-Inflammatory Agents, Non-Steroidal
• Glucocorticoids
• Mesalamine
• Budesonide

Topics

• Anti-Inflammatory Agents (therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Budesonide (therapeutic use)
• Crohn Disease (drug therapy)
• Glucocorticoids (therapeutic use)
• Humans
• Mesalamine (therapeutic use)
• Randomized Controlled Trials as Topic
• Remission Induction