Oral budesonide in the management of Crohn's disease

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of oral budesonide (Entocort EC) in the treatment of mild to moderate Crohn's disease (CD). DATA SOURCES: The MEDLINE database (1966-December 2002) was searched using the key words budesonide and inflammatory bowel diseases and restricted to the English language. The references from relevant articles were also reviewed for additional citations. STUDY SELECTION AND DATA EXTRACTION: Articles and abstracts that evaluated oral budesonide for management of CD were considered, with emphasis on randomized, controlled clinical trials. DATA SYNTHESIS: Budesonide's high potency at the glucocorticoid receptor and extensive first-pass hepatic metabolism result in a topical antiinflammatory effect on intestinal tissue, with minimal systemic glucocorticoid adverse effects. Clinical trials have demonstrated that budesonide is effective in the treatment of patients with mild to moderate CID of the ileum and ascending colon, with efficacy similar to prednisolone and superior to mesalamine. Long-term therapy with budesonide increased the duration of CID remission, but the effect was not sustained up to 1 year. Budesonide failed to prevent postsurgical relapse of CID. Adrenal suppression and glucocorticoid-related adverse effects have been reported at lower rates in patients treated with budesonide compared with prednisolone. Patients prescribed budesonide should be monitored for hepatic dysfunction and potential drug interactions. CONCLUSIONS: Budesonide is an effective and relatively safe option for treatment of mild to moderate CD of the ileum and ascending colon.