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ORAL BUDESONIDE FOR CROHN'S DISEASE.

Budesonide is a relatively new corticosteroid with potent topical antiinflammatory activity but low systemic activity because of rapid inactivation in the liver. An oral controlled-release preparation that delivers budesonide to the ileum would thus be a promising treatment for Crohn's disease. Two randomized studies tested controlled-release budesonide for mild-to-moderate Crohn's disease of the ileum and proximal colon.

The first study randomized 258 patients to one of three oral doses of budesonide (3, 9, or 15 mg daily) or placebo for eight weeks. Patients taking the two highest doses of budesonide had significantly higher remission rates than those taking placebo (about 50 vs. 20 percent). Budesonide did not cause significant steroid side effects but did suppress plasma cortisol.

The second study randomized 176 patients to receive 10- week oral courses of budesonide (9 mg daily) or prednisolone (40 mg daily for two weeks, followed by tapering). Patients given prednisolone had somewhat higher remission rates than those given budesonide (67 vs. 40 percent at four weeks and 66 vs. 53 percent at 10 weeks), but also had more steroid side effects and suppression of plasma cortisol.

Comment: Sustained-release oral budesonide, which is not yet available in the U.S., is clearly effective against Crohn's disease. An editorial notes that prednisone or prednisolone may still be better for acute treatment, and that budesonide may be more attractive for long-term maintenance therapy because it is less toxic.

— AS Brett

Published in Journal Watch General Medicine October 12, 1994

Citation(s):

Sachar DB. Budesonide for inflammatory bowel disease: is it a magic bullet. N Engl J Med 1994 Sep 29 331 842-845.

• Original article (Subscription may be required)
• Medline abstract (Free)

Rutgeerts P et al. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med 1994 Sep 29 331 836-841.

• Original article (Subscription may be required)
• Medline abstract (Free)

Greenberg GR et al. Oral budesonide for active Crohn's disease. N Engl J Med 1994 Sep 29 331 873-874.

• Original article (Subscription may be required)
• Medline abstract (Free)