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Is budesonide the preferred treatment in mild to moderate Crohn's disease? (Pro & Con).

YES I consider budesonide the drug of choice for inducing remission. The Alternatives--prednisolone, sulfasalazine, and mesalamine--compare unfavorably.

Budesonide is a topical steroid with a high first-pass hepatic metabolism. In a metaanalysis of the randomized trials, budesonide at 9 mg/day has shown efficacy for induction of remission. Admittedly, the response rate is 10%-15% less than that with 40 mg/day of prednisolone, but the safety profile and tolerability are superior. For every four patients treated with budesonide instead of prednisolone, one less patient experiences a significant steroid side effect. Indeed, the randomized trials indicate that up to 9 mg/day of budesonide has a side-effect profile no different than placebo.

In the National Cooperative CROHN'S Disease Study, sulfasalazine showed a modest benefit over placebo for induction of remission. I would characterize the difference as statistically significant but not clinically meaningful. And sulfasalazine has shown no benefit for maintenance of remission.

Budesonide at 9 mg/day is significantly more effective than high-dose mesalamine for induction of remission. Likewise, there is little evidence that mesalamine provides a clinically meaningful benefit when used for maintenance of remission.

In contrast, a metaanalysis of three maintenance therapy trials showed that budesonide at 6 mg/day prolonged time to relapse, with a median of 363 days, compared with 154 days with placebo, but the difference was not significant at 1 year.

While it doesn't make sense to use budesonide as maintenance therapy in all patients with Crohn's disease, budesonide may have a niche as maintenance therapy in those who have steroid-dependent Crohn's disease and are unable to taper off prednisolone. Maintenance therapy is most needed in these patients because they have a serious form of the disease. Among steroid-dependent patients in remission, those randomized to 6 mg/day of budesonide were more than twice as likely to be able to discontinue prednisolone at 1-year follow-up as were patients on mesalamine at 3 mg/day.

Dr. William J. Sandborn is director of inflammatory bowel disease clinical research at the Mayo Clinic, Rochester, Minn.

No I prefer high-dose mesalamine as initial therapy in patients with mild-to-moderate Crohn's disease. The various formulations of mesalamine (Asacol, Pentasa, Rowasa) have been used for years. Their safety profile is exemplary. Comprehensive safety data are available, based upon their use in thousands of closely monitored patients. The same can't be said for budesonide.

Budesonide has been shown to induce a dose-dependent reduction in plasma cortisol. Does this interference with the hypothalamic-pituitary-adrenal axis result in aseptic necrosis and other long-term side effects? We simply don't know. The data aren't there.

The crux of the problem regarding budesonide is that the 9-mg/day dosage, while modestly more effective than high-dose mesalamine, results in decreased adrenal axis function. But the dosage of budesonide that might be safe for long-term maintenance therapy--6 mg/day--was no better than placebo for maintenance of remission.

We have two large studies showing that sulfasalazine is effective at inducing remission of Crohn's disease. Three randomized controlled trials confirm that high-dose mesalamine--Pentasa at 4 g/day or Asacol at 3.2 g/day--is effective for this purpose, too. End of story There's no need to resort to steroids, budesonide included, for most patients with mild to moderate Crohn's disease.

My debate opponent and I agree upon a key point: the need to limit the use of conventional steroids.

While prednisolone is effective for inducing remission, it has a high rate of side effects. From 40% to 50% of patients with Crohn's disease treated with prednisolone become steroid dependent. Another 15%-20% become steroid refractory. Many will ultimately require surgery Starting patients on conventional steroids for induction of remission is truly a road to nowhere. And low-dose prednisolone isn't effective in maintaining remission.

I like to save budesonide for mesalamine failures, reserving conventional steroids for patients who experience remission failure on these drugs.

Dr. Brian G. Feagan is professor of medicine epidemiology and biostatistics at the University of Western Ontario, London.
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Publication:Internal Medicine News
Article Type:Brief Article
Date:Aug 1, 2002
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