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| |  DDW: Budesonide Capsules Safe And Effective For Crohn’s Disease By Bruce Wilson Special to DG News
ATLANTA, GA -- May 25, 2001 -- Two doses of encapsulated budesonide CIR, a glucocorticosteroid, have been demonstrated to be safe and effective for treating Crohn’s disease, according to researchers reporting at Digestive Disease Week being held here this week. Budesonide possesses high topical activity to the distal ileum and the proximal colon, while conveying low systemic activity. In four previous controlled trials in Crohn’s disease, remission rates with budesonide CIR ranged from 51 to 69 percent. Dr. William J. Tremaine of the Mayo Clinic, Rochester, Minnesota, presented the findings of a multicenter, double-blind, randomized trial in 307 patients with symptomatic Crohn’s disease of the distal ileum and/or ascending colon. Crohn’s disease was defined as Crohn’s Disease Activity Index (CDAI) between 200 and 450. Patients received budesonide CIR 9 mg once daily, 4.5 mg twice daily or placebo for eight weeks. The primary efficacy variable was remission defined as CDAI£150. Secondary efficacy variables included treatment benefit (defined as remission or decrease in CDAI of at least 100 points), quantitative changes in CDAI from study enrollment to each return visit, and corticotropin stimulation to assess adrenal function. After eight weeks, remission was achieved in 48 percent, 53 percent and 33 percent with budesonide 9 mg once daily, 4.5 mg twice daily, and placebo, respectively. Differences between the groups were not significant (p=0.14), Dr. Tremaine reported. However, the mean change from baseline CDAI between the combined budesonide groups and placebo was significant (p=0.024) and the time to remission was significantly different between the three groups (35 days, budesonide 9 mg; 22 days, budesonide 4.5 mg; and 68 days, placebo). There was no difference in observed adverse events between treatment groups, although a modest decrease in plasma cortisol levels was observed compared to placebo (p<0.0001). At weeks 2 and 4, statistically significant differences were seen between both budesonide treatments and placebo (p<0.01); this difference was no statistically significant at week 8 (p=-0.067). Dr. Tremaine noted that a comparison of this trial with four other independent trials of budesonide 9 mg daily versus mesalamine, prednisolone or placebo showed that both doses of budesonide and prednisolone differ significantly from placebo in the probability of being in remission, whereas mesalamine does not. The investigators concluded that budesonide CIR 9 mg daily was safe and remission rates were similar to those achieved in previous trials. "Although the remission rate was not significantly different from the placebo response in this study, there was a significant change in the mean CDAI from baseline in the combined treatment groups compared to placebo," they noted.
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