Budesonide CIR capsules once or twice daily in active Crohn's disease. A randomized placebo controlled study in the USA

Hanauer, Stephen B.; Katz, Seymour; Winston, Barry; Levine, Jeffrey G.; Persson, Tore; Persson, Anders

doi:10.1016/s0016-5085(08)83726-2

Cited by 2 publications

(7 citation statements)

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“… 20 , 26–31 Multiple abstracts meeting the inclusion criteria were identified, but all of these had also been published as full manuscripts. Communication with inflammatory bowel disease experts identified one additional trial that was in press during the development of this meta‐analysis 18 . Correspondence with AstraZeneca, LP, the manufacturer of budesonide, also identified two 32 , 33 additional trials that were in press at the time of this analysis.…”

Section: Characteristics Of the Studiesmentioning

confidence: 99%

“…The majority of the trials met the highest methodological quality criteria, including the use of concealed allocation, appropriate double‐blinding, use of an intention‐to‐treat analysis, and complete follow‐up of patients. Ten trials 12, 13, 15, 17, 18, 26–28, 31, 33 had the highest quality score of 5, and an additional two trials 14 , 29 had a quality score of 4.…”

Section: Characteristics Of the Studiesmentioning

confidence: 99%

“…Two trials 17 , 18 compared budesonide to placebo for the treatment of active Crohn's disease. Budesonide induced the remission of Crohn's disease more frequently than placebo: RR=1.85 (95% CI: 1.31–2.61).…”

Section: Budesonide or Placebo For The Treatment Of Active Crohn's DImentioning

confidence: 99%

“…Multiple trials 12–17 have compared budesonide to placebo, 5‐ASA products and conventional corticosteroids. Some trials only demonstrated nonstatistically significant trends showing that budesonide is superior to placebo 18 or nonsignificant trends showing that conventional corticosteroids are more effective than budesonide for inducing remission 13–16 …”

Section: Introductionmentioning

confidence: 99%

“…This is an important issue, since 5‐ASA products are commonly used as a first line therapy for active Crohn's disease. In addition, additional trials of budesonide are now available 18 , 20 which allow a more precise estimate of treatment effect. Finally, the previous analysis did not evaluate important sub‐group questions, including the effectiveness of budesonide for patients with a low disease activity (CDAI=200–300) or the effectiveness of budesonide in maintaining remission in steroid‐dependent patients.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Systematic review: the effectiveness of budesonide therapy for Crohn's disease

Kane

Schoenfeld

Sandborn

et al. 2002

Aliment Pharmacol Ther

111

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Summary 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 ≤ 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.

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