Budesonide as maintenance treatment in Crohn's disease: a placebo‐controlled trial

Hanauer, Stephen B.; Sandborn, William J.; Persson, Anders; Persson, Tore

doi:10.1111/j.1365-2036.2005.02338.x

Cited by 74 publications

(56 citation statements)

References 26 publications

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“…A further trial investigating oral pH-modified-release budesonide also found that budesonide was not effective for maintaining steroid-induced remission compared with placebo (Table 1) [Gross et al 1998]. Finally, a trial investigating modifiedrelease budesonide showed that budesonide and placebo had similar relapse rates after 1 year of treatment (Table 1) [Hanauer et al 2005].…”

Section: Efficacy In Crohn's Diseasementioning

confidence: 99%

Glucocorticosteroids in the treatment of inflammatory bowel disease and approaches to minimizing systemic activity

Prantera

Marconi

2013

Therap Adv Gastroenterol

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Inflammatory bowel diseases (IBDs) are a group of inflammatory conditions characterized by chronic, uncontrolled inflammation of the gastrointestinal tract. Reported prevalence is high in the United States and northern Europe, while the incidence varies greatly across the rest of Europe. Glucocorticosteroids are the standard treatment for IBD, but due to adverse events their use can be limited. However, new formulations of glucocorticosteroids have been developed to reduce systemic activation. The aim of this review was to assess and summarize the efficacy and safety of new formulations of glucocorticosteroids. A MEDLINE search identified publications focused on new formulations of nonsystemic steroidbased drugs for IBD and benefits and limitations of each of the new glucocorticosteroid formulations were identified. Budesonide has good efficacy and is an established treatment for Crohn's disease; it has been shown to be beneficial for the induction of remission in these patients, although it is not recommended for the maintenance of induced remission. Glucocorticosteroids are not recommended for the maintenance of remission in patients with IBD. However, a recent study suggested that beclomethasone dipropionate may be effective for prolonged treatment in patients in the postacute phase of Crohn's disease who were treated with a short course of systemic steroids. The efficacy of fluticasone propionate and prednisolone metasulphobenzoate in IBD is not well established given the small number of patients enrolled in the few published clinical trials. While the tolerability of these glucocorticosteroids is favourable, more research comparing these new agents with traditional systemic glucocorticosteroids is warranted.

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Section: Efficacy In Crohn's Diseasementioning

confidence: 99%

Glucocorticosteroids in the treatment of inflammatory bowel disease and approaches to minimizing systemic activity

Prantera

Marconi

2013

Therap Adv Gastroenterol

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“…The results of these trials show that budesonide is comparable to prednisone in inducing clinical remission in patients with ileo-colonic CD [31]. However, it is not significantly more effective than placebo [21,32,33,34,35,36,37,38,39] or systemic corticosteroids [40] in maintaining clinical remission in CD patients.…”

Section: Resultsmentioning

confidence: 99%

“…Furthermore, preliminary data from ongoing trials show that budesonide MMX 9 mg has a good tolerability: steroid-related side effects were reported by 5.5% of patients and consisted of moon face, mood and sleep changes. Hanauer et al [39] showed that plasma cortisol was slightly decreased in patients administered budesonide MMX, but the cortisol levels of the majority of patients remained within acceptable limits (unpubl. data: Randomized Placebo Controlled Trial of Budesonide-MMX™ 6 and 9 mg in Patients with Ulcerative Colitis: http://clinicaltrials.gov/ct2/show/NCT00679380).…”

Section: Resultsmentioning

confidence: 99%

Second-Generation Corticosteroids for the Treatment of Crohn’s Disease and Ulcerative Colitis: More Effective and Less Side Effects?

Cassan¹,

Fiorino²,

Danese³

2012

Dig Dis

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Background/Aims: Systemic corticosteroids are highly effective at inducing clinical remission in cases of acute exacerbation of Crohn’s disease (CD) and ulcerative colitis (UC); however, their use is limited by their frequent and sometimes severe side effects. Thus, a second generation of corticosteroids with less systemic effects has been developed. This review analyzed all of the studies on the new formulations of steroids with limited absorption (budesonide, budesonide MMX®, beclomethasone dipropionate and erythrocyte-mediated delivery of dexamethasone) in patients with CD and UC. Methods: All relevant articles published in English between September 1960 and April 2011 were reviewed. Results: Budesonide is superior to placebo, and as effective as systemic corticosteroids in inducing clinical remission in patients with ileo-colonic CD, but evidence of mucosal healing is limited. When administered as an MMX formula, budesonide can also effectively induce clinical remission in patients with UC, but budesonide alone is not effective in maintaining clinical remission in CD or UC. Beclomethasone dipropionate seems to be effective in patients with mild-to-moderate left-sided and extensive UC, while data on erythrocyte-mediated delivery of dexamethasone are encouraging but still limited. The safety profile for all these products is good but more studies are needed. Conclusion: Steroids remain the mainstay for the induction of clinical remission in cases of acute relapse of both CD and UC. Second-generation corticosteroids are an interesting alternative, with the advantage of high topical activity, less systemic toxicity and limited side effects.

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“…Budesonide: Lower doses of budesonide (3 or 6 mg) have also been studied for their potential to be effective in the maintenance of remission. Although earlier metaanalyses have not shown that budesonide was superior over placebo [16,48] , a recent randomized, placebo-controlled trial found a trend towards a longer quiescent disease in budesonide treated patients compared to placebo [49] . In this trial, no significant difference in total adverse events or corticosteroid-associated events was demonstrated between placebo and budesonide.…”

Section: Maintenance Of Remissionmentioning

confidence: 99%

Conventional therapy for Crohn’s disease

Büning

Lochs²

2006

WJG

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Crohn's disease (CD) is a multifactorial disorder of unknown cause. Outstanding progress regarding the pathophysiology of CD has led to the development of innovative therapeutic concepts. Numerous controlled trials have been performed in CD over the last years. However, many drugs have not been approved by regulatory authorities due to lack of efficacy or severe side effects. Therefore, well-known drugs, including 5-ASA, systemic or topical corticosteroids, and immunosuppressants such as azathioprine, are still the mainstay of CD therapy. Importantly, biologicals such as infliximab have shown to be efficacious in problematic settings such as fistulizing or steroid-dependent CD. This review is intended to give practical guidelines to clinicians for the conventional treatment of CD. We concentrated on the results of randomized, placebo-controlled trials and meta-analyses, when available, that provide the highest degree of evidence. We provide evidence-based treatment algorithms whenever possible. However, many clinical situations have not been answered by controlled clinical trials and it is important to fill these gaps through expert opinions. We hope that this review offers a useful tool for clinicians in the challenging treatment of CD.

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Budesonide as maintenance treatment in Crohn's disease: a placebo‐controlled trial

Cited by 74 publications

References 26 publications

Glucocorticosteroids in the treatment of inflammatory bowel disease and approaches to minimizing systemic activity

Glucocorticosteroids in the treatment of inflammatory bowel disease and approaches to minimizing systemic activity

Second-Generation Corticosteroids for the Treatment of Crohn’s Disease and Ulcerative Colitis: More Effective and Less Side Effects?

Conventional therapy for Crohn’s disease

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