Low dose oral pH modified release budesonide for maintenance of steroid induced remission in Crohn's disease

Andus, Tilo; Kw, Ecker; Raedler, Andreas; Loeschke, K; Plauth, Mathias; Rasenack, J.; Weber, Audrey; Gierend, M.; K, Ewe; Schölmerich, Jürgen

doi:10.1136/gut.42.4.493

Cited by 90 publications

(64 citation statements)

References 15 publications

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“…Another study of comparable design suggested otherwise, showing no difference between budesonide and placebo in terms of relapse rate and time to relapse [Ferguson et al 1998]. 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%

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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“…Die Analyse der wesentlichen Faktoren, die das P..ezidivrisiko erh6hten, ergab einen initial erh6hten Aktivitfitsindex (CDAI) und weibliches Geschlecht als wesentliche Risikofaktoren [12]. [20]. Eine gemeinsame Analyse der vier publizierten Studien zeigt, dab in der Tat der Zeitpunkt bis zum Rezidiv bei allen Studien eine Verschiebung durch die Gabe von Budesonid aufweist, daf3 die Rezidivraten nach einemJahr aber in allen Studien in einem sehr engen Bereich liegen und sich nicht zwischen den verschiedenen Gruppen unterscheiden (Tabelle 15).…”

Section: -4unclassified

Klinische Wirkung der verschiedenen Budesonid-Präparationen bei Morbus Crohn

Schölmerich

1999

Med Klin

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Budesonide in the pH-dependent and time-dependent release preparation is at a dose of 9 mg/day useful for treatment of mild to moderate active Crohn's disease. Although the remission rates are somewhat lower as compared to systemic steroids, the number of side effects is significantly decreased. Differences between both preparations based on theoretical and pharmacological considerations have not yet been proven in clinical practice. With regard to maintenance of steroid-induced remission the data available do not justify continuous treatment. This is also true for postoperative remission maintenance. It is not clear at the moment if higher doses could possibly be effective for this indication. It has to be expected, however, that side effects than will increase as well.

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Low dose oral pH modified release budesonide for maintenance of steroid induced remission in Crohn's disease

Cited by 90 publications

References 15 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?

Klinische Wirkung der verschiedenen Budesonid-Präparationen bei Morbus Crohn

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