3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: A double-blind, double-dummy, randomised trial

Groß, Volker; Bunganič, Ivan; Belousova, Elena; Mikhailova, T. L.; Kupčinskas, Limas; Kiudelis, Gediminas; Tulassay, Zsolt; Gabalec, Libor; Dorofeyev, A. E.; Derova, Jelena; Dilger, Karin; Greinwald, Roland; Müeller, Ralph

doi:10.1016/j.crohns.2010.11.006

Cited by 57 publications

(49 citation statements)

References 41 publications

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“…The absolute clinical and endoscopic remission rates seen in this study are lower than the remission rates reported in several recent UC trials 2 9 11. There are a number of potential reasons for these differences, which relate primarily to the study endpoints and inclusion/evaluation criteria used.…”

Section: Discussioncontrasting

confidence: 63%

“…Additionally, endoscopic improvements, particularly mucosal healing, may be an important indicator of longer-term outcomes, such as the likelihood of colectomy over the following year 22. In their study comparing Budenofalk with Salofalk, Gross et al 9 defined remission as a Rachmilewitz CAI score of ≤4, which might mean anything up to a score of 2 for stool frequency (defined as 30–60 bowel actions/week) and 2 for rectal bleeding (defined as a little blood). The mesalazine MMX studies2 11 12 used similar UCDAI criteria to our study, but employed a less thorough method (flexible sigmoidoscopy) for endoscopic evaluation.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Travis

Danese²,

Kupčinskas

et al. 2013

Gut

Self Cite

232

196

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ObjectiveBudesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC).DesignPatients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score ≤1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a ≥1-point reduction in endoscopic index score from baseline.Results410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4%, 8.3%, 12.6% and 4.5%, respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95% CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2% vs 33.7%) and endoscopic improvement (42.2% vs 31.5%) versus placebo. The rate of histological healing (16.5% vs 6.7%; p=0.0361) and proportion of patients with symptom resolution (23.9% vs 11.2%; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups.ConclusionBudesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.

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Section: Discussioncontrasting

confidence: 63%

Section: Discussionmentioning

confidence: 99%

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Travis

Danese²,

Kupčinskas

et al. 2013

Gut

Self Cite

232

196

View full text Add to dashboard Cite

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“…This is contrary to the results from the earlier trial by Gross et al , which compared the efficacy of (PH-dependent release) budesonide (9mg/day) to oral mesalamine (3g/day) and concluded that budesonide is inferior to mesalamine. 39 The two studies used different primary outcome (clinical remission in Gross et al study vs. combined endoscopic and clinical remission in CORE I) and different mesalamine dosages (3 g vs 2.4g), both factors and the different budesonide formulations may have contributed to the inconsistent results. Furthermore, the CORE I trial was not sufficiently powered to detect differences between the active compactor groups.…”

Section: Clinical Efficacymentioning

confidence: 99%

Budesonide for the treatment of ulcerative colitis

Abdalla

Herfarth

2016

Expert Opinion on Pharmacotherapy

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Introduction Budesonide is a synthetic corticosteroid characterized by enhanced topical potency and limited systemic bioavailability. Its use in ulcerative colitis (UC) was limited to rectal preparations until recently when the new oral budesonide formulation incorporating the multi-matrix system technology was introduced. The purpose of this review is to evaluate the current role of oral and rectal budesonide in managing UC patients Areas Covered In this paper, we described the chemical structure and pharmacologic characteristics of the different oral and rectal budesonide preparations, provided a summary of the published trials that evaluated the efficacy and safety of budesonide in UC, and discussed the current status of its use in this population Expert Opinion Budesonide is effective in inducing remission in a subset of patients with mild-moderate UC. Nevertheless, the current evidence suggests inferiority of oral budesonide to 5-aminosalisylates (5-ASA) and systemic steroids, whereas rectal applications are comparable to other rectal steroid preparations but still inferior to rectal 5-ASA. In clinical practice, several issues need clarification including, its exact position in the line of induction agents; the role of combining budesonide and 5-ASAs; the role of combining oral and rectal budesonide; and the role of budesonide in maintenance therapy.

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“…10,11 Therefore, an ideal colon-specific delivery system for UC therapeutics should prevent premature drug release before reaching the colon and deliver sufficient amounts of the drug to the inflamed area of the distal colon. Fine tuning of the formulation may be necessary to account for longer transit times in the gut, as well as slightly higher pH values (around 7.3) in the distal small intestine.…”

Section: Introductionmentioning

confidence: 99%

Enhanced therapeutic efficacy of budesonide in experimental colitis with enzyme/pH dual-sensitive polymeric nanoparticles

Naeem

Cao

Choi

et al. 2015

IJN

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Current colon-targeted drug-delivery approaches for colitis therapy often utilize single pH-triggered systems, which are less reliable due to the variation of gut pH in individuals and in disease conditions. Herein, we prepared budesonide-loaded dual-sensitive nanoparticles using enzyme-sensitive azo-polyurethane and pH-sensitive methacrylate copolymer for the treatment of colitis. The therapeutic potential of the enzyme/pH dual-sensitive nanoparticles was evaluated using a rat colitis model and compared to single pH-triggered nanoparticles. Clinical activity scores, colon/body weight ratios, myeloperoxidase activity, and proinflammatory cytokine levels were markedly decreased by dual-sensitive nanoparticles compared to single pH-triggered nanoparticles and budesonide solution. Moreover, dual-sensitive nanoparticles accumulated selectively in inflamed segments of the colon. In addition, dual-sensitive nanoparticle plasma concentrations were lower than single pH-triggered nanoparticles, and no noticeable in vitro or in vivo toxicity was observed. Our results demonstrate that enzyme/pH dual-sensitive nanoparticles are an effective and safe colon-targeted delivery system for colitis therapy.

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3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: A double-blind, double-dummy, randomised trial

Cited by 57 publications

References 41 publications

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Budesonide for the treatment of ulcerative colitis

Enhanced therapeutic efficacy of budesonide in experimental colitis with enzyme/pH dual-sensitive polymeric nanoparticles

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