Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis

Figures & data

Table 1 Characteristics of the three oral budesonide formulations

Type of oral budesonide	Formulation	pH-release	Liberation
Controlled ileal release (pH- and time-dependent release)	Gelatin capsule and enteric coated pellets with L 100–55 Eudragit® granules	≥5.5	Terminal ileum and/or ascending colon
pH-dependent release	Capsule containing enteric coated pellets with L, S, LS, and RS Eudragit® granules	>6.4	Terminal ileum and/or ascending colon
Multimatrix formulation (budesonide-MMX)	Gastroresistant and pH-dependent coating with lipophilic matrix	>7	Homogeneously through ascending, transverse, and descending colon

Abbreviation: MMX, multimatrix formulation.

Table 2 Published studies comparing budesonide’s safety and efficacy with other drugs as maintenance treatment for ulcerative colitis patients

Author	Type of study	Drugs	Population	Conclusions
		Time of the treatment	N patients
Lofberg et al^Citation32	Randomized, doubleblind, controlled trial	BDS 10 mg Prednisolone 40 mg 9 weeks	Left sided active UC N = 72	BDS is as effective as prednisolone with less cortisol level suppression
Gross et al^Citation34	Multicentric, randomized, double-blind	BDS 9 mg Mesalazine 3 g 8 weeks	Mild to moderate active UC N = 343	Mesalazine is superior to BDS for achieving remission at week 8
D’Haens et al^Citation18	Multicentric, randomized, double-blind, pilot and PB-controlled trial	BDS-MMX 9 mg versus PB 8 weeks	Left sided active UC N = 32	BDS-MMX is no better than PB. BDS induces fast improvement without suppression of adrenal function and without toxicity
Sandborn et al^Citation9	Multicentric, randomized, double-blind, PB-controlled trial	BDS-MMX 9 mg or 6 mg versus 2.4 g mesalazine versus PB 8 weeks	Mild to moderate active UC N = 489	BDS-MMX 9 mg is safe and more effective than PB but no better than mesalazine

Abbreviations: BDS, budesonide; UC, ulcerative colitis; MMX, multimatrix formulation; N, number of patients; PB, placebo.

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GrossVBunganicIBelousovaEAInternational BUC-57 Study Group3 g mesalazine granules are superior to 9 mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trialJ Crohns Colitis20115212913821453882

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D’HaensGRKovacsAVergauwePClinical trial: Preliminary efficacy and safety study of a new Budesonide-MMX(R) 9 mg extended-release tablets in patients with active left-sided ulcerative colitisJ Crohns Colitis20104215316021122499

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SandbornWJTravisSMoroLOnce-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I studyGastroenterology2012143512181226. e1e222892337

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