Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission.
Dig Dis Sci
; 61(1): 221-9, 2016 Jan.
Article
em En
| MEDLINE
| ID: mdl-26563167
ABSTRACT
BACKGROUND:
Patients with ulcerative colitis (UC) who achieve remission with corticosteroids often relapse after tapering or discontinuation; alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended-release capsule formulation for maintenance of UC remission in adults.AIMS:
Efficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission.METHODS:
Data from patients with previous corticosteroid use to achieve baseline UC remission were analyzed from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months.RESULTS:
Included were 158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 74/105 MG-treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio [HR] 0.45; 95 % CI 0.25-0.79). There was a similar (49.2 %) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31-0.84; P = 0.009) that was sustained during the OLE.CONCLUSIONS:
MG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs. CLINICALTRIALS.GOV NCT00744016, NCT00767728, and NCT00326209.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fármacos Gastrointestinais
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Colite Ulcerativa
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Corticosteroides
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Mesalamina
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Anti-Inflamatórios
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
/
Systematic_reviews
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Dig Dis Sci
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Estados Unidos