Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis.
Inflamm Bowel Dis
; 16(11): 1947-56, 2010 Nov.
Article
em En
| MEDLINE
| ID: mdl-20310020
ABSTRACT
BACKGROUND:
Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day. The primary objective of this study was to show the noninferiority of once-daily administration of a novel 1 g mesalamine suppository versus thrice-daily administration of the 0.5 g mesalamine suppository.METHODS:
This was a single-blind (investigator-blinded), randomized, multicenter, comparative, Phase III clinical trial. Patients with mild to moderately active ulcerative proctitis inserted either one mesalamine 1 g suppository at bedtime or one mesalamine 0.5 g suppository thrice daily over a 6-week period. The primary endpoint was rate of remission (Disease Activity Index below 4).RESULTS:
In all, 354 patients were evaluable for safety and per-protocol analysis. The new regimen demonstrated noninferiority The percentage of patients with remission was 87.9% for the once-daily 1 g mesalamine suppository and 90.7% for the thrice-daily 0.5 g mesalamine suppository. Each regimen resulted in prompt cessation of clinical symptoms (e.g., median time to ≤3 stools per day (all without blood) 5 days in the 1 g mesalamine once-daily and 7 days in the 0.5 g mesalamine thrice-daily group). Patients preferred applying suppositories once a day.CONCLUSIONS:
In active ulcerative proctitis the once-daily administration of a 1 g mesalamine suppository is as effective and safe, yet considerably more convenient, than the standard thrice-daily administration of a 0.5 g mesalamine suppository.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Proctite
/
Colite Ulcerativa
/
Anti-Inflamatórios não Esteroides
/
Mesalamina
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Adolescent
/
Adult
/
Aged
/
Female
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Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Inflamm Bowel Dis
Assunto da revista:
GASTROENTEROLOGIA
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Alemanha