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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.

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.

journal_name

Inflamm Bowel Dis

journal_title

Inflammatory bowel diseases

authors

Andus T,Kocjan A,Müser M,Baranovsky A,Mikhailova TL,Zvyagintseva TD,Dorofeyev AE,Lozynskyy YS,Cascorbi I,Stolte M,Vieth M,Dilger K,Mohrbacher R,Greinwald R,International Salofalk Suppository OD Study Group.

doi

10.1002/ibd.21258

subject

Has Abstract

pub_date

2010-11-01 00:00:00

pages

1947-56

issue

eissn

1078-0998

issn

1536-4844

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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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.