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

作者：Andus Tilo^*; Kocjan Andreas; Mueser Moritz; Baranovsky Andrey; Mikhailova Tatyana L; Zvyagintseva Tatyana D; Dorofeyev Andrey E; Lozynskyy Yurii S; Cascorbi Ingolf; Stolte Manfred; Vieth Michael; Dilger Karin; Mohrbacher Ralf; Greinwald Roland

来源：Inflammatory Bowel Diseases, 2010, 16(11): 1947-1956.

DOI：10.1002/ibd.21258

• mesalamine
• N-acetyltransferase
• once-daily
• proctitis
• suppository
• distal ulcerative colitis

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 I 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.

• 出版日期2010-11