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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
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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
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Journal Article
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
2010
Overview
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.MethodsThis 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).ResultsIn 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.ConclusionsIn 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. (Inflamm Bowel Dis 2010)
Publisher
Oxford University Press,Wiley Subscription Services, Inc., A Wiley Company
Subject
/ Adult
/ Aged
/ Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
/ Anti-Inflammatory Agents, Non-Steroidal - adverse effects
/ Blood
/ Colitis, Ulcerative - drug therapy
/ Drug Administration Schedule
/ Feces
/ Female
/ Humans
/ Male
/ Mesalamine - administration & dosage
