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.

• Authors: Tilo Andus, Andreas Kocjan, Moritz Müser, Andrey Baranovsky, Tatyana L Mikhailova, Tatyana D Zvyagintseva, Andrey E Dorofeyev, Yurii S Lozynskyy, Ingolf Cascorbi, Manfred Stolte, Michael Vieth, Karin Dilger, Ralf Mohrbacher, Roland Greinwald, International Salofalk Suppository OD Study Group
• Journal: Inflammatory bowel diseases (Inflamm Bowel Dis) Vol. 16 Issue 11 Pg. 1947-56 (Nov 2010) ISSN: 1536-4844 [Electronic] England
• PMID: 20310020 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Suppositories
• Mesalamine

Topics

• Adolescent
• Adult
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Colitis, Ulcerative (drug therapy)
• Drug Administration Schedule
• Female
• Humans
• Male
• Mesalamine (administration & dosage, adverse effects)
• Middle Aged
• Patient Preference
• Proctitis (drug therapy)
• Remission Induction
• Single-Blind Method
• Suppositories
• Young Adult