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
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 (2010)
Publication Type: Journal article
Publication year: 2010
Journal
Book Volume: 16
Pages Range: 1947-1956
Journal Issue: 11
DOI: 10.1002/ibd.21258
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. (Inflamm Bowel Dis 2010) © Copyright © 2010 Crohns & Colitis Foundation of America, Inc.
Authors with CRIS profile
Involved external institutions
Klinikum Stuttgart
Germany (DE)
Donetsk National Medical University (DNMU) / Донецький національний медичний університет імені Максима Горького
Ukraine (UA)
North-Western State Medical University named after I.I. Mechnikov / Санкт-Петербургская государственная медицинская академия (СЗГМУ) имени И. И. Мечникова
Russian Federation (RU)
Universitätsklinikum Schleswig-Holstein (UKSH)
Germany (DE)
Klinikum Bayreuth
Germany (DE)
Kharkiv National Medical University / Харківський національний медичний університет
Ukraine (UA)
Lviv Regional Clinical Hospital
Ukraine (UA)
Germany (DE)
Donetsk National Medical University (DNMU) / Донецький національний медичний університет імені Максима Горького
Ukraine (UA)
North-Western State Medical University named after I.I. Mechnikov / Санкт-Петербургская государственная медицинская академия (СЗГМУ) имени И. И. Мечникова
Russian Federation (RU)
Universitätsklinikum Schleswig-Holstein (UKSH)
Germany (DE)
Klinikum Bayreuth
Germany (DE)
Kharkiv National Medical University / Харківський національний медичний університет
Ukraine (UA)
Lviv Regional Clinical Hospital
Ukraine (UA)
How to cite
APA:
Andus, T., Kocjan, A., Müser, M., Baranovsky, A., Mikhailova, T.L., Zvyagintseva, T.D.,... Greinwald, R. (2010). 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. Inflammatory Bowel Diseases, 16(11), 1947-1956. https://doi.org/10.1002/ibd.21258
MLA:
Andus, Tilo, et al. "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." Inflammatory Bowel Diseases 16.11 (2010): 1947-1956.
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