期刊
POSTGRADUATE MEDICINE
卷 128, 期 3, 页码 273-281出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/00325481.2016.1152876
关键词
Inflammatory bowel disease; remission; ulcerative colitis; mesalamine
资金
- Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA [MPUC3003, MPUC3004]
- Salix
- AbbVie
- Aptalis
- Avaxia
- Coronado
- Cubist
- Dr. Falk
- Evoke
- Ferring
- Furiex
- GlaxoSmithKline
- Hutchinson
- Janssen Pharmaceuticals, Inc.
- Lexicon
- Pfizer Inc.
- Prometheus
- Red Hill BioPharma
- Revogenex
- Sanofi-Aventis U.S.
- Shire
- Takeda Pharmaceutical Company Limited
- Theravance
- Tranzyme
- UBC
- UCB
- Ventrus
- Warner Chilcott
Objectives: A capsule formulation of mesalamine granules (MG) was developed for once-daily dosing and better compliance. The study aim was to evaluate MG efficacy and tolerability in maintaining ulcerative colitis (UC) remission. Methods: Pooled analysis of 2 identical phase 3, randomized, double-blind trials of once-daily MG 1.5 g or placebo for up to 6 months. The primary endpoint was percentage of patients remaining relapse-free at month 6 versus placebo. Relapse was defined as revised Sutherland Disease Activity Index (SDAI) rectal bleeding score >= 1 and mucosal appearance score >= 2, UC flare, or UC-related adverse event (AE). Results: Data were pooled for patients receiving MG (n = 373) and placebo (n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4%) than placebo (62.4%; P < 0.001) and across subgroups based on select demographic and baseline characteristics (P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG (P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9% and 7.6%), diarrhea (7.9% and 7.0%), and abdominal pain (6.3% and 6.5%). Conclusion: Once-daily MG was more efficacious than and as well tolerated as placebo in maintaining UC remission. ClinicalTrials.gov identifiers: NCT00744016 and NCT00767728.
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