期刊
GASTROENTEROLOGY
卷 143, 期 5, 页码 1218-+出版社
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2012.08.003
关键词
Inflammatory Bowel Disease; Clinical Trial Result; Inflammation; Colon
资金
- Abbott Laboratories
- ActoGeniX NV
- AGI Therapeutics Inc
- Alba Therapeutics Corp
- Albireo
- Alfa Wasserman
- Amgen
- AM-Pharma BV
- Anaphore
- Astellas
- Athersys Inc
- Atlantic Healthcare Ltd
- Aptalis
- BioBalance Corp
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Celgene Corp
- Celek Pharmaceuticals
- Cellerix SL
- Cerimon Pharmaceuticals
- ChemoCentryx
- CoMentis
- Cosmo Technologies
- Coronado Biosciences
- Cytokine PharmaSciences Inc
- Eagle Pharmaceuticals
- enGene Inc
- Eli Lilly and Company
- EnteroMedics
- Exagen Diagnostics Inc
- Ferring Pharmaceuticals
- Flexion Therapeutics Inc
- Funxional Therapeutics Ltd
- Genzyme Corp
- Gilead Sciences
- Given Imaging
- GlaxoSmithKline
- Human Genome Sciences
- Ironwood Pharmaceuticals
- KaloBios Pharmaceuticals Inc
- Lexicon Pharmaceuticals
- Lycera Corp
- Meda Pharmaceuticals
- Merck Research Laboratories
- Merck Serono
- Millennium Pharmaceuticals
- Nisshin Kyorin Pharmaceuticals
- Novo Nordisk
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics Inc
- PDL BioPharma
- Pfizer Inc
- Procter Gamble
- Prometheus Laboratories
- ProtAb Ltd
- PurGenesis Technologies Inc
- Relypsa Inc
- Roche
- Salient Pharmaceuticals
- Salix Pharmaceuticals
- Santarus Inc
- Schering-Plough
- Shire Pharmaceuticals
- Sigmoid Pharma Ltd
- Sirtris Pharmaceuticals
- SLA Pharma UK Ltd
- Targacept
- Teva Pharmaceuticals
- Therakos
- Tillotts Pharma AG
- TxCell SA
- UCB Pharma
- Viamet Pharmaceuticals
- Vascular Biogenics Ltd
- Warner Chilcott UK Ltd
- Wyeth
- Genentech
- Janssen
- Novartis
- Pfizer
- Asahi
- Aspreva
- Elan
- Glenmark
- Vertex
- Vifor
- Abbott
- Santarus, Inc
- Cosmo Pharmaceuticals SpA
BACKGROUND & AIMS: Budesonide is a corticosteroid with minimal systemic corticosteroid activity due to first-pass hepatic metabolism. Budesonide MMX (R) is a once-daily oral formulation of budesonide that extends budesonide release throughout the colon using multimatrix system (MMX) technology. METHODS: We performed a randomized, double-blind, double-dummy, placebo-controlled trial to evaluate the efficacy of budesonide MMX for induction of remission in 509 patients with active, mild to moderate ulcerative colitis (UC). Patients were randomly assigned to groups that were given budesonide MMX (9 mg or 6 mg), mesalamine (2.4 g, as reference), or placebo for 8 weeks. The primary end point was remission at week 8. RESULTS: The rates of remission at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 17.9%, 13.2%, and 12.1%, respectively, compared with 7.4% for placebo (P = .0143, P = .1393, and P = .2200). The rates of clinical improvement at week 8 among patients given 9 mg or 6 mg budesonide MMX or mesalamine were 33.3%, 30.6%, and 33.9%, respectively, compared with 24.8% for placebo (P = .1420, P = .3146, and P = .1189). The rates of endoscopic improvement at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 41.5%, 35.5%, and 33.1%, respectively, compared with 33.1% for placebo. The rates of symptom resolution at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 28.5%, 28.9%, and 25.0%, respectively, compared with 16.5% for placebo (P = .0258, P = .0214, and P = .1025). Adverse events occurred at similar frequencies among groups. CONCLUSIONS: Budesonide MMX (9 mg) was safe and more effective than placebo in inducing remission in patients with active, mild to moderate UC. ClinicalTrials.gov, Number: NCT00679432.
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