期刊
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
卷 37, 期 8, 页码 767-775出版社
WILEY-BLACKWELL
DOI: 10.1111/apt.12266
关键词
-
资金
- Ferring Pharmaceuticals
- Ferring
- UCB Pharma
- Baxter
- Fresenius Kabi
- Vifor
- MSD Pharma
- Unilever
- DSM
- Pentax
- Abbott
- AstraZeneca
- Warner Chilcott
Background Aminosalicylates are first-choice treatment for mild-to-moderately active ulcerative colitis (UC); however, multi-dosing regimens are inconvenient. Aim To compare the efficacy and safety of once- (OD) vs. twice- (BD) daily prolonged-release mesalazine (Pentasa, Ferring, Saint-Prex, Switzerland) for active mild-to-moderate UC in a non-inferiority study. Methods Eligible patients (n=206) were randomised to 8weeks of mesalazine (4g/day), either OD with two sachets of 2g mesalazine granules in the morning (n=102) or BD with one 2g sachet in the morning and one in the evening (n=104). Patients also received 4weeks of mesalazine enema 1g/day. Disease activity was assessed at randomisation, weeks 4, 8 and 12 using the UC Disease Activity Index (UC-DAI). Clinical and endoscopic remission (primary endpoint) was assessed after 8weeks. Patients recorded stool frequency and rectal bleeding in a daily diary. Results The primary endpoint, non-inferiority in clinical and endoscopic remission with OD vs. BD mesalazine at 8weeks, was met (intent-to-treat population: 52.1% vs. 41.8%, respectively, 95% confidence interval 3.4, 24.1; P=0.14). Improvement of UC-DAI score (92% vs. 79%; P=0.01) and mucosal healing (87.5% vs. 71.1%; P=0.007) were significantly better, time to remission significantly shorter (26 vs. 28days; P=0.04) and safety similar with OD vs. BD dosing. Conclusions When combined with mesalazine enema, prolonged-release mesalazine once-daily 4g is as effective and well tolerated as 2g twice-daily for inducing remission in patients with mild-to-moderately active ulcerative colitis (Clinicaltrials.gov: NCT00737789).
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据