Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question

被引:26
作者
Orchard, T. R. [1 ]
van der Geest, S. A. P. [2 ]
Travis, S. P. L. [3 ]
机构
[1] Imperial Coll Healthcare NHS Trust, St Marys Hosp, GI Unit, London W2 1NY, England
[2] Warner Chilcott UK Ltd, Larne, North Ireland
[3] John Radcliffe Hosp, Translat Gastroenterol Unit, Oxford OX3 9DU, England
关键词
INFLAMMATORY-BOWEL-DISEASE; EVIDENCE-BASED CONSENSUS; END-POINTS; MANAGEMENT; ADULTS; DEFINITIONS; GUIDELINES; DIAGNOSIS; REMISSION; CROHNS;
D O I
10.1111/j.1365-2036.2011.04620.x
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background Rapid resolution of rectal bleeding and stool frequency are important goals for ulcerative colitis therapy and may help guide therapeutic decisions. Aim To explore patient diary data from ASCEND I and II for their relevance to clinical decision making. Methods Data from two randomised, double-blind, Phase III studies were combined. Patients received mesalazine (mesalamine) 4.8 g/day (Asacol 800 mg MR) or 2.4 g/day (Asacol 400 mg MR). Time to improvement or resolution of rectal bleeding and stool frequency was assessed and the proportion of patients experiencing symptom improvement or resolution at day 14 evaluated using survival analysis. Symptoms after 14 days were compared to week 6. A combination of prespecified and post hoc analyses were used. Results Median times to resolution and improvement of both rectal bleeding and stool frequency were shorter with 4.8 g/day than 2.4 g/day (resolution, 19 vs. 29 days, P = 0.020; improvement, 7 vs. 9 days, P = 0.024). In total, 73% of patients experienced improvement in both rectal bleeding and stool frequency by day 14 with 4.8 g/day, compared to 61% with 2.4 g/day. More patients achieved symptom resolution by day 14 with 4.8 g/day than 2.4 g/day (43% vs. 30%; P = 0.035). Symptom relief after 14 days was associated with a high rate of symptom relief after 6 weeks. Conclusions High-dose mesalazine 4.8 g/day provides rapid relief of the cardinal symptoms of moderately active ulcerative colitis. Symptom relief within 14 days was associated with symptom relief at 6 weeks in the majority of patients. Day 14 is a practical timepoint at which response to treatment may be assessed and decisions regarding therapy escalation made
引用
收藏
页码:1028 / 1035
页数:8
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