Authors: Hawthorne Barney A Stenson Rachel Gillespie David Swarbrick Edwin T Dhar Anjan Kapur Kapil C Hood Kerry Probert Chris SJ
Publish Date: 2012/10/01
Volume: 18, Issue: 10, Pages: 1885-1893
Abstract
Barney A Hawthorne Rachel Stenson David Gillespie Edwin T Swarbrick Anjan Dhar Kapil C Kapur Kerry Hood Chris SJ Probert Oneyear Investigatorblind Randomized Multicenter Trial Comparing Asacol 24 g Once Daily with 800 mg Three Times Daily for Maintenance of Remission in Ulcerative Colitis Inflammatory Bowel Diseases Volume 18 Issue 10 1 October 2012 Pages 1885–1893 https//doiorg/101002/ibd21938Mesalazine Asacol is still widely prescribed in divided doses for ulcerative colitis UC despite evidence that adherence is improved by oncedaily OD prescribing We aimed to investigate whether OD Asacol was as effective as three times TDS daily dosing and to evaluate the role of treatment adherenceAn investigatorblind randomized trial was undertaken comparing OD Asacol three 800 mg tablets versus one 800 mg TDS in maintenance of remission of UC over 1 year The primary endpoint was relapse rate and noninferiority would be concluded if the lower limit of the twosided 95 confidence interval CI of the difference in proportions relapsing TDSOD exceeded −10 Adherence was measured by tablet counts and selfreported adherence A subgroup of patients used a bottle cap that recorded all bottle opening eventsIn all 213 patients were randomized In the intentiontotreat ITT population relapse rates were 31 95 CI 22–40 in the OD and 45 95 CI 35–54 in the TDS group Primary analysis confirmed the noninferiority of OD dosing Two of the study populations ITT and perprotocol PP showed potential superiority of OD dosing All measures of adherence showed that it was significantly better in the OD group Multivariate analysis however showed OD dosing was associated with lower relapse risk independently of adherence
Keywords: