BACKGROUND Mesalazine (Asacol) is still widely prescribed in divided doses for ulcerative colitis (UC), despite evidence that adherence is improved by once-daily (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 adherence. METHODS An investigator-blind… (More)
This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. investigators. Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial.
The goal of a non-inferiority (NI) trial is to determine whether or not a new treatment is no worse than an existing treatment on some outcome of interest. Analysis based on the intention-to-treat (ITT) principle is anti-conservative in this instance, so current guidelines recommend analysing on a per-protocol (PP) population in addition. However, PP… (More)
Background The Colitis Once Daily Asacol ® (CODA) study assessed the efficacy and safety of once daily (OD) dosing with Mesalazine (Asacol ® , 2.4g as 3 x 800mg tablets) versus one 800mg tablet three times daily (TDS) over a 12 month period for patients in remission with ulcerative colitis (UC). Emerging evidence suggests OD Mesalazine is as effective as… (More)