CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RESEARCH SUPPORT, NON-U.S. GOV'T
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The effect of third-party reporting on adoption of evidence-based mesalazine regimens in ulcerative colitis: an observational study.

BACKGROUND AND AIMS: The optimal mesalazine dosing strategy for ulcerative colitis (UC) continues to evolve. The current study aimed to explore whether documenting drug use could prompt changes in prescribing habits.

METHODS: In a multicenter, prospective, observational study, outpatients with active or quiescent UC were enrolled if they were receiving, or were planned to receive, sustained release mesalazine microgranules (Pentasa). Clinical and prescribing data were collected at study entry, after 2 and 8 weeks. Physician-reported influences on prescribing decisions were recorded at study entry.

RESULTS: 360 patients were analyzed (203 active UC, 157 remission). Prior to study entry, the range of oral mesalazine doses was 0.50-6.00 g/day in active UC patients, and 0.50-4.00 g/day for patients in remission. These changed to 1.50-5.00 g/day and 1.00-4.00 g/day, respectively, at study entry with little change thereafter. Use of a single daily mesalazine dose increased from 16.7% to 58.0% of active cases during the study, and from 5.9% to 46.8% in remission cases. Gastroenterologists reported that their basis for prescription decision-making was most frequently medical experience (80.8%), followed by guidelines (67.2%), further education or colleagues' recommendations (50.0%) and current study results (20.0%).

CONCLUSION: In this analysis of mesalazine dosing in routine clinical practice, there was an improvement in adherence to European Crohn's and Colitis Organisation (ECCO) guidelines and in use of once-daily dosing, consistent with recent trial results, following documentation of dosing regimens. Written reporting of drug dosing schedules should be considered fundamental for chronic, complex diseases such as UC.

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