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180 MESALAMINE STARTING DOSE AND TIME TO FLARE AMONG ULCERATIVE COLITIS AND CROHN'S DISEASE PATIENTS BR Yacyshyn, RL Sheer, M Steinbuch PURPOSE: To quantify the time to flare among IBD patients receiving at or above the median average daily starting dose versus below the median average daily starting dose.
Procter & Gamble Pharmaceuticals, Mason, Ohio, USA
METHODS: A retrospective cohort study was conducted using data from Saskatchewan Health. Patients with a 400 mg strength/tablet mesalamine prescription between January 1, 1990 and December 31, 2002 (index date) were followed until the time of a flare. A flare was defined as an interval of => 6 months until a subsequent 5-aminosalicylate (5-ASA) prescription at the same dose or a 5-ASA prescription at a higher dose; or a glucocorticosteroid or immunomodulator prescription => 4 months after the index date. We identified ulcerative colitis (UC) and Crohn's disease (CD) patients with a diagnosis ± 60 days from the index date. Mesalamine patients with a UC or CD diagnosis > 60 days to <= 12 months before the index date and patients with a record of 5-ASA or immunomodulator therapy in the 12-month period prior to the index date were excluded from the study. The median average daily starting dose over the first 100 days following the index date was computed to differentiate between higher starting dose and lower starting dose.
RESULTS: 829 UC and CD patients with a 400 mg strength/tablet mesalamine prescription were identified (566 patients were UC and 330 were CD). The median time to flare after the index date was 346 days among patients with UC (n=310) and an average daily starting dose of => 1.6 g/day, compared to a median time to flare of 269 days for UC patients (n=256) with an average daily dose of < 1.6 g/day (p=0.01). CD patients (n=165) with an average daily starting dose of => 1.35 g/day had a median time to flare of 286 days versus 260 days for CD patients (n=165) averaging < 1.35 g/day (p=0.02).
CONCLUSIONS: The results suggest that patients with UC or CD starting mesalamine therapy and receiving a higher average daily starting dose prolong their time to flare occurrence compared to patients with a lower average daily starting dose. Further investigation involving the effect of subsequent dosing patterns on time-to-flare is warranted.
This research was funded by Procter & Gamble Pharmaceuticals