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- W2325795779 abstract "The practice of dosing 5-aminosalicylates in divided doses for the treatment of ulcerative colitis (UC) began with sulfasalazine and was driven by sulfapyridine toxicity. This convention and the assumption that dosing multiple times a day is necessary to treat UC had not been challenged until recently. To determine the efficacy and safety of once daily (QD) dosing of delayedrelease mesalamine (400mg tablets) compared to twice daily (BID) dosing for maintaining remission in patients with UC. A multi-center, randomized, investigator-blinded, 12-month, activecontrol trial (QDIEM) was conducted to assess the non-inferiority of QD versus BID dosing for maintaining clinical remission in patients with UC. Patients who had been maintained in clinical remission (Simple Clinical Colitis Activity Index [SCCAI] score ≤ 2 points) on mesalamine doses ranging from 1.6 g/day to 2.4 g/day were randomized to either a QD or BID dosing regimen at the same total daily dose that the patients had been maintained on prior to study entry. The primary endpoint was the percent of patients remaining in remission at Month 6 for QD dosing as compared with BID dosing. Relapse was defined as an SCCAI score ≥ 5 points. In order to assess whether non-inferiority was met a 95% confidence interval for the difference between the BID and QD groups was computed. Safety parameters included investigator reports of Serious Adverse Events (SAEs) and withdrawals due to adverse events. One thousand twenty three (1023) patients with UC in clinical remission were randomized and dosed. Seventy percent (70%) of patients received 2.4 g/day, 28% received 1.6 g/day and 2% received 2.0 g/day. The primary objective of noninferiority was met with 90.5% (428/473) and 91.8% (435/474) of patients dosed QD and BID, respectively, remaining in clinical remission at Month 6 (95% CI for BID-QD, -2.3, 4.9). At Month 12, 85.4% (379/444) of patients receiving QD dosing had maintained clinical remission, compared with 85.4% (380/445) of patients receiving BID dosing (95% CI for BID-QD, -4.6, 4.7). The number of SAEs and withdrawals due to AEs were similar between the QD and BID dosing regimens. In this study, once-daily dosing of delayed-release mesalamine (400mg tablets) at doses of 1.6-2.4 g/day was shown to be as effective as twice daily dosing for maintenance of clinical remission in patients with UC." @default.
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- W2325795779 date "2009-12-01" @default.
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- W2325795779 title "Once daily dosing of delayed-release oral mesalamine for maintenance of remission of Ulcerative Colitis (the QDIEM Trial): 6 and 12 month results" @default.
- W2325795779 doi "https://doi.org/10.1097/00054725-200912002-00041" @default.
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