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Once-Daily Delayed-Release Mesalamine as Effective as Twice-Daily Dosing in Maintenance of Remission for Patients With Ulcerative Colitis: Presented at CDDW By Cameron Johnston TORONTO -- March 4, 2010 -- For more than 5 decades now, the mainstay of treatment for ulcerative colitis (UC) has been 5-aminosalicylic acid, taken twice daily. However, a newly released study has reported that the same daily amount of the drug, taken at 1 time in 400-mg delayed-release tablets, is as effective as the split-dose regimen for maintaining remission from the disease. The QD Dosing Investigation for Efficacy in UC Maintenance (QDIEM) study is believed to be the largest prospective controlled investigation ever undertaken to compare the safety and efficacy of using once-daily versus twice-daily dosing of mesalamine in treating patients with UC. Results were presented here on March 2 by Bret Lashner MD, Inflammatory Bowel Disease Center, the Cleveland Clinic, Cleveland, Ohio, at the Canadian Digestive Diseases Week 2010 (CDDW). The study was conducted among 1,023 patients at 193 clinics in Canada and the United States. Patients were already in remission from their colitis. Seventy percent were being maintained on mesalamine 2.4 g/day and 28% were receiving 1.6 g/day. The drugs were taken either twice daily (65%) or 3 times daily (31%). Less than 4% of patients were on once-daily dosing. Patients then continued receiving the same dose of mesalamine they had been on, but now that regimen was made up of multiple 400-mg delayed-release tablets, taken either once- or twice-daily. In an intent-to-treat analysis, 90.5% of patients who received the drug once daily, and 91.8% of those who received it twice daily remained in remission after 6 months of therapy. This was the primary objective of the study, and demonstrated noninferiority between the 2 regimens. At months 3, 6, and 12, there were no significant differences in the patients’ Simple Clinical Colitis Activity Index (SCCAI) scores, whether the patient had been on the once-daily or twice-daily regimen. At months 6 and 12, there were no significant differences in scores taken from a patient-defined component of the index. There was no difference in the time to relapse, with both groups experiencing a relapse rate (SCCAI of >5) of approximately 15% at 12 months. Numerically more serious adverse events were seen in the once-daily treatment arm (18 patients, 3.5%, 25 events) compared with the twice-daily arm (9 patients, 1.8%, 15 events). However, more patients in the twice-daily arm withdrew because of adverse events (7 patients, 1.4%) compared with the once-daily arm (2 patients, 0.4%). On the basis of these data, the authors concluded that once-daily dosing with multiple 400 mg delayed-release mesalamine tablets is as safe and effective at maintaining remission among patients with UC as when the patients take the same daily total, split into 2 doses. CDDW is the annual scientific conference of the Canadian Association of Gastroenterology (CAG) and the Canadian Association for the Study of the Liver (CASL). [Presentation title: Once-Daily Dosing of Delayed Release Oral Mesalamine (400 mg Tablet) Is as Effective as Twice Daily Dosing for Maintenance of Remission of Ulcerative Colitis: Results of the QDIEM Study. Abstract 212] E-mail this page to a friend or colleague! To print, use this version