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- Title
A Multicenter, Open-Label, Controlled, Randomized Study Comparing 4 g Once Daily with 2 g Two Times Daily Prolonged-Release Mesalamine for Mild to Moderate active Ulcerative Colitis.
- Authors
Kang-Moon Lee; Chang Hwan Choi; Yoon Jae Kim; Ji Won Kim; Ja Seol Koo; Jong Pil Im; Tae Oh Kim; Byung Ik Jang; Jae Jun Park; Seong Ran Jeon; You Sun Kim; Jun Lee; Sung-ae Jung; Young Sook Park; Dong Il Park
- Abstract
Background/Aims Aminosalicylates are mainstay for inducing and maintaining remission in mild to moderate ulcerative colitis (UC). Multi-dosing regimen is inconvenient and may negatively affect patients' compliance to medication. We conducted this study to determine the therapeutic equivalence and safety of once daily (OD) versus two times daily (BD) dosing of a total daily dose of 4 g prolonged-release mesalamine in inducing clinical and endoscopic remissions in patients with mild to moderated UC. Methods In this open-label, controlled study, UC patients with Mayo score of 3 to 10 were randomly assigned either to four tablets OD or two tablets BD of prolonged-release mesalamine (1 g tablet) treatment. Disease activity was assessed at weeks 0, 4, 8 and 12 and endoscopic assessment was performed prior to and 8 weeks after treatment. Clinical remission was defined as Mayo Clinic score of 2 or lower and no individual subscore higher than 1, and endoscopic remission as Mayo endoscopic subscore of 0. Primary endpoint was composite clinical and endoscopic remission at week 8. Results Of the total 256 eligible patients, 129 were assigned to the OD group and 127 to the BD group. There was no significant difference in composite clinical and endoscopic remission at week 8 between OD and BD groups (intention-to-treat population: 20.9% vs 15.0%, 95% confidence interval, -3.4 to 15.3; p=0.25) and non-inferiority of OD to BD was demonstrated. Clinical and endoscopic improvement, complete remission, and time to remission were similar between the two groups. Adverse events were reported in 20.9% in OD and 18.1% in BD group (p=0.57). Conclusions Prolonged-release mesalamine 4 g once-daily is as effective and well tolerated as 2 g twice-daily for inducing clinical and endoscopic remission in patients with mild-to-moderately UC.
- Subjects
MAYO Clinic; ULCERATIVE colitis; DISEASE remission; MESALAMINE; PATIENT compliance; CONFIDENCE intervals
- Publication
Gut & Liver, 2019, Vol 13, Issue 6(suppl. 1), p58
- ISSN
1976-2283
- Publication type
Article