Once-daily Mesalamine Formulation for Maintenance of Remission in Ulcerative Colitis: A Randomized, Placebo-controlled Clinical Trial. Issue 4 (April 2016)

• Record Type: Journal Article
• Authors: Gordon, Glenn L.; Zakko, Salam; Murthy, Uma; Sedghi, Shahriar; Pruitt, Ronald; Barrett, Andrew C.; Bortey, Enoch; Paterson, Craig; Forbes, William P.; Lichtenstein, Gary R.
• Is Part Of: Journal of clinical gastroenterology. Volume 50:Issue 4(2016)
• Publication Date: 2016-04
• Subjects: ulcerative colitis -- mesalamine -- remission -- efficacy -- safety; Gastroenterology -- Periodicals; Digestive organs -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Digestive organs -- Diseases; Gastroenterology; Periodicals; Periodicals; 616.33005
• DOI: 10.1097/MCG.0000000000000414
• Languages: English
• ISSNs: 0192-0790

Abstract

Abstract : Goals: To evaluate the efficacy and safety of mesalamine granules 1.5 g once daily for maintenance of ulcerative colitis (UC) remission. Background: Mesalamine is a first-line treatment for induction and maintenance of UC remission. Study: A phase 3, randomized, double-blind, placebo-controlled trial of patients with a history of mild to moderate UC, currently in remission, who received mesalamine granules once daily for 6 months. The primary efficacy endpoint was percentage of patients maintaining UC remission at 6 months. Results: A significantly greater percentage of patients receiving mesalamine granules versus placebo were in remission at 6 months (79.9% vs. 66.7%; P =0.03). A greater percentage of patients receiving mesalamine granules maintained a revised Sutherland Disease Activity Index (SDAI)⩽2 with no individual component of revised SDAI>1 and rectal bleeding=0 at 6 months (72.0% vs. 58.1%; P =0.04). No significant differences between groups were observed for change from baseline to 6 months for total SDAI score or its components (ie, stool frequency, rectal bleeding, mucosal appearance, physician's rating of disease). Mesalamine granules treatment resulted in a significantly longer remission duration versus placebo ( P =0.02) and decreased patients' risk of relapse by 43% (hazard ratio=0.57; 95% confidence interval, 0.35-0.93; P =0.02). Mesalamine granules were well tolerated, and adverse events related to hepatic, renal, and pancreatic function—potential concerns with long-term treatment—occurred at a rate similar to placebo. Conclusions: Once-daily mesalamine granules are efficacious and safe for the maintenance of UC remission.