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Once-daily MMX ( ® ) mesalamine for endoscopic maintenance of remission of ulcerative colitis . OBJECTIVES Treatment with mesalamine to maintain endoscopic remission ( mucosal healing ) of ulcerative colitis ( UC ) has been shown to reduce the risk of relapse and is the recommended first-line maintenance therapy . To improve treatment adherence , a mesalamine formulation that can be administered once-daily , MMX ( ® ) mesalamine ( Lialda ; Shire Pharmaceuticals LLC , Wayne , PA ) , was developed . This study was conducted to determine the efficacy and safety of once-daily MMX mesalamine compared with twice-daily delayed-release mesalamine ( Asacol ; Warner Chilcott , Dublin , Ireland ) for maintaining endoscopic remission in patients with UC . METHODS A multicenter , randomized , double-blind , 6-month , active-control trial was conducted to assess the non-inferiority of once-daily MMX mesalamine 2.4 g/day compared with twice-daily delayed-release mesalamine at a total daily dose of 1.6 g/day in patients with UC in endoscopic remission . The primary end point was maintenance of endoscopic remission at month 6 in the per-protocol ( PP ) population . RESULTS Overall , 826 patients were randomized and dosed . The primary objective ( non-inferiority ) was met . At month 6 , 83.7 and 77.8 % of patients receiving MMX mesalamine in the PP and intent-to-treat ( ITT ) populations , respectively , had maintained endoscopic remission compared with 81.5 % ( PP ) and 76.9 % ( ITT ) of patients receiving delayed-release mesalamine ( 95 % confidence interval for difference : -3.9 % , 8.1 % ( PP ) ; -5.0 % , 6.9 % ( ITT ) ) . Time to relapse was not significantly different between the two treatment groups ( log-rank test , P=0.5116 ( PP ) ; P=0.5455 ( ITT ) ) . The proportion of patients with adverse events was 37.1 and 36.0 % in patients receiving MMX mesalamine and delayed-release mesalamine , respectively . CONCLUSIONS Once-daily dosing of MMX mesalamine 2.4 g/day was shown to be well tolerated and non-inferior to twice-daily dosing with delayed-release mesalamine 1.6 g/day for maintenance of endoscopic remission in patients with UC .
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Intervention_Pharmacological
mesalamine
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Intervention_Pharmacological
Asacol
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Participant_Condition
ulcerative colitis
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Participant_Sample-size
826