***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objectives : To determine the therapeutic equivalence and safety of once daily ( OD ) versus three times daily ( TID ) dosing of a total daily dose of 3 g Salofalk ( mesalazine ) granules in patients with active ulcerative colitis . Design : A r and omised , double-blind , double-dummy , parallel group , multicentre , international , phase III non-inferiority study . Setting : 54 centres in 13 countries . Patients : 380 patients with confirmed diagnosis of established or first attack of ulcerative colitis ( clinical activity index (CAI)>4 and endoscopic index ⩾4 at baseline ) were r and omised and treated . Interventions : 8-week treatment with either 3 g OD or 1 g TID mesalazine granules . Main outcome measures : Clinical remission ( CAI⩽4 ) at study end . Results : 380 patients were evaluable for efficacy and safety by intention-to-treat ( ITT ) ; 345 for per protocol ( PP ) analysis . In the ITT population , 79.1 % in the OD group ( n = 191 ) and 75.7 % in the TID group ( n = 189 ) achieved clinical remission ( p<0.0001 for non-inferiority ) . Significantly more patients with proctosigmoiditis achieved clinical remission in the OD group ( 86 % ; n = 97 ) versus the TID group ( 73 % ; n = 100 ; p = 0.0298 ) . About 70 % of patients in both treatment groups achieved endoscopic remission , and 35 % in the OD group and 41 % in the TID group achieved histological remission . About 80 % of all patients preferred OD dosing . Similar numbers of adverse events occurred in 55 patients ( 28.8 % ) in the OD group and in 61 patients ( 32.3 % ) in the TID group , indicating that the two dosing regimens were equally safe and well tolerated . Conclusions : OD 3 g mesalazine granules are as effective and safe as a TID 1 g schedule . With respect to the best possible adherence of patients to the treatment , OD dosing of mesalazine should be the preferred application mode in active ulcerative colitis . Clinical Trials.gov Identifier : Background and Aims Multiple studies have demonstrated the efficacy of aminosalicylates in maintaining remission in ulcerative colitis ( UC ) . A newer formulation of mesalamine can be administered once daily . We aim ed to examine the efficacy and tolerability of pH-dependent mesalamine for long-term maintenance , and compare the rates of medication consumption between groups over a prolonged period . Methods Subjects whose UC had been quiescent for at least 4 months , and who had been receiving mesalamine for maintenance only , were r and omized to once daily or conventional dosing for 12 months .  Disease activity and medication consumption was assessed every 3 months . The primary endpoint was the percentage of those with quiescent disease at 12 months . Results We enrolled 20 patients , 12 to once daily and 8 to conventional dosing . Six of the 12 patients ( 50 % ) in the once daily group compared with 5 of the 8 patients ( 62.5 % ) in the conventional group experienced a flare ( p = 0.31 ) . Only 5 of the 12 ( 42 % ) patients in the once daily group were adherent compared with 3 of 8 patients ( 37.5 % ) in the conventional dosing group ( p = NS ) . Median amount consumed in the once daily group was 63 % ( range 0%–100 % ) and in the conventional group 55 % ( range 0%–100 % ) , ( p > 0.5 ) . None of the adherent subjects in the once daily group experienced a flare , while 6 out of 7 ( 86 % ) who were non-adherent experienced a flare ( p < 0.01 ) . In the conventional dosing group , 1 in 3 adherent patients ( 33 % ) experienced a flare compared with 4 out of 5 ( 80 % ) in the non-adherent group ( p < 0.01 ) . Conclusion Adherence , rather than medication regimen , appeared to be important in disease outcome at 12 months Background : Mesalazine ( Asacol ) is still widely prescribed in divided doses for ulcerative colitis ( UC ) , despite evidence that adherence is improved by once‐daily ( OD ) prescribing . We aim ed to investigate whether OD Asacol was as effective as three times ( TDS ) daily dosing , and to evaluate the role of treatment adherence . Methods : An investigator‐blind r and omized trial was undertaken comparing OD Asacol ( three 800 mg tablets ) versus one 800 mg TDS in maintenance of remission of UC over 1 year . The primary endpoint was relapse rate , and noninferiority would be concluded if the lower limit of the two‐sided 95 % confidence interval ( CI ) of the difference in proportions relapsing ( TDS‐OD ) exceeded −10 % . Adherence was measured by tablet counts and self‐reported adherence . A subgroup of patients used a bottle cap that recorded all bottle opening events . Results : In all , 213 patients were r and omized . In the intention‐to‐treat ( ITT ) population , relapse rates were 31 % ( 95 % CI 22%–40 % ) in the OD and 45 % ( 95 % CI 35%–54 % ) in the TDS group . Primary analysis confirmed the noninferiority  of OD dosing . Two of the study population s , ITT and per‐ protocol ( PP ) , showed potential superiority of OD dosing . All measures of adherence showed that it was significantly better in the OD group . Multivariate analysis , however , showed OD dosing was associated with lower relapse risk independently of adherence . Conclusions : OD dosing with Asacol 2.4 g is as safe and effective  as TDS dosing , and secondary analysis confirmed significantly reduced relapse rates . The benefit , however , was clinical ly borderline and may relate in part to ease of adherence . ( Inflamm Bowel Dis 2012 BACKGROUND & AIMS SPD476 ( MMX mesalamine ) , a novel , once-daily mesalamine formulation , uses MMX Multi Matrix System ( MMX ) technology to delay and extend delivery of active drug throughout the colon . We performed a r and omized , double-blind , parallel-group , placebo-controlled , multicenter phase III study in patients with mild to moderately active ulcerative colitis . METHODS Two hundred eighty patients with mild to moderately active ulcerative colitis received MMX mesalamine 2.4 g/day given twice daily ( n = 93 ) , 4.8 g/day given once daily ( n = 94 ) , or placebo ( n = 93 ) for 8 weeks . The primary end point was the percentage of patients in clinical and endoscopic remission ( modified ulcerative colitis disease activity index score of < or = 1 , with a score of 0 for rectal bleeding and stool frequency , and at least a 1-point reduction in sigmoidoscopy score ) at week 8 . Patients with mucosal friability were not considered to have achieved this end point . RESULTS Clinical and endoscopic remission at week 8 was achieved by 34.1 % and 29.2 % of patients receiving MMX mesalamine 2.4 g/day given twice daily and MMX mesalamine 4.8 g/day given once daily , respectively , versus 12.9 % receiving placebo ( P < .01 ) . MMX mesalamine was generally well-tolerated . CONCLUSIONS MMX mesalamine given once or twice daily is well-tolerated and , compared with placebo , demonstrated efficacy for the induction of clinical and endoscopic remission in mild to moderately active ulcerative colitis BACKGROUND & AIMS This study was conducted to assess , in a small sample , the short-term outcomes of once-daily mesalamine versus conventional dosing in maintaining quiescent ulcerative colitis ( UC ) and to assess adherence rates with both regimens . METHODS Consecutive patients were r and omly assigned to either a once-daily regimen , or they continued current conventional regimen ( twice daily or 3 times daily ) . Patients were assessed at 3 months and 6 months . At each point , a clinical symptom disease score was obtained using patient question naires , and medication rates via pharmacy data . Adherence was defined as consumption of > 80 % of prescribed medication . Information was collected by an investigator blinded to treatment regimen . RESULTS Twenty-two patients were enrolled in the study , 12 in the once-daily group ( QD ) and 10 in the conventional group ( CD ) . At 3 months , no patients had experienced a relapse . All of the patients in the QD group and 70 % of patients in the CD group were adherent ( P = 0.04 ) . The average amount of medication consumed in the QD group was significantly higher than in the CD group ( 90 % vs. 75 % , P = 0.02 ) . At 6 months , 2 patients ( 1 patient from each group ) experienced a clinical relapse ( P = 0.76 ) . Seventy-five percent vs. 70 % of patients were adherent ( P = 0.8 ) ; the amount of medication taken approached significance ( 90 % vs. 76 % , P = 0.07 ) . All patients in the QD group reported being either " very satisfied " or " satisfied " with their regimen . CONCLUSIONS In this r and omized pilot trial , patients taking once-daily mesalamine had outcomes similar to those for patients on conventional regimens . A larger trial is warranted to assess whether true differences between regimens exist BACKGROUND & AIMS The practice of dosing mesalamines 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 . This study was conducted to determine the efficacy and safety of once-daily dosing of delayed-release mesalamine ( Asacol 400-mg tablets ) compared with twice-daily dosing for maintaining remission in UC patients . METHODS A multicenter , r and omized , investigator-blinded , 12-month , active-control trial was conducted to assess the noninferiority of delayed-release mesalamine 1.6 - 2.4 g/day administered once daily compared with twice daily in patients with mild-to-moderate UC currently in clinical remission . The primary end point was maintenance of clinical remission at month 6 . RESULTS A total of 1023 patients were r and omized and dosed . The primary objective of noninferiority was met . At month 6 , 90.5 % of patients receiving once-daily dosing had maintained clinical remission , compared with 91.8 % of patients receiving twice-daily dosing ( 95 % confidence interval for twice daily - once daily , -2.3 to 4.9 ) . At month 12 , 85.4 % of patients receiving once-daily dosing had maintained clinical remission , compared with 85.4 % of patients receiving twice-daily dosing ( 95 % confidence interval for twice daily - once daily , -4.6 to 4.7 ) . Both regimens had low rates of withdrawals as a result of adverse events and serious adverse events . CONCLUSIONS Once-daily dosing of delayed-release mesalamine 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 Background : Ulcerative colitis ( UC ) , a chronic , relapsing , and remitting inflammatory bowel disease , requires long-term treatment to maintain remission . In this study , the long-term safety and tolerability of mesalamine granules ( MG ) therapy was evaluated in the maintenance of UC remission . Previous prospect i ve studies evaluating different oral mesalamine formulations have not exceeded a duration of 14 months . Methods : A phase 3 , multicenter , 24-month , open-label extension study evaluating MG 1.5 g once daily in patients who achieved previous remission from mild to moderate UC was performed . Eligible patients had successfully participated in 1 of 2 previous 6-month double-blind , placebo-controlled trials or were new patients in remission . Safety assessment s included monitoring of adverse events ( AEs ) and clinical laboratory tests . Risk of UC recurrence was assessed by the occurrence of UC-related AEs . Results : Of the 393 patients enrolled ( 280 from the double-blind studies ; 113 new patients ) , 388 were included in the safety population . The most common AEs included nasopharyngitis ( 13.9 % ) , headache ( 11.6 % ) , and diarrhea ( 10.8 % ) , and the incidence of these events was generally lower in the MG group versus historical placebo group from the double-blind studies . Pancreatic , renal , and hepatic AEs occurred in 23 patients ( 5.9 % ) . The risk of UC-related AEs was low and was maintained for 24 months during the open-label study . Conclusions : Once-daily MG has a favorable safety profile for the maintenance of remission for up to 2 years in patients with UC BACKGROUND & AIMS SPD476 ( LIALDA in the US ; MEZAVANT in the EU ; otherwise known as MMX mesalamine ; Shire Pharmaceuticals Inc. , Wayne , PA , under license from Giuliani SpA , Milan , Italy ) is a novel , once-daily , high- 
    Output:
    
No significant differences were noted in rates of medication adherence or adverse events between OD and MD dosing .
With regard to mesalamine suppository , no significant differences were noted for comparisons between dosing regimens and adverse events for induction of remission .
OD dose of mesalamine is as effective and safe as MD doses for the induction and maintenance treatment of mild to moderate UC .
OD mesalamine given as a suppository can attain the same effect and safety as MD mesalamine in inducing remission of mild to moderate ulcerative colitis