title: Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis.
abstract: OBJECTIVE
  Maintenance treatment in ulcerative colitis should be as convenient as possible, to increase the chance of compliance. MMX mesalazine is a once-daily, high-strength (1.2 g/tablet) formulation of 5-aminosalicylic acid. This study evaluated the safety and efficacy of MMX mesalazine dosed once or twice daily as maintenance therapy in patients with ulcerative colitis.
  
  
  METHODS
  This multicentre, randomised, open-label trial enrolled patients with strictly defined clinical and endoscopic remission, immediately following an episode of mild to moderate ulcerative colitis. Patients were randomised to MMX mesalazine 2.4 g/day as a single (2x1.2 g tablet) or divided dose (1x1.2 g tablet twice daily) for 12 months.
  
  
  RESULTS
  174 patients (37.9%; safety population n = 459) experienced 384 adverse events, the majority of which were mild or moderate in intensity. Eighteen patients (3.9%), nine in each group, experienced a total of 22 serious adverse events (10 in the once-daily and 12 in the twice-daily group). Most serious adverse events were gastrointestinal, experienced by 5 patients in the once-daily and 4 in the twice-daily group. At month 12, 64.4% (efficacy population, n = 451) of patients in the once-daily and 68.5% of patients in the twice-daily group were in clinical and endoscopic remission (p = 0.351). At month 12, 88.9% and 93.2% in each group, respectively, had maintained clinical remission (were relapse free).
  
  
  CONCLUSIONS
  MMX mesalazine 2.4 g/day administered as a single or divided dose demonstrated a good safety profile, was well tolerated and was effective as maintenance treatment. High clinical and endoscopic remission rates can be achieved with once-daily dosing.
  
  
  BACKGROUND
  NCT00151944.
authors.affiliation: Department of Medicine, St Vincent's Hospital, Melbourne, Australia. Kamm@ic.ac.uk
authors.forename: M A
authors.initials: MA
authors.lastname: Kamm
authors.forename: G R
authors.initials: GR
authors.lastname: Lichtenstein
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: S
authors.initials: S
authors.lastname: Schreiber
authors.forename: K
authors.initials: K
authors.lastname: Lees
authors.forename: K
authors.initials: K
authors.lastname: Barrett
authors.forename: R
authors.initials: R
authors.lastname: Joseph
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000473:pathology; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D010349:Patient Compliance; D012008:Recurrence; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D019804:Mesalamine