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Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence
Author(s) -
Kruis W.,
Kardalinos V.,
Eisenbach T.,
Lukas M.,
Vich T.,
Bunganic I.,
Pokrotnieks J.,
Derova J.,
Kondrackiene J.,
Safadi R.,
Tuculanu D.,
Tulassay Z.,
Banai J.,
Curtin A.,
Dorofeyev A. E.,
Zakko S. F.,
Ferreira N.,
Björck S.,
Diez Alonso M. M.,
Mäkelä J.,
Talley N. J.,
Dilger K.,
Greinwald R.,
Mohrbacher R.,
Spiller R.
Publication year - 2017
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.14152
Subject(s) - mesalazine , medicine , placebo , diverticulitis , gastroenterology , clinical endpoint , placebo controlled study , randomized controlled trial , surgery , ulcerative colitis , double blind , pathology , alternative medicine , disease
Summary Background Previous studies have reached conflicting conclusions regarding the efficacy of mesalazine in the prevention of recurrent diverticulitis. Aim To investigate the efficacy and safety of mesalazine granules in the prevention of recurrence of diverticulitis after acute uncomplicated diverticulitis. Methods Two phase 3, randomised, placebo‐controlled, double‐blind multicentre trials ( SAG ‐37 and SAG ‐51) investigated mesalazine granules in patients with prior episodes (<6 months) of uncomplicated left‐sided diverticulitis. Patients were randomised to receive either 3 g mesalazine once daily or placebo ( SAG ‐37, n=345) or to receive either 1.5 g mesalazine once daily, 3 g once daily or placebo for 96 weeks ( SAG ‐51, n=330). The primary endpoint was the proportion of recurrence‐free patients during 48 weeks ( SAG ‐37 and SAG ‐51) or 96 weeks ( SAG ‐51) of treatment. Results Mesalazine did not increase the proportion of recurrence‐free patients over 48 or 96 weeks compared to placebo. In SAG ‐37, the proportion of recurrence‐free patients during 48 weeks was 67.9% with mesalazine and 74.4% with placebo ( P =.226). In SAG ‐51, the proportion of recurrence‐free patients over 48 weeks was 46.0% with 1.5 g mesalazine, 52.0% with 3 g mesalazine and 58.0% with placebo ( P =.860 for 3 g mesalazine vs placebo) and over 96 weeks 6.9%, 9.8% and 23.1% respectively ( P =.980 for 3 g mesalazine vs placebo). Patients with only one diverticulitis episode in the year prior to study entry had a lower recurrence risk compared to >1 episode. Safety data revealed no new adverse events. Conclusion Mesalazine was not superior to placebo in preventing recurrence of diverticulitis.