Kruis, W.Kardalinos, V.Eisenbach, T.Lukas, M.Vich, T.Bunganic, I.Pokrotnieks, JurisDerova, 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.2021-12-132021-12-132017-08Kruis, 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 2017, 'Randomised clinical trial : mesalazine versus placebo in the prevention of diverticulitis recurrence', Alimentary Pharmacology and Therapeutics, vol. 46, no. 3, pp. 282-291. https://doi.org/10.1111/apt.141520269-2813https://dspace.rsu.lv/jspui/handle/123456789/7037Publisher Copyright: © 2017 The Authors. Alimentary Pharmacology and Therapeutics published by John Wiley & Sons LtdBackground: 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.10465389enginfo:eu-repo/semantics/openAccess3.1 Basic medicine3.2 Clinical medicine1.1. Scientific article indexed in Web of Science and/or Scopus databaseHepatologyGastroenterologyPharmacology (medical)/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article10.1111/apt.14152http://www.scopus.com/inward/record.url?scp=85019564492&partnerID=8YFLogxK