Browsing by Author "Kardalinos, V."

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    Randomised clinical trial : mesalazine versus placebo in the prevention of diverticulitis recurrence
    (2017-08) Kruis, W.; Kardalinos, V.; Eisenbach, T.; Lukas, M.; Vich, T.; Bunganic, I.; Pokrotnieks, Juris; 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.
    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.