Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence

W Kruis, V Kardalinos, T Eisenbach, M Lukas, T Vich, I Bunganic, J Pokrotnieks, J Derova, J Kondrackiene, R Safadi, D Tuculanu, Z Tulassay, J Banai, A Curtin, A E Dorofeyev, S F Zakko, N Ferreira, S Björck, M M Diez Alonso, J Mäkelä, N J Talley, K Dilger, R Greinwald, R Mohrbacher, R Spiller, W Kruis, V Kardalinos, T Eisenbach, M Lukas, T Vich, I Bunganic, J Pokrotnieks, J Derova, J Kondrackiene, R Safadi, D Tuculanu, Z Tulassay, J Banai, A Curtin, A E Dorofeyev, S F Zakko, N Ferreira, S Björck, M M Diez Alonso, J Mäkelä, N J Talley, K Dilger, R Greinwald, R Mohrbacher, R Spiller

Abstract

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.

© 2017 The Authors. Alimentary Pharmacology and Therapeutics published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Patient disposition (ITT and PP population)
Figure 2
Figure 2
Proportion of patients free of diverticulitis recurrence over 48 weeks (SAG‐37: ITT population; SAG‐51: modified ITT population)

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Source: PubMed

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