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

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.; Bj�rck, S.; Diez Alonso, M. M.; M�kel�, J.; Talley, N. J.; Dilger, K.; Greinwald, R.; Mohrbacher, R.; Spiller, R.

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 ([less than]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.

Citation

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., …Spiller, R. (2017). Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence. https://doi.org/10.1111/apt.14152

• Journal Article Type: Article
• Acceptance Date: Apr 27, 2017
• Online Publication Date: May 23, 2017
• Publication Date: 2017-08
• Deposit Date: Nov 26, 2020
• Publicly Available Date: Nov 26, 2020
• Journal: Alimentary Pharmacology and Therapeutics [2] (Deleted)
• Print ISSN: 0269-2813
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 46
• Issue: 3
• Pages: 282-291
• DOI: https://doi.org/10.1111/apt.14152
• Public URL: https://nottingham-repository.worktribe.com/output/5071707
• Publisher URL: https://onlinelibrary.wiley.com/doi/full/10.1111/apt.14152