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., Bjorck, S., Alonso, M. M. Diez, Makela, J., Talley, N. J., Dilger, K., Greinwald, R., Mohrbacher, R. and Spiller, R. (2017). Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence. Aliment. Pharmacol. Ther., 46 (3). S. 282 - 292. HOBOKEN: WILEY. ISSN 1365-2036

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Kruis, W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kardalinos, V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eisenbach, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lukas, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vich, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bunganic, I.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pokrotnieks, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Derova, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kondrackiene, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Safadi, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tuculanu, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tulassay, Z.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Banai, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Curtin, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dorofeyev, A. E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zakko, S. F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ferreira, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bjorck, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alonso, M. M. DiezUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Makela, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Talley, N. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dilger, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Greinwald, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mohrbacher, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spiller, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-224520
DOI: 10.1111/apt.14152
Journal or Publication Title: Aliment. Pharmacol. Ther.
Volume: 46
Number: 3
Page Range: S. 282 - 292
Date: 2017
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1365-2036
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
DOUBLE-BLIND; DISEASE; MANAGEMENT; MESALAMINE; COLON; MULTICENTER; ARTICLEMultiple languages
Gastroenterology & Hepatology; Pharmacology & PharmacyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/22452

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