Article ; Online: Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence.
Alimentary pharmacology & therapeutics
2017 Volume 46, Issue 3, Page(s) 282–291
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 ... ...
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. |
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MeSH term(s) | Anti-Inflammatory Agents, Non-Steroidal/administration & dosage ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Diverticulitis/prevention & control ; Double-Blind Method ; Female ; Humans ; Male ; Mesalamine/therapeutic use ; Middle Aged ; Recurrence ; Treatment Outcome |
Chemical Substances | Anti-Inflammatory Agents, Non-Steroidal ; Mesalamine (4Q81I59GXC) |
Language | English |
Publishing date | 2017-05-23 |
Publishing country | England |
Document type | Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial |
ZDB-ID | 639012-2 |
ISSN | 1365-2036 ; 0269-2813 ; 0953-0673 |
ISSN (online) | 1365-2036 |
ISSN | 0269-2813 ; 0953-0673 |
DOI | 10.1111/apt.14152 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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