Journal article
Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials
JB Raskin, MA Kamm, MM Jamal, J Márquez, E Melzer, RE Schoen, T Szalóki, K Barrett, P Streck
Gastroenterology | Published : 2014
Abstract
Background & Aims No therapy has been proven to prevent the recurrence of diverticulitis. Mesalamine has shown efficacy in preventing relapse in inflammatory bowel disease, and there is preliminary evidence that it might be effective for diverticular disease. We investigated the efficacy of mesalamine in preventing recurrence of diverticulitis in 2 identical but separate phase 3, randomized, double-blind, placebo-controlled, multicenter trials (identical confirmatory trials were conducted for regulatory reasons). Methods We evaluated the efficacy and safety of multimatrix mesalamine vs placebo in the prevention of recurrent diverticulitis in 590 (PREVENT1) and 592 (PREVENT2) adult patients w..
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Funding Acknowledgements
This work was funded by the sponsor, Shire Development LLC. Although the sponsor was involved in the design, collection, analysis, interpretation, and fact checking of information, the content of this manuscript, the ultimate interpretation, and the decision to submit it for publication in Gastroenterology was made by the authors.