title: Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials.
abstract: OBJECTIVE
  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 with ≥1 episodes of acute diverticulitis in the previous 24 months that resolved without surgery. Patients received mesalamine (1.2 g, 2.4 g, or 4.8 g) or placebo once daily for 104 weeks. The primary end point was the proportion of recurrence-free patients at week 104. Diverticulitis recurrence was defined as surgical intervention at any time for diverticular disease or presence of computed tomography scan results demonstrating bowel wall thickening (>5 mm) and/or fat stranding consistent with diverticulitis. For a portion of the study, recurrence also required the presence of abdominal pain and an increase in white blood cells.
  
  
  RESULTS
  Mesalamine did not reduce the rate of diverticulitis recurrence at week 104. Among patients in PREVENT1, 53%-63% did not have disease recurrence, compared with 65% of those given placebo. Among patients in PREVENT2, 59%-69% of patients did not have disease recurrence, compared with 68% of those given placebo. Mesalamine did not reduce time to recurrence, and the proportions of patients requiring surgery were comparable among treatment groups. No new adverse events were identified with mesalamine administration.
  
  
  CONCLUSIONS
  Mesalamine was not superior to placebo in preventing recurrent diverticulitis. Mesalamine is not recommended for this indication. ClinicalTrials.gov ID: NCT00545740 and NCT00545103.
authors.affiliation: University of Miami Miller School of Medicine, Miami, Florida. Electronic address: JRaskin@med.miami.edu.
authors.forename: Jeffrey B
authors.initials: JB
authors.lastname: Raskin
authors.affiliation: St Vincent's Hospital and University of Melbourne, Melbourne, Australia; Imperial College, London, UK.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Kamm
authors.affiliation: VA Long Beach Healthcare System, Long Beach, California.
authors.forename: M Mazen
authors.initials: MM
authors.lastname: Jamal
authors.affiliation: Clínica Las Américas, Medellin, Colombia.
authors.forename: Juan
authors.initials: J
authors.lastname: Márquez
authors.affiliation: Department of Gastroenterology and Liver Disease, Kaplan Medical Center, Rehovot, Israel.
authors.forename: Ehud
authors.initials: E
authors.lastname: Melzer
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Schoen
authors.affiliation: Department of Gastroenterology, Ödön Jávorszky Hospital, Vác, Hungary.
authors.forename: Tibor
authors.initials: T
authors.lastname: Szalóki
authors.affiliation: Shire, Basingstoke, UK.
authors.forename: Karen
authors.initials: K
authors.lastname: Barrett
authors.affiliation: Shire, Wayne, Pennsylvania.
authors.forename: Paul
authors.initials: P
authors.lastname: Streck
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003082:Colectomy; D003108:Colonic Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery; D004238:Diverticulitis / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000893:Anti-Inflammatory Agents; D005765:Gastrointestinal Agents; D019804:Mesalamine
keywords: Anti-Inflammatory; Clinical Trial; Colon Inflammation; Diverticula