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A Randomized Controlled Study of Mesalamine After Acute Diverticulitis: Results of the DIVA Trial

Stollman, Neil MD, FACP, AGAF, FACG*,†; Magowan, Simon MD; Shanahan, Fergus MD§; Quigley, Eamonn M.M. MD, FRCP, FACP, FACG, FRCPI§; for the DIVA Investigator Group

Journal of Clinical Gastroenterology:
doi: 10.1097/MCG.0b013e31828003f6
ALIMENTARY TRACT: Original Articles
Abstract

Background/Aims: We evaluated the efficacy of mesalamine (Asacol) in reducing gastrointestinal symptoms after an acute attack of diverticulitis.

Methods: This was a 1-year double-blind, randomized, placebo-controlled study in which patients with computed tomography scan confirmed acute diverticulitis received placebo, mesalamine, or mesalamine+Bifidobacterium infantis 35624 (Align) for 12 weeks and followed for 9 additional months. Efficacy was assessed using a global symptom score (GSS) of 10 symptoms (abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus, urgency, painful straining, and dysuria). Patients were required to have a GSS≥12 at baseline, including an abdominal pain score >2.

Results: One hundred seventeen patients (placebo, 41; mesalamine, 40; mesalamine+probiotic, 36) were randomized and treated. GSS decreased in all groups during treatment without a statistically significant difference between mesalamine and placebo, however; scores were consistently lower for mesalamine at all time points. The rate of complete response (GSS=0) was significantly higher with mesalamine than placebo at weeks 6 and 52 (P<0.05), and was particularly high for rectosigmoid symptoms at weeks 6, 12, 26, and 52. Recurrence of diverticulitis was low and comparable across groups. Probiotic in combination with mesalamine did not provide additional efficacy.

Conclusions: In the first US randomized placebo-controlled trial of anti-inflammatory treatment after a documented case of diverticulitis, mesalamine demonstrated a consistent trend in reducing symptoms. Addition of probiotic did not increase mesalamine efficacy. This study supports further investigation into the use of anti-inflammatory agents, such as mesalamine, in the long-term management of diverticulitis.

ClinicalTrials.gov NCT00554099.

Author Information

*Division of Gastroenterology, Department of Medicine, University of California San Francisco

Department of Medicine, Alta Bates Summit Medical Center, Oakland, CA

Procter & Gamble Company, Cincinnati, OH

§Department of Medicine, Alimentary Pharmabiotic Centre, University College Cork, Cork, Ireland

Presented at the Plenary Session of the Annual Meeting of the American College of Gastroenterology (ACG), San Antonio, TX, October 2010.

The study was funded by and writing support provided by Warner Chilcott.

All authors were involved in study concept and design planning, acquisition/analysis/interpretation of data, and manuscript drafting and review.

N.S.: study grant support, consulting fees, and speaking honoraria from Warner Chilcott. S.M.: employee of Procter and Gamble. F.S.: study grant support from GlaxoSmithKline and Alimentary Health Ltd., and supported, in part by Science Foundation, Ireland. E.Q.: study grant support and speaking honoraria from Procter and Gamble; non-executive director of Alimentary Health Ltd.

Reprints: Neil Stollman, MD, FACP, AGAF, FACG, Northern California Gastroenterology Consultants, 3300 Webster St, Suite 312, Oakland, CA, 94609. (e-mail: neil@stollman.com).

Received June 24, 2012

Accepted November 27, 2012

© 2013 by Lippincott Williams & Wilkins