Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials

Area of Science:

• Gastroenterology
• Clinical Trials
• Pharmacology

Background:

• Diverticulitis recurrence lacks proven preventative therapies.
• Mesalamine shows promise for inflammatory bowel disease and preliminary evidence for diverticular disease.

Purpose of the Study:

• To investigate the efficacy of mesalamine in preventing recurrent diverticulitis.
• Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter trials were conducted.

Main Methods:

• Adult patients with recent diverticulitis episodes received mesalamine (1.2 g, 2.4 g, or 4.8 g) or placebo daily for 104 weeks.
• The primary endpoint was the proportion of recurrence-free patients at week 104.
• Recurrence was defined by surgical intervention or CT scan findings consistent with diverticulitis.

Main Results:

• Mesalamine did not significantly reduce diverticulitis recurrence rates at 104 weeks compared to placebo.
• No difference in time to recurrence or surgical intervention rates was observed between mesalamine and placebo groups.
• No new adverse events were associated with mesalamine administration.

Conclusions:

• Mesalamine demonstrated no superiority over placebo in preventing recurrent diverticulitis.
• Current evidence does not support the use of mesalamine for preventing diverticulitis recurrence.
• ClinicalTrials.gov IDs: NCT00545740 and NCT00545103.