Mesalazine not beneficial in preventing diverticulitis recurrence
Mesalazine is not superior to placebo in terms of preventing recurrence in patients with diverticulitis, according to data from two phase III trials.
Patients with prior episodes (<6 months) of uncomplicated left-sided diverticulitis were randomized to receive either 3 g mesalazine once daily (n=171) or placebo (n=174) in SAG-37 or to receive either 1.5 g mesalazine once daily (n=125), 3 g once daily (n=92) or placebo for 96 weeks (n=113) in SAG-51. The primary outcome measure was the proportion of recurrence-free patients during 48 weeks (SAG-37 and SAG-51) or 96 weeks (SAG-51) of treatment.
Compared with placebo, treatment with mesalazine did not result in an increased proportion of recurrence-free patients over 48 or 96 weeks. At week 48, the proportion of recurrence-free patients was 67.9 percent with mesalazine vs 74.4 percent with placebo in SAG-37; 46.0 percent with 1.5 g mesalazine and 52.0 percent with 3 g vs 58.0 percent with placebo in SAG-51. At week 96, the respective proportions of recurrence-free patients with mesalazine 1.5 g, 3g and placebo were 6.9, 9.8 and 23.1 percent.
Overall, 71.2 percent of patients in SAG-37 and 51.9 percent of those in SAG-51 were recurrence-free at week 48. By week 96, only 13 percent remained free of disease recurrence in SAG-51. The risk of recurrence was particularly lower among patients with only one diverticulitis episode in the year prior to study entry as compared with those who had more than one episodes.
Safety data showed no new adverse events.
The findings demonstrate that mesalazine offers no recurrence-reduction benefit in patients with diverticulitis.
“Whether the anti-inflammatory effects of mesalazine are too weak to prevent recurrence or whether the pathophysiology of acute diverticulitis cannot be compared to chronic inflammatory conditions such as ulcerative colitis remains highly speculative,” researchers said.
Uncomplicated diverticulitis is characterized by colonic wall thickening and peridiverticulitis by cross-sectional imaging, whereas complicated diverticulitis is linked to abscesses or fistula or obstruction or perforation. About 13 to 36 percent of patients with uncomplicated diverticulitis and 47 percent of those with complicated disease experience a recurrent episode. [Aliment Pharmacol Ther 2015;42:664-684; Nat Rev Gastroenterol Hepatol 2015;12:629-638; Aliment Pharmacol Ther 2014;39:359-370]