Budesonide MMX™ is effective in patients having persistent symptoms and raised fecal calprotectin following treatments for diverticular disease

Abstract

Background & Aim: Although rifaximin and mesalazine seem to be effective in treating the majority of people suffering from diverticular disease (DD), some patients still experience symptoms following those treatments. The aim of this study was to assess the efficacy of budesonide MMX™ in managing symptoms and raised fecal calprotectin (FC) in patients with endoscopic diagnosis of DD and not responding to standard treatments. Methods: We performed a post-hoc analysis of the patients enrolled in the DICA prospective study. All patients were at the first diagnosis of DD, scored according to DICA classification. We assessed abdominal pain, meteorism, constipation and diarrhea (scored from 0 to 10) and FC expression at baseline and after six months. Patients were treated with budesonide MMX™ for 4 weeks (9 mg/day for 2 weeks, followed by 9 mg every other day for further 2 weeks), followed by mesalazine 2.4 grams/day for further 5 months. Results: We studied 24 patients (18 females and 6 males, median age 64, inter quartile range (IQR): 57.5-73.5), previously treated with mesalazine and/or rifaximin (equally subdivided between DICA 2 and DICA 3). At 6-month follow-up, a significant reduction of all symptoms assessed was observed (abdominal pain and meteorism: p<0.001; constipation: p=0.007; diarrhea: p=0.009). Median (IQR) FC level was 244.5 (171.5-322.0) µg/g at baseline and 51.0 (IQR: 35.5-61.5) µg/g (p< 0.001) after 6 months. No side effects were recorded. Conclusions: Treatment with budesonide MMX™ seems to be effective in obtaining symptoms’ control and dropping of FC in patients with DD and not responding to standard treatments.