2881 Can Eluxadoline Be Useful in Managing Patients With Functional Diarrhea?

Abstract

INTRODUCTION: Eluxadoline is an FDA approved medication for use in patients with irritable bowel syndrome with diarrhea (IBS-d). It is a peripheral mu-opioid receptor agonist resulting in a reduction in colonic motility while antagonizing central delta receptors that modify pain and thus targets the two key components of IBS-d. Functional diarrhea (FD) is similar to IBS-d, but there is no pain with FD and there are currently no FDA approved medications for its treatment. This caseseries examines the efficacy of eluxadoline in managing FD. METHODS: Electronic medical records at a private gastroenterology clinic were reviewed from May 2015-present. Patients must have undergone diagnostic evaluation including stool elastase, lactoferrin, breath testing, celiac serology, and both upper and lower endoscopy with biopsies. Detailed clinical histories and medication reconciliation were also performed to exclude other causes for diarrhea. Patients found to have other FGIDs, IBD, bowel obstruction, malabsorption, or cholecystectomy were excluded. Patients must also have failed or demonstrated intolerance to OTC anti-diarrheals, dietary changes and supplemental fiber, and anticholinergics or tricyclics. Eligible patients were treated for 6 months with open label eluxadoline and clinical follow up was required. All patients began 100 mg bid, but were allowed to reduce the dose to 75 mg bid if constipation or abdominal discomfort occurred. There were 2 primary endpoints: Improvement in Bristol Stool Scale (BSS) and decrease in daily stool frequency by 30%. RESULTS: Eleven patients with FD were identified by Rome IV criteria and were included in the series. All completed 6 months of therapy with eluxadoline. Patients had a mean BSS of 6.2 (range 6-7) and mean daily stool frequency of 4.8 (range 3-10) at baseline. Eight patients (73%) satisfied both clinical endpoints with an average reduction in stool frequency to 2.8 (range: every other day to 4 per day). The mean BSS decreased from 6.2 to 4.2, with a range of 2-5. 2 patients developed constipation but responded to the lower dose. The remaining 3 patients (27%) showed moderate clinical improvement but did not meet one or both of the primary endpoints. CONCLUSION: 1. Eluxadoline may be an effective tool in managing FD where conventional therapy has failed. 2. The length of the trial demonstrated durability. 3. This open label case series should stimulate interest into funding a blinded placebo controlled trial.