1 Digestive Disease Week (DDW) 2018 June 2-5

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Jun 2, 2018 - Abstract Submission Deadline: Friday, December 1, 2017, at 9 PM ET. CHARACTERIZATION OF LONG-TERM RIFAXIMIN RESPONDERS ...
Digestive Disease Week (DDW) 2018 June 2-5, 2018; Washington, DC Abstract Submission Deadline: Friday, December 1, 2017, at 9 PM ET

CHARACTERIZATION OF LONG-TERM RIFAXIMIN RESPONDERS FROM A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED REPEAT TREATMENT TRIAL FOR DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS-D) (character count, 192; limit including spaces: 255)

Leonard B. Weinstock, MD1,2; Mark Pimentel, MD3; Zeev Heimanson, PharmD4; Anthony Lembo, MD5

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Washington University School of Medicine, St. Louis, MO; 2Specialists in Gastroenterology,

LLC, St. Louis, MO; 3Cedars-Sinai Medical Center, Los Angeles, CA; 4Salix Pharmaceuticals, Bridgewater, NJ; 5Beth Israel Deaconess Medical Center, Boston, MA

Submitting/presenting author: Leonard B. Weinstock, MD Submission type: AGA Oral or Poster Presentation type: AGA Institute Poster Category: Basic and Clinical Intestinal Disorders Subcategory/Descriptors: Irritable Bowel Syndrome: Clinical Science Type: Clinical

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Trial registration: NCT01543178 Previous publication or presentation? No

ABSTRACT (Character count, 2898 [limit, including spaces: 2900]) Background: Rifaximin is approved in the United States for the treatment of adults with IBS-D. Factors impacting maintenance of rifaximin response are unknown. This post hoc analysis of a phase 3 trial characterized patients with IBS-D who maintained response with repeat rifaximin treatment. Methods: Adults with IBS-D received 2 weeks of open-label rifaximin 550 mg three times daily (TID). Those who responded (4-week assessment period) and then had symptom recurrence during an 18-week observation period were randomly assigned to receive two 2-week courses of double-blind rifaximin 550 mg TID or placebo. The 2 courses were separated by 10 weeks (4-week follow-up phase [primary evaluation period], then 6-week additional observation phase) and a second 4-week follow-up phase occurred after the second 2-week course. Longterm response was defined as a ≥30% decrease from baseline in mean weekly pain score and ≥50% decrease from baseline in number of days/week with Bristol Stool Scale type 6 or 7 stool for ≥2 of first 4 weeks post-treatment during the primary evaluation period and was maintained through the second 4-week follow-up phase. Stool urgency was calculated as 7 multiplied by (number of days felt/experienced sense of urgency with any of the bowel movements/number of days with diary data). Abdominal pain, bloating, and IBS symptoms were determined by patient responses to the following: In regards to your specific IBS symptom of abdominal pain, on a scale of 0 (no pain at all) to 10 (worst possible pain you can imagine), what was your worst IBSrelated abdominal pain over the last 24 hours?; In regards to your specific IBS symptom of bloating, on a scale of 0 (not at all) to 6 (a very great deal), how bothersome was your IBS-

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related bloating in the last 24 hours?; and In regards to all your symptoms of IBS, on a scale of 0 to 6, how bothersome were your symptoms of IBS in the last 24 hours?, respectively. Results: 571 patients with IBS-D were included (observed case; rifaximin [n=290]; placebo [n=281]). Long-term response was achieved by 39 (13.4%) rifaximin- and 21 (7.5%) placebo-treated patients (P=0.01). At double-blind baseline, long-term rifaximin responders had a significantly greater mean number of daily bowel movements, and greater number of days with stool urgency, versus rifaximin-treated patients who did not have long-term response (bowel movements, 4.7 vs 3.2, respectively; P=0.0001; urgency, 6.4 vs 4.8; P=0.0001). Also, rifaximin long-term responders had greater mean daily baseline scores for abdominal pain, bloating, and IBS symptoms versus rifaximin-treated patients who did not have long-term response (abdominal pain, 5.8 vs 4.4; P=0.0002; bloating, 4.5 vs 3.6; P=0.0001; IBS symptoms, 4.4 vs 3.6; P=0.0004). Conclusions: Patients with IBS-D with more severe symptoms appeared more likely to maintain long-term response to short-course rifaximin.

Funding source (separate submission field): Salix Pharmaceuticals, Bridgewater, NJ, USA.

Disclosures Leonard Weinstock is a consultant for Salix Pharmaceuticals. Mark Pimentel is a consultant for and has received research grants from Salix Pharmaceuticals. Additionally, Cedars-Sinai Medical Center has a licensing agreement with Salix Pharmaceuticals. Zeev Heimanson is an employee of Salix Pharmaceuticals. Anthony Lembo is a consultant for Salix Pharmaceuticals.

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