December 05, 2022
1 min read
Cash BD, et al. Rifaximin improves both fecal urgency and stool consistency in adults with irritable bowel syndrome with diarrhea: A composite endpoint analysis of two randomized, phase 3 trials. Presented at: ACG Annual Scientific Meeting; Oct. 21-26, 2022; Charlotte, N.C. (hybrid meeting).
Cash reports serving as a speaker, consultant and advisory board member for Salix Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.
CHARLOTTE, N.C. — Daily treatment with Xifaxan over 2 weeks improved stool consistency and fecal urgency in adults with irritable bowel syndrome-diarrhea, according to a poster at the ACG Annual Scientific Meeting.
“This research was conducted to evaluate rifaximin treatment for simultaneously improving IBS-D symptoms of fecal urgency and loose or watery stool consistency as a unique composite bowel symptom endpoint,” Brooks D. Cash, MD, chief of the division of gastroenterology, hepatology and nutrition at the University of Texas Health Science Center at Houston, and colleagues told Healio.
Researchers conducted a pooled, post-hoc analysis of two phase 3, randomized, double-blind trials in which 1,258 adults with IBS-D received rifaximin (Xifaxan, Salix Pharmaceuticals) 550 mg three times daily (n = 624) or placebo (n = 634) for 2 weeks, followed by a 4-week treatment-free phase and an additional 6 weeks of treatment-free follow-up. Included patients had daily mean stool consistency scores of at least 3.5 and mean daily abdominal discomfort and bloating scores of 2 to 4.5. Researchers further assessed daily fecal urgency based on patient response to the question: “Have you felt or experienced a sense of urgency today?”
According to analysis, similar values at baseline were reported for rifaximin and placebo groups for percentage of days with fecal urgency (82%), mean daily stool consistency score (3.9) and mean number of daily bowel movements. In addition, a significantly greater percentage of patients treated with rifaximin were composite bowel symptom responders for at least two of the first 4 weeks post-treatment compared with placebo (47.9% vs. 39.3%, respectively).”
Researchers also reported that patients treated with rifaximin maintained response during at least three of the additional 6 weeks of treatment-free follow-up compared with the placebo group (44.7% vs. 36.1%). When analyzed weekly, a higher percentage of patients treated with rifaximin were composite bowel symptom responders compared with placebo.
“A 2-week course of daily rifaximin treatment significantly and simultaneously improved fecal urgency and stool consistency compared with placebo in adults with IBS-D,” Cash and colleagues concluded. “This research may help health care practitioners make better informed decisions to continue to help their patients living with IBS symptoms.”