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Association Between Symptoms in Irritable Bowel Syndrome With Diarrhea: A Pooled Correlation and Tricomposite Endpoint Analysis of Two Phase 3, Randomized, Placebo-Controlled, Rifaximin Trials Narrated by Kyle Staller MD, Assistant Professor of Medicine, Harvard Medical School, Boston, Massachusetts

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BACKGROUND AND AIM

Criteria for establishing a diagnosis of irritable bowel syndrome (IBS) include recurrent abdominal pain and altered stool consistency/frequency; however, other symptoms (eg, bloating) are common and bothersome^1-3
Rifaximin (Xifaxan®, Salix Pharmaceuticals, Bridgewater, NJ) is indicated in the United States for the treatment of adults with IBS with diarrhea (IBS-D)⁴ and has been shown to improve multiple IBS-D symptoms, including abdominal pain, bloating, and stool consistency^5,6
Aim: to evaluate rifaximin effectiveness in improving a unique trisymptom (“tricomposite”) endpoint (abdominal pain/discomfort, bloating, bowel movement [BM] urgency) and to assess potential relationships between improvement between global and individual symptom improvements in patients with IBS-D

METHODS

Pooled post hoc analysis of two phase 3, identically designed, randomized, double-blind, placebo-controlled trials⁵
Population included adults with IBS-D with mean daily abdominal pain/discomfort and bloating scores, rated separately, of 2 to 4.5 and a daily mean stool consistency score of ≥3.5 (evaluated during a ≥7-day screening period)
- Daily abdominal pain/discomfort and bloating assessed separately using a 7-point scale: 0 (“not at all”) to 6 (“a very great deal”)
- Daily stool consistency assessed using a 5-point scale: 1 (“very hard”) to 5 (“watery”)
Patients were randomly assigned to receive rifaximin 550 mg three times daily or placebo for 2 weeks, followed by a 10-week follow-up period
BM urgency was assessed daily, based on patients’ yes/no responses to “Have you felt or experienced a sense of urgency today?”

METHODS

Global IBS symptoms were also assessed daily (“In regards to all your symptoms of IBS; on scale of 0 [“not at all”] to 6 [“a very great deal”], how bothersome were your symptoms of IBS today?”)
Tricomposite responders: defined as patients with ≥30% decrease from baseline in both weekly mean abdominal pain/discomfort and bloating scores and ≥30% decrease from baseline in the percentage of days with BM urgency, for ≥2 of first 4 weeks post-treatment7
Pearson correlation analyses compared change from baseline in abdominal pain/discomfort, bloating, stool consistency, or BM urgency and global IBS symptoms (overall [12 weeks] and by week)
- Coefficient (r) value of >0.70 to 1.00 was considered a strong positive correlation (>0.50-0.70
  [moderate] and ≤0.50 [weak-to-negligible])

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