P1129 (S0492). - Tegaserod 6 Mg BID for Treating Abdominal Pain and Bloating in Women With Irritable Bowel Syndrome With Constipation but Without Cardiovascular Risk Factors: A Pooled Analysis of 4 Clinical Trials
Assistant Professor of Medicine; Director, Center for Gastrointestinal Motility Dartmouth-Hitchcock Medical Center Lebanon, NH
Eric D. Shah, MD, MBA1, Brian E. Lacy, MD, PhD, FACG2, William D. Chey, MD, FACG3, Lin Chang, MD4, Darren M. Brenner, MD, FACG5; 1Dartmouth-Hitchcock Medical Center, Lebanon, NH; 2Mayo Clinic, Jacksonville, FL; 3University of Michigan Health System, Ann Arbor, MI; 4David Geffen School of Medicine at UCLA, Los Angeles, CA; 5Northwestern University Feinberg School of Medicine, Chicago, IL
Introduction: Irritable bowel syndrome with constipation (IBS-C) is characterized by symptoms that extend beyond bowel movement frequency and are worrisome to most patients (e.g., abdominal pain, bloating). The 5-HT4 receptor agonist tegaserod 6 mg BID is approved for treating IBS-C in women < 65 years of age without cardiovascular disease (CVD) histories. Methods: These pooled analyses evaluated tegaserod 6 mg BID using data from four, 12-week, randomized, placebo-controlled trials in IBS-C patients with ≥3-month symptom histories. Consistent with the indicated population, these analyses primarily focused on women < 65 years without CVD histories. The outcomes of interest were key secondary endpoints, including proportions of patients experiencing complete, considerable, and somewhat IBS symptom relief, and abdominal pain/discomfort, bloating, and bowel movement treatment response (≥2 point improvement on a 7-point Likert scale) in ≥50% of patients over 12 weeks. Differences in treatment response rates and odds ratios (OR) with corresponding 95% confidence intervals (CI) were calculated using Cochran-Mantel-Haenszel estimates controlling for investigator site. Results: Among the analysis population (tegaserod: n=1122; placebo: n=1079), 99.7% was aged < 65 years. Mean ages were 38.2-40.1 years and duration of IBS symptoms was ~15 years. At the end of 12 weeks, a significantly higher proportion of patients experienced IBS symptom relief (tegaserod: 67.3%; placebo: 58.2%; difference [95% CI]: 8.2% [3.4, 13.1]; P≤.001). The OR (95% CI) for achieving IBS symptom relief was 1.43 (1.16, 1.76); P< .001. At 12 weeks, a significantly higher proportion of patients also met response criteria for bloating (tegaserod: 21.8%; placebo: 15.6%; difference [95% CI]: 6.0% [2.9, 9.2]; P< .001), abdominal pain/discomfort (tegaserod: 22.9%; placebo: 17.5%; difference [95% CI]: 5.2% [1.9, 8.4]; P=.002), and bowel movements (tegaserod: 49.7%; placebo: 33.1%; difference [95% CI]: 16.2% [12.1, 20.3]; P< .001). The OR (95% CI) for achieving response on bloating (1.54 [1.23, 1.93]), abdominal pain/discomfort (1.43 [1.14, 1.78]), and bowel movements (1.99 [1.67, 2.38]) were statistically significant in favor of tegaserod 6 mg BID (P< .001). Discussion: Based on these pooled analyses, tegaserod 6 mg BID significantly improved the core symptoms of IBS-C, including bloating, abdominal pain/discomfort, and bowel movement frequency in women < 65 years of age without CVD histories.
FIGURE: Bloating and abdominal pain/discomfort and bloating improved with tegaserod 6 mg BID compared to placebo in treating women with IBS-C. Response was defined as a ≥2 point improvement on a 7-point Likert scale.
Disclosures: Eric Shah indicated no relevant financial relationships. Brian Lacy: Alfasigma – Consultant. Arena – Advisory Committee/Board Member. Ironwood – Advisory Committee/Board Member. Salix/Bausch – Advisory Committee/Board Member. Urovant – Advisory Committee/Board Member. William Chey: Allergan – Consultant. Alnylam – Consultant. American College of Gastroenterology – Advisory Committee/Board Member. American Neurogastroenterology Motility Society – Advisory Committee/Board Member. Bayer – Consultant. Biomerica – Consultant. GI Health Foundation – Advisory Committee/Board Member. GI on Demand – Advisory Committee/Board Member. IM Health – Consultant. International Foundation of Functional GI Disorders – Advisory Committee/Board Member. Ironwood – Consultant. Phathom – Consultant. QOL Medical – Consultant. Ritter – Consultant. Ritter – Stockholder/Ownership Interest (excluding diversified mutual funds). Rome Foundation – Advisory Committee/Board Member. Salix/Valeant – Consultant. Takeda – Consultant. Urovant – Consultant. Vibrant – Consultant. Zespri – Consultant. Lin Chang: Alfasigma – Consultant. Darren Brenner: Alfasigma – Consultant. Irene D. Pritzker Foundation – Grant/Research Support.