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

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 < 0.001). CONCLUSION: 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 1.: 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.