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Tegaserod in Treating IBS Symptoms

Tegaserod has a unique pharmacologic action that addresses IBS symptoms, such as abdominal pain, bloating, and constipation. Clinical trials have shown positive effects in reducing these symptoms, making it an effective treatment option.

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Tegaserod in Treating IBS Symptoms

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  1. Sidney Cohen, MD Chairman, Department of MedicineTemple University School of Medicine Philadelphia, Pennsylvania Conclusions

  2. Irritable Bowel Syndrome (IBS) • Difficult to diagnose and treat • No measurable serologic or gastrointestinal motility marker of IBS • Diagnosis based on a compilation of symptoms • IBS treatment is empiric; no proven efficacious therapies for patients with abdominal pain, bloating, and constipation as their predominant symptoms

  3. Tegaserod: Pharmacodynamic Effects • Tegaserod has a unique pharmacologic action that addresses the clinical components in IBS patients with abdominal pain, bloating, and constipation • Stimulates the peristaltic reflex, augmenting aboral propulsion • Diminishes visceral sensitivity,reducing pain

  4. Tegaserod Clinical Trials • Recruited a largely unrestricted population of patients with IBS who identified abdominal pain or discomfort and constipation as their predominant symptoms • Reflective of patients seen in common practice

  5. Tegaserod Clinical Effects: Symptoms of IBS Patients • Global relief of symptoms • Specific IBS symptoms • Abdominal discomfort and pain • Bloating • Constipation • Stool frequency • Stool consistency

  6. Effect on IBS Symptoms (B301) † * † † † † † † † † † † * * † * * † * * * Placebo 12 mg/d Pain score Bloating score Bowel movements Stool consistency † † † † † † * † † * * † † † † † † † † † † † † *P < .05 versus placebo; †P < .01 versus placebo (change from baseline).

  7. Effect on IBS Symptoms (B351) † † † † * * † * * * * * * * * Placebo 12 mg/d Pain score Bloating score Bowel movements Stool consistency † † † † † † † † † † † * * † † * † * † † † † † † *P < .05 versus placebo; †P < .01 versus placebo (change from baseline). Significant: at least mild;  2 on a 6-point scale.

  8. Effect on IBS Symptoms (B307) * * * * * Pain score Bloating score * * Bowel movements Stool consistency † † † † † * † † † † † † † † † * † *P < .05 versus placebo; †P < .01 versus placebo (change from baseline). Significant: at least mild;  2 on a 6-point scale. Placebo 4-12 mg/d

  9. Phase III Studies: Complete, Considerable, or Somewhat Relief † * * † * † * * † † * † † * * * * * * * * * B351 B301 B307 *P< .05 versus placebo. †P< .01 versus placebo.

  10. Phase III StudiesComplete or Considerable Relief † † † † † † † † * † * * * * * * † B351 B301 B307 *P< .05 versus placebo. †P< .01 versus placebo.

  11. Summary • Tegaserod at a dose of 12 mg/d (6 mg BID) has been demonstrated to be effective in the treatment of abdominal pain, bloating, and constipation in IBS • Tegaserod is safe and well-tolerated • Diarrhea is the only drug-related side effect, which is self limiting and infrequently led to discontinuation

  12. Conclusion • Unique pharmacologic action that addresses the clinical components of constipation-predominant IBS • Enhances the peristaltic reflex and decreases visceral sensitivity • Positive and significant clinical effect in reducing abdominal pain, bloating, constipation and stool consistency, the hallmark symptoms of IBS • Effective in providing overall or global relief of the symptoms of IBS

  13. Bottom Line • In a clinical syndrome in which there has been no proven treatment, tegaserod is a strong first step in the management of constipation-predominant IBS

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