# Presentation: 030703

## Conclusions

**Sidney Cohen, MD**
**Chairman, Department of Medicine****Temple University School of Medicine**
**Philadelphia, Pennsylvania**

## 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**

## 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**

## 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**

## Tegaserod Clinical Effects: Symptoms of IBS Patients

**Global relief of symptoms**
**Specific IBS symptoms**
**Abdominal discomfort and pain**
**Bloating**
**Constipation**
**Stool frequency**
**Stool consistency**

## Effect on IBS Symptoms (B301)

**Pain score**

**Bloating score**

********P***** < .05 versus placebo; ****†*****P***** < .01 versus placebo (change from baseline).**

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**Bowel movements**

**Stool consistency**

## Effect on IBS Symptoms (B351)

**Pain score**

**Bloating score**

**Bowel movements**

**Stool consistency**

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********P***** < .05 versus placebo; ****†*****P***** < .01 versus placebo (change from baseline).**
**Significant: at least mild; ******** ****2 on a 6-point scale.**

## Effect on IBS Symptoms (B307)

**Pain score**

**Bloating score**

**Bowel movements**

**Stool consistency**

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**Placebo**

**4-12 mg/d**

********P***** < .05 versus placebo; ****†*****P***** < .01 versus placebo (change from baseline).**
**Significant: at least mild; ******** ****2 on a 6-point scale.**

## Phase III Studies: Complete, Considerable, or Somewhat Relief

**B351**

**B301**

**B307**

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**†*****P***** < .01 versus placebo.**

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## Phase III StudiesComplete or Considerable Relief

**B351**

**B301**

**B307**

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**†*****P***** < .01 versus placebo.**

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## 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**

## 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**

## 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**