Conclusions

1
Conclusions

• Sidney Cohen, MD
• Chairman, Department of MedicineTemple
  University School of Medicine
• Philadelphia, Pennsylvania

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)
Pain score
Bloating score
Bowel movements
Stool consistency























P (change from baseline).
7
Effect on IBS Symptoms (B351)
Pain score
Bloating score
Bowel movements
Stool consistency
























P (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 (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 10
Phase III StudiesComplete or Considerable Relief

















B351
B301
B307
P 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