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Conclusions

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Tegaserod has a unique pharmacologic action that addresses the clinical ... pain, bloating, constipation and stool consistency, the hallmark symptoms of IBS ... – PowerPoint PPT presentation

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Title: 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
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