Stakeholder Opinions: Irritable Bowel Syndrome

Content

• Chapter 1 Executive Summary
  • Scope of the analysis
  • Datamonitor insight into the irritable bowel syndrome market
  • Contributing experts
• Chapter 2 Epidemiology And Patient Segmentation
  • Definition of disorder
  • Irritable bowel syndrome is a functional gastrointestinal disorder
  • Diagnostic criteria separate this chronic condition from transient gut symptoms
  • Etiology
  • Irritable bowel syndrome is best considered as an interaction of biological and psychosocial factors
  • Prevalence of irritable bowel syndrome
  • A standardized approach is needed in epidemiological studies
  • Over 50 million adults suffer from IBS across the US and
  • Segmentation of the irritable bowel syndrome population
  • Segmentation by symptoms
  • Irritable bowel syndrome can be sub-classified based on predominant stool form
  • Alternating irritable bowel syndrome is the most common subtype reported
  • Abdominal pain is the most common symptom of irritable bowel syndrome
  • Segmentation by severity
  • Only a third of patients have moderate to severe irritable bowel syndrome
  • Segmentation by sex and age
  • The female-to-male ratio of IBS in the population is close to two
  • Co-morbidities of irritable bowel syndrome
  • High co-morbidity with other disorders
• Chapter 3 Presentation And Diagnosis
  • Presentation
  • Patient presentation rates are low
  • Abdominal pain is a common reason for consulting a physician
  • Diagnosis
  • There is no simple test for irritable bowel syndrome so diagnosis is based on symptoms
  • The Manning criteria helped identify the symptoms suggestive of irritable bowel syndrome
  • The Rome criteria have superseded the Manning criteria
  • Rome III attempts to deal with confusion regarding consistency of stools
  • Quality of life measures are useful for assessing severity
  • Within clinical practice, measures are rarely used to assess severity
  • Many irritable bowel syndrome sufferers remain undiagnosed
  • Irritable bowel syndrome management and referral patterns
  • The majority of patients present and are managed by primary care
• Chapter 4 Current Treatment
  • There is no cure for irritable bowel syndrome
  • Treatment guidelines
  • Guidelines recommend treatment strategy is based on nature and severity of symptoms
  • US guidelines are based on consensus documents and reviews of existing studies
  • Japanese guidelines
  • European guidelines suggest a similar approach to those in the US
  • Non-pharmacological management
  • Psychological and behavioral treatment
  • Pharmacological management
  • Pharmacological therapies are not normally recommended unless non-pharmacological therapies have proved ineffective
  • Laxatives are widely used in constipation-predominant irritable bowel syndrome
  • Antidiarrheal agents are widely used in diarrhea-predominant irritable bowel syndrome
  • Antispasmodics are the most common treatment for abdominal pain
  • Antidepressants treat multiple symptoms of irritable bowel syndrome
  • Serotonergic agents are a new approach to treating irritable bowel syndrome
  • Lotronex (alosetron)
  • Zelnorm (tegaserod)
• Chapter 5 Unmet Needs And Market Opportunities
  • Diagnostic unmet needs
  • Public understanding of irritable bowel syndrome is poor
  • Improved patient-physician communication is a key goal
  • Disease awareness programs and celebrity endorsement drive public awareness
  • Direct-to-consumer advertising has helped increase awareness and presentation rates
  • Physicians frequently do not recognize irritable bowel syndrome as a 'distinct' disease
  • Continuing physician education is needed to improve diagnosis
  • Development of simple diagnostic guidelines could aid diagnosis
  • Therapeutic unmet needs
  • Few primary care physicians follow current treatment guidelines in clinical practice
  • Efficacy of current pharmacological therapies is unclear
  • Patient satisfaction with current therapies is low
• Chapter 6 New Product Development
  • Clinical trial design
  • Issues with and limitations of previous clinical trials for irritable bowel syndrome
  • EMEA has provided guidance on clinical trial design
  • A different trial design for short-term and long-term treatments is advocated
  • A broad spectrum of irritable bowel syndrome patients who meet Rome II criteria should be included
  • Primary and secondary efficacy endpoints should be included
  • Impact of safety issues with marketed therapies for future therapies
  • Pipeline in 2007
  • Pipeline overview
  • Key Phase III pipeline drugs
  • Cilansetron (KC-9946)
  • Ramosetron (YM-060)
  • Renzapride (ATL-1251)
  • Dexloxiglumide
  • Lubiprostone (SP1-0211)
  • Other pipeline drugs
• Bibliography
  • Journal papers
  • Websites
• Appendix
  • Contributing experts
  • About Datamonitor
  • About Datamonitor Healthcare
  • About the Central Nervous System analysis team
  • Disclaimer