[英文調查報告書] 代謝症候群

ABOUT DATAMONITOR HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the Metabolic Syndrome market
  - The lack of a consensus definition for Metabolic Syndrome is complicating the diagnosis and management of patients.
  - The prevalence of Metabolic Syndrome is driven by the obesity epidemic. However, its great diversity makes it hard to identify treatment targets.
  - Lifestyle intervention may not be the most rational approach when treating Metabolic Syndrome patients.
  - The significant patient potential and unmet need characteristic to the Metabolic Syndrome market are counterbalanced by a significant number of challenges.
CHAPTER 2 INTRODUCTION AND SCOPE
- Coverage of the Stakeholder Insight Survey
CHAPTER 3 COUNTRY TREATMENT TREES
- Introduction to the treatment trees
- US
- France
- Germany
- Italy
- Spain
- UK
CHAPTER 4 DEFINITION OF METABOLIC SYNDROME
- Background
- Pre-diabetic population
- Metabolic Syndrome
  - Confusion over syndrome name
  - Disease definition
  - Pathogenesis
  - Clinical criteria for diagnosis
  - Controversy surrounding definitions
  - Metabolic Syndrome as a marker for cardiovascular disease
  - Progression of Metabolic Syndrome to disease/events
- Insulin resistance and its associated conditions
  - Insulin resistance and obesity
  - Insulin resistance and aging
  - Insulin resistance and dyslipidemia
  - Insulin resistance and hypertension
  - Insulin resistance and thrombosis
  - Insulin resistance and advanced glycation end products
  - Insulin resistance and the hepatic insulin-sensitizing substance effect
- Detection, screening and diagnosis - a topic of debate
  - Diagnosis of insulin resistance
  - IGT versus IFG
    - Impact on drug development
  - Who should be screened?
  - Screening tests
  - Other considerations
CHAPTER 5 EPIDEMIOLOGY OF METABOLIC SYNDROME
- Disease definition and classification
- Prevalence of Metabolic Syndrome
  - Metabolic Syndrome prevalence methodology
    - US
    - France
    - Germany
    - Italy
    - Spain
    - UK
- Impaired fasting glucose prevalence
  - Impaired fasting glucose prevalence methodology
- Dyslipidemia prevalence
  - Hypercholesterolemia prevalence methodology
    - US
    - France
    - Germany
    - Italy
    - Spain
    - UK
- Hypertension prevalence
  - Hypertension prevalence methodology
    - US
    - France
    - Germany
    - Italy
    - Spain
    - UK
- Obesity prevalence
  - Obesity forecasts
  - Obesity prevalence methodology
    - US
    - France
    - Germany
    - Italy
    - Spain
    - UK
  - Forecast methodology
  - Prevalence of obesity in juveniles
CHAPTER 6 SEGMENTATION OF METABOLIC SYNDROME PATIENTS
- Breakdown by demographic characteristics
- Breakdown by risk factor
- High risk patient profile
- Treatment guidelines
- Importance of treating Metabolic Syndrome
CHAPTER 7 LIFESTYLE MANAGEMENT VERSUS PHARMACOLOGICAL TREATMENT
- Management of Metabolic Syndrome
- Lifestyle Management
  - Lifestyle management and clinical practice.
  - Delayed diagnosis of Metabolic Syndrome
  - Therapeutic Lifestyle Changes (TLC)
CHAPTER 8 PRESCRIBING TRENDS
- Current role for pharmacological treatment
  - Approaches to the pharmacological treatment of Metabolic Syndrome
- Overall prescribing trends
- Obesity
  - Xenical
    - The XENDOS study shows orlistat reduces risk of type 2 diabetes
    - The FDA approves the use of orlistat in adolescents
    - The European Commission approves label extension
    - Meridia
    - Behavior therapy and sibutramine for the treatment of adolescent obesity
    - STORM trial shows weight-maintenance success after weight loss is positively influenced by sibutramine and leisure-time activity.
    - Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome (PCOS)
    - Sibutramine effective in the treatment of binge-eating disorder
    - No benefits shown in health-related quality of life study in sibutramine-treated obese patients with type 2 diabetes
    - SCOUT study
  - Acomplia
    - Clinical trial data
  - Prescription trends
- Dyslipidemia
  - Statins
    - ASCOT
    - AVALON
  - Ezetimibe
  - Combination therapies
    - Vytorin
    - Caduet
  - Fibrates
  - Nicotinic acid derivatives
  - Prescription trends
- Hypertension
  - ARBs
  - ACEIs
  - Beta-blockers (BBs)
  - Calcium-channel blockers (CCBs)
  - Diuretics
  - Prescription trends
- Diabetes
  - Biguanides
  - Sulfonylureas
  - Thiazolidinediones
  - Alpha glucosidase inhibitors
  - Insulin
  - Prandial Glucose Regulators
  - Prescription Trends
- Pill Burden
- Metabolic Syndrome and disease prevention
  - Insulin Resistance
  - Obesity
- Awareness of developmental classes of compounds
CHAPTER 9 CRITICAL ISSUES AFFECTING METABOLIC SYNDROME
- Unmet needs - Challenges
  - Clinical unmet needs - challenges
    - Consensus definition
    - Efficacy goals not met by current treatment
    - Need to curb the epidemic rise in the prevalence of Metabolic Syndrome.
    - Avoiding compensatory feedback mechanisms
    - Need to take advantage of synergies between drugs, diet, exercise and behavior
    - If possible, address underlying cause(s) to the Metabolic Syndrome
  - Commercial unmet needs-challenges
    - Metabolic Syndrome not approved as indication
    - Prevention of disease in "healthy" subjects associated with higher demands on side effects and tolerability
    - Safety
    - Outcome studies will be required to demonstrate benefits of CVD and diabetes prevention
- Clinical trial issues
APPENDIX A BIBLIOGRAPHY
- References
APPENDIX B PRIMARY RESEARCH
- Physician research methodology
  - Physician sample breakdown
  - US
  - France
  - Germany
  - Italy
  - Spain
  - UK
- Questionnaire
  - 1. Patient Segmentation and Diagnosis
  - 2. Treatment of Metabolic Syndrome
  - 3. Future developments
  - 4. Patient outcomes
- Disclaimer
- List of Tables
  - Table 1: ATP III diagnostic criteria for Metabolic Syndrome
  - Table 2: WHO working criteria for Metabolic Syndrome
  - Table 3: EGIR diagnostic criteria for Metabolic Syndrome
  - Table 4: AACE diagnostic criteria for Metabolic Syndrome
  - Table 5: IDF diagnostic criteria for Metabolic Syndrome
  - Table 6: Comparison of IGT and IFG prevalence in the US
  - Table 7: Summary of major diabetes prevention studies
  - Table 8: Prevalence of Metabolic Syndrome in the six major markets, 2005
  - Table 9: The impact of the new IFG definition on the prevalence of Insulin Resistance in US population
  - Table 10: US prevalence of impaired fasting glucose broken down by age, 2005
  - Table 11: Prevalence of dyslipidemia in the seven major markets (000s), 2005-15
  - Table 12: Prevalence of hypertension across the six major markets (000s), 2005 to 2015
  - Table 13: Prevalence of obesity in the seven major markets by age (000s), 2005
  - Table 14: Prevalence of overweight in the six major markets by age (000s), 2005
  - Table 15: Forecast prevalence of obesity in the US (000s), 2005-15
  - Table 16: Forecast prevalence of overweight in the US (000s), 2005-15
  - Table 17: Forecast prevalence of obesity in the UK (000s), 2005-15
  - Table 18: Forecast prevalence of overweight in the UK (000s), 2005-15
  - Table 19: AVALON trial results
  - Table 20: US physician sample breakdown, 2005
  - Table 21: France physician sample breakdown, 2005
  - Table 22: Germany physician sample breakdown, 2005
  - Table 23: Italy physician sample breakdown, 2005
  - Table 24: Spain physician sample breakdown, 2005
  - Table 25: UK physician sample breakdown, 2005
- List of Figures
  - Figure 1: Overview of the treatment of the Metabolic Syndrome population in the US
  - Figure 2: Demographic characteristics of the PCP-treated Metabolic Syndrome population in the US
  - Figure 3: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in the US
  - Figure 4: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in the US
  - Figure 5: Treatment characteristics of the PCP-treated Metabolic Syndrome population in the US
  - Figure 6: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in the US
  - Figure 7: Treatment characteristics of the Diabetologist-treated Metabolic Syndrome population in the US
  - Figure 8: Overview of the treatment of the Metabolic Syndrome population in France
  - Figure 9: Demographic characteristics of the PCP-treated Metabolic Syndrome population in France
  - Figure 10: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in France
  - Figure 11: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in France
  - Figure 12: Treatment characteristics of the PCP-treated Metabolic Syndrome population in France
  - Figure 13: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in France
  - Figure 14: Treatment characteristics of the Diabetologist-treated Metabolic Syndrome population in France
  - Figure 15: Overview of the treatment of the Metabolic Syndrome population in Germany
  - Figure 16: Demographic characteristics of the PCP-treated Metabolic Syndrome population in Germany
  - Figure 17: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in Germany
  - Figure 18: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in Germany
  - Figure 19: Treatment characteristics of the PCP-treated Metabolic Syndrome population in Germany
  - Figure 20: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in Germany
  - Figure 21: Treatment characteristics of the Diabetologist-treated Metabolic Syndrome population in Germany
  - Figure 22: Overview of the treatment of the Metabolic Syndrome population in Italy
  - Figure 23: Demographic characteristics of the PCP-treated Metabolic Syndrome population in Italy
  - Figure 24: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in Italy
  - Figure 25: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in Italy
  - Figure 26: Treatment characteristics of the PCP-treated Metabolic Syndrome population in Italy
  - Figure 27: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in Italy
  - Figure 28: Treatment characteristics of the Endocrinologist-treated Metabolic Syndrome population in Italy
  - Figure 29: Overview of the treatment of the Metabolic Syndrome population in Spain
  - Figure 30: Demographic characteristics of the PCP-treated Metabolic Syndrome population in Spain
  - Figure 31: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in Spain
  - Figure 32: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in Spain
  - Figure 33: Treatment characteristics of the PCP-treated Metabolic Syndrome population in Spain
  - Figure 34: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in Spain
  - Figure 35: Treatment characteristics of the Endocrinologist-treated Metabolic Syndrome population in Spain
  - Figure 36: Overview of the treatment of the Metabolic Syndrome population in the UK
  - Figure 37: Demographic characteristics of the PCP-treated Metabolic Syndrome population in the UK
  - Figure 38: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in the UK
  - Figure 39: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in the UK
  - Figure 40: Treatment characteristics of the PCP-treated Metabolic Syndrome population in the UK
  - Figure 41: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in the UK
  - Figure 42: Treatment characteristics of the Endocrinologist-treated Metabolic Syndrome population in the UK
  - Figure 43: Pathophysiological progression to impaired fasting glucose
  - Figure 44: Relationship between insulin resistance, IFG and Metabolic Syndrome
  - Figure 45: Proportion of physicians using each set of guidelines
  - Figure 46: Physicians rating of the expected impact of the IDFs definition for Metabolic Syndrome on clinical practice.
  - Figure 47: Proportion of physicians considering existing guidelines for Metabolic Syndrome adequate.
  - Figure 48: Percentage of Metabolic Syndrome patients progressing to type 2 Diabetes
  - Figure 49: Percentage of Metabolic Syndrome patients progressing to hypertension
  - Figure 50: Percentage of Metabolic Syndrome patients progressing to cardiovascular disease
  - Figure 51: Percentage of Metabolic Syndrome patients progressing to acute myocardial infarction
  - Figure 52: Percentage of Metabolic Syndrome patients progressing to stroke
  - Figure 53: Inter-relationship of components of Metabolic Syndrome resulting in increased cardiovascular risk
  - Figure 54: Body mass index (BMI) chart
  - Figure 55: Diagrammatical summary of the HISS hypothesis
  - Figure 56: Progression of IGT and/or IFT to type 2 diabetes
  - Figure 57: Comparison of glucose testing
  - Figure 58: Segmentation of male vs. female patients with Metabolic Syndrome, %, 2005
  - Figure 59: Segmentation of patients by age, %, 2005
  - Figure 60: Segmentation of Metabolic Syndrome patients by ethnicity, %, 2005
  - Figure 61: Percentage of Metabolic Syndrome patients with each diagnostic criterion, %
  - Figure 62: Mean ranking given to each criterion by level of concern
  - Figure 63: Percentage of respondents citing each combination as the most common, total
  - Figure 64: Percentage of respondents citing each combination as the most common ,US
  - Figure 65: Percentage of respondents citing each combination as the most common , France
  - Figure 66: Percentage of respondents citing each combination as the most common , Germany
  - Figure 67: Percentage of respondents citing each combination as the most common, Italy
  - Figure 68: Percentage of respondents citing each combination as the most common, Spain
  - Figure 69: Percentage of respondents citing each combination as the most common, UK
  - Figure 70: Combinations of risk factors that represent most risk
  - Figure 71: Proportion of Metabolic Syndrome patients treated by each type of physician
  - Figure 72: Percentage of Metabolic patients referred to another physician for confirmation of diagnosis by each type of physician
  - Figure 73: Proportion of Metabolic Syndrome patients referred to each type of physician
  - Figure 74: Steps in therapeutic lifestyle changes for Metabolic Syndrome
  - Figure 75: The level of impact each driver has on the prescription decisions (1 - most impact)
  - Figure 76: Proportion of Metabolic Syndrome patients on each therapy
  - Figure 77: Most popular regimens for treatment of Metabolic Syndrome
  - Figure 78: Monitoring frequency
  - Figure 79: Xenical SWOT analysis
  - Figure 80: Meridia SWOT analysis
  - Figure 81: Percentage of patients receiving each anti-obesity drug
  - Figure 82: Percentage of patients receiving each anti-obesity drug in three years time
  - Figure 83: Percentage of patients receiving each antidyslipidemic drug currently
  - Figure 84: Percentage of patients receiving each antidyslipidemic drug in three years time
  - Figure 85: Recommendations for the combining of blood pressure lowering drugs (AB/CD rule) (adapted from Williams et al., 2004)
  - Figure 86: Percentage of patients receiving each antihypertensive drug currently
  - Figure 87: Percentage of patients receiving each antihypertensive drug in three years time
  - Figure 88: When to start insulin therapy in type 2 diabetes?
  - Figure 89: Percentage of patients receiving each antidiabetic drug currently
  - Figure 90: Percentage of patients receiving each antidiabetic drug in three years time
  - Figure 91: Top drug combinations for treating Metabolic Syndrome patients
  - Figure 92: Proportion of the physicians aware of the compounds in development
  - Figure 93: Importance of the elements of trial design and trial outcomes
  - Figure 94: The most commonly cited attributes of a desired drug to treat Metabolic Syndrome

代謝症候群相關市場

Stakeholder Insight: Metabolic Syndrome - Multiple definitions complicate treatment

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