Table of Contents
- 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
- Prescription trends
- Dyslipidemia
- Statins
- Ezetimibe
- Combination therapies
- 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
- 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
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