Stakeholder Insight: Metabolic Syndrome - Ticking Time Bomb

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Publication Date: 2004-06-08

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Datamonitor estimates that approximately 115 million individuals suffer from metabolic syndrome in the seven major markets. This patient population is set to grow rapidly in response to the rising obesity and diabetes epidemics. Research conducted by Datamonitor reveals that there is a strong unmet need for clearer guidance regarding the diagnosis and treatment of metabolic syndrome patients.

Scope

Determination of the prevalence of metabolic syndrome and its component conditions

Evaluation of physician awareness of metabolic syndrome and its importance, with analysis of physician perceptions of the treatment of the condition

Assessment of the potential of existing drug classes and developmental compounds in the treatment of metabolic syndrome

Discussion of non-physician stakeholder issues, such as reimbursement and regulatory issues, drawing on examples from each of the 7 major markets

Report Highlights
The awareness of metabolic syndrome has greatly increased although there remains an unmet need for clearer and more applicable diagnostic and treatment guidelines and for a strong public health message to increase public awareness of the consequences of obesity and sedentary lifestyles.

There is a certain resistance among physicians to use pharmacological therapy to treat metabolic syndrome. This is fueled by concerns over the effects of long-term drug administration in asymptomatic patients, by a lack of officially indicated drugs and by the limited availability of clinical trial data for the use of drug therapy in this setting.

Reasons to Purchase

Target physicians more effectively, through an understanding of prescribing behavior and its influences

Evaluate the potential of existing and developmental drug classes for the treatment of metabolic syndrome

Recognize lucrative target populations, in terms of unmet need and patient potential, in order to successfully position developmental products

CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the metabolic syndrome market - page 5
  - Summary - page 12
- Key metrics - page 12
TABLE OF CONTENTS - page 15
CHAPTER 2 INTRODUCTION AND SCOPE - page 23
- Coverage of the Stakeholder Insight Survey - page 23
CHAPTER 3 DEFINITION OF METABOLIC SYNDROME - page 25
- Background - page 25
- Pre-diabetic population - page 26
- Metabolic syndrome - page 26
  - Confusion over syndrome name - page 26
  - Disease definition - page 27
  - Pathogenesis - page 29
  - Clinical criteria for diagnosis - page 31
  - Metabolic syndrome as a marker for cardiovascular disease - page 34
- Insulin resistance and its associated conditions - page 34
  - Insulin resistance and obesity - page 36
  - Insulin resistance and aging - page 38
  - Insulin resistance and dyslipidemia - page 38
  - Insulin resistance and hypertension - page 39
  - Insulin resistance and thrombosis - page 39
  - Insulin resistance and advanced glycation end products - page 40
  - Insulin resistance and the hepatic insulin-sensitizing substance effect - page 40
- Detection, screening and diagnosis - a topic of debate - page 43
  - Diagnosis of insulin resistance - page 44
  - IGT versus IFG - page 45
  - Who should be screened? - page 50
  - Screening tests - page 51
  - Other considerations - page 52
CHAPTER 4 EPIDEMIOLOGY - page 53
- Disease definition and classification - page 53
- Prevalence of metabolic syndrome - page 53
  - Metabolic syndrome prevalence methodology - page 54
- Impaired fasting glucose prevalence - page 57
  - Impaired fasting glucose prevalence methodology - page 58
- Dyslipidemia prevalence - page 58
  - Hypercholesterolemia prevalence methodology - page 61
  - Key patient segmentations - page 63
- Hypertension prevalence - page 71
  - Hypertension prevalence methodology - page 73
- Obesity prevalence - page 76
  - Obesity forecasts - page 79
  - Obesity prevalence methodology - page 84
  - Forecast methodology - page 86
  - Prevalence of obesity in juveniles - page 86
CHAPTER 5 CURRENT AND FUTURE TREATMENT OPTIONS - page 88
- Importance of treating metabolic syndrome - page 88
- Treatment guidelines - page 89
- Lifestyle management versus pharmacological treatment - page 91
  - Lifestyle management - page 91
  - Current role for pharmacological treatment - page 93
- Future treatment options - page 122
  - Compounds in development for the treatment of metabolic syndrome - page 122
  - Treatment of insulin resistance - page 127
  - Cross risk-factor single-pill combination therapies - reducing the pill burden - page 144
  - Anti-obesity drugs - page 148
CHAPTER 6 CURRENT CLINICAL RESEARCH - page 152
CHAPTER 7 STAKEHOLDER AWARENESS AND INFLUENCE - page 177
- Growing awareness and recognition of metabolic syndrome - page 177
- Physician perceptions and influences - page 179
  - PCPs versus specialists - page 181
- Factors influencing physician decision-making - page 192
  - Physician resistance versus increasing disease awareness - page 192
  - Concerns regarding long-term compliance with therapy - page 195
  - Long-term effect of drug therapy - page 196
- Other stakeholder perceptions and influences - page 198
  - Regulatory agencies - page 199
  - Payers/providers - page 201
  - Patient awareness - page 209
  - Clinical trial data - page 212
  - Epidemiology data - page 218
  - Epidemiology sources - page 219
- Physician research methodology - page 222
  - Physician sample breakdown - page 222
  - US - page 222
  - Japan - page 223
  - France - page 223
  - Germany - page 224
  - Italy - page 224
  - Spain - page 225
  - UK - page 225
- Contributing experts - page 226
- Methodology of metabolic syndrome prevalence in STOP-NIDDM trial - page 227
  - Disclaimer - page 229

List of Tables
Table 1: Prevalence of metabolic syndrome and key associated diseases in the seven major markets in 2003 - page 13
Table 2: Key developmental compound with a potential use in the treatment of metabolic syndrome - page 14
Table 3: ATP III diagnostic criteria for metabolic syndrome - page 32
Table 4: WHO working criteria for metabolic syndrome - page 33
Table 5: Comparison of IGT and IFG prevalence in the US - page 50
Table 6: Summary of major diabetes prevention studies - page 51
Table 7: Prevalence of metabolic syndrome in the seven major markets, 2003 - page 54
Table 8: US prevalence of impaired fasting glucose broken down by age, 2003 - page 58
Table 9: Prevalence of hypercholesterolemia in the seven major markets (000s), 2003-12 - page 60
Table 10: US prevalence of hypertriglyceridemia, 2003 - page 65
Table 11: US prevalence of low HDL, 2003 - page 68
Table 12: Prevalence of low HDL cholesterol (<40mg/dL) in England in 2003 - page 70
Table 13: Prevalence of hypertension in the seven major markets (000s), 2003-12 - page 72
Table 14: Prevalence of obesity in the seven major markets by age (000s), 2003 - page 78
Table 15: Prevalence of overweight in the seven major markets by age (000s), 2003 - page 79
Table 16: Forecast prevalence of obesity in the US (000s), 2003-12 - page 80
Table 17: Forecast prevalence of overweight in the US (000s), 2003-12 - page 81
Table 18: Forecast prevalence of obesity in the UK (000s), 2003-12 - page 82
Table 19: Forecast prevalence of overweight in the UK (000s), 2003-12 - page 83
Table 20: Management of patients with IFG and/or IGT - page 91
Table 21: Treatment of patients with metabolic syndrome and impaired fasting glucose - page 99
Table 22: Primary and secondary CHD prevention trials with statins in diabetic patients - page 105
Table 23: Treatment of patients with metabolic syndrome and low HDL cholesterol or hypertriglyceridemia - page 115
Table 24: Treatment of patients with metabolic syndrome and hypertension - page 120
Table 25: Developmental pipeline for the treatment of metabolic syndrome - page 123
Table 26: Dual PPARs currently in development - page 133
Table 27: Selected discontinued dual PPARs - page 140
Table 28: Effect of acarbose on disease progression or regression in IGT patients in STOP-NIDDM trial - page 161
Table 29: First-year changes in glucose and insulin levels in PIPOD for subjects receiving troglitazone in the TRIPOD study - page 175
Table 30: First-year changes in glucose and insulin levels in PIPOD for subjects receiving placebo in the TRIPOD study - page 176
Table 31: Physician perceptions statements - page 179
Table 32: Physician perceptions regarding metabolic syndrome (1 = strong disagreement - 5 = strong agreement) - page 180
Table 33: Physician perceptions regarding metabolic syndrome broken down by country and physician type (1 = strong disagreement - 5 = strong agreement) - page 182
Table 34: Cost of therapy associated with metabolic syndrome - page 202
Table 35: US physician sample breakdown, 2003 - page 222
Table 36: Japan physician sample breakdown, 2003 - page 223
Table 37: France physician sample breakdown, 2003 - page 223
Table 38: Germany physician sample breakdown, 2003 - page 224
Table 39: Italy physician sample breakdown, 2003 - page 224
Table 40: Spain physician sample breakdown, 2003 - page 225
Table 41: UK physician sample breakdown, 2003 - page 225
Table 42: Metabolic syndrome prevalence methodology - page 227

List of Figures
Figure 1: Key drivers of the metabolic syndrome market to 2012 - page 12
Figure 2: Pathophysiological progression to impaired fasting glucose - page 30
Figure 3: Relationship between insulin resistance, IFG and metabolic syndrome - page 31
Figure 4: Inter-relationship of components of metabolic syndrome resulting in increased cardiovascular risk - page 35
Figure 5: Body mass index (BMI) chart - page 37
Figure 6: Diagrammatical summary of the HISS hypothesis - page 42
Figure 7: Progression of IGT and/or IFT to type 2 diabetes - page 46
Figure 8: Comparison of glucose testing - page 49
Figure 9: Proportion of diagnosed dyslipidemia patients with low HDL cholesterol in the seven major markets, 2003 - page 67
Figure 10: Steps in therapeutic lifestyle changes for metabolic syndrome - page 93
Figure 11: Treatment of patients with metabolic syndrome and low HDL cholesterol - page 116
Figure 12: Treatment of patients with metabolic syndrome and hypertriglyceridemia - page 117
Figure 13: Treatment of patients with metabolic syndrome and hypertension - page 121
Figure 14: Factors for and against the Polypill, 2003 - page 146
Figure 15: Trial design: the Finnish Diabetes Prevention Study (FDPS) - page 154
Figure 16: Cumulative probability of remaining free of diabetes in the Finnish Diabetes Prevention Study (FDPD) - page 155
Figure 17: Trial design: Diabetes Prevention Program (DPP) - page 157
Figure 18: Cumulative incidence of diabetes in the Diabetes Prevention Program (DPP) - page 158
Figure 19: Trial design: STOP-NIDDM - page 160
Figure 20: Clinical trial design: TRIPOD study - page 164
Figure 21: Clinical trial design: XENDOS - page 167
Figure 22: Prevalence of weight loss after four years of orlistat administration - page 168
Figure 23: Clinical trial design: EDIT trial - page 170
Figure 24: Clinical trial design: NAVIGATOR - page 172
Figure 25: Clinical trial design: DREAM trial - page 174
Figure 26: Statement: I have a good understanding of the elevated risk of type 2 diabetes and cardiovascular disease in metabolic syndrome - page 183
Figure 27: Statement: I am comfortable prescribing drugs for the primary prevention of diabetes and cardiovascular disease - page 185
Figure 28: Statement: I have been closely following research on metabolic syndrome - page 186
Figure 29: Statement: I am concerned about long-term compliance with medications - page 187
Figure 30: Statement: I believe that lifestyle modification is sufficient for borderline levels of metabolic syndrome - page 189
Figure 31: Statement: I am waiting for data from clinical trials demonstrating long-term benefit before I would consider prescribing medications to patients with borderline abnormalities - page 190
Figure 32: Statement: I am waiting for new clinical guidelines before I would consider prescribing medications to patients with borderline abnormalities - page 191
Figure 33: Opposing forces influencing physician decision making: physician resistance versus increasing disease awareness - page 193
Figure 34: Cardiovascular and diabetes stakeholders: Interactions and challenges - page 199

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Stakeholder Insight: Metabolic Syndrome - Ticking Time Bomb

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