Metabolic Syndrome - Multiple definitions complicate treatment
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the cardiovascular pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the Metabolic Syndrome market - page 5
- The lack of a consensus definition for Metabolic Syndrome is complicating the diagnosis and management of patients. - page 6
- The prevalence of Metabolic Syndrome is driven by the obesity epidemic. However, its great diversity makes it hard to identify treatment targets. - page 8
- Lifestyle intervention may not be the most rational approach when treating Metabolic Syndrome patients. - page 9
- The significant patient potential and unmet need characteristic to the Metabolic Syndrome market are counterbalanced by a significant number of challenges. - page 11
- CHAPTER 2 INTRODUCTION AND SCOPE - page 22
- Coverage of the Stakeholder Insight Survey - page 23
- CHAPTER 3 COUNTRY TREATMENT TREES - page 25
- Introduction to the treatment trees - page 25
- US - page 27
- France - page 34
- Germany - page 41
- Italy - page 48
- Spain - page 55
- UK - page 62
- CHAPTER 4 DEFINITION OF METABOLIC SYNDROME - page 69
- Background - page 69
- Pre-diabetic population - page 70
- Metabolic Syndrome - page 70
- Confusion over syndrome name - page 70
- Disease definition - page 71
- Pathogenesis - page 73
- Clinical criteria for diagnosis - page 75
- Controversy surrounding definitions - page 84
- Metabolic Syndrome as a marker for cardiovascular disease - page 90
- Progression of Metabolic Syndrome to disease/events - page 93
- Insulin resistance and its associated conditions - page 99
- Insulin resistance and obesity - page 100
- Insulin resistance and aging - page 102
- Insulin resistance and dyslipidemia - page 102
- Insulin resistance and hypertension - page 103
- Insulin resistance and thrombosis - page 104
- Insulin resistance and advanced glycation end products - page 104
- Insulin resistance and the hepatic insulin-sensitizing substance effect - page 105
- Detection, screening and diagnosis - a topic of debate - page 107
- Diagnosis of insulin resistance - page 108
- IGT versus IFG - page 109
- Impact on drug development - page 113
- Who should be screened? - page 114
- Screening tests - page 115
- Other considerations - page 116
- CHAPTER 5 EPIDEMIOLOGY OF METABOLIC SYNDROME - page 117
- Disease definition and classification - page 117
- Prevalence of Metabolic Syndrome - page 117
- Metabolic Syndrome prevalence methodology - page 118
- US - page 119
- France - page 119
- Germany - page 119
- Italy - page 120
- Spain - page 120
- UK - page 120
- Metabolic Syndrome prevalence methodology - page 118
- Impaired fasting glucose prevalence - page 121
- Impaired fasting glucose prevalence methodology - page 123
- Dyslipidemia prevalence - page 124
- Hypercholesterolemia prevalence methodology - page 125
- US - page 126
- France - page 126
- Germany - page 127
- Italy - page 127
- Spain - page 127
- UK - page 128
- Hypercholesterolemia prevalence methodology - page 125
- Hypertension prevalence - page 128
- Hypertension prevalence methodology - page 129
- US - page 130
- France - page 131
- Germany - page 131
- Italy - page 131
- Spain - page 132
- UK - page 132
- Hypertension prevalence methodology - page 129
- Obesity prevalence - page 132
- Obesity forecasts - page 135
- Obesity prevalence methodology - page 138
- US - page 138
- France - page 138
- Germany - page 139
- Italy - page 139
- Spain - page 139
- UK - page 139
- Forecast methodology - page 139
- Prevalence of obesity in juveniles - page 140
- CHAPTER 6 SEGMENTATION OF METABOLIC SYNDROME PATIENTS - page 142
- Breakdown by demographic characteristics - page 142
- Breakdown by risk factor - page 144
- High risk patient profile - page 146
- Treatment guidelines - page 152
- Importance of treating Metabolic Syndrome - page 155
- CHAPTER 7 LIFESTYLE MANAGEMENT VERSUS PHARMACOLOGICAL TREATMENT - page 157
- Management of Metabolic Syndrome - page 157
- Lifestyle Management - page 160
- Lifestyle management and clinical practice. - page 162
- Delayed diagnosis of Metabolic Syndrome - page 163
- Therapeutic Lifestyle Changes (TLC) - page 164
- CHAPTER 8 PRESCRIBING TRENDS - page 167
- Current role for pharmacological treatment - page 167
- Approaches to the pharmacological treatment of Metabolic Syndrome - page 170
- Overall prescribing trends - page 171
- Obesity - page 174
- Xenical - page 175
- The XENDOS study shows orlistat reduces risk of type 2 diabetes - page 176
- The FDA approves the use of orlistat in adolescents - page 177
- The European Commission approves label extension - page 178
- Meridia - page 180
- Behavior therapy and sibutramine for the treatment of adolescent obesity - page 181
- STORM trial shows weight-maintenance success after weight loss is positively influenced by sibutramine and leisure-time activity. - page 182
- Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome (PCOS) - page 182
- Sibutramine effective in the treatment of binge-eating disorder - page 183
- No benefits shown in health-related quality of life study in sibutramine-treated obese patients with type 2 diabetes - page 184
- SCOUT study - page 184
- Acomplia - page 185
- Clinical trial data - page 186
- Prescription trends - page 189
- Xenical - page 175
- Dyslipidemia - page 191
- Statins - page 192
- ASCOT - page 193
- AVALON - page 194
- Ezetimibe - page 195
- Combination therapies - page 196
- Vytorin - page 196
- Caduet - page 197
- Fibrates - page 197
- Nicotinic acid derivatives - page 198
- Prescription trends - page 199
- Statins - page 192
- Hypertension - page 200
- ARBs - page 200
- ACEIs - page 201
- Beta-blockers (BBs) - page 204
- Calcium-channel blockers (CCBs) - page 206
- Diuretics - page 207
- Prescription trends - page 208
- Diabetes - page 211
- Biguanides - page 211
- Sulfonylureas - page 212
- Thiazolidinediones - page 212
- Alpha glucosidase inhibitors - page 214
- Insulin - page 214
- Prandial Glucose Regulators - page 218
- Prescription Trends - page 219
- Pill Burden - page 221
- Metabolic Syndrome and disease prevention - page 223
- Insulin Resistance - page 223
- Obesity - page 224
- Awareness of developmental classes of compounds - page 226
- Current role for pharmacological treatment - page 167
- CHAPTER 9 CRITICAL ISSUES AFFECTING METABOLIC SYNDROME - page 228
- Unmet needs - Challenges - page 228
- Clinical unmet needs - challenges - page 228
- Consensus definition - page 228
- Efficacy goals not met by current treatment - page 229
- Need to curb the epidemic rise in the prevalence of Metabolic Syndrome. - page 230
- Avoiding compensatory feedback mechanisms - page 230
- Need to take advantage of synergies between drugs, diet, exercise and behavior - page 231
- If possible, address underlying cause(s) to the Metabolic Syndrome - page 231
- Commercial unmet needs-challenges - page 232
- Metabolic Syndrome not approved as indication - page 232
- Prevention of disease in "healthy" subjects associated with higher demands on side effects and tolerability - page 232
- Safety - page 232
- Outcome studies will be required to demonstrate benefits of CVD and diabetes prevention - page 233
- Clinical unmet needs - challenges - page 228
- Clinical trial issues - page 234
- Unmet needs - Challenges - page 228
- APPENDIX A BIBLIOGRAPHY - page 240
- References - page 240
- APPENDIX B PRIMARY RESEARCH - page 259
- Physician research methodology - page 259
- Physician sample breakdown - page 259
- US - page 259
- France - page 260
- Germany - page 261
- Italy - page 262
- Spain - page 263
- UK - page 264
- Questionnaire - page 265
- 1. Patient Segmentation and Diagnosis - page 267
- 2. Treatment of Metabolic Syndrome - page 276
- 3. Future developments - page 285
- 4. Patient outcomes - page 289
- Disclaimer - page 293
- Physician research methodology - page 259
- List of Tables
- Table 1: ATP III diagnostic criteria for Metabolic Syndrome - page 76
- Table 2: WHO working criteria for Metabolic Syndrome - page 77
- Table 3: EGIR diagnostic criteria for Metabolic Syndrome - page 78
- Table 4: AACE diagnostic criteria for Metabolic Syndrome - page 79
- Table 5: IDF diagnostic criteria for Metabolic Syndrome - page 80
- Table 6: Comparison of IGT and IFG prevalence in the US - page 114
- Table 7: Summary of major diabetes prevention studies - page 115
- Table 8: Prevalence of Metabolic Syndrome in the six major markets, 2005 - page 118
- Table 9: The impact of the new IFG definition on the prevalence of Insulin Resistance in US population - page 122
- Table 10: US prevalence of impaired fasting glucose broken down by age, 2005 - page 123
- Table 11: Prevalence of dyslipidemia in the seven major markets (000s), 2005-15 - page 125
- Table 12: Prevalence of hypertension across the six major markets (000s), 2005 to 2015 - page 129
- Table 13: Prevalence of obesity in the seven major markets by age (000s), 2005 - page 134
- Table 14: Prevalence of overweight in the six major markets by age (000s), 2005 - page 135
- Table 15: Forecast prevalence of obesity in the US (000s), 2005-15 - page 136
- Table 16: Forecast prevalence of overweight in the US (000s), 2005-15 - page 136
- Table 17: Forecast prevalence of obesity in the UK (000s), 2005-15 - page 137
- Table 18: Forecast prevalence of overweight in the UK (000s), 2005-15 - page 137
- Table 19: AVALON trial results - page 195
- Table 20: US physician sample breakdown, 2005 - page 259
- Table 21: France physician sample breakdown, 2005 - page 260
- Table 22: Germany physician sample breakdown, 2005 - page 261
- Table 23: Italy physician sample breakdown, 2005 - page 262
- Table 24: Spain physician sample breakdown, 2005 - page 263
- Table 25: UK physician sample breakdown, 2005 - page 264
- List of Figures
- Figure 1: Overview of the treatment of the Metabolic Syndrome population in the US - page 27
- Figure 2: Demographic characteristics of the PCP-treated Metabolic Syndrome population in the US - page 28
- Figure 3: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in the US - page 29
- Figure 4: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in the US - page 30
- Figure 5: Treatment characteristics of the PCP-treated Metabolic Syndrome population in the US - page 31
- Figure 6: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in the US - page 32
- Figure 7: Treatment characteristics of the Diabetologist-treated Metabolic Syndrome population in the US - page 33
- Figure 8: Overview of the treatment of the Metabolic Syndrome population in France - page 34
- Figure 9: Demographic characteristics of the PCP-treated Metabolic Syndrome population in France - page 35
- Figure 10: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in France - page 36
- Figure 11: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in France - page 37
- Figure 12: Treatment characteristics of the PCP-treated Metabolic Syndrome population in France - page 38
- Figure 13: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in France - page 39
- Figure 14: Treatment characteristics of the Diabetologist-treated Metabolic Syndrome population in France - page 40
- Figure 15: Overview of the treatment of the Metabolic Syndrome population in Germany - page 41
- Figure 16: Demographic characteristics of the PCP-treated Metabolic Syndrome population in Germany - page 42
- Figure 17: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in Germany - page 43
- Figure 18: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in Germany - page 44
- Figure 19: Treatment characteristics of the PCP-treated Metabolic Syndrome population in Germany - page 45
- Figure 20: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in Germany - page 46
- Figure 21: Treatment characteristics of the Diabetologist-treated Metabolic Syndrome population in Germany - page 47
- Figure 22: Overview of the treatment of the Metabolic Syndrome population in Italy - page 48
- Figure 23: Demographic characteristics of the PCP-treated Metabolic Syndrome population in Italy - page 49
- Figure 24: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in Italy - page 50
- Figure 25: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in Italy - page 51
- Figure 26: Treatment characteristics of the PCP-treated Metabolic Syndrome population in Italy - page 52
- Figure 27: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in Italy - page 53
- Figure 28: Treatment characteristics of the Endocrinologist-treated Metabolic Syndrome population in Italy - page 54
- Figure 29: Overview of the treatment of the Metabolic Syndrome population in Spain - page 55
- Figure 30: Demographic characteristics of the PCP-treated Metabolic Syndrome population in Spain - page 56
- Figure 31: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in Spain - page 57
- Figure 32: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in Spain - page 58
- Figure 33: Treatment characteristics of the PCP-treated Metabolic Syndrome population in Spain - page 59
- Figure 34: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in Spain - page 60
- Figure 35: Treatment characteristics of the Endocrinologist-treated Metabolic Syndrome population in Spain - page 61
- Figure 36: Overview of the treatment of the Metabolic Syndrome population in the UK - page 62
- Figure 37: Demographic characteristics of the PCP-treated Metabolic Syndrome population in the UK - page 63
- Figure 38: Demographic characteristics of the Cardiologist-treated Metabolic Syndrome population in the UK - page 64
- Figure 39: Demographic characteristics of the Diabetologist-treated Metabolic Syndrome population in the UK - page 65
- Figure 40: Treatment characteristics of the PCP-treated Metabolic Syndrome population in the UK - page 66
- Figure 41: Treatment characteristics of the Cardiologist-treated Metabolic Syndrome population in the UK - page 67
- Figure 42: Treatment characteristics of the Endocrinologist-treated Metabolic Syndrome population in the UK - page 68
- Figure 43: Pathophysiological progression to impaired fasting glucose - page 74
- Figure 44: Relationship between insulin resistance, IFG and Metabolic Syndrome - page 75
- Figure 45: Proportion of physicians using each set of guidelines - page 82
- Figure 46: Physicians' rating of the expected impact of the IDF's definition for Metabolic Syndrome on clinical practice. - page 82
- Figure 47: Proportion of physicians considering existing guidelines for Metabolic Syndrome adequate. - page 89
- Figure 48: Percentage of Metabolic Syndrome patients progressing to type 2 Diabetes - page 94
- Figure 49: Percentage of Metabolic Syndrome patients progressing to hypertension - page 95
- Figure 50: Percentage of Metabolic Syndrome patients progressing to cardiovascular disease - page 96
- Figure 51: Percentage of Metabolic Syndrome patients progressing to acute myocardial infarction - page 97
- Figure 52: Percentage of Metabolic Syndrome patients progressing to stroke - page 98
- Figure 53: Inter-relationship of components of Metabolic Syndrome resulting in increased cardiovascular risk - page 99
- Figure 54: Body mass index (BMI) chart - page 101
- Figure 55: Diagrammatical summary of the HISS hypothesis - page 106
- Figure 56: Progression of IGT and/or IFT to type 2 diabetes - page 110
- Figure 57: Comparison of glucose testing - page 113
- Figure 58: Segmentation of male vs. female patients with Metabolic Syndrome, %, 2005 - page 142
- Figure 59: Segmentation of patients by age, %, 2005 - page 143
- Figure 60: Segmentation of Metabolic Syndrome patients by ethnicity, %, 2005 - page 144
- Figure 61: Percentage of Metabolic Syndrome patients with each diagnostic criterion, % - page 145
- Figure 62: Mean ranking given to each criterion by level of concern - page 146
- Figure 63: Percentage of respondents citing each combination as the most common, total - page 147
- Figure 64: Percentage of respondents citing each combination as the most common ,US - page 148
- Figure 65: Percentage of respondents citing each combination as the most common , France - page 148
- Figure 66: Percentage of respondents citing each combination as the most common , Germany - page 149
- Figure 67: Percentage of respondents citing each combination as the most common, Italy - page 149
- Figure 68: Percentage of respondents citing each combination as the most common, Spain - page 150
- Figure 69: Percentage of respondents citing each combination as the most common, UK - page 150
- Figure 70: Combinations of risk factors that represent most risk - page 151
- Figure 71: Proportion of Metabolic Syndrome patients treated by each type of physician - page 158
- Figure 72: Percentage of Metabolic patients referred to another physician for confirmation of diagnosis by each type of physician - page 159
- Figure 73: Proportion of Metabolic Syndrome patients referred to each type of physician - page 160
- Figure 74: Steps in therapeutic lifestyle changes for Metabolic Syndrome - page 165
- Figure 75: The level of impact each driver has on the prescription decisions (1 - most impact) - page 166
- Figure 76: Proportion of Metabolic Syndrome patients on each therapy - page 172
- Figure 77: Most popular regimens for treatment of Metabolic Syndrome - page 173
- Figure 78: Monitoring frequency - page 174
- Figure 79: Xenical SWOT analysis - page 179
- Figure 80: Meridia SWOT analysis - page 185
- Figure 81: Percentage of patients receiving each anti-obesity drug - page 190
- Figure 82: Percentage of patients receiving each anti-obesity drug in three years time - page 191
- Figure 83: Percentage of patients receiving each antidyslipidemic drug currently - page 199
- Figure 84: Percentage of patients receiving each antidyslipidemic drug in three years time - page 200
- Figure 85: Recommendations for the combining of blood pressure lowering drugs (AB/CD rule) (adapted from Williams et al., 2004) - page 205
- Figure 86: Percentage of patients receiving each antihypertensive drug currently - page 209
- Figure 87: Percentage of patients receiving each antihypertensive drug in three years time - page 210
- Figure 88: When to start insulin therapy in type 2 diabetes? - page 216
- Figure 89: Percentage of patients receiving each antidiabetic drug currently - page 220
- Figure 90: Percentage of patients receiving each antidiabetic drug in three years time - page 221
- Figure 91: Top drug combinations for treating Metabolic Syndrome patients - page 222
- Figure 92: Proportion of the physicians aware of the compounds in development - page 226
- Figure 93: Importance of the elements of trial design and trial outcomes - page 237
- Figure 94: The most commonly cited attributes of a desired drug to treat Metabolic Syndrome - page 239
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