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Metabolic Syndrome - Multiple Definitions Complicate Treatment


Description: It is estimated that there are nearly 86 million Metabolic Syndrome patients in the six major markets. Although the patient pool in need of treatment for Metabolic Syndrome is large, the lack of an approved indication for Metabolic Syndrome, the lack of a consensus definition and the aversion of physicians to pharmacotherapy limit the size of the Metabolic Syndrome market, considerably

Scope of this title:
of this report:

- Determination of the prevalence of Metabolic Syndrome and its component conditions
- Evaluation of physician awareness of Metabolic Syndrome and its importance, and of physician perceptions of treatment options for the condition
- Assessment of the potential of existing drug classes and developmental compounds in the treatment of Metabolic Syndrome
- Understanding of the critical issues affecting the Metabolic Syndrome market

Report Highlights
The lack of a consensus definition for Metabolic Syndrome is complicating the diagnosis and management of patients.

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.

Reasons to order your copy:
- Target physicians more effectively, through an understanding of prescribing behavior and its influences
- Assess the impact that the different definitions of the condition have in the management of Metabolic Syndrome
- Recognize lucrative target populations, in terms of unmet need and patient potential, in order to successfully position developmental products



Contents:
Chapter 1
Executive summary
Scope of the analysis 3
We insight into the Metabolic Syndrome market 5
The lack of a consensus definition for Metabolic Syndrome is complicating the diagnosis and management of patients. 6
The prevalence of Metabolic Syndrome is driven by the obesity epidemic. However, its great diversity makes it hard to identify treatment targets. 8
Lifestyle intervention may not be the most rational approach when treating Metabolic Syndrome patients. 9
The significant patient potential and unmet need characteristic to the Metabolic Syndrome market are counterbalanced by a significant number of challenges. 11


Chapter 2
Introduction and scope
Coverage of the Stakeholder Insight Survey 23


Chapter 3
Country treatment trees
Introduction to the treatment trees 25
US 27
France 34
Germany 41
Italy 48
Spain 55
UK 62


Chapter 4
Definition of metabolic syndrome
Background 69
Pre-diabetic population 70
Metabolic Syndrome 70
Confusion over syndrome name 70
Disease definition 71
Pathogenesis 73
Clinical criteria for diagnosis 75
Controversy surrounding definitions 84
Metabolic Syndrome as a marker for cardiovascular disease 90
Progression of Metabolic Syndrome to disease/events 93
Insulin resistance and its associated conditions 99
Insulin resistance and obesity 100
Insulin resistance and aging 102
Insulin resistance and dyslipidemia 102
Insulin resistance and hypertension 103
Insulin resistance and thrombosis 104
Insulin resistance and advanced glycation end products 104
Insulin resistance and the hepatic insulin-sensitizing substance effect 105
Detection, screening and diagnosis – a topic of debate 107
Diagnosis of insulin resistance 108
IGT versus IFG 109
Impact on drug development 113
Who should be screened? 114
Screening tests 115
Other considerations 116


Chapter 5
Epidemiology of metabolic syndrome
Disease definition and classification 117
Prevalence of Metabolic Syndrome 117
Metabolic Syndrome prevalence methodology 118
US 119
France 119
Germany 119
Italy 120
Spain 120
UK 120
Impaired fasting glucose prevalence 121
Impaired fasting glucose prevalence methodology 123
Dyslipidemia prevalence 124
Hypercholesterolemia prevalence methodology 125
US 126
France 126
Germany 127
Italy 127
Spain 127
UK 128
Hypertension prevalence 128
Hypertension prevalence methodology 129
US 130
France 131
Germany 131
Italy 131
Spain 132
UK 132
Obesity prevalence 132
Obesity forecasts 135
Obesity prevalence methodology 138
US 138
France 138
Germany 139
Italy 139
Spain 139
UK 139
Forecast methodology 139
Prevalence of obesity in juveniles 140


Chapter 6
Segmentation of metabolic syndrome patients
Breakdown by demographic characteristics 142
Breakdown by risk factor 144
High risk patient profile 146
Treatment guidelines 152
Importance of treating Metabolic Syndrome 155


Chapter 7
Lifestyle management versus pharmacological treatment
Management of Metabolic Syndrome 157
Lifestyle Management 160
Lifestyle management and clinical practice. 162
Delayed diagnosis of Metabolic Syndrome 163
Therapeutic Lifestyle Changes (TLC) 164


Chapter 8
Prescribing trends
Current role for pharmacological treatment 167
Approaches to the pharmacological treatment of Metabolic Syndrome 170
Overall prescribing trends 171
Obesity 174
Xenical 175
The XENDOS study shows orlistat reduces risk of type 2 diabetes 176
The FDA approves the use of orlistat in adolescents 177
The European Commission approves label extension 178
Meridia 180
Behavior therapy and sibutramine for the treatment of adolescent obesity 181
STORM trial shows weight-maintenance success after weight loss is positively influenced by sibutramine and leisure-time activity. 182
Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome (PCOS) 182
Sibutramine effective in the treatment of binge-eating disorder 183
No benefits shown in health-related quality of life study in sibutramine-treated obese patients with type 2 diabetes 184
SCOUT study 184
Acomplia 185
Clinical trial data 186
Prescription trends 189
Dyslipidemia 191
Statins 192
ASCOT 193
AVALON 194
Ezetimibe 195
Combination therapies 196
Vytorin 196
Caduet 197
Fibrates 197
Nicotinic acid derivatives 198
Prescription trends 199
Hypertension 200
ARBs 200
ACEIs 201
Beta-blockers (BBs) 204
Calcium-channel blockers (CCBs) 206
Diuretics 207
Prescription trends 208
Diabetes 211
Biguanides 211
Sulfonylureas 212
Thiazolidinediones 212
Alpha glucosidase inhibitors 214
Insulin 214
Prandial Glucose Regulators 218
Prescription Trends 219
Pill Burden 221
Metabolic Syndrome and disease prevention 223
Insulin Resistance 223
Obesity 224
Awareness of developmental classes of compounds 226


Chapter 9
Critical issues affecting metabolic syndrome
Unmet needs - Challenges 228
Clinical unmet needs - challenges 228
Consensus definition 228
Efficacy goals not met by current treatment 229
Need to curb the epidemic rise in the prevalence of Metabolic Syndrome. 230
Avoiding compensatory feedback mechanisms 230
Need to take advantage of synergies between drugs, diet, exercise and behavior 231
If possible, address underlying cause(s) to the Metabolic Syndrome 231
Commercial unmet needs-challenges 232
Metabolic Syndrome not approved as indication 232
Prevention of disease in “healthy” subjects associated with higher demands on side effects and tolerability 232
Safety 232
Outcome studies will be required to demonstrate benefits of CVD and diabetes prevention 233
Clinical trial issues 234

APPENDIX A BIBLIOGRAPHY
References 240

APPENDIX B PRIMARY RESEARCH
Physician research methodology 259
Physician sample breakdown 259
US 259
France 260
Germany 261
Italy 262
Spain 263
UK 264
Questionnaire 265
1. Patient Segmentation and Diagnosis 267
2. Treatment of Metabolic Syndrome 276
3. Future developments 285
4. Patient outcomes 289





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