世界主要 7 カ国における代謝症候群治療

Introduction

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 of this report

• 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

Research and analysis 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.

Key reasons to read this report

• 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

Scope of the analysis

Datamonitor insight into the metabolic syndrome market

Summary

Key metrics

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight Survey

CHAPTER 3 DEFINITION OF METABOLIC SYNDROME

Background

Pre-diabetic population

Metabolic syndrome

Confusion over syndrome name

Disease definition

Pathogenesis

Clinical criteria for diagnosis

Metabolic syndrome as a marker for cardiovascular disease

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

Who should be screened?

Screening tests

Other considerations

CHAPTER 4 EPIDEMIOLOGY

Disease definition and classification

Prevalence of metabolic syndrome

Metabolic syndrome prevalence methodology

Impaired fasting glucose prevalence

Impaired fasting glucose prevalence methodology

Dyslipidemia prevalence

Hypercholesterolemia prevalence methodology

Key patient segmentations

Hypertension prevalence

Hypertension prevalence methodology

Obesity prevalence

Obesity forecasts

Obesity prevalence methodology

Forecast methodology

Prevalence of obesity in juveniles

CHAPTER 5 CURRENT AND FUTURE TREATMENT OPTIONS

Importance of treating metabolic syndrome

Treatment guidelines

Lifestyle management versus pharmacological treatment

Lifestyle management

Current role for pharmacological treatment

Future treatment options

Compounds in development for the treatment of metabolic syndrome

Treatment of insulin resistance

Cross risk-factor single-pill combination therapies - reducing the pill burden

Anti-obesity drugs

CHAPTER 6 CURRENT CLINICAL RESEARCH

Finnish diabetes prevention study group (FDPS)

STOP-NIDDM

Troglitazone in prevention of diabetes (TRIPOD)

Xenical in the prevention of diabetes in obese subjects (XENDOS)

Early diabetes intervention trial (EDIT)

Ongoing trials

CHAPTER 7 STAKEHOLDER AWARENESS AND INFLUENCE

Growing awareness and recognition of metabolic syndrome

Physician perceptions and influences

PCPs versus specialists

Factors influencing physician decision-making

Physician resistance versus increasing disease awareness

Concerns regarding long-term compliance with therapy

Long-term effect of drug therapy

Other stakeholder perceptions and influences

Regulatory agencies

Payers/providers

Patient awareness

Clinical trial data

Epidemiology data

Epidemiology sources

Physician research methodology

Physician sample breakdown

US

Japan

France

Germany

Italy

Spain

UK

Contributing experts

Methodology of metabolic syndrome prevalence in STOP-NIDDM trial

Disclaimer

List of Tables

Table 1: Prevalence of metabolic syndrome and key associated diseases in the seven major markets in 2003

Table 2: Key developmental compound with a potential use in the treatment of metabolic syndrome

Table 3: ATP III diagnostic criteria for metabolic syndrome

Table 4: WHO working criteria for metabolic syndrome

Table 5: Comparison of IGT and IFG prevalence in the US

Table 6: Summary of major diabetes prevention studies

Table 7: Prevalence of metabolic syndrome in the seven major markets, 2003

Table 8: US prevalence of impaired fasting glucose broken down by age, 2003

Table 9: Prevalence of hypercholesterolemia in the seven major markets (000s), 2003-12

Table 10: US prevalence of hypertriglyceridemia, 2003

Table 11: US prevalence of low HDL, 2003

Table 12: Prevalence of low HDL cholesterol (<40mg/dL) in England in 2003

Table 13: Prevalence of hypertension in the seven major markets (000s), 2003-12

Table 14: Prevalence of obesity in the seven major markets by age (000s), 2003

Table 15: Prevalence of overweight in the seven major markets by age (000s), 2003

Table 16: Forecast prevalence of obesity in the US (000s), 2003-12

Table 17: Forecast prevalence of overweight in the US (000s), 2003-12

Table 18: Forecast prevalence of obesity in the UK (000s), 2003-12

Table 19: Forecast prevalence of overweight in the UK (000s), 2003-12

Table 20: Management of patients with IFG and/or IGT

Table 21: Treatment of patients with metabolic syndrome and impaired fasting glucose

Table 22: Primary and secondary CHD prevention trials with statins in diabetic patients

Table 23: Treatment of patients with metabolic syndrome and low HDL cholesterol or hypertriglyceridemia

Table 24: Treatment of patients with metabolic syndrome and hypertension

Table 25: Developmental pipeline for the treatment of metabolic syndrome

Table 26: Dual PPARs currently in development

Table 27: Selected discontinued dual PPARs

Table 28: Effect of acarbose on disease progression or regression in IGT patients in STOP-NIDDM trial

Table 29: First-year changes in glucose and insulin levels in PIPOD for subjects receiving troglitazone in the TRIPOD study

Table 30: First-year changes in glucose and insulin levels in PIPOD for subjects receiving placebo in the TRIPOD study

Table 31: Physician perceptions statements

Table 32: Physician perceptions regarding metabolic syndrome (1 = strong disagreement - 5 = strong agreement)

Table 33: Physician perceptions regarding metabolic syndrome broken down by country and physician type (1 = strong disagreement - 5 = strong agreement)

Table 34: Cost of therapy associated with metabolic syndrome

Table 35: US physician sample breakdown, 2003

Table 36: Japan physician sample breakdown, 2003

Table 37: France physician sample breakdown, 2003

Table 38: Germany physician sample breakdown, 2003

Table 39: Italy physician sample breakdown, 2003

Table 40: Spain physician sample breakdown, 2003

Table 41: UK physician sample breakdown, 2003

Table 42: Metabolic syndrome prevalence methodology

List of Figures

Figure 1: Key drivers of the metabolic syndrome market to 2012

Figure 2: Pathophysiological progression to impaired fasting glucose

Figure 3: Relationship between insulin resistance, IFG and metabolic syndrome

Figure 4: Inter-relationship of components of metabolic syndrome resulting in increased cardiovascular risk

Figure 5: Body mass index (BMI) chart

Figure 6: Diagrammatical summary of the HISS hypothesis

Figure 7: Progression of IGT and/or IFT to type 2 diabetes

Figure 8: Comparison of glucose testing

Figure 9: Proportion of diagnosed dyslipidemia patients with low HDL cholesterol in the seven major markets, 2003

Figure 10: Steps in therapeutic lifestyle changes for metabolic syndrome

Figure 11: Treatment of patients with metabolic syndrome and low HDL cholesterol

Figure 12: Treatment of patients with metabolic syndrome and hypertriglyceridemia

Figure 13: Treatment of patients with metabolic syndrome and hypertension

Figure 14: Factors for and against the Polypill, 2003

Figure 15: Trial design: the Finnish Diabetes Prevention Study (FDPS)

Figure 16: Cumulative probability of remaining free of diabetes in the Finnish Diabetes Prevention Study (FDPD)

Figure 17: Trial design: Diabetes Prevention Program (DPP)

Figure 18: Cumulative incidence of diabetes in the Diabetes Prevention Program (DPP)

Figure 19: Trial design: STOP-NIDDM

Figure 20: Clinical trial design: TRIPOD study

Figure 21: Clinical trial design: XENDOS

Figure 22: Prevalence of weight loss after four years of orlistat administration

Figure 23: Clinical trial design: EDIT trial

Figure 24: Clinical trial design: NAVIGATOR

Figure 25: Clinical trial design: DREAM trial

Figure 26: Statement: I have a good understanding of the elevated risk of type 2 diabetes and cardiovascular disease in metabolic syndrome

Figure 27: Statement: I am comfortable prescribing drugs for the primary prevention of diabetes and cardiovascular disease

Figure 28: Statement: I have been closely following research on metabolic syndrome

Figure 29: Statement: I am concerned about long-term compliance with medications

Figure 30: Statement: I believe that lifestyle modification is sufficient for borderline levels of metabolic syndrome

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

Figure 32: Statement: I am waiting for new clinical guidelines before I would consider prescribing medications to patients with borderline abnormalities

Figure 33: Opposing forces influencing physician decision making: physician resistance versus increasing disease awareness

Figure 34: Cardiovascular and diabetes stakeholders: Interactions and challenges