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市場調查報告書
代謝症候群
Will Metabolic Syndrome Emerge as a Commercial Market?
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本報告已在2011年12月21日停止出版。
專門於醫療產業相關廣泛調查的美國市調公司Decision Resources Inc. (總公司：Massachusetts State) 針對代謝症候群進行調查分析，並出版經系統整理的報告書"Will Metabolic Syndrome Emerge as a Commercial Market?" 。
本報告書內容包括：代謝症候群概要及目前的治療方法、新藥開發策略、未來的治療動向等。內容綱要摘記如下：
實施概要
介紹
- 代謝症候群概要
- 代謝症候群是疾病嗎？
- 目前的治療方法
- 異常血脂症／高血壓治療用的FDC
- 肥胖治療藥
- 糖尿病治療藥
- 針對代謝症候群的藥物開發策略
- 代謝症候群未來的治療動向
表
- 代謝症候群的定義
- 代謝症候群的罹患事例：2006年
- 代謝症候群：目前的治療及2006年全球的銷售金額
- 代謝症候群複合要素治療用的開發中藥物
- 代謝症候群單一要素治療用的開發中藥物
圖
- 主要7大市場中代謝症候群的罹患案例
- 美國的代謝症候群處方：2000年至2006年
- 代謝症候群單一要素用多重治療模式及低容量複合藥劑的標的
Abstract
Introduction:
Is metabolic syndrome a disease itself-or merely a grouping of diagnoses that
identify a person as being at increased risk for cardiovascular disease?
Current medical practice, regulatory guidance, and drug development appear to
be shifting away from the concept of metabolic syndrome as a discrete
condition; rather, aspects of metabolic syndrome-including diabetes,
hypertension, dyslipidemia, and obesity-are beginning to be included as part
of an assessment of patients' overall global cardiovascular risk. Drug makers
are thus likely to have greater success developing agents for the individual
components of metabolic syndrome rather than trying to treat multiple aspects
concurrently.
Get the Answers Needed to Shape Your Strategy:
- The FDA recently increased the challenges associated with obtaining
approval for an agent for metabolic syndrome, stating that the only way an
agent will be approved is if it addresses multiple aspects of the disease.
What approaches are drug companies taking to fi nding agents that
effectively treat multiple components of metabolic syndrome? Which companies
already have such agents in Phase II and Phase III trials?
- DiObex is developing an agent to inhibit cortisol production-the primary
glucocorticoid in humans. Inhibiting cortisol production provides a potential
approach to treating both diabetes and metabolic syndrome. What aspect of
DiObex' s agent should help facilitate the agent' s clinical development?
- Despite being the only available agent that treats multiple components of
metabolic syndrome, Pfi zer' s Caduet has seen limited uptake. Why aren' t
physicians prescribing Caduet more frequently?
- Currently, type 2 diabetes appears to be the indication of focus for most
companies developing drugs for metabolic syndrome. Why do companies fi nd
type 2 diabetes to be a particularly attractive indication?
- 11beta-HSD1, one of the two 11beta-hydroxysteroid dehydrogenase enzymes
that regulate the production of cortisol from cortisone, is attracting a great
deal of attention from pharmaceutical companies. Three 11beta-HSD1 inhibitors
are currently confi rmed to be in clinical development. Which companies are
developing these agents? Which company has reported preliminary results of a
Phase IIa trial that indicated a compound' s complete inhibition of
11beta-HSD1?
Scope:
- The metabolic syndrome controversy: disease defi nitions, FDA
perspective, payer reimbursement issues.
- Current treatment options: lifestyle modifi cations; treatments for
obesity, dyslipidemia, hypertension, and insulin resistance; Pfi zer' s Caduet.
- Strategies for drug development: multimodal approaches and fi
xed-dose combinations.
- The future for metabolic syndrome treatment: FDA requirements for
new agents, the shift to a focus on reducing overall cardiovascular risk, the
likelihood of new agents being approved, reimbursement challenges, antiobesity
agents currently in development, and will metabolic syndrome emerge as a
discrete indication?
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- An Overview of Metabolic Syndrome
- Disease Defi nition
- Prevalence
- Is Metabolic Syndrome a Discrete Disease?
- Perspective of Regulatory Agencies
- Perspective of Payers
- Current Treatment Options
- FDCs to Treat Dyslipidemia/Hypertension (Pfi zer' s Caduet)
- Agents to Treat Obesity
- Agents to Treat Diabetes
- Strategies for Developing Agents for Metabolic Syndrome
- Multimodal Approaches
- Peroxisome Proliferator-Activated Receptor Agonists
- Cortisol Modulators
- Fixed-Dose Combinations
- What Is the Future for Metabolic Syndrome Treatment?
Tables
- 1. Defi nitions for Metabolic Syndrome
- 2. Prevalent Cases of Metabolic Syndrome, 2006
- 3. Metabolic Syndrome: Current Therapies and 2006 Worldwide Sales
- 4. Agents in Development to Treat Multiple Components of Metabolic Syndrome
- 5. Agents in Development to Treat Single Components of Metabolic Syndrome
Figures
- 1. Prevalent Cases of Metabolic Syndrome and Component Diseases in the
Seven Major Markets, 2006
- 2. Prescriptions Attributed to Metabolic Syndrome in the United States,
2000-2006
- 3. Disease Targets of Multimodal and Fixed-Dose Combination Agents for
Metabolic Syndrome Components
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