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市場調查報告書
近年來的安全問題及過氧化物增殖因子活性受體（PPAR）Gamma促效劑
How Will Recent Safety Concerns Affect PPAR-Gamma Agonists?
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本報告已在2011年12月21日停止出版。
過氧化物增殖因子活性受體（PPAR）Gamma促效劑是在第II型糖尿病市場中快速成長的藥物。但是近年來Avandia的安全性遭到質疑，也影響到今後新治療藥的上市機會。
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) 針對近年來的安全問題及進行調查分析，並出版經系統整理的報告書 "How Will Recent Safety Concerns Affect PPAR-Gamma Agonists?"。
本報告書內容包括：過氧化物增殖因子活性受體Gamma促效劑的作用機制及副作用、Avandia相關安全問題、新藥的上市機會、今後該市場的發展預測等。內容綱要摘記如下：
實施概要
介紹
過氧化物增殖因子活性受體（PPAR）Gamma促效劑概要
- 作用機制
- 過氧化物增殖因子活性受體Gamma促效劑的副作用
- 第II型糖尿病治療時的過氧化物增殖因子活性受體Gamma促效劑
- 第II型糖尿病市場中的過氧化物增殖因子活性受體Gamma促效劑
與Avandia相關的議論
- 關於利用Avandia的新顧慮
- 反應及影響
- 心血管風險的動向
Avandia的安全問題會影響上市機會嗎？
- The Incretin Pathway
- Eli Lilly/amlyn的Byetta
- Merck的Januvia
過氧化物增殖因子活性受體Gamma促效劑及第II型糖尿病市場的發展預測
補充資料／專家的看法
- Avandia對GlaxoSmithKline而言有多重要
- 各界要求醫療實驗的結果更加透明化
表
圖
- 過氧化物增殖因子活性受體Gamma促效劑的作用機制
- 全球過氧化物增殖因子活性受體Gamma促效劑：1999年至2006年
- Avandia相關醫療實驗的綜合分析結果
- Incretin Pathway
- 第II型糖尿病市場中藥物分類的發展：1999年至2006年
- Actos及Avandia的銷售金額比較：1999年至2006年
Abstract
Introduction
The peroxisome proliferator-activated receptor (PPAR)-gamma agonist class of
drugs is the fastest-growing drug class in the type 2 diabetes market. Sales
of the two PPAR-gamma agonists, GlaxoSmithKline' s Avandia and Takeda' s Actos,
are signifi cant drivers of type 2 diabetes market sales. However, a recent
study has questioned the safety of Avandia and has triggered a debate about
the use of PPAR-gamma agonists, thereby presenting commercial opportunities
for new agents in the treatment of type 2 diabetes.
Questions Answered in This Spectrum Report
- PPAR-gamma agonists are among the most popular therapies in the treatment
of type 2 diabetes. However, a recent meta-analysis has highlighted the
potential for cardiovascular side effects with Avandia and has affected both
sales of the agent and GlaxoSmithKline' s stock price. What are the strengths
and weaknesses of the Avandia study? Are the safety concerns raised by the
study relevant only to Avandia or to the entire PPAR-gamma agonist class?
- The safety concerns about PPAR-gamma agonists present a commercial
opportunity for new agents that offer a unique mechanism of action, an
improved safety profi le, and evidence of effi cacy. Which newly launched
agents threaten to compete with the PPAR-gamma agonists for the position of
preferred third-line therapy in type 2 diabetes? What advantages-and
shortcomings-do these new agents have?
- Novartis is developing a drug that that promises to compete heavily with
newly launched agents and further change the landscape of the type 2 diabetes
market. How will this agent differentiate itself from the currently available
type 2 diabetes therapies?
Scope
- Overview of PPAR-gamma agonists: mechanism of action, side effects, role
in the treatment of type 2 diabetes.
- Avandia controversy: safety concerns, the response to the recent
meta-analysis, implications for the PPAR-gamma agonist drug class.
- Commercial opportunities for new agents: description of agents that are
newly launched or in development.
- Outlook: how recent developments will affect the PPAR-gamma agonist drug
class and the type 2 diabetes market.
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- An Overview of PPAR-Gamma Agonists
- Mechanism of Action
- Side Effects of PPAR-Gamma Agonists
- PPAR-Gamma Agonists in the Treatment of Type 2 Diabetes
- PPAR-Gamma Agonists in the Type 2 Diabetes Market
- The Controversy Surrounding Avandia
- New Concerns Arise Over Avandia Use
- Response and Repercussions
- Are the Cardiovascular Risks a Class Effect?
- Do Avandia' s Safety Concerns Represent a Commercial Opportunity?
- The Incretin Pathway
- Eli Lilly/Amylin' s Byetta
- Merck' s Januvia
- Outlook for PPAR-Gamma Agonists and the Type 2 Diabetes Market
Sidebar/Expert Commentary
- How Important Is Avandia to GlaxoSmithKline?
- Greater Transparency Needed for Clinical Trial Results
Tables
- 1. Results from Large-Scale Trials Involving Avandia
Figures
- 1. Mechanism of Action for PPAR-Gamma Agonists
- 2. Worldwide Sales of PPAR-Gamma Agonists, 1999-2006
- 3. Results from a Meta-Analysis of Trials Involving Avandia
- 4. Incretin Pathway
- 5. Growth of Key Drug Classes in the Type 2 Diabetes Market, 1999-2006
- 6. Comparison of Sales for Actos and Avandia, 1999-2006
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