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市場調查報告書
糖尿病藥物臨床實驗 PROactive 結果分析
PROactive Results - The Diabetes Trial That Could Have Been
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本報告已在2011年07月19日停止出版。
糖尿病是同時影響社會經濟與公眾衛生的一大疾病，糖尿病患者的平均年齡比健康人短 25％，主要死因是心臟血管疾病。由於 Pioglitazone 這種糖尿病藥物不但能控制血糖值，對心臟血管疾病也有效果，因此歐洲實施了大規模 Pioglitazone 實驗「PROactive」。
擅長多領域市調分析的英國專業公司 Datamonitor Corporation（總公司：倫敦），調查分析了 糖尿病藥物臨床實驗 PROactive 結果後，出版了一本綜合報告書 “PROactive Results - The Diabetes Trial That Could Have Been”。
報告書內容包括：歐洲主要七大市場糖尿病患者數現況與預測、PROactive 實驗設計相關理論根據、實驗結果對未來的處方影響等等，報告書含圖表，內容綱要摘記如下：
摘要
第 1 章 背景
- 前言
- 理論根據
- 使用中藥物
- 實驗設計
- 實驗對象患者標準
- 例外標準
- 有效性評量
- 安全性評量
- 基準指標
第 2 章 實驗結果
- 實驗品質
- 心臟血管相關效果
- 代謝相關效果
- 作為藥物的使用方法變化
- 安全性
第 3 章 嚴格的評估
附錄
Abstract
Overview
Introduction
The socio-economic consequences of diabetes and its complications make it a
major public health issue. Patients with diabetes have a 25% reduction in life
expectancy compared with the general population, mainly due to cardiovascular
deaths. Pioglitazone is known to improve glycemic control and also to possess
additional properties that may have an impact on clinical vascular outcomes.
Scope
- Evaluation of the current and future prevalence of diabetes in the seven
major markets
- Discussion of the rationale for and study design of the PROactive trial
- Presents the cardiovascular and metabolic results of the PROactive trial
- Provides independent commentary and explores the likely impact of the
study on future prescribing trends
Report Highlights
The drivers for growth in the diabetic patient population include the aging
demographic profile and the explosion in obesity rates. While the evidence for
growth in type 1 diabetes is equivocal, the overwhelming majority of the
diabetic population suffers from type 2 and the characteristics of this
segment will dictate future growth patterns.
In PROactive, the primary endpoint did not reach statistical significance,
while the principal secondary did. The difference between the two composites
was mainly explained by an increased number of peripheral vascular procedures
performed in the pioglitazone group.
Several limitations to the study arose: the inclusion of procedural outcomes
in the primary composite may have led to the failure in achieving
significance; the study population was devoid of ethnic minorities; and CV
risk factor reduction remained suboptimal in a minority of patients even by
study end, particularly concerning the use of statins.
Reasons to Purchase
- Gain an independent view on the results of one of the most important
diabetic trials to date
- Examine the reasons driving the need for outcome trials such as PROactive
- Assess the metabolic and cardiovascular results of the PROactive trial
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Cardiovascular pharmaceutical analysis team
- EXECUTIVE SUMMARY
- Introduction
- Scope and coverage of the Brief
- Key findings about the the topic
- CHAPTER 1 - BACKGROUND
- Introduction
- Epidemiology of diabetes
- Current prevalence of type 1 and type 2 diabetes
- Future prevalence of type 2 diabetes
- Rationale
- Pharmaceutical agent used
- Study design
- Inclusion criteria
- Exclusion criteria
- Efficacy evaluations
- Safety evaluations
- Baseline characteristics
- Demography
- Other patient history.
- Physical examination and laboratory data.
- Concomitant medication.
- CHAPTER 2 - RESULTS
- Study quality
- Cardiovascular outcomes
- Metabolic outcomes
- Changes in medication use
- Safety
- CHAPTER 3 - CRITICAL EVALUATION
- Discussion of results
- Study limitations and comments
- Conclusion
- APPENDIX
- Bibliography
- Epidemiology
- Clinical trial data
- Research methodology
- Disclaimer
- List of Tables
- Table 1: Prevalence of type 1 and type 2 diabetesacross the seven major
markets, 2004
- Table 2: Future prevalence of type 1 and type 2diabetes in the seven
major markets, 2004-12
- Table 3: Characteristics of patient population atbaseline
- Table 4: Medications taken by the patient populationat study entry
- Table 5: Previous macrovascular events
- Table 6: Cardiovascular outcomes PROactive
- Table 7: Numbers of first events contributing toprimary endpoints
- Table 8: Change in laboratory data from baseline
- Table 9: Change in proportion of patients usingconcomitant medications
- Table 10: Safety of pioglitazone
- List of Figures
- Figure 1: Pioglitazones effects on triglyceride andHDL cholesterol
levels
- Figure 2: PROactive study design
- Figure 3: Inclusion criteria for PROactive
- Figure 4: PROactive endpoints
- Figure 5: Overlap of previous macrovascular events
- Figure 6: Factors possibly contributing to thebeneficial effect of
pioglitazone
- Figure 7: Definition of a serious adverse effect
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