糖尿病治療薬臨床試験 PROactive の結果分析

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
    • Thiazolidinediones
    • Actos
  • 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