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