Abstract
The life-threatening complications of type 2 diabetes constitute a significant
unmet medical need worldwide, particularly because the prevalence of type 2
diabetes has soared in recent years as a result of changing eating habits and
lifestyles. The current selection of antidiabetic drugs successfully manage
the disease, but until the late 2005 release of results from the Prospective
Pioglitazone Clinical Trial in Macrovascular Events (PROactive) study, no data
quantified the effects of antidiabetic drugs on the incidence of
cardiovascular disease (CVD). While the results of the PROactive study suggest
that pioglitazone, a peroxisome proliferator-activated receptor-gamma
(PPAR-gamma) agonist, may mitigate the occurrence of cardiovascular events in
type 2 diabetes patients with a history of CVD, certain aspects of the
PROactive study have been a cause for concern among members of the medical
community. This report discusses the PROactive study, beginning with an
overview of type 2 diabetes, including information on its increasing
prevalence and associated comorbidities, particularly cardiovascular
complications, and available therapies. Next, we discuss pioglitazone's
pharmacological profile as well as the design, results, and possible
shortcomings of this breakthrough trial. Finally, we forecast the potential
effect of the PROactive study on sales of pioglitazone and the commercial
opportunities for other antidiabetic agents.
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