|
|
 |
|
Viewing report
|
|
|
|
Impact of the PROactive Study on the Treatment of Type 2 Diabetes
Decision Resources, Inc, May 2006, Pages: 20
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, Decision Resources 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.
Business Implications
More than 150 million individuals worldwide suffer from type 2 diabetes, and the prevalence continues to grow as the prevalence of obesity and sedentary lifestyles increases. The management of the life-threatening macrovascular complications of diabetes (coronary artery disease, stroke, peripheral vascular disease) constitutes a significant unmet medical need. However, although available oral antidiabetic agents are efficacious in maintaining glycemic control, most do little to mitigate these macrovascular complications.
The PROactive study was the first outcomes study to specifically investigate whether an antidiabetic agent, pioglitazone (Takeda/Eli Lilly’s Actos), had an effect on risk factors for macrovascular morbidity and mortality and the actual incidence of fatal and nonfatal cardiovascular events in type 2 diabetes patients who had previously experienced a cardiovascular episode. Results of the PROactive study suggest that pioglitazone may, in contrast to most other antidiabetic treatments, not only control blood glucose levels but, importantly, also mitigate the occurrence of cardiovascular events in type 2 diabetes patients with a history of cardiovascular disease. Although sales of pioglitazone—and possibly other PPAR-? agonists—are likely to benefit from the results of the PROactive study, the extent of that benefit is difficult to determine. It remains to be seen whether the cardiovascular benefits seen in the PROactive study are specific to pioglitazone and PPAR-? agonists or whether the same results can be achieved with other antidiabetic treatments.
Pioglitazone is most often used concomitantly with other antidiabetic agents, and 96% of patients in the PROactive study were taking concomitant medications. This indicates that there is significant demand for single-pill combination therapies that would eliminate the need for polypharmacy. This is highlighted by the strong uptake of GlaxoSmithKline's Avandamet, a rosiglitazone/metformin combination that had sales exceeding $400 million in 2004. It is likely that this agent and other PPAR-? agonist combination therapies, including Takeda's recently launched pioglitazone/metformin combination Actoplus Met, will also see a benefit from the PROactive trial results.
|
|
|
|
