Landmark data from the PROactive Study, presented today at the 41st meeting of the European Association for the Study of Diabetes (EASD) demonstrated that ACTOS® (pioglitazone HCl) significantly reduced the combined risk of heart attacks, strokes and death by 16% in high-risk patients with type 2 diabetes.
"The PROactive study is the first in the world to prospectively show that a specific oral glucose lowering medication, namely pioglitazone, can significantly improve cardiovascular outcomes by helping to delay or reduce heart attacks, strokes and death in high-risk patients," said John Dormandy, M.D., professor of Vascular Sciences at St. George's Hospital, London, UK, and chairman of the PROactive Study Steering Committee. "This groundbreaking study gives new hope to people with type 2 diabetes who, despite their attempts to control blood glucose and take medications, fear these life-threatening events."

PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was a randomized, double blind, placebo-controlled outcome study to determine the effects of ACTOS on mortality and morbidity associated with cardiovascular disease progression in more than 5,000 high risk patients with type 2 diabetes when added to standard of care treatment.

Standard of care included the routine use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose-lowering agents such as metformin, sulfonylureas and insulin; antiplatelet drugs such as aspirin, and lipid-modifying medicines such as statins and fibrates.

Compelling Study Results

This study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events of varying clinical importance; and a principal secondary combination endpoint of life-threatening events including death, heart attack and stroke.

The primary endpoint was reduced by 10% but had not reached statistical significance by study end (p=0.095). The principal secondary endpoint of life-threatening events showed that pioglitazone significantly reduced the risk of heart attacks, strokes and death by 16% (p=0.027).

According to Professor Dormandy, these results predict that 10 heart attacks, strokes or deaths will be prevented for every 500 high-risk patients treated with ACTOS® (pioglitazone HCl) over three years. Additional PROactive study results of ACTOS showed:


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