Data from the PROactive Study, presented at the 41st meeting of the European Association for the Study of Diabetes ( EASD ) in Athens, demonstrated that Actos ( Pioglitazone ) significantly reduces 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, at St. George's Hospital, London, UK, and chairman of the PROactive Study Steering Committee. "
PROactive ( PROspective PioglitAzone Clinical Trial In MacroVascular Events ) was a randomised, double blind, placebo-controlled outcome study to determine the effects of Pioglitazone 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, sulphonylureas and Insulin; antiplatelet drugs such as Aspirin, and lipid-modifying medicines such as statins and fibrates.
This PROactive 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 Dormandy, these results predict that 10 heart attacks, strokes or deaths will be prevented for every 500 high-risk patients treated with Actos over three years.
Additional PROactive study results of Actos showed:
- HbA1c levels ( a measurement of long-term blood glucose control ) were significantly reduced as compared to placebo ( p