“These data assessed the effects of ACTOS on cardiovascular morbidity and mortality in 2,445 high-risk patients who had previously had a heart attack, a population that tends to have a very poor prognosis. The results show that in patients taking ACTOS on top of standard of care treatment:

• The recurrence of fatal or non-fatal heart attacks was reduced by 28 percent (P =0.045)
• The risk of acute coronary syndrome or ACS (a term used to describe potentially life-threatening, acute cardiovascular events) was reduced by 37 percent (P =0.035)
• There was a 19 percent (P=0.034) risk reduction in the cardiac composite endpoint of non-fatal heart attacks, coronary revascularization, ACS and cardiac death

“These results are very meaningful for the diabetes community, especially when you consider that people with type 2 diabetes are more likely than those without diabetes to die from a heart attack and to have a second event,” continued Dr. Spanheimer. “ACTOS is a type 2 diabetes medication that has now been shown to reduce the recurrence of heart attacks. Until we know how ACTOS works to provide this life-saving benefit, the results of PROactive should not be generalized to any other glucose-lowering medication.”

About the PROactive Study: PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was the first study to prospectively look at the reduction in total mortality and macrovascular morbidity using a glucose-lowering agent. It was a randomized, double blind, placebo-controlled outcome study of 5,238 patients with type 2 diabetes and macrovascular disease. Patients were randomized to receive either ACTOS or placebo in addition to other blood-glucose medications and on top of standard of care treatment (including 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).

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.