Takeda’s Actos(R) reduced heart attacks In people with Type 2 Diabetes

Newswise — New results from secondary analyses of the landmark PROactive Study found that ACTOS® (pioglitazone HCl) significantly reduced the occurrence of fatal and non-fatal heart attacks and acute coronary syndrome (ACS) in high-risk patients with type 2 diabetes who had a previous heart attack. Importantly, these results were above and beyond those seen with standard of care treatment.

The findings, which were revealed today at the American Heart Association’s Scientific Sessions 2005, build on previously-reported results from the PROactive Study, showing that ACTOS, an oral antidiabetic medication, significantly reduced the combined risk of heart attacks, strokes and death by 16 percent in high-risk patients with type 2 diabetes.

“Takeda is breaking new ground with the PROactive Study. Never before have this many high-risk people with type 2 diabetes and cardiovascular disease been studied,” said Robert Spanheimer, M.D., medical director for diabetes and metabolism at Takeda Pharmaceuticals North America. “Through this innovative research, we now know that ACTOS can markedly reduce the recurrence of heart attacks.”

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.

As reported at the European Association for the Study of Diabetes (EASD) Annual Meeting in September 2005, the primary endpoint was reduced by 10 percent but had not reached statistical significance by study end (P =0.095). The principal secondary endpoint of life-threatening events showed that ACTOS significantly reduced the risk of heart attacks, strokes and death by 16 percent (P =0.027).

ACTOS, an insulin sensitizer belonging to the thiazolidinedione (TZD) class of oral anti-diabetic medications, directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. ACTOS is taken once daily as an adjunct to diet and exercise, and is approved for use in type 2 diabetes as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.