A new analysis of data from the PROactive Study shows that pioglitazone significantly reduces the risk for recurrent ischemic stroke in patients with type 2 diabetes who had had a first stroke, according to a presentation at the annual World Congress of Cardiology.

“These results are very encouraging news for people with type 2 diabetes because they demonstrated that ACTOS (pioglitazone) reduced the incidence of strokes in patients who had already experienced a stroke from 10.2 percent down to 5.6 percent, translating to a risk reduction of almost 50 percent,” said Robert Wilcox, MD, Queen’s Medical Centre, University Hospital, Nottingham, United Kingdom.

These new analyses examined the effects of pioglitazone on risk of stroke and other cardiovascular outcomes in high-risk patients with type 2 diabetes with and without prior stroke. Pre-specified study endpoints included all-stroke and cardiovascular disease death, myocardial infarction (MI, excluding silent MI) or stroke.

Researchers found there were statistically significant benefits in patients with a prior stroke. The incidence of recurrent stroke was reduced by 47 percent (P=0.008) and the combined risk of death, myocardial infarction, or stroke was reduced by 28 percent (P<0.05). There was no effect on strokes in patients who had never experienced a stroke.

Patients with diabetes are at an increased risk of stroke. In fact, the risk is two to four times higher for people with diabetes than the general population. Results from the PROactive Study demonstrated that an oral glucose-lowering medication could substantially impact the risk of some cardiovascular events, including the combined risk of death, myocardial infarction and stroke in high-risk patients with type 2 diabetes.

The PROactive Study 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 pioglitazone or placebo in addition to 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).

The study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events including both disease and procedural endpoints; and a principal secondary combination endpoint of death, myocardial infarction, 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 showed that pioglitazone significantly reduced the combined risk of myocardial infarctions, strokes and death by 16 percent (P=0.027) in high-risk patients with type 2 diabetes.