BARCELONA, Spain, September 3, 2006 — Results of new analyses found that Actos (pioglitazone HCl), an oral antidiabetic medication, significantly reduced the risk of recurrent stroke in high-risk patients with type 2 diabetes. The findings were presented today in a late-breaker session at the World Congress of Cardiology in Barcelona.
“These results are very encouraging news for people with type 2 diabetes because they demonstrated that Actos 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, M.D., professor in the Department of Cardiovascular Medicine at Queen’s Medical Centre, University Hospital, Nottingham, United Kingdom.
These new analyses from the landmark PROactive Study examined the effects of Actos on the risk of stroke and other cardiovascular (CV) outcomes in high-risk patients with type 2 diabetes with and without prior stroke. Pre-specified study endpoints included all-stroke and CV disease death, myocardial infarction (MI, excluding silent MI) or stroke.
According to the results, there were statistically significant benefits of Actos in patients who had suffered a prior stroke. The incidence of recurrent stroke was reduced by 47 percent (P=0.008) and the combined risk of death, MI or stroke was reduced by 28 percent (P<0.05). There was no effect of Actos on subsequent 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 CV events, including the combined risk of death, MI and stroke in high-risk patients with type 2 diabetes.
About the PROactive Study
PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was a landmark study that prospectively looked at the impact in total mortality and macrovascular morbidity using Actos, a glucoselowering 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 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 including both disease and procedural endpoints; and a principal secondary combination endpoint of 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 showed that Actos significantly reduced the combined risk of heart attacks, strokes and death by 16 percent (P=0.027) in high-risk patients with type 2 diabetes.
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Tags: Actos (Pioglitazone), Conditions & Treatments, Medications, Type 2 Diabetes