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New Data Showed ACTOS(R) (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients With Type 2 Diabetes
Date:3/31/2008

Data expands body of evidence in high risk population using IVUS, a unique

marker for coronary atherosclerosis

CHICAGO, March 31 /PRNewswire/ -- New data from a clinical trial using intravascular ultrasound (IVUS) technology found that in patients living with type 2 diabetes, ACTOS(R) (pioglitazone HCl) reduced the atherosclerotic burden in the coronary arteries compared to glimepiride, and prevented progression compared to baseline. These data stem from the PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) trial.

The PERISCOPE trial was presented today as a late breaker at the 57th Annual Scientific Session of the American College of Cardiology in Chicago. This trial adds to the body of cardiovascular data for ACTOS. ACTOS studies, conducted over the past 10 years in more than 16,000 patients, including short- and long-term trials, as well as prospective and observational studies, have shown no evidence that ACTOS is associated with an increased risk of heart attack, stroke, or death.

"We are pleased with the results of the PERISCOPE, which further expands our cardiovascular data with ACTOS," said David P. Recker, M.D., senior vice president, Clinical Sciences and interim president at Takeda Global Research & Development. "While not definitive, data from PERISCOPE combined with results from a previous study, looking at surrogate endpoints, have shown a consistent trend toward decreasing cardiovascular risk by reducing the atherosclerotic burden in people with type 2 diabetes."

PERISCOPE is the first clinical trial to examine the effects of an oral antidiabetic medication on the development of coronary atherosclerosis in patients with type 2 diabetes using IVUS technology. The trial conducted in 97 centers in the U.S., Canada and Latin America with 543 patients, used IVUS imaging of the coronary arteries. The analysis demonstrated a statisticall
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SOURCE Takeda Global Research & Development Center, Inc.
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