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New Data Published in Circulation Showed an Increase in HDL Cholesterol Levels with ACTOS(R) (pioglitazone HCl)
Date:4/15/2008

DEERFIELD, Ill., April 15 /PRNewswire/ --

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Additional results from the clinical trial CHICAGO (Carotid intima-media tHICkness in Atherosclerosis using pioGlitazOne) published today in Circulation revealed that reduced progression of carotid intima-media thickness (CIMT) with ACTOS(R) (pioglitazone HCl) was associated with increased levels of HDL cholesterol (HDL-C, or "good cholesterol") when compared to glimepiride.

The increased effect on HDL-C levels at 24 weeks is expected to have contributed to the reduction of atherosclerosis progression as measured by CIMT at 72 weeks. These results suggest that suppression of atherosclerosis with pioglitazone therapy is linked to its effect to raise HDL cholesterol. An increase in CIMT, the thickness of the inner lining of a patient's carotid, is an indicator of atherosclerotic burden, a condition which leads to reduced or blocked blood flow and is a surrogate marker for the risk of heart attack and stroke.

CHICAGO examined the effects of ACTOS on measures of the atherosclerotic disease process in patients with type 2 diabetes. The randomized, double-blind, controlled study enrolled 462 patients with type 2 diabetes. Patients were treated with a 15 to 45 mg dose of ACTOS or 1 to 4 mg dose of glimepiride for 72 weeks with evaluation after 6 months.

These data, coupled with the recently presented and published PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) trial, add to the body of cardiovascular data for ACTOS. While not definitive, data from CHICAGO and PERISCOPE, looking at two surrogate markers, have shown a consistent trend toward a reduction of atherosclerotic burden in people living with type 2 diabetes. 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
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SOURCE Takeda Pharmaceuticals North America, Inc.
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