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ACTOS® (pioglitazone HCl) To Be Studied In New Trial Investigating Its Effects On Atherosclerosis In Patients With Type 2 Diabetes

June 9, 2006
Study further examines possible cardiovascular effects of ACTOS beyond glycemic control

Washington, DC, June 9, 2006 – Researchers today at the American Diabetes Association (ADA) 66th Annual Scientific Sessions presented data showing the relationship between baseline characteristics and cardiac risk factors in patients enrolled in a new clinical trial called CHICAGO (Carotid intima-media tHICkness in Atherosclerosis using pioGlitazOne). This is the largest and longest study to examine the effects of ACTOS on measures of the atherosclerotic disease process in patients with type 2 diabetes, most of whom had no clinical evidence of heart disease.

“While earlier and smaller studies found that ACTOS reduced carotid intima-media thickness, given the size and duration of the CHICAGO trial, we hope to gather further information about the effect of ACTOS on blood vessel health and atherosclerosis,” said Theodore Mazzone, M.D., F.A.C.P., professor of medicine and director of the Section of Endocrinology, Diabetes and Metabolism at the University of Illinois at Chicago. “We look forward to further study findings, as we hope they can provide important information and insight about management of cardiovascular disease in people with type 2 diabetes.”

The CHICAGO trial is an 18-month, multicenter, randomized study that has enrolled 439 patients with type 2 diabetes, all from the Chicago area, thus the name of the study. The primary goal was to compare the effects of ACTOS versus glimepiride, a sulfonylurea, on carotid intima-media thickness (CIMT), defined as the thickness of the inner lining of a patient’s neck arteries. It is also assessing the occurrence of cardiovascular events (i.e., death, heart attack and stroke) and cardiovascular disease risk factors among patients with type 2 diabetes.

CIMT is a preferred, noninvasive measure of atherosclerosis, which can lead to heart attack or stroke because of reduced or blocked blood flow through the arteries. CHICAGO will also examine another marker of atherosclerosis, coronary artery calcium (CAC): calcium build-up in the arteries of the heart in the same population. Heart disease and stroke account for 65% of deaths in patients with diabetes.

CHICAGO Data: Relationship Between Baseline Characteristics and Coronary Artery Calcium
A multivariable analysis, a tool for determining the relative contributions of different causes to a significant event, of over 30 traditional and emerging cardiac risk factors (including apolipoproteins, inflammatory and coagulation markers and visceral and total abdominal fat) confirmed that age, systolic blood pressure, gender, race/ethnicity, and triglyceride levels were significant predictors of CAC.

“There is a growing body of science suggesting that ACTOS may have benefits beyond glycemic control,” said Robert Spanheimer, M.D., medical director for diabetes and metabolism at Takeda Pharmaceuticals North America, Inc. “CHICAGO will be viewed in the context of other large cardiovascular studies with ACTOS: the PROactive study, which found that ACTOS may reduce the combined risk of heart attack, stroke and death in high-risk patients with type 2 diabetes; and the PERISCOPE trial, which is studying the effects of ACTOS on progression or regression of atherosclerosis in the coronary arteries using intravascular ultrasound.”

ACTOS works by directly targeting 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 for type 2 diabetes as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.

Additional Information
ACTOS is not for everyone. ACTOS can cause fluid retention that may lead to or worsen heart failure, so tell your doctor if you have a history of these conditions. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath while taking ACTOS. If you have moderate to severe heart failure, ACTOS is not recommended. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter.

Do not take ACTOS if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS as it could increase your chance of becoming pregnant. Some people taking ACTOS may experience flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood glucose.

Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol-lowering and gastroenterology treatments, and through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com .

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