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Takeda Pharmaceuticals North America Initiates Cardiac Clinical Trials

April 1, 2003
PERISCOPE and CHICAGO studies investigate potential of ACTOS to reduce the risk for cardiovascular disease

LINCOLNSHIRE, IL, April 1, 2003 - Takeda Pharmaceuticals North America (TPNA) announced the initiation of two significant clinical trials, PERISCOPE and CHICAGO, to investigate the effect of ACTOS® (pioglitazone HCl) on reducing the risk for cardiovascular disease in patients with type 2 diabetes. These two trials together will study up to 1,000 people using both non-invasive and invasive techniques for measuring atherosclerotic plaque and looking at key biochemical markers for heart disease, such as C-reactive protein (CRP) and brain naturietic peptide (BNP).

"Heart disease is the leading cause of death for people living with diabetes, and while significant progress has been made in understanding the link between diabetes and heart disease, we still have a long way to go. These are important studies that should enable us to better understand the effects of a diabetes therapy such as ACTOS on atherosclerosis, which is the major cause of MI and stroke in patients with diabetes," said Theodore Mazzone, M.D., F.A.C.P., professor of medicine and director of the Section of Endocrinology and Metabolism at the Rush Presbyterian St. Luke's Medical Center in Chicago. Dr. Mazzone is the principal investigator for the CHICAGO trial.

The CHICAGO trial, named for the location of all 25 sites, is a double-blind, randomized trial with a treatment period of 72 weeks (18 months). The purpose of the trial is to investigate the potential for reduction of atherosclerosis using ACTOS by looking at changes in carotid intima-media thickness (CIMT) and coronary artery calcium using electron beam computed tomography (EBT). EBT and CIMT are non-invasive cardiac procedures allowing cardiologists to examine the health of arteries in the neck and heart. The trial begins this month.

The PERISCOPE trial also is a double-blind, randomized trial with 80 sites nationwide. The trial will evaluate the effect of treatment with ACTOS on coronary artery disease using intravascular ultrasound (IVUS). IVUS is an invasive cardiac procedure that allows cardiologists to examine plaque inside arteries in the heart. The trial also begins enrolling patients this month, with planned treatment period lasting 72 weeks (18 months).

According to the American Heart Association, approximately 1.1 million Americans this year will have a first or recurrent heart attack, the nation's single leading cause of death. In addition, about 7.6 million Americans age 20 or older have survived a heart attack. Type 2 diabetes dramatically increases a person's risk for heart disease and stroke, and is associated with other cardiovascular risk factors such as high blood pressure, cholesterol disorders, obesity and insulin resistance.

"Through our clinical trial experience and past four years in the marketplace, ACTOS has demonstrated it can be an effective part of therapeutic treatment for type 2 diabetes," said Claire Thom, Pharm.D., vice president of Research and Development at TPNA. "We also know from our clinical trials that ACTOS has a favorable effect on lowering triglyceride levels and increasing HDL which, as a result, led us to design the CHICAGO and PERISCOPE trials."

As an adjunct to diet and exercise, ACTOS, taken once per day, is approved for use as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin. It is known as an insulin resistance reducer because it directly targets insulin resistance, a condition where the body does not effectively use its own insulin. ACTOS significantly reduces mean blood glucose levels among people with type 2 diabetes, by helping increase the body's sensitivity to its own insulin.

Additional Information
ACTOS is not for everyone. ACTOS can cause fluid retention or swelling, which 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, swelling, or shortness of breath while taking ACTOS. If you have moderate to severe heart failure, ACTOS is not recommended. Also, your doctor should perform a blood test to check for serious liver problems or active liver disease before you start ACTOS and regularly thereafter. Do not take ACTOS if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, anorexia, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS because it could increase your chance of becoming pregnant.

Some people taking ACTOS may experience cold and flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. Occasionally, blood sugar levels increased during clinical trials. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar.

Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly-owned subsidiary of Takeda Chemical Industries, Ltd. in Osaka, Japan. Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the industry's leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

ACTOS is a registered trademark of Takeda Chemical Industries, Ltd. and used under license by Takeda Pharmaceuticals North America, Inc. and Eli Lilly and Company.

Please visit the ACTOS website at www.actos.com for complete Prescribing Information. For company information, visit Takeda Pharmaceuticals North America's Web site at www.tpna.com .


Jocelyn Gerst
Takeda Pharmaceuticals North America

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