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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/ --

What and When

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 ACTOS is associated with an increased risk of heart attack, stroke, or death.

About ACTOS

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, a prescription medication, 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. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause or worsen congestive heart failure. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath.

Do not take ACTOS if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter. 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 flulike symptoms, mild-to-moderate swelling of legs and ankles, and anemia. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Very rarely, some patients have experienced visual changes while taking ACTOS.

Please visit the ACTOS Web site at http://www.actos.com for Complete Prescribing Information.

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, 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, 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 http://www.tpna.com.

ACTOS(R) (pioglitazone HCl) is a registered trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals North America, Inc.


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SOURCE Takeda Pharmaceuticals North America, Inc.
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