SOURCE: Takeda Pharmaceuticals North America

November 06, 2007 09:20 ET

MEDIA ADVISORY: Data Presented at the American Heart Association Scientific Sessions 2007 Demonstrated Increased HDL With ACTOS® (pioglitazone HCl) Slowed the Progression of Carotid Intima-Media Thickness in Patients with Type 2 Diabetes

ORLANDO, FL--(Marketwire - November 6, 2007) -


What and When

Additional results from the clinical trial, CHICAGO (Carotid intima-media tHICkness in Atherosclerosis using pioGlitazOne), will be presented as an oral session at the American Heart Association Scientific Sessions 2007 being held November 4 through 7, 2007 in Orlando, Florida.

Results revealed that reduced progression of carotid intima-media thickness (CIMT), the thickness of the inner lining of a patient's carotid, with ACTOS was associated with increased HDL cholesterol and decreased insulin levels when compared to glimepiride. An increase in CIMT is an indicator of atherosclerosis, a condition that leads to reduced or blocked blood flow and is a surrogate marker for the risk of heart attack and stroke.

CHICAGO 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. 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. The results from the CHICAGO study demonstrated significant improvements on cardiovascular risk markers beyond glycemic control with ACTOS.

The CHICAGO trial adds to the already substantial body of evidence regarding cardiovascular data that has been developed over several years of research on ACTOS.

ORAL PRESENTATION ON NOVEMBER 6, 2007 FROM 9:15 TO 9:30 A.M. EASTERN STANDARD TIME

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 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 www.tpna.com.

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