Actos (pioglitazone HCl) Demonstrates Reduced Risk of Ischemic Cardiovascular Disease in Patients with Type 2 Diabetes

Results presented at the 43rd European Association for the Study of Diabetes Annual Meeting

AMSTERDAM, The Netherlands, September 19, 2007 /PRNewswire/ -- Results presented today at the 43rd Annual Meeting of the European Association for the Study of Diabetes demonstrate the ability of ACTOS(R) (pioglitazone HCl) to reduce the risk of ischemic cardiovascular disease in patients with type 2 diabetes. ACTOS is an oral antidiabetic agent for type 2 diabetes belonging to the thiazolidinedione (TZD) class of drugs.

Study Design and Results (PS130 / Abstract #1257)

This retrospective analysis of case records from a large managed care database of patients with diabetes showed that therapeutic regimens that included ACTOS were associated with reductions in the risk for stroke or myocardial infarction (MI) compared to non-thiazolidinedione therapies. The adjusted relative risk of stroke for the ACTOS group was 20 percent lower than that for the group not receiving ACTOS. Likewise, the risk of sustaining a heart attack over the study period was 38 percent lower in the patients receiving ACTOS than in those taking an antidiabetes drug regimen that did not include ACTOS.

"In this study, ACTOS was associated with reduced risk of heart attack and stroke," said Robert Spanheimer, M.D., Takeda Pharmaceuticals North America, Inc., senior medical director of diabetes and metabolism. "These outcomes - in a real world setting - are consistent with findings of no increase in total macrovascular events or death from PROactive, a prospective, randomized, controlled outcomes study."

Case records from January 2003 through June 2006 from a large managed care database of diabetes patients who were at least 45 years of age:

    -- had not had a stroke or MI for the last six months and who were taking

       either ACTOS (11,433 patients) with or without any other antidiabetes

       treatment (excluding rosiglitazone, another member of the TZD class);

       or

    -- who were taking an antidiabetes drug regimen that did not include ACTOS

       or rosiglitazone (55,273 patients).

The study endpoint was timed to the first stroke or MI or end of the study period, whichever occurred first.

Additional data presented include a post hoc analysis of the GLAI study, a six-month head-to-head study of patients treated with ACTOS and rosiglitazone examining blood glucose levels and lipid levels. The abstract examines three- month data from the study.

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 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.

Important Safety Information About ACTOS(R) (pioglitazone HCl)

The prescription medication ACTOS is used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes. ACTOS is taken once daily either alone or in combination with insulin, sulfonylureas, or metformin.

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

North America, Inc.

CONTACT: Elissa J. Johnsen of Takeda Pharmaceuticals North America, Inc.,+1-224-554-3185; or Amy Losak of Ketchum, +1-646-935-3917

Web site: http://www.tpna.com/http://www.actos.com/

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Posted: September 2007

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