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Pioglitazone HCl Demonstrates Significant Improvements in Cardiovascular Outcomes for High-Risk Patients with Type 2 Diabetes

Results presented at the 42nd European Association for the Study of Diabetes Annual Meeting

COPENHAGEN, DENMARK -- September 14, 2006 -- Several abstracts presented today at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD) indicated that Actos® (pioglitazone HCl), an oral antidiabetic medication, demonstrated significant cardiovascular benefits such as reducing the risk of heart attack and/or stroke and acute coronary syndrome in patients with type 2 diabetes.

Cardiovascular disease (CVD) is the leading cause of premature death in patients with diabetes. An estimated 171 million people worldwide have diabetes, and CVD is responsible for 50% to 80% of deaths in people with diabetes.

"We are continuing to see the benefits of Actos beyond glycemic control," said Erland Erdmann, MD, chairman of the PROactive Executive Committee and director of the Clinic III for Internal Medicine, University of Cologne, Germany. "We know that patients with diabetes are two to four times more likely to develop heart disease or have a stroke than people without diabetes. The data presented at EASD showed that Actos can have a positive effect on several measures of cardiovascular disease outcomes in high-risk patients with type 2 diabetes."

Reduced Occurrence of Major Adverse Cardiovascular Events (MACE)
Results from one of the studies showed that Actos significantly reduced the occurrence of major adverse cardiovascular events (MACE), such as heart attacks, nonfatal stroke, acute coronary syndrome and cardiovascular death in high-risk patients with type 2 diabetes.

Compared to placebo, patients treated with Actos demonstrated statistically significant risk reductions of heart attacks (23%, P =.046), the combined risk of cardiovascular death, nonfatal heart attack or nonfatal stroke (18%, P =.020) and the combined risk of all-cause mortality, nonfatal heart attack, nonfatal stroke or acute coronary syndrome (17%, P =.010). These results were part of the landmark PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study.

Decreased Incidence of Heart Attacks
Compared with the general population, individuals with type 2 diabetes have an increased incidence of myocardial infarction (MI), commonly known as a heart attack. In patients who had experienced a previous heart attack, Actos, on top of standard-of-care treatment, reduced the recurrence of fatal or nonfatal (excluding silent MI) heart attacks by 28% (P =.045).

Prevented Recurrent Strokes
Patients with diabetes have a markedly higher risk of stroke than those without. In fact, strokes occur twice as often in people with diabetes. Of the estimated 750,000 people in the U.S. who experience a stroke each year, 5 to 14% will have an additional stroke within one year. A recent analysis examined the effects of Actos on the risk of stroke and other cardiovascular outcomes in patients with type 2 diabetes with and without prior stroke. The results showed that:

- The incidence of recurrent stroke was reduced by 47%.
- The combined risk of CV death, MI or stroke was reduced by 28%.
- There was no effect of Actos on subsequent strokes in patients who had never experienced a stroke.

Improved Triglycerides & HDL-C
Additional data presented at the meeting showed that Actos improved components of diabetic dyslipidemia, a condition commonly found in people with type 2 diabetes and an important risk factor for CVD, the leading cause of death for people with type 2 diabetes. Diabetic dyslipidemia is characterized by increased triglycerides and decreased HDL-C. People with diabetic dyslipidemia also tend to have normal levels of LDL-C ("bad" cholesterol), but smaller, denser LDL-C particles that are likely to contribute to cholesterol build-up in arteries. The data indicated that:

- Actos decreased triglycerides (a type of lipid or fat found in food and the body)
- Actos increased HDL-C ("good" cholesterol)

"All of the results seen from the PROactive trial significantly impact the lives of those with type 2 diabetes and cardiovascular disease. Because they are at higher risk, it is important to find solutions that impact not only glycemic control but overall cardiovascular health. These findings show the potential benefits Actos can have in managing diabetes and the risk factors that contribute to cardiovascular disease," said Robert Spanheimer, MD, senior medical director for Diabetes and Metabolism at Takeda Pharmaceuticals North America, Inc., in Lincolnshire, Illinois.

About the PROactive Study
PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) is a landmark study that prospectively looked at the impact in total mortality and macrovascular morbidity using Actos, a glucose-lowering agent. It was a randomized, double-blind, placebo-controlled outcome study of 5,238 patients with type 2 diabetes and macrovascular disease.

Patients were randomized to receive either Actos or placebo in addition to standard-of-care treatment (including the routine use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose-lowering agents such as metformin, sulfonylureas and insulin; antiplatelet drugs such as aspirin, and lipid- modifying medicines such as statins and fibrates).

This study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events including both disease and procedural endpoints; and a principal secondary combination endpoint of death, heart attack and stroke.

As reported at the European Association for the Study of Diabetes (EASD) Annual Meeting in September 2005, the primary endpoint was reduced by 10% but had not reached statistical significance by study end (P =.095). The principal secondary endpoint showed that Actos significantly reduced the combined risk of heart attacks, strokes and death by 16% (P =.027) in high-risk patients with type 2 diabetes.

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.

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.

Please visit the Actos Web site at www.actos.com for complete Prescribing Information.


SOURCE: Takeda Pharmaceuticals North America, Inc.

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