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Diabetes Drug Actos (pioglitazone HCl) Showed Anti-Inflammatory Effects in Patients with Type 2 Diabetes in a Clinical Study

SAN DIEGO, CA -- June 16, 2005 -- A new study presented today at the American Diabetes Association (ADA) 65^th Annual Scientific Sessions showed that the type 2 diabetes drug Actos reduced C-reactive protein (CRP), a marker of inflammation and a risk factor for cardiovascular disease.

"This study contributes to increasing data pool suggesting that Actos may have benefits beyond blood glucose control and an improvement in insulin resistance, although further studies are required," said Robert Spanheimer, MD, medical director for diabetes and metabolism at Takeda Pharmaceuticals North America.

Study Design
The study found that treatment with Actos reduced levels of CRP and interleukin (IL-6), both of which are markers of inflammation in patients with type 2 diabetes. In this randomized, placebo-controlled, double-blind study, patients with stable glycemic control receiving insulin with or without metformin were randomized to add-on therapy with Actos (15 mg/day titrated to 30 mg/day, if tolerated) or placebo.

After eight to ten weeks, there were significantly greater decreases in levels of the two markers in the Actos arm. CRP decreased by 6.98 mg/L compared to 1.55 mg/L for placebo (p= 0.001). IL-6 decreased by 0.78 pg/mL compared to 0.22 pg/ml for placebo (P=0.002).

Cardiovascular Disease and Diabetes
In recent years, scientists and physicians are recognizing a growing association of two epidemic diseases – cardiovascular disease and diabetes. "CardioDiabetes" is a term being used to refer to this association. According to a joint American Heart Association and American Diabetes Association consensus statement, diabetes is an independent risk factor for cardiovascular disease. In fact, some experts are of the opinion that "diabetes is a cardiovascular disease."

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.


SOURCE: Takeda Pharmaceuticals North America, Inc.

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