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Studies Show ACTOS® (pioglitazone HCl) Has Positive Effects on Various Components of Dyslipidemia

June 5, 2004

Orlando, FL, June 5, 2004 – Two clinical studies presented at the American Diabetes Association’s (ADA) Scientific Sessions showed that ACTOS® (pioglitazone HCl) has favorable effects on dyslipidemia (low HDL-C levels, high triglycerides and high levels of small, dense LDL-C) and insulin resistance. Dyslipidemia and insulin resistance are two key components of the metabolic syndrome, which is often exhibited in patients with type 2 diabetes.

“When you put the pieces together, these separate findings are very exciting because they show that ACTOS therapy can provide benefits extending beyond improvements in glucose levels,” said Mehmood Khan, M.D., F.A.C.E., senior vice president for medical and scientific affairs, Takeda Pharmaceuticals. “These studies showed that ACTOS can affect certain components of the metabolic syndrome, each of which must be managed when treating people with type 2 diabetes. We now have reason to believe that, when a physician prescribes ACTOS for type 2 diabetes, the patient may also benefit from a reduction of other risk factors.”

Results of a pooled analysis of four separate, double-blind, randomized, multi-center trials conducted over the course of one year demonstrated that ACTOS has favorable effects on dyslipidemia in patients with type 2 diabetes. In each of the four trials, patients with poorly controlled type 2 diabetes were randomized to receive monotherapy consisting of ACTOS, metformin or a sulfonylurea (gliclazide), or a combination of ACTOS with these two agents.

Analysis of the data showed that, in addition to reducing hyperglycemia by addressing insulin resistance, ACTOS alone, or in combination with either metformin or the sulfonylurea, brought about a statistically significant decrease in serum triglycerides from baseline, and a statistically significant increase in HDL (“good”) cholesterol, versus either of the other drugs alone or in combination with each other. Additionally, statistically significant decreases in both systolic and diastolic blood pressure were noted in the ACTOS monotherapy and ACTOS/sulfonylurea groups.

A second study presented at the ADA Scientific Sessions demonstrated that, in people with type 2 diabetes and dyslipidemia, ACTOS had a robust effect on both lipid and glucose levels, regardless of whether the patient was receiving stable lipid-lowering therapy. People with diabetes are about twice as likely as those without diabetes to have high triglyceride and low HDL cholesterol levels, a condition commonly referred to as diabetic dyslipidemia.

In this study of 859 patients with type 2 diabetes, 736 were taking statins and 123 were taking fibrates, both of which are established therapies to treat dyslipidemia. These patients were matched with controls that were not taking lipid-lowering drugs and all participants were given ACTOS (30 mg/day) for 16 weeks.

Significant beneficial effects of ACTOS were seen on HDL (“good”) cholesterol, fasting triglycerides, non-HDL cholesterol (total cholesterol minus HDL-C) and A1C (a measure of average blood glucose levels over the previous 90 to 120 days). Additionally, the benefits seen with ACTOS were not significantly influenced by the patient’s age, diabetes duration, body mass index or gender.

ACTOS is an oral treatment for type 2 diabetes belonging to the thiazolidinedione class of drugs. It is known as an “insulin sensitizer” because it directly targets insulin resistance, a condition in which the body does not effectively use the insulin it produces. It is taken once daily as an adjunct to diet and exercise, and is approved for use 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 or edema (swelling), which 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, edema (swelling), or shortness of breath while taking ACTOS. If you have moderate to severe heart failure, ACTOS is not recommended. Also, your doctor should perform a blood test to check for serious liver problems or active liver disease before you start ACTOS and regularly thereafter. Do not take ACTOS if you have active liver disease. Talk to your
doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, anorexia, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS because it could increase your chances of becoming pregnant.

Some people taking ACTOS may experience cold and flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. Occasionally, blood sugar levels increased during clinical trials. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar.

Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly-owned subsidiary of Takeda Chemical Industries, Ltd. (Osaka, Japan). Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the industry’s leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products. For company information, visit Takeda Pharmaceuticals North America’s Web site at www.tpna.com .

Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers—through medicines and information—for some of the world’s most urgent medical needs. Additional information about Lilly is available on www.lilly.com .

Final Notes
ACTOS is a registered trademark of Takeda Chemical Industries, Ltd. and used under license by Takeda Pharmaceuticals North America, Inc. and Eli Lilly and Company. Please visit the ACTOS Web site at www.actos.com for complete Prescribing Information. For company information, visit Takeda Pharmaceuticals North America’s Web site at www.tpna.com .

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