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.

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Contact: Julio Cantre
julio.cantre@ketchum.com
646-935-4122
Ketchum
6-Jun-2004

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