ACTOS® (pioglitazone HCl) significantly improved components of diabetic dyslipidemia

(I-Newswire) July 4, 2005 - Diabetic dyslipidemia is a condition commonly found in people with type 2 diabetes and is an important risk factor for cardiovascular disease, 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, but smaller, denser LDL-C particles that are likely to contribute to cholesterol build-up in arteries.

"This study provides important insight into the relative impact of each drug on important cardiovascular risk markers," noted principal investigator Ronald B. Goldberg, M.D., professor of Medicine and Associate Director of the Diabetes Research Institute at the University of Miami Miller School of Medicine. "The results demonstrate a clear difference between ACTOS and Avandia on their effects on diabetic dyslipidemia, with ACTOS lowering triglycerides and raising HDL-C to a greater extent than Avandia."

Study Design

This 24-week prospective, randomized, multicenter, double-blind clinical trial enrolled 802 people with type 2 diabetes (treated with diet alone or oral monotherapy) and dyslipidemia (not treated with any lipid-lowering medications).

Following a four-week "washout" period where patients discontinued their current diabetes medication and received a placebo, patients were randomized to receive either 30 mg of ACTOS® (pioglitazone HCl) once daily for 12 weeks followed by 45 mg of ACTOS once daily for the remainder of the study, or 4 mg of Avandia® (rosiglitazone maleate) once a day for 12 weeks followed by 4 mg of Avandia twice daily for the remainder of the study. These represent the maximally effective therapeutic doses for both medications.

"By eliminating other factors such as statins to control lipids and other medications to control blood glucose levels, we obtained a clear assessment of the blood sugar and lipid effects of both drugs," added Dr. Goldberg.

Results

The study showed that blood glucose control, which was measured by A1C (a measure of blood glucose over a several-month period), was significantly improved in both ACTOS- and Avandia-treated patients with comparable changes from baseline. At baseline, average A1C scores were 7.6 percent in the ACTOS group and 7.5 percent in the Avandia group. Following treatment, average A1C was reduced by 0.7 percent and 0.6 percent respectively (P=NS), and mean A1C for both treatment groups was below the ADA goal of less than 7 percent.

Additionally, the study demonstrated that ACTOS and Avandia differed significantly in their effects on blood lipids:

* triglyceride levels decreased 12.0 percent in the ACTOS patients, and rose 14.9 percent in the Avandia patients (P<0.001).

* HDL-C rose 14.9 percent in the ACTOS patients, whereas it increased 7.8 percent in the Avandia patients (P<0.001).

* LDL-C particle concentration was reduced with ACTOS and increased with Avandia (P<0.001). LDL-C particle size increased more with ACTOS (P=0.005).

Total cholesterol (TC) and LDL-C increased with both drugs, but to a lesser extent with ACTOS. TC and LDL-C rose 15.9 and 23.3 percent, respectively, in the Avandia patients; they increased 5.7 percent and 15.7 percent, respectively, in the ACTOS patients (TC: P<0.001; LDL-C: P=0.002).

"Our knowledge regarding the association between type 2 diabetes and cardiovascular disease, which can be referred to as 'CardioDiabetes,' continues to grow," said Robert Spanheimer, M.D., medical director for diabetes and metabolism at Takeda Pharmaceuticals North America. "Many factors can contribute to the increased risk of cardiovascular disease in people with diabetes, including multiple lipid abnormalities. It is important to understand the impact medications can have on individual lipid parameters. This study underscores the potential benefits of ACTOS beyond glycemic control in improving diabetic dyslipidemia in patients with type 2 diabetes. These findings require further research in order to determine whether the results reported here may affect cardiovascular risk."

ACTOS® (pioglitazone HCl) Avandia® (rosiglitazone maleate) are insulin sensitizers belonging to the thiazolidinedione (TZD) class of oral anti-diabetes medications that have been approved by the Food and Drug Administration to improve blood glucose control in type 2 diabetes as an adjunct to diet and exercise.

About ACTOS

ACTOS works by directly targeting insulin resistance, a condition in which the body does not effectively 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 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.

While ACTOS may confer some lipid benefits, ACTOS is not indicated to treat lipid disorders and should not be used as a substitute for lipid-lowering therapy.

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 http://www.lilly.com.

Takeda Pharmaceuticals North America, Inc.

Based in Lincolnshire, 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 and cholesterol-lowering treatments, and through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, sleep, 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 http://www.tpna.com.

ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited 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. The brand names included in this piece are properties of their respective owners.

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