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Actos (Pioglitazone HCl) Significantly Improves Components of Diabetic Dyslipide

Results from the first head-to-head study between Actos and Avandia® (rosiglitazone maleate).

A new study published in the July issue of Diabetes Care demonstrated that Actos improved components of diabetic dyslipidemia to a significantly greater extent than Avandia

Specifically, the results indicated that treatment with Actos lowered triglycerides (a type of lipid, or fat, found in food and the body), increased HDL-C ("good" cholesterol), and improved LDL-C ("bad" cholesterol) particle concentration and particle size. These differences were independent of blood glucose control and occurred without the use of a traditional lipid-lowering statin medication.

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."

The 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 4-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.

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.

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

· Triglyceride levels decreased 12.0% in the Actos patients, and rose 14.9% in the Avandia patients (P<0.001).
· HDL-C rose 14.9% in the Actos patients, whereas it increased 7.8% 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%, respectively, in the Avandia patients; they increased 5.7% and 15.7%, respectively, in the Actos patients (TC: P<0.001; LDL-C: P=0.002).

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."

Diabetes Care, July 2005

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