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

06/28/05

Results from the first head-to-head study between ACTOS and Avandia® (rosiglitazone maleate) published in Diabetes Care

Lincolnshire, IL, June 29, 2005 – A new study published in today's 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."

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.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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