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Back To Vidyya Study Findings Show Pioglitazone HCl Improves Glucose Control And Lipid Profiles

In Patients With Type 2 Diabetes

Pioglitazone HCl (ACTOS ®) can significantly improve lipid profiles among subjects with type 2 diabetes, according to data presented today at the American Diabetes Association's 60th Annual Scientific Sessions in San Antonio, TX. Results from clinical studies presented at the meeting showed pioglitazone HCl increased mean HDL ("good") cholesterol levels by as much as 19.1% from baseline. Pioglitazone HCl is a member of the class referred to as thiazolidinediones (TZDs) or glitazones, which are insulin sensitizing agents -- a therapy option for reducing insulin resistance in patients with type 2 diabetes.

"We've evaluated the effect of Pioglitazone HCl on lipid profiles in subjects in both monotherapy and in combination therapy, and each time we reached the same conclusion. Pioglitazone HCl not only substantially improves mean HbA1c and mean fasting blood glucose levels, but it also has measurable benefits on lipid profiles," said Wendell Cheatham, M.D., Director of Medical and Regulatory Affairs for Takeda Pharmaceuticals America, Inc.

Patients with type 2 diabetes typically have low HDL cholesterol levels and high triglyceride levels, two abnormalities that can increase the risk for heart disease.

Study Findings

In the first study, the effects of pioglitazone HCl on lipids in subjects with type 2 diabetes was evaluated during a 26-week, multicenter, double-blind, fixed-dose, placebo-controlled trial which was designed primarily to measure the effect of pioglitazone HCl on glucose levels.

A total of 408 subjects with HbA1c levels greater than or equal to 8% were randomized to receive placebo, 7.5 mg, 15 mg, 30 mg or 45 mg of pioglitazone HCl once daily for 26 weeks. Mean HDL ("good") cholesterol levels increased by 19.1% from baseline on a dose of pioglitazone HCl 45 mg.

The study also evaluated participants' response by measuring triglyceride levels, which showed a mean decrease of as much as 9.3% from baseline at the 45 mg dose. Participants in the study demonstrated improved glycemic control when taking pioglitazone HCl 45 mg once daily with mean HbA1c levels decreasing by 1.6 percentage points versus placebo and mean fasting blood glucose levels decreasing by 65.3 mg/dL versus placebo. The conclusion was that pioglitazone HCl monotherapy improved glycemic control and lipid profiles in patients with type 2 diabetes.

A second study reported was a randomized, multicenter, double-blind, placebo-controlled, dose escalation evaluation that included 260 subjects with type 2 diabetes. Subjects were randomized to receive pioglitazone HCl 7.5 mg for four weeks, 15 mg for four weeks, and 30 mg for 16 weeks (7.5/15/30 pioglitazone HCl); or pioglitazone HCl 15 mg for four weeks, 30 mg for four weeks, and 45 mg for 16 weeks (15/30/45 pioglitazone HCl); versus placebo (mock-dose-titration) for the same period of time. Study participants stopped any prior antidiabetic medications six weeks before randomization began. In this study in which the maximum dose of pioglitazone HCl decreased subjects' HbA1c levels by a mean of 1.53 percentage points, the participants' mean HDL cholesterol levels increased significantly, by 13.1% and mean triglyceride levels decreased by as much as 12.4% from baseline*. Mean percent change in total cholesterol and low-density lipoprotein cholesterol with pioglitazone HCl were similar to placebo. The reported conclusion is that pioglitazone HCl monotherapy improves glycemic control and lipid profiles in patients with type 2 diabetes.

In U.S. placebo-controlled clinical trials, there have been no reported cases of jaundice or liver failure associated with use of ACTOS(R) (pioglitazone HCl). However, since liver toxicity has been observed with the earliest-approved drug in the TZD class, patients should obtain medical monitoring of liver enzyme levels (via a blood test) prior to the start of therapy, every two months for the first year of therapy, and periodically thereafter. ACTOS should not be initiated in patients exhibiting clinical evidence of active liver disease. ACTOS has not been evaluated in patients with NYHA Class III or Class IV cardiac status; therefore, ACTOS is not indicated in these patients. Therapy with ACTOS, like other thiazolidinediones, may result in ovulation in some premenopausal women who are not ovulating. As a result, these patients may be at risk for pregnancy while taking ACTOS and adequate contraception should be recommended. Administration of oral contraceptives has not been fully evaluated in patients being treated with ACTOS. Therefore, additional caution regarding co-administration of ACTOS and an oral contraceptive should be exercised.

ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The majority of side effects reported during ACTOS clinical trials were mild. Those most commonly reported included symptoms of upper respiratory tract infection, headache, sinusitis, muscle pain, tooth disorder and sore throat. Occasionally, blood sugar levels increased during clinical trials. As observed with other members of this class of drugs, weight gain has been noted. Additionally, mild to moderate edema and anemia have been reported in patients taking ACTOS. ACTOS should be used with caution in patients with edema. Patients receiving ACTOS in combination with insulin or sulfonylureas may be at risk for hypoglycemia, and a reduction in the dose of insulin or sulfonylureas may be necessary.

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Editor: Susan K. Boyer, RN
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