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Item #1

Rosiglitazone Shown to Lower Cardiovascular Disease Risk

New Data Shown to Increase Good Cholesterol Levels Up to 25 Percent and a  one percent increase in HDL cholesterol is associated with a one percent lower risk of cardiovascular disease.

Data presented last week at the 52nd Annual Scientific Session of the American College of Cardiology showed that the Type 2 diabetes treatment rosiglitazone increased "good" cholesterol levels and improved the ratio of total cholesterol-to-"good" cholesterol in patients with the Type 2 diabetes, especially among patients at greatest risk for cardiovascular disease. Cardiovascular disease is one of the most serious complications of Type 2 diabetes, causing approximately 80 percent of diabetes-related deaths.

The study, which analyzed data from open-label extensions of two placebo-controlled, double-blind studies, examined the long-term effect of rosiglitazone on high-density lipoprotein (HDL cholesterol) -- also known as "good" cholesterol -- in patients with Type 2 diabetes. HDL protects against cardiovascular disease by moving cholesterol from the arteries to the liver, where it is passed from the body. Many patients with Type 2 diabetes also have low HDL cholesterol levels. Recent guidelines from the National Cholesterol Education Program state that an HDL cholesterol level lower than 40 mg/dL is a major risk factor for heart disease.

A total of 269 patients in the two studies were given 8 mg of the diabetes drug rosiglitazone daily for 24 months. In all patients, mean HDL cholesterol levels increased 15 percent, with increases of 25 percent in patients with HDL cholesterol levels of less than 40 mg/dL at baseline.

"Previous research has shown that a one percent increase in HDL cholesterol is associated with a one percent lower risk of cardiovascular disease," said Ernst J. Schaefer, MD, abstract author and Director of the Lipid and Heart Disease Prevention Clinic at Tufts-New England Medical Center's Division of Endocrinology, Diabetes, Metabolism and Molecular Medicine, and Professor of Medicine at Tufts University School of Medicine. "The data from this research shows the HDL-raising effect of rosiglitazone has the potential to significantly reduce the risk of cardiovascular disease."

An individual's total cholesterol-to-HDL cholesterol ratio is a commonly used tool for assessing cardiovascular disease risk, with a low ratio being associated with a lower risk. The ratio of cholesterol-to-HDL cholesterol improved for all patients in the study, with an overall decrease from 5.06 to 4.7 over the 24-month treatment period. In patients with a ratio greater than 5, the mean ratio decreased from 6.25 to 5.6.

"As cardiovascular disease is the number one cause of death in diabetes patients, it is important to consider treatment options, such as rosiglitazone, that can control blood sugar levels by reducing insulin resistance, and increase HDL cholesterol, which may reduce the risk of cardiovascular disease," said Schaefer.

Individuals with Type 2 diabetes produce insulin, but their bodies do not utilize it properly. Rosiglitazone treats Type 2 diabetes by sensitizing the cells in a diabetic's body to the insulin being produced, enabling the cells to absorb needed nutrients.

Cholesterol is a waxy substance found among the fats in the bloodstream and in the body's cells. In high levels, HDL cholesterol protects against cardiovascular disease by slowing arterial build-up.  Funding for the study and media relations assistance was provided by GlaxoSmithKline

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