Cardiologists Study Impact of Statin on Metabolic Syndrome

March 18, 2005

A study being conducted by cardiologists at the Strong Heart and Vascular Center is considering the effects of a statin drug on metabolic syndrome, a condition that increases women’s risk for heart disease and stroke.

Metabolic syndrome is a collection of health risk factors that include being overweight, having borderline glucose (sugar) levels, borderline blood pressure, and abnormal  cholesterol levels with high triglycerides (fat content in blood). People with three or more risk factors are considered to have metabolic syndrome.

Little research has been done regarding the syndrome in women who comprise a large segment of the population with the syndrome, according to cardiologist Gladys Velarde, M.D., director of the Strong Women’s Heart Program at the University of Rochester Medical Center.

The purpose of the study is to evaluate the effect of atorvastatin, in this case, Lipitor, on some important blood markers known to be abnormal in the syndrome, Velarde says. The hope is to determine the ability of statins to lower risk factors of the condition, and to determine the impact of treatment on the syndrome’s individual components. Atorvastatin is approved by the U.S. Food and Drug Administration for the treatment of high cholesterol.

“Metobolic syndrome is a constellation of conditions,” Velarde says. “We are trying to ascertain if we can affect the components that make up the syndrome using statin drugs, with the goal of someday decreasing the risk of heart disease and stroke in women who have it.”

Volunteers should be between the ages of 18 and 75, not pregnant and not planning to become pregnant in the next 12 months. They must have at least three of the five components that comprise the metabolic syndrome.

About 60 subjects will be enrolled in Rochester, with participation lasting 18 weeks. Four visits to the Strong Women’s Heart Program office at Clinton Crossings will be required, to discuss lifestyle changes and do blood tests, blood pressure checks, among other measures.

Patients will be assigned to one of two study groups. Starting the first week, both groups will be on the American Heart Association Step 1 diet, a low-fat program designed to reduce the risk of cardiovascular disease. All will continue their diet plans through the end of the study.

Starting the sixth week, one group will receive a statin drug, the other a placebo, to be taken through the end of the study. Neither volunteers nor researchers will know which group volunteers are in.

“The more we can discover about how to decrease the risk of heart attack and stroke in women, the fewer the number of patients who will suffer from the disease as a result,” Velarde says. “This is a very  important step in that direction.”

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Karin Christensen
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