Cleveland Researchers Lead National Heart Disease Prevention Trial.



NIH awards $13 million to study diabetes drugs

CLEVELAND, Oct. 11 /PRNewswire/ -- Physicians at University Hospitals of Cleveland and Case Western Reserve University School of Medicine have been awarded $13.2 million from the National Heart, Lung, and Blood Institute at the National Institutes of Health to help design and perform an historic nationwide study that will define the best treatment for the prevention of heart disease among patients with Type 2 diabetes mellitus.

The Prevention of Cardiovascular Disease in Diabetes (PCDD) trial will study the benefits of intensified-versus-conventional control of high blood sugar and two different drug strategies to achieve control. Researchers also will test for treatment of high blood pressure and high cholesterol in these diabetic patients, and assess the effectiveness of several new medications to reduce the complications of diabetes. The principal investigators for the PCDD trial are Marc Thibonnier, M.D., and Saul Genuth, M.D., of the Department of Medicine at University Hospitals of Cleveland and CWRU School of Medicine.

Drs. Thibonnier and Genuth will lead one of seven networks of hospitals and physicians to recruit 10,000 patients. Those patients will be treated for at least five years with free medications during the course of the trial. Adults ages 50 to 75 with Type 2 diabetes, the most common form of the disease, will be eligible for the study, provided they have not already developed cardiac disease or had a heart attack.

Diabetics are at especially high risk for developing cardiovascular complications, including heart disease, stroke, atherosclerosis, cardiomyopathy, congestive heart failure and poor circulation in the legs. Cardiovascular complications are now the leading causes of illness and death among the nation's 16 million diabetics.

"The current standard of care simply isn't good enough, while the incidence of Type 2 diabetes keeps rising in all age groups, including children," says Dr. Thibonnier, a professor of medicine and pharmacology and international expert in hypertension. "It's not good enough to control blood sugar alone, once high blood pressure and high cholesterol have appeared. Research shows that there also must be stricter control of blood pressure and cholesterol in diabetic patients to prevent deadly cardiovascular complications. But we don't know how strict is strict enough, or which medications offer the best control and prevention."

This landmark study aims to answer these questions and will define new strategies for preventing cardiovascular complications in diabetic patients, Dr. Thibonnier added.

Dr. Saul Genuth is nationally renowned for decades of research proving that tighter control of blood sugar in Type 1 diabetes (the disease that strikes children) could delay and prevent serious and deadly complications. The PCDD study will focus on a much wider range of cardiovascular risk factors, including obesity, smoking and physical inactivity as well as diabetes, high blood pressure and high cholesterol.

"There are many new medications to treat the complications of diabetes, but they are very expensive, costing the average patient upwards of $200 a month," says Dr. Genuth. "As part of this new study, patients will receive their medicines free and will be closely monitored to see if these drugs are working and to determine the most effective dosages of drugs."

Drs. Thibonnier and Genuth assembled a network of clinical sites in Ohio and Michigan that will recruit 1500 patients for the PCDD trial. The Ohio/Michigan Clinical Center Network includes University Hospitals of Cleveland, Cleveland Clinic, Cleveland Veterans Administration Medical Center, Ohio State University, University Suburban Health Center, North Coast Institute of Diabetes and Endocrinology, University of Cincinnati Hospitals, Cincinnati VA Medical Center, Medical College of Ohio at Toledo, and the Henry Ford Health System in Detroit, Mich.

Recruitment for the study will begin next spring. People interested in participating in the study may contact the researchers by phone at 216-368-6129, Fax 216-368-5824, or e-mail mxt10@po.cwru.edu or smg15@cwru.edu.

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