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Posted 11-22-99
CLEVELAND -- Physicians at Case Western Reserve University's School of Medicine and University Hospitals of Cleveland have received $13.2 million from the National Heart, Lung, and Blood Institutes at the National Institutes of Health to help design and perform a 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, high blood pressure, and cholesterol. Researchers also will test the effectiveness of several new medications and drug strategies to reduce the cardiovascular complications of diabetes.
The principal investigators for the PCDD trial are Marc Thibonnier and Saul Genuth, both professors of medicine. They 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 age 50-75 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," said Thibonnier, an international expert in hypertension.
"It's not good enough to control blood sugar alone, once high blood pressure and high cholesterol have appeared," he added. "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. Thibonnier said, "There have been no studies like this one, on such a scale, for such a long time."
Genuth is nationally renowned for decades of research proving that tighter control of blood sugar in Type I 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.
Genuth said that 70 percent of people with Type 2 diabetes develop cardiovascular complications which are likely to be their cause of death. While deaths from coronary heart disease has been declining for the general population, he added, they have remained constant in people with diabetes. "People with diabetes are more likely to die from a heart attack," he said.
"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," said 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."
Thibonnier and Genuth assembled a network of clinical sites in Ohio and Michigan that will recruit 1,500 patients for the PCDD trial. The Ohio/Michigan Clinical Center Network includes University Hospitals of Cleveland, Cleveland Clinic Foundation, Louis Stokes 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.
Recruitment for the study will begin next spring. People interested in participating in the study may contact the researchers by phone (368-6129), fax (368-5824), or e-mail (mxt10 or smg15).
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