For Release Upon Receipt April 24, 2000
Sharon Regional invited
to participate in three major pharmaceutical studies
Sharon Regional Health System has been invited to participate in three major pharmaceutical research studies, one involving an innovative treatment for heart attack patients presenting to Sharon Regional's Emergency Care Center and two others for diabetic patients through its Diabetes and Endocrinology Center.
The heart attack study, known as Gusto IV, is a multinational, multicenter study that will involve 16,600 patients at 800 centers worldwide. The study will look at patients having a heart attack to determine whether the drug known as ReoPro (a medication designed to prevent blood platelets from sticking together to form clots), given in combination with a reduced dose of a clot buster known as Reteplase, is safer and more effective in treating heart attacks as compared to standard doses of Reteplase alone.
The study is also being conducted to see if a combination of ReoPro and reduced dose Reteplase will decrease the heart attack death rate at 30 days compared to standard dose Reteplase alone. The Cleveland Clinic, with whom Sharon Regional shares a clinical affiliation, is coordinating the study regionally. Primary investigator for the Gusto IV study is Sergio Segarra, M.D., FACEP, director of Sharon Regional's Emergency Care Center.
Patients that choose to participate in the Gusto IV trial must meet strict eligibility criteria. These include an age of 18 years or older, experiencing continuous chest pain of at least 30 minutes in duration, presenting to Sharon Regional's Emergency Care Center/Chest Pain Center within six hours of the onset of chest pain, receiving heart attack confirmation through an EKG study, and several other criteria. Patients participating will be contacted at 30 days and one year to obtain data for the study. Heart attack patients who choose not to participate in the study will receive the Emergency Care Center's current advanced heart attack treatment.
Dr. Segarra felt that the study offers a great opportunity for patients in this region to benefit from what is believed to be improved therapy. "We strongly support eligible heart attack patients enrolling in this study and taking advantage of the potential benefits it may offer them," said Dr. Segarra. "Heart attack patients presenting at Sharon Regional's Emergency Care Center have an opportunity to take advantage of futuristic treatment modalities not typically available outside of larger cities," Dr. Segarra stated.
James Landis, Jr., M.D., cardiologist and medical director of Sharon Regional's Heart Institute, said the invitation to participate in Gusto IV was based on several factors. "Not only did the Gusto IV investigators look at our Emergency Care Center and Chest Pain Center, they also recognized our existing high volume of cardiac patients and advancements we're making through our Heart Institute," Dr. Landis said. "We're honored their researchers asked us to participate."
The two diabetes research studies, being conducted through Sharon Regional's Diabetes and Endocrinology Center on Highland Road in Hermitage, are the ADOPT (A Diabetes Outcome Progression Trial) and the Rosiglitazone/137 Study. Andrew Behnke, M.D., FACP, endocrinologist, is the primary investigator for both studies. Patients participating in either study must meet detailed eligibility criteria to participate plus come to Sharon Regional's Diabetes and Endocrinology Center for regular follow-up visits and laboratory work.
Sharon Regional's Diabetes and Endocrinology Center was selected by Smith Kline Beecham's research division to participate in the studies following an on-site inspection and interview process.
The ADOPT study is a four year worldwide study involving 300 centers sponsored by SmithKline Beecham. It is designed for patients with Type 2 diabetes who have been diagnosed less than two years and who are not taking any diabetes medications. The goal of the ADOPT study is to determine whether a new diabetes drug known as Avandia can be used as a sole diabetes treatment for an extended period of time.
Avandia is already FDA approved and is utilized for lowering blood sugar. The study will help determine additional benefits the drug is believed to have for diabetic patients.
Avandia is an insulin sensitizer, meaning it helps the body to utilize its naturally produced insulin more efficiently, thereby possibly delaying or eliminating a diabetic's need to go on additional medications such as Glucotrol or Glucophage.
The project is a blind study, meaning those participating will not know what diabetes medication they're receiving.
The second diabetes research project is a 40-week study limited to 46 centers within the United States. It is intended for patients with Type 2 diabetes with microalbuminuria (protein in the urine), which indicates damage to the kidneys related to their diabetes.
The goal of the study is to study the effectiveness of Avandia in reducing kidney damage caused by diabetes. The study is also blind; patients participating will take either Avandia or Glucotrol.
Diabetes research goes on extensively but is often limited to large university hospital systems. "We're pleased to be part of these two major diabetes research studies," stated Dr. Behnke. "One of our goals at our Diabetes and Endocrinology Center is to bring our patients access to the latest in diabetes education, treatment, and research without having the inconvenience of traveling to a large city. The fact we were chosen as one of a relatively few sites worldwide recognizes our leadership in diabetes," Dr. Behnke concluded.
For more information on the diabetes studies call Sharon Regional's Diabetes and Endocrinology Center at 347-1861.