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.