posted 10/17/02
New screening tool can identify “silent coronary artery
disease at an early stage in patients with diabetes
The preliminary results of a groundbreaking study
show that non-invasive imaging with Cardiolite(R) can identify "silent" coronary
artery disease (CAD) at an early stage in diabetes patients -- a high-risk
population who often do not exhibit any apparent symptoms of heart disease. If
confirmed, these research findings, presented last week at the Annual Scientific
Session of the American Society of Nuclear Cardiology (ASNC), could pave the way
for evidence-based guidelines for selectively screening these at-risk patients,
potentially allowing for earlier intervention and saving many from premature
heart attack or death.
Heart disease is the leading cause of death for
the nearly 16 million Americans with type II diabetes -- whose risk is two to
four times that of the general population. Identifying coronary artery disease
in these patients is difficult because many have no apparent "chest pain"
symptoms. As a result, this so-called silent ischemia may go undiagnosed until
symptoms of late-stage heart disease occur, including heart attack and cardiac
death.
"These preliminary results are very important
because recent studies have shown that patients with diabetes are still not
fully aware of their risk for heart disease despite the fact that it is their
leading cause of reduced life expectancy," said Frans J. Th. Wackers, M.D.,
professor of medicine, Yale University School of Medicine, who designed the
study. "If these findings are confirmed, selectively screening these patients
early with Cardiolite can help identify CAD in patients with no outward
symptoms, potentially protecting many from more severe coronary events."
The study -- Detection of Ischemia in
Asymptomatic Diabetics (DIAD) -- is the first multi center study to detect
"silent" ischemia (heart disease) in patients with diabetes. Last weeks
preliminary analysis of 522 patients represents initial results of this two-year
study. In this data set, twenty- six percent of patients had an abnormal
Cardiolite(R) (Kit for the Preparation of Technetium Tc99m Sestamibi for
Injection) test suggesting "silent" CAD. Of those exhibiting an abnormal
finding, 83 percent (114 patients) were found to have abnormal blood flow, while
the remaining 17 percent (23 patients) were found to have other abnormal
findings such as depressed left ventricular ejection fraction, another measure
of heart health. These results were made more remarkable by the absence of CAD
symptoms in all patients tested.
"As the doctors who see patients with diabetes
every day, we know that many don't display the classic symptoms of heart
disease, making it difficult to detect ischemia before the onset of advanced and
symptomatic disease," said Paul S. Jellinger, MD, former president of the
American Association of Clinical Endocrinologists. "Given this significant
diagnostic challenge and the disproportionate threat CAD poses to this patient
population, identifying tests that assist in detecting heart disease at an early
stage are critical. Needless to say, today's results are an encouraging first
step."
The prospective study involves more than 1,000
patients with type II diabetes aged 50 to 75 years with no known coronary artery
disease. Enrolled patients were randomized to receive Cardiolite, the leading
stress myocardial perfusion imaging (stress MPI) agent, and five year follow-up,
or follow-up alone. Prior studies have shown Cardiolite to be an accurate
predictor of major cardiac events in patients with diabetes known to have heart
disease.
Stress MPI is a nuclear cardiology procedure that
uses a radiopharmaceutical, such as Cardiolite, to measure blood flow to various
structures of the heart. Patients undergo a Cardiolite study both to diagnose
heart disease as well as to assess their risk for a future cardiac event. In
patients with known or suspected coronary artery disease, a normal stress
Cardiolite study is associated with a less than one percent chance that the
patient will experience a hard cardiac event (death or myocardial infarction) in
the next 12 months.
Bristol-Myers Squibb Medical Imaging, Inc., the
makers of Cardiolite, has provided more than $2 million in a research grant to
Yale University School of Medicine for the two-year study. The company also
supplies product and technical support. Fujisawa Healthcare, Inc. also provides
funding for the trial.
Cardiolite(R) (Kit for the Preparation of
Technetium Tc99m Sestamibi for Injection) is the leading cardiac stress imaging
agent in the United States. It is the only heart imaging agent that is
FDA-approved to both non-invasively evaluate the heart's pumping ability
(function) and gauge the amount of blood flow to the heart muscle itself
(perfusion) -- and thus is used to quickly assess whether a patient has already
had a heart attack or is at risk for one in the future. Cardiolite is also the
only technetium agent in the U.S. approved for acquiring diagnostic information
for use in patient management decisions. Cardiolite is a registered
trademark of Bristol-Myers Squibb Medical Imaging, Inc
Source: Diabetes In Control Dot Com.
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