Screening Diabetics for Coronary Artery Disease
Shows No Significant Lowering of Risk
Researchers say it is unnecessary and may lead
initially to more invasive and costly heart procedures
April 15, 2009 - Screening for coronary artery
disease in patients with type 2 diabetes did not result in a significant
reduction in the rate of heart attacks or cardiac death compared to
patients who were not screened, according to a study in the April 15
issue of the Journal of the American Medical Association (JAMA),
a theme issue on diabetes. This is important news for senior citizens
the age group most threatened by diabetes and cardiovascular problems.
Researchers say the testing is unnecessary and may
lead initially to more invasive and costly heart procedures.
Coronary artery disease is a major cause of death
and disability in patients with type 2 diabetes, who often undergo
routine screening with stress testing. Almost 200 million people
worldwide have type 2 diabetes and most are senior citizens.
U.S. trial shows no early mortality benefit from
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link to video in news report.
Frans J. Wackers, M.D., Ph.D., of the Yale
University School of Medicine, New Haven, Conn., presented the findings
of the study at a JAMA media briefing at the National Press Club in
Washington, D.C.
Wackers, Lawrence Young, M.D., Silvio Inzucchi,
M.D., Deborah Chyun, and other colleagues from the Yale School of
Medicine sought to determine whether routinely screening diabetic
patients without a history of heart problems helped identify those at
higher cardiac risk.
"Coronary artery disease (CAD) is a major health
concern and the leading cause of death in individuals with type 2
diabetes. CAD is often asymptomatic (having no symptoms) in these
patients until the onset of myocardial infarction (heart attack) or
sudden cardiac death," according to the article.
There has been substantial interest in the early
detection of asymptomatic CAD by screening of patients with type 2
diabetes. However, the potential of routine screening to alter treatment
and to prevent cardiac events in persons without clinically apparent CAD
is largely unknown, according to background information in the article.
Dr. Wackers and colleagues of the Detection of
Ischemia in Asymptomatic Diabetics (DIAD) study group tested
prospectively whether systematic screening for CAD would identify
higher-risk individuals and beneficially affect their risk of heart
attack or cardiac death.
In the trial, that included 1,123 participants with
type 2 diabetes and no symptoms of CAD, patients were randomly assigned
to be screened (561 patients) for CAD with the imaging method of
adenosine-stress radionuclide myocardial perfusion imaging (MPI), or not
be screened (562 patients). The average follow-up was 4.8 years.
The overall cumulative 5-year cardiac event rate
was 2.9 percent and averaged 0.6 percent per year, lower than
anticipated.
The researchers found that when analyzed according
to randomization, there were
● In the screening group - 15 events (7 nonfatal heart attacks; 8
cardiac deaths; 2.7 percent )
● In the no-screening group 17 events (10 nonfatal heart attacks; 7
cardiac deaths; 3.0 percent).
Of those in the screened group, 409 participants
(78 percent) with normal results and 50 (10 percent) with small MPI
defects had lower event rates than the 33 with moderate or large MPI
defects; 0.4 percent per year vs. 2.4 percent per year.
Coronary angiography was performed within 120 days
after screening in 4.4 percent of 561 participants, including in 15
percent of 33 with moderate or large defects.
In comparison, only 3 (0.5 percent) of 562
participants in the no-screening group underwent angiography within 120
days after randomization.
The overall rate of coronary revascularization was
low in both groups: 5.5 percent in the screened group and 7.8 percent in
the unscreened group.
During the course of the study there was a
significant and equivalent increase in primary medical prevention with
aspirin, statins and angiotension-converting enzyme (ACE) inhibitors in
both groups.
"The strategy of routine screening for CAD in
patients with type 2 diabetes is based on the premise that testing could
accurately identify a significant number of individuals at particularly
high risk and lead to various interventions that prevent cardiac events.
"However, the results of the DIAD study would appear to refute this
notion," the authors write. " participants had a low cardiac event rate
and the identification of participants with abnormal screening results
did not serve to eliminate their risk over 5 years of follow-up."
"However, rather than viewing this study as a
negative screening study, clinicians might consider the results as a
positive message: patients with type 2 diabetes without symptoms to
suggest CAD, receiving contemporary medical care, close follow-up, and
appropriate diagnostic evaluation for symptoms of ischemia have
relatively favorable outcomes in the current era."
"Patients with type 2 diabetes with no symptoms who
are feeling well can generally be managed effectively with preventive
therapies such as lipid-lowering drugs, blood pressure medication,
aspirin and diabetes treatment," said Young.
"This is a bit of good news in the field of
diabetes where patients and their physicians have real concern for heart
disease. In patients getting modern medical therapy in our study,
serious heart problems were infrequent," added Young.
Other authors on the study included Janice Davey,
Eugene Barrett, M.D., Raymond Taillefer, M.D., Gary Heller, M.D., Ami
Iskandrian, M.D., Steven Wittlin, M.D., Neil Filipchik, M.D., Robert
Ratner, M.D.
Thiazolidinediones medications (including rosiglitazone
(Avandia)
produced a significantly increased risk of heart attack, congestive
heart failure and death
Dec. 12, 2007
About Rosiglitazone,
marketed as Avandia
Combination products: Avandaryl (containing
rosiglitazone and glimepiride) and Avandamet (containing rosiglitazone
and metformin)
Why is this medication prescribed?
Rosiglitazone is used along with a diet and
exercise program and sometimes with one or more other medications to
treat type 2 diabetes (condition in which the body does not use insulin
normally and, therefore, cannot control the amount of sugar in the
blood). Rosiglitazone is in a class of medications called
thiazolidinediones. It works by increasing the body's sensitivity to
insulin, a natural substance that helps control blood sugar levels.
Rosiglitazone is not used to treat type 1 diabetes (condition in which
the body does not produce insulin and, therefore, cannot control the
amount of sugar in the blood) or diabetic ketoacidosis (a serious
condition that may occur if high blood sugar is not treated).
How should this medicine be used?
Rosiglitazone comes as a tablet to take by mouth.
It is usually taken once or twice daily with or without meals. Take
rosiglitazone at about the same time(s) every day. Follow the directions
on your prescription label carefully, and ask your doctor or pharmacist
to explain any part you do not understand. Take rosiglitazone exactly as
directed. Do not take more or less of it or take it more often than
prescribed by your doctor.
Your doctor may increase your dose of rosiglitazone
after 8-12 weeks, based on your body's response to the medication.
Rosiglitazone helps control type 2 diabetes but
does not cure it. It may take 2 weeks for your blood sugar to decrease,
and 2-3 months or longer for you to feel the full benefit of
rosiglitazone. Continue to take rosiglitazone even if you feel well. Do
not stop taking rosiglitazone without talking to your doctor.
Other uses for this medicine
This medication may be prescribed for other uses;
ask your doctor or pharmacist for more information.
Warning:
Rosiglitazone and other similar medications
for diabetes may cause or worsen congestive heart failure
(condition in which the heart is unable to pump enough blood to
the other parts of the body). Some studies have shown that
people who take rosiglitazone and insulin are more likely to
have a heart attack or to die of heart problems than people who
take insulin alone. Before you start to take rosiglitazone, tell
your doctor if you have or have ever had congestive heart
failure, especially if your heart failure is so severe that you
must limit your activity and are only comfortable when you are
at rest or you must remain in a chair or bed. Also tell your
doctor if you were born with a heart defect, and if you have or
have ever had swelling of the arms, hands, feet, ankles, or
lower legs; heart disease, high blood pressure; coronary artery
disease (narrowing of the blood vessels that lead to the heart);
a heart attack; an irregular heartbeat; or high cholesterol or
fats in the blood. Your doctor may tell you not to take
rosiglitazone or may monitor you carefully during your
treatment.
If you develop congestive heart failure or
other heart problems, you may experience certain symptoms. Tell
your doctor immediately if you have any of the following
symptoms, especially when you first start taking rosiglitazone
or after your dose is increased: large weight gain in a short
period of time; shortness of breath;swelling of the arms, hands,
feet, ankles, or lower legs; chest pain.swelling or pain in the
stomach; waking up short of breath during the night; needing to
sleep with extra pillows in order to breathe while lying down;
frequent dry cough; or increased tiredness.
Talk to your doctor about the risks of
taking rosiglitazone.
Dec.
17, 2008