Senior Citizens at Greater Risk of Heart Failure,
Death Taking Avandia Than Actos for Diabetes
Rosiglitazone (Avandia) and pioglitazone (Actos)
already carry black box warnings for seniors with heart trouble
Nov.
24, 2008 Two ever popular drugs for senior citizens to use in treating
diabetes are in the news again, but this time one stands alone as the
culprit. The new study finds seniors taking rosiglitazone (Avandia)
appear to have a higher risk of death and heart failure than those
taking the related medication pioglitazone (Actos), according to a
report in the November 24 issue of Archives of Internal Medicine, one of
the JAMA/Archives journals.
Thiazolidinediones medications (including rosiglitazone
(Avandia)
produced a significantly increased risk of heart attack, congestive
heart failure and death
The two drugs are members of a class of oral
medications known as thiazolidinediones, which were introduced in 1997.
These drugs offered several clinical benefits, including decreased
insulin resistance, better control of blood sugar and, for some
patients, a delay in beginning insulin therapy.
Rosiglitazone maleate and pioglitazone
hydrochloride were approved and marketed beginning in 1999.
Not long after, it became apparent that these drugs
had important adverse effects, including heart failure and heart attack.
A black box warning was recently added to both drugs cautioning against
their use in patients with existing heart failure.
In a reporter earlier this year, it was found that
diabetics taking Avandia
or pioglitazone approximately double or triple their odds of hip
and other non-spine fractures. The report was in the April 28 issue of
Archives of Internal Medicine.
Yet, these two drugs, earlier this year, accounted
for 21 percent of oral diabetes medications prescribed in the United
States and five percent of those in Europe.
Action to Control Cardiovascular Risk in
Diabetes (ACCORD) Trial
The ACCORD (Action to Control
Cardiovascular Risk in Diabetes) Trial (www.accordtrial.org ) is
a large clinical study of adults with established type 2
diabetes who are at especially high risk of cardiovascular
disease (CVD).
Click Here
Recent meta-analyses have suggested that the risks
associated with rosiglitazone may be higher than those associated with
pioglitazone, which motivated the new research.
To compare cardiovascular outcomes and death rates
between the two therapies, Wolfgang C. Winkelmayer, M.D., Sc.D., and
colleagues at Brigham and Womens Hospital and Harvard Medical School,
Boston, used medical claims data to study 28,361 patients older than 65
years who began taking either rosiglitazone or pioglitazone between 2000
and 2005.
Of these, 14,260 (50.3 percent) began treatment
with pioglitazone and 14,101 (49.7 percent) with rosiglitazone.
After an average of 380 days taking pioglitazone or
369 taking rosiglitazone, 1,869 patients died.
After adjusting for other factors, individuals
taking rosiglitazone had a 15 percent higher rate of death and a 13
percent greater risk of heart failure compared with those taking
pioglitazone.
However, there were no differences in heart attack
or stroke risk between the two groups.
"This study confirms the safety concerns that have
been raised for rosiglitazone compared with pioglitazone, which, in
turn, also cannot be considered a very safe drug given its
well-documented effect on the risk of congestive heart failure," the
authors write.
"Although previous studies have indicated that the
increased risk with rosiglitazone use resides predominantly in
cardiovascular outcomes, the present study suggests that differences in
all-cause mortality [death] risk may be even more important to consider
in elderly patients."
Editor's Note: This study was supported by a
Scientist Development Grant from the American Heart Association; a
Norman S. Coplon Extramural Research Program Award from Satellite
Healthcare Inc.; and investigator-initiated grants from Amgen, Fresenius
Medical Care and GlaxoSmithKline.
More News on Diabetes from SeniorJournal.com
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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.
Nov.
24, 2008 Two ever popular drugs for senior citizens to use in treating
diabetes are in the news again, but this time one stands alone as the
culprit. The new study finds seniors taking rosiglitazone (Avandia)
appear to have a higher risk of death and heart failure than those
taking the related medication pioglitazone (Actos), according to a
report in the November 24 issue of Archives of Internal Medicine, one of
the JAMA/Archives journals. 