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Senior Citizen Health & Medicine
Senior Citizens Increase Risk of
Serious Heart Problems with Diabetes Drugs Like Avandia
Thiazolidinediones medications (including rosiglitazone
(Avandia)
produced a significantly increased risk of heart attack, congestive
heart failure and death
 Dec. 12, 2007 - Older patients those 66 and older
- treated with the diabetes medications known as thiazolidinediones
(which include rosiglitazone, marketed as Avandia) had a significantly
increased risk of heart attack, congestive heart failure and death,
compared with the use of other hypoglycemic drugs, according to a study
in the December 12 issue of the Journal of the American Medical
Association (JAMA). These results provide further evidence that this
class of medication may cause more harm than good, the study says.
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The thiazolidinediones (TZDs) rosiglitazone and
pioglitazone are oral hypoglycemic agents used to treat type 2 diabetes
and have been shown to improve glycemic control. While improved
glycemic control has been linked to better clinical outcomes in diabetes
and TZDs have been suggested as having potential cardiovascular
benefits, recent concerns have arisen regarding adverse cardiac effects
of these drugs, the authors write.
Some research has indicated that both rosiglitazone
and pioglitazone may increase the risk of congestive heart failure (CHF),
and that rosiglitazone may be associated with an increased risk of acute
myocardial infarction (AMI; heart attack) and death.
 These findings prompted a recent hearing by a U.S.
Food and Drug Administration advisory panel regarding the safety of
rosiglitazone; however the panel voted against removing rosiglitazone
from the market because of insufficient data, the study says.
Lorraine L. Lipscombe, M.D., M.Sc., of the
Institute for Clinical Evaluative Sciences, Toronto, and colleagues
evaluated the risks of CHF, heart attack, and all-cause death associated
with the use of TZDs, compared with other oral hypoglycemic agents among
patients age 66 years or older with diabetes.
This older patient population has often been
under-represented in trials of TZDs, even though they have a high
prevalence of diabetes, and may be at greater risk of medication-related
harms.
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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. >>
More information from MedlinePlus for Seniors
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The researchers analyzed data from health care
databases in Ontario that included 159,026 individuals with diabetes who
were treated with oral hypoglycemic agents and were followed for a
median (midpoint) of 3.8 years, through March 2006. During this time,
7.9 percent of patients had a hospital visit for congestive heart
failure (n = 12,491), 7.9 percent had a hospital visit for a heart
attack (n = 12,578), and 19 percent died (n = 30,265).
Compared to oral hypoglycemic agent combination
therapy users, current users of TZD monotherapy had a 60 percent
increased risk of congestive heart failure; had a 40 percent increased
risk of heart attack; and had a 29 percent increased risk of death.
These increased risks associated with TZD use
appeared limited to rosiglitazone.
Our findings argue against current labeling of
TZDs that warns against use only in persons at high risk of CHF, as we
did not identify any subgroup of older diabetes patients who may be
protected from adverse effects of TZDs, the authors write. These
findings provide evidence from a real-world setting and support data
from clinical trials that the harms of TZDs may outweigh their benefits,
even in patients without obvious baseline cardiovascular disease.
Further studies are needed to better quantify the
risk-benefit tradeoffs associated with TZD therapy and to explore
whether the hazards associated with these agents are specific to
rosiglitazone. In the interim, treatment decisions must remain
individualized, with clinicians weighing the potential benefits and
harms of TZD treatment, especially among high-risk elderly populations.
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Controversy over Diabetes
Drug - Avandia
Diabetes, a
major chronic disease among senior citizens, is found in
about 1 out of 5
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Sen. Grassley Says FDA Knew Dangers of Avandia,
Wants Faster Action
Ranking Senate Finance Committee members says there
should already be black box warning
May 25, 2007
Read more...
Finding Avandia Heart Risk Underscores Need for
Urgent Drug Safety Reform
Consumers Union urges House pass strong drug safety
reforms
May 23, 2007 -
Read more...
Senate Committee Wants Answers About Avandia,
Company Defends Record
Committee leaders send letters to FDA and
GlaxoSmithKline
May 22, 2007
Read more...
Avandia Drug Maker Disagrees with Study Saying the
Diabetes Drug Increases Heart Attacks, Deaths
GlaxoSmithKline says it's highly effective
treatment for type 2 diabetes
May 22, 2007
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Major Heart, Diabetes Groups Urge Caution in Wake of
Avandia Warning
Study raises concerns; Groups advise patients with
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May 22, 2007
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Finding of
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Sparks FDA Alert
FDA issues immediate alert on the drug marketed as
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May 21, 2007
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