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Senior Citizen Health & Medicine
Avandia and Astos Diabetes Drugs Found to Double
Heart Failure Risk
Avandia already associated with heart attack,
cardiovascular deaths
July 27, 2007 – Avandia, the type 2 diabetes drug
already associated with increasing the risk of heart attack and fatal
cardiovascular events, has now been found to double the risk of heart
failure, which is common in senior citizens. The adverse reaction,
however, was not limited to the elderly – one-quarter of cases occurred
in people younger than 60. Heart failure also occurred equally among men
and women.
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Based on a review of research studies and case
reports involving more than 78,000 patients, the authors concluded that
the risk of heart failure may be up to 100 percent higher (depending on
the type of study) in patients taking thiazolinediones (which includes
Avandia® and Actos®), according to researchers at Wake Forest University
School of Medicine and colleagues.
These drugs are known to enhance insulin
sensitivity. The authors estimated that one additional patient with type
2 diabetes would develop heart failure for every 50 patients taking the
drugs over a 26-month period.
“These drugs are currently used by more than 3
million diabetic patients in the U.S. alone, suggesting that several
thousand could be harmed,” said Sonal Singh, M.D., lead author and an
assistant professor in internal medicine at Wake Forest.
Earlier this year, one of the drugs in this class (Avandia®)
was linked to an increased risk of heart attack and death from
cardiovascular causes.
The current analysis looked at a potential link
between the drugs and heart failure, which is the inability of the heart
to meet the body’s demands. Heart failure is a very common condition in
the elderly and one of the costliest to society. Common symptoms include
shortness of breath and the inability to exercise including, in some
cases, even to walk short distances.
The authors hypothesize that fluid retention caused
by the drugs may trigger heart failure in susceptible people.
Heart failure occurred equally at high and low
doses. Heart failure even occurred in some patients who were taking
doses below those commonly prescribed. The medium time for the onset of
heart failure was 24 weeks after beginning drug therapy.
The product label for both drugs warns against
their use in patients with more severe cases of heart failure. The label
also cautions about the increased risk of heart failure if used in
combination with insulin. However, the current analysis found that the
risk wasn’t confined just to patients on insulin, and it occurred even
among patients without any risk factors for heart failure. “Our findings
support current efforts by the FDA to add a black box warning to the
labeling for those agents,” said co-investigator Curt Furberg, M.D.,
Ph.D., from Wake Forest.
“The occurrence of heart failure several months
after initiation of treatment suggests a long-term effect of the drugs,
which may not be avoided by beginning with low doses,” said Singh.
The authors called for additional research to
evaluate whether there are differences between drugs in the class and
how to best manage patients who experience heart failure while on the
drugs.
Editor’s Notes:
The results were published online in May 2007 by
Diabetes Care and will appear in the August print issue.
In addition to Furberg, Yoon K. Loke, M.B.B.S.,
M.D., with the University of East Anglia in the United Kingdom, was also
a co-researcher.
Media Contacts: Karen Richardson,
krchrdsn@wfubmc.edu, or Shannon Koontz,
shkoontz@wfubmc.edu, 336-716-4587.
Wake Forest University Baptist Medical Center is an
academic health system comprised of North Carolina Baptist Hospital and
Wake Forest University Health Sciences, which operates the university’s
School of Medicine. U.S. News & World Report ranks Wake Forest
University School of Medicine 18th in primary care and 44th in research
among the nation's medical schools. It ranks 35th in research funding by
the National Institutes of Health. Almost 150 members of the medical
school faculty are listed in Best Doctors in America.
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