The results were published online in May
2007 by Diabetes Care and will appear
in the August print issue.
“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. In fact, 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 adverse reaction was not limited to the
elderly – one-quarter of cases occurred in
people younger than 60. Heart failure
occurred equally among men and women.
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.
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.
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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