Diabetes Drug Avandia: Heart Risk?
Study Shows 43% More Heart Attacks With Avandia; Drugmaker Says Study Is Flawed
May 21, 2007 – The diabetes drug Avandia may increase a person's risk of
heart attack and death due to heart disease, a new study warns.
Avandia maker GlaxoSmithKline says the study is flawed and that better data
-- some already submitted to the FDA, some from an ongoing clinical trial --
show Avandia poses no significant risk to patients' heart health.
The FDA says that based on this "contradictory evidence about the risks
in patients treated with Avandia," patients taking the drug -- especially
those who have had heart attacks or who have underlying heart disease -- should
talk with their doctors about whether to continue taking the drug.
The new warning comes from an analysis of publicly available, short-term
clinical studies comparing Avandia to other diabetes treatments. It shows that
Avandia increases heart attack risk by 43% -- and increases risk of death from
heart disease by 64%.
However, the overall risk was small. Among the 15,560 Avandia patients there
were 86 heart attacks and 39 deaths, compared with 72 heart attacks and 22
deaths among the 12,283 patients not taking Avandia.
"In susceptible patients, [Avandia] therapy may be capable of provoking
myocardial infarction [heart attack] or death from cardiovascular causes after
relatively short-term exposure," suggest study investigators Steven Nissen,
MD, and Kathy Wolski, MPH. Nissen chairs the Cleveland Clinic's department of
cardiovascular medicine; he is past president of the American College of
The Nissen/Wolski report will be published in The New England Journal of
Medicine. The journal today made the report public under its early-release
Avandia is sold by itself and, as Avandamet and Avandaryl, in pills that
combine Avandia with other diabetes medications. The findings do not appear to
immediately affect Actos (made by Takeda Pharmaceuticals), a diabetes drug in
the same class as Avandia.
Avandia Benefit, Avandia Risk
The FDA in 1999 approved Avandia on the basis of clinical trials showing
that the drug could reduce blood-sugar levels in people with type 2 diabetes.
Diabetes has been linked to both microvascular problems (problems of tiny blood
vessels) such as blindness, kidney failure, and loss of circulation in the
extremities. It has also been linked to heart disease.
But none of the trials on which Avandia was approved showed that the drug
actually prevented the greatest threats to people with diabetes: microvascular
problems, heart disease, or heart death.
In a strongly worded editorial accompanying the study, University of
Washington researcher Bruce M. Psaty, MD, PhD, says the Nissen study means
there's no good reason for most patients to take Avandia.
"There is little evidence for using this drug," Psaty tells WebMD.
"The purpose of reducing blood sugar is to prevent cardiovascular events.
Now the possibility of cardiovascular benefit associated with Avandia appears
remote -- indeed, it appears linked to harm. So the rationale for prescribing
it at this time is just not clear."
Psaty warns patients taking Avandia not to just stop using it. They should
continue taking the drug until they can discuss the matter with their
"This is not an immediate risk. It is the absence of an expected benefit
and the possibility of harm over the years," he says. "Patients should
talk with their doctors and see if they are getting the benefit they expected.
Doctors can look at the data and say whether there is a compelling reason for
them to prescribe this drug. I don't think there is."