warning for those taking Avandia

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This article is from today's edition of USA Today

1 study for Avandia, 2 against

By Brophy Marcus

ORLANDO -- Two new studies call into question the heart safety of the

diabetes drug Avandia, while a third shows it does not pose a significantly

higher

risk for death, stroke or heart attack, although fractures increased.

The first study, published online Monday in The Journal of the American

Medical Association, shows that in older patients, Avandia -- which is used

to lower

blood glucose levels -- is associated with an increased risk of stroke,

heart failure and death compared with Actos, another diabetes drug in the

same

class, called thiazolidinediones (TZDs).

In the study, scientists from the Center for Drug Evaluation and Research at

the Food and Drug Administration evaluated data from 227,571 Medicare

beneficiaries

taking either Avandia or Actos. Analysis showed no differences in the risk

for heart attack between the two drugs, but the study found that compared

with

Actos, Avandia was associated with a 25% increased risk of heart failure, a

27% increased risk of stroke and a 14% increased risk of death.

The study comes before a much-anticipated FDA meeting July 13-14 that will

review the safety of Avandia. Previous studies have suggested Avandia may be

associated with an increased risk of serious cardiovascular events.

The second study, in this week's Archives of Internal Medicine, is a new

meta-analysis of data from existing clinical trials that shows an increased

heart

attack risk for Avandia patients.

Study author Nissen, chairman of the department of cardiovascular

medicine at the Cleveland Clinic Foundation, and his colleagues identified

56 trials

involving 35,531 patients. Of those, 19,509 received Avandia. In the

combined studies, Avandia was associated with a 28% to 39% increased risk

for heart

attack.

Diabetic patients are extraordinarily vulnerable to heart disease. A drug

that increases the risk of heart attack by a third is a huge health risk, "

Nissen

said.

Avandia's maker, GlaxoKline, said in a statement that there are

limitations to a meta-analysis and observational studies and that six

controlled clinical

trials show Avandia does not raise the risk of heart attack, stroke or

death.

In the third study, BARI 2D, which was presented at the 70th Scientific

Sessions of the American Diabetes Association here, Avandia was found to

pose no

significant increased cardiovascular risks among heart patients with

diabetes, says study author Bach, associate professor at the

Washington University

School of Medicine. We saw a 28% lower rate of death, heart attack and

stroke for the patients receiving (Avandia), " Bach says. But fractures were

up 62%.

Some experts say more research is needed and are weary of what they call

drug politics.

TZDs are important agents in the management of diabetes, " says

Zonszein, professor of clinical medicine at Montefiore Medical Center in the

Bronx.

Avandia is already rarely prescribed. Let the free markets work following

science, not politics.