Drug News Diabetes drug Avandia linked to higher risk of death
By Jimmy Downs
Nov 24, 2008 - 3:08:40 PM
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Monday Nov 24, 2008 (foodconsumer.org) -- A new study
suggests that use of drug rosiglitazone, sold under the brand name Avandia and
made by GlaxoSmithKline may significantly increase the risk of heart failure
and death than its competitor pioglitazone, sold as Actos and made by Takeda
Pharmaceutical Co.
The study led by researchers at Harvard Medical School
found death rates for patients treated with Avandia were 15 percent more likely
and congestive heart failure rates were 13 percent higher than those who took
Actos.
This is only a suggestion that taken Avandia may increase
risk of death and heart failure because the study is an observation but not a
trial, meaning that the association between the drug use and an increase in the
heart failure and death risk may not be a causal relation.
Glaxo already dismissed the findings saying the results
were inconsistent with previous studies.
One trial it referred to is a six-year trial of 4,447 patients, which
company officials were cited as noting has found no significant increases in
deaths from any cause including cardiovascular disease in patients taking
rosiglitazone.
For the current study, Dr. Wolfgang C. Winkelmayer,
assistant professor of medicine at the Harvard Medical School and first author
of the study and colleagues meta-analyzed 42 studies involving 28,361 patients
who had been tracked for up to five years.
They found patients taking Avandia were at higher risk of
heart failure and death than those who took Actos.
But the rates of heart attacks and stroke
among those taking Avandia were not greater than that for those using
pioglitazone.
"In much older adults, it is possible if they do
have a stroke or myocardial infarction, they might actually die immediately and
never make it to the hospital for a diagnosis, so the excess cardiac events
might show up as deaths," Dr. Winkelmayer was quoted by New York Times as
saying.
The American Diabetes Association and the European Association
for the Study of Diabetes have already stopped recommending rosiglitazone for
type 2 diabetes.
And the consumer
advocate Public Citizen has been pushing the Food and Drug Administration to
ban the drug because the not-for-profit organization said last month to the agency
that Avandia causes live failure, vision impairment and other serious side
effect in addition to high profile cardiovascular risk.
Steven Nissen, a prominent heart specialist and chief of
cardiovascular medicine at the Cleveland Clinic, one of the best heart clinics
in the world, early analyzed data from 42 clinical trials of Avandia and he
found that Avandia patients were 43 percent more likely to have a heart attack
or be hospitalized for blocked coronary arteries than others in the studies.
His findings were reported in the New England Journal, a
prestigious medical journal in the world.
But Glaxo based in the United Kingdom claimed that Dr. Nissen's study
was flawed and has maintained that Avandia is safe for the heart like other
diabetes drugs.
The FDA held a hearing last year.
Dr. David Graham of the FDA's Office of
Surveillance and Epidemiology told panelists who have the power to determine
the fate of the drug that the Glaxo's diabetes drug should come off the market,
according to USA Today.
Dr. Graham also said Actos does not increase heart risk
like Avandia and suggested that there is no reason for the Glaxo's drug to stay
on the market.
But the FDA panel did not
heed Dr. Graham's suggestion and voted 22 to 1 to keep the drug on the market.