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May 30, 2007: New study says
anti-diabetes pill Avandia may increase the risk
of heart attacks.
A widely used drug to control elevated blood
glucose levels in diabetes has been found to raise
the chances of having a heart attack.
An analysis based on a review of more than 40
existing clinical studies involving nearly 28,000
patients, showed that GlaxoSmithKline’s Avandia
significantly increased the risk of heart attacks.
The article appeared in The New England Journal of
Medicine, was conducted by Dr. Nissen and Kathy
Wolski of the Cleveland Clinic.
Dr. Nissen, who had been among the first doctors
to raise questions about the cardiovascular safety
of Vioxx, first publicly raised concerns about
Avandia in a letter published last December in the
British medical journal Lancet.
Dr. Nissen’s letter noted increased cardiovascular
problems in a 5,000-patient clinical study, called
Dream. Glaxo had sponsored the Dream trial in an
effort to expand the product beyond a treatment
for diabetes.
In the Dream trial, intended to determine if
Avandia could prevent diabetes, patients taking
Avandia had 66 percent more heart attacks, 39
percent more strokes, and 20 percent more deaths
from cardiovascular-related problems compared with
a placebo. That outcome, Dr. Nissen wrote,
“virtually precludes the possibility of an overall
benefit and suggest an unexpected mechanism for
harm.”
In an interview, Dr. Nissen said that the average
diabetic has a 20.2 percent risk of a heart attack
over a seven-year period. A diabetic taking
Avandia has a 28.9 percent risk during that same
seven-year period, according to his analysis.
“It’s a huge risk,” he said, estimating that “tens
of thousands of people” had heart attacks as a
result of taking the drug.
BY OUR PHARMA CORRESPONDENT
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