Doubt Cast on Use of Genetic Test Before Plavix

WEDNESDAY, Dec. 28 (HealthDay News) — A new review of existing
research suggests that, despite a federal recommendation, genetic testing
won’t help physicians determine which heart patients should get Plavix, a
blood-thinning drug used to treat certain cardiac conditions.

Plavix, also known as clopidogrel, is used to treat or prevent blood
clots due to the clogging of arteries and after such surgical procedures
as balloon angioplasty.

But some patients won’t experience the drug’s clot-preventing benefits
if their bodies don’t process it properly, potentially leading to heart
attack, blood clots in stents and death, according to Dr. Jean-Sebastien
Hulot, associate professor of medicine at the Cardiovascular Research
Center at Mount Sinai School of Medicine. Or, he said, they could
experience the reverse — excessive bleeding if the medication has too
much of an effect. Hulot was not involved with the study, but is familiar
with the findings.

The U.S. Food and Drug Administration believes that genetic testing
could help identify patients who won’t respond well to the drug. But the
American Heart Association and the American College of Cardiologists have
been skeptical that the genetic testing in question is useful.

In the new review, Dr. Michael V. Holmes of University College London
and colleagues examined 32 studies that included over 42,000 patients.
They looked for signs of bleeding problems, blood clots in stents and
cardiovascular problems.

They also conducted a meta-analysis in which they examined statistics
in the studies as a whole.

While they mention some statistical caveats, the researchers found that
a specific genetic trait — linked to the body’s ability to respond to the
drug — did not significantly affect the risk of cardiovascular problems.

In a commentary accompanying the study, Dr. Steven E. Nissen, borrowing
a phrase from a former chairman of the Federal Reserve, wrote, “It now
appears that the FDA warning reflected a case of ‘irrational
exuberance.'”

Nissen, chair of cardiovascular medicine at the Cleveland Clinic, noted
that the review has limitations. But, he added, for the time being
physicians should “rarely, if ever” use the genetic testing in question
and should “interpret the results with caution.”

Hulot, the Mount Sinai School of Medicine professor, is skeptical. He
said the findings are “far from convincing” and questioned their
statistical validity. He also pointed to an earlier study, also a
meta-analysis, that suggested a genetic trait did indeed boost the risk of
problems for those who took the drug in certain cases.

The study is published in the Dec. 28 issue of the Journal of the
American Medical Association
.

More information

For more on Plavix (clopidogrel), visit the U.S. National Library of
Medicine.

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