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Experts Support FDA Panel's Backing of New Blood Thinner
Date:7/29/2010

icine and physiology in the Cardiovascular Division at the University of Miami Miller School of Medicine. "Their gene makeup is such that they don't metabolize Plavix as the majority of the population [does]."

With Plavix, the drug has to be metabolized for it to be effective, he said. Since Brilinta does not appear to have this problem, it has another advantage over Plavix, Myerburg said. So it should be effective in all patients.

The international PLATO trial, funded by Brilinta's maker, AstraZeneca, showed that in patients with a heart attack, treatment with the drug reduced the rate of death, heart attack or stroke compared to treatment with Plavix. The benefit was seen without any increased risk in major bleeding, a prime worry with blood thinners, Fonarow said.

The trial results were not without controversy, however. That's because when investigators focused only on patients in PLATO who were from the United States, Brilinta actually performed worse compared to those who got Plavix -- contrary to results for patients treated elsewhere. According to Dow Jones, the FDA advisory panel wrestled with that discrepancy, suggesting that differences in levels of care, or the "generally higher" dose of aspirin that American patients received may have been to blame.

And Fonarow mentioned another potential drawback with Brilinta. "While this [drug] has a number of attractive features and results in improved outcomes compared to standard-dose clopidogrel, it does need to be taken twice daily," Fonarow noted. Both Plavix and another anticoagulant, Effiant, need to be taken only once a day, he said.

However, if Brilinta gains FDA approval, it is likely that all three of these antiplatelet medications will have an important role in the management of acute coronary syndrome patients, "with the choice among these agents depending on a number of patient, physician and system factors," he added.

Another expert, Dr. Jeffrey S. Borer, dire
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Experts Support FDA Panel's Backing of New Blood Thinner
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