FDA watchers require patience. AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the…

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Genetic substudies across a broad range of large clinical trials that used clopidogrel raise questions about the clinical utility of clopidogrel genotyping. The substudies come from large and important trials like PLATO, TRITON-TIMI 38, CURE, and ACTIVE A. A genetic substudy of PLATO finds that ticagrelor is superior to clopidogrel irrespective of genetic subtype. Therefore,…

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PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used in the…

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PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used in the…

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PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US were found to have no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses…

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PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used…

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The Cardiovascular and Renal Drugs Advisory Committee recommended today that ticagrelor (Brilinta, AstraZeneca) be approved for the treatment of STEMI and NSTEMI patients intended to be managed both invasively and medically. The committee spent most of the day trying to sort through the confusing finding in the pivotal PLATO trial that U.S. patients, unlike patients…

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