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New antiplatelet agent approved by FDA


 

The US Food and Drug Administration (FDA) has approved the antiplatelet agent ticagrelor for reducing thrombotic events in patients with acute coronary syndromes.

The FDA based its decision on results of the PLATO trial, which compared ticagrelor to clopidogrel.

Some 9.8% of patients treated with ticagrelor experienced cardiovascular death, myocardial infarction, or stroke at 12 months compared to 11.7% of patients treated with clopidogrel, which amounted to a relative risk reduction of 16% (P<0.001).

The product label includes a boxed warning that aspirin doses above 100 mg per day decrease the effectiveness of the medication and should be avoided.

For more information on the approval, visit FDA.gov.

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