Photo courtesy of AstraZeneca
The US Food and Drug Administration (FDA) has approved a new administration option for the antiplatelet agent ticagrelor (Brilinta).
The agency has decided that, for patients with acute coronary syndrome (ACS) who cannot swallow ticagrelor tablets whole, the pills may be crushed and administered in water by swallowing or via nasogastric tube.
Ticagrelor is the only P2Y12 inhibitor that is FDA-approved to be administered in this way.
“We know that some patients who experience a heart attack are unable to swallow medications whole, yet it is important for these patients to receive and continue their oral antiplatelet therapy,” said Steven Zelenkofske, DO, Vice President of US Medical Affairs, Cardiovascular, at AstraZeneca, the company developing ticagrelor.
Survey data have shown that 40% of adults in the general population experience problems swallowing pills, and this difficulty may increase with age. Moreover, some patients who experience a heart attack have difficulty swallowing medications in the emergency setting.
So the new administration option for ticagrelor is intended to give healthcare professionals flexibility in treating their ACS patients.
Ticagrelor is a direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. The drug is available in 90 mg tablets, to be administered with a single 180 mg oral loading dose (two 90 mg tablets) followed by a twice daily, 90 mg maintenance dose.
Following an initial loading dose of aspirin, ticagrelor should be used with a maintenance dose of aspirin at 75 mg to 100 mg once daily (an 81 mg dose in the US).
Results of the PLATO trial showed that, in ACS patients, ticagrelor can reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction, and stroke, when compared to clopidogrel. The difference between treatments was driven by cardiovascular death and myocardial infarction, with no difference in the rate of stroke.
For more information on ticagrelor, see the full prescribing information.
