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FDA: drugs approved for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome


Currently, there are no Factor X inhibitors approved for indication to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome. There are three P2Y12 inhibitors approved for this indication and Warfarin.

Brilinta ( Ticagrelor ) - Ticagrelor is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome ( ACS ) ( unstable angina, non-ST-elevation myocardial infarction, or ST elevation myocardial infarction ).
Ticagrelor has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction, or stroke compared to Clopidogrel. The difference between treatments was driven by cardiovascular death and myocardial infarction with no difference in stroke.
In patients treated with PCI, it also reduces the rate of stent thrombosis.

Effient ( Prasugrel ) - Prasugrel is a P2Y12 inhibitor indicated for the reduction of thrombotic cardiovascular events ( including stent thrombosis ) in patients with acute coronary syndrome who are to be managed with PCI as follows: a) patients with unstable angina or, non-ST-elevation myocardial infarction ( NSTEMI ); b) patients with ST-elevation myocardial infarction ( STEMI ) when managed with either primary or delayed PCI.

Ticlid ( Ticlopidine ) - Ticlopidine is indicated: a) to reduce the risk of thrombotic stroke ( fatal or non-fatal ) in patients who have experienced stroke precursors, and in patients who have had a completed thrombotic stroke. Ticlopidine is associated with a risk of life-threatening blood dyscrasias including thrombotic thrombocytopenic purpura ( TTP ), neutropenia / agranulocytosis and aplastic anemia; b) as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation.

Coumadin ( Warfarin sodium ) - Warfarin is a vitamin K antagonist indicated for a) prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism; b) prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement; c) reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction. ( Xagena )

Source: FDA, 2012

XagenaMedicine_2012



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