On Jul. 11, 1999, Daiichi Sankyo and Eli Lilly announced the U.S. Food and Drug Administration (FDA) had approved Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI). PCI usually includes the placement of a stent to help keep the artery open.

Effient (pronounced Ef-fee-ent) helps keep blood platelets from sticking together to form clots, which can block an artery. Taking Effient with aspirin after PCI has been shown to reduce the chances of having a cardiac event (such as a heart attack) and stent-related blood clots (known as stent thrombosis) among patients with acute coronary syndromes (ACS), a common cardiovascular condition.

Effient should be initiated with a loading dose of 60 mg followed by a maintenance dose of 10 mg once daily. In addition, for those patients who weigh less than 132 pounds (60 kg), physicians should consider lowering the maintenance dose to 5 mg once daily. Patients taking Effient should also take 75 mg to 325 mg aspirin orally once daily, according to their doctors’ instructions.

The risk of bleeding was highest in Effient-treated patients who were either 75 years of age or older, weighed less than 132 pounds (60 kg), or who had a prior history of transient ischemic attacks (TIA) or stroke. Effient is contraindicated in patients with a history of prior TIA/stroke. It is generally not recommended in patients 75 years of age or older, except for patients in high-risk situations, such as those with diabetes or a history of prior heart attack.

ACS, which includes heart attacks and unstable angina (chest pain), affects nearly 1.5 million people in the United States annually, many of whom are managed with PCI. In 2009, an estimated 785,000 people in the United States will have a new heart attack and about 470,000 will have a recurrent attack.