Effient Helps Reduce Stent Thrombosis
Effient (prasugrel) tablets are indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with percutaneous coronary intervention (PCI).
Effient helps keep blood platelets from sticking together to form clots, which can block an artery. Daiichi Sankyo Inc. and Eli Lilly and Company said taking Effient with aspirin after PCI has been shown to reduce the chances of having a cardiac event and stent-related blood clots among patients with acute coronary syndromes.
Effient should be initiated with a loading dose of 60 mg followed by a maintenance dose of 10 mg once daily, the companies said. 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 approval of the drug was based on results from the pivotal phase III TRITON-TIMI 38 clinical trial, which compared Effient with Plavix (clopidogrel bisulfate) in reducing cardiovascular events in 13,608 acute coronary patients managed with PCI. The study showed that Effient taken with aspirin had a 19 percent relative risk reduction of the combined endpoint of cardiovascular death, nonfatal heart attack or nonfatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by reduction in heart attacks, the companies said. The benefit of Effient compared with Plavix was seen as early as three days and continued over the 15 months of the trial. In addition, there were fewer stent-related clots in patients treated with Effient compared with Plavix (a relative risk reduction of about 50 percent).
The FDA cleared the drug in July 2009.