April 1, 2011 – Oral antiplatelet therapy Effient (prasugrel) has been added to the updated clinical practice guidelines as a Class I recommended treatment option for patients undergoing percutaneous coronary intervention (PCI) after experiencing heart-related chest pain at rest (unstable angina) or non-ST segment elevation myocardial infarction (NSTEMI).
NSTEMI is a type of heart attack that that does not need to be treated with emergent opening of a blocked coronary artery. The update to the clinical guidelines, jointly developed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA), was published in the Journal of the American College of Cardiology and Circulation.
“Class I” means that a given “procedure/treatment should be performed/administered” to patients, given it was found to be “useful/effective/beneficial.” Class I is the highest recommendation provided by the guidelines committee.
Effient tablets are approved by the U.S. Food and Drug Administration to reduce the risk of future heart-related events, such as heart attack or stent thrombosis, in patients with acute coronary syndromes (ACS) who are treated with PCI. ACS includes heart attack and unstable angina (UA).
The guidelines also include the following recommendations for the use of prasugrel: Patients with UA or NSTEMI who are at medium to high risk and will have a PCI may be treated with aspirin and prasugrel at the time of PCI. (Class I recommendation) Patients with UA or NSTEMI who undergo PCI and prescribed prasugrel should remain on 10 mg of prasugrel plus aspirin for at least 12 months. (Class I recommendation) A loading dose of 60 mg of prasugrel may be considered for administration promptly as pre-treatment for a UA/NSTEMI patient for whom PCI is planned, the bleeding risk is low and coronary artery bypass graft surgery is unlikely. (Class IIb recommendation, which means treatment may be considered) Consistent with the U.S. prasugrel label, the new UA/NSTEMI guidelines provide a Class III recommendation to avoid the use of prasugrel plus aspirin in patients with a prior history of TIA or stroke as part of a dual-antiplatelet therapy regimen.
"The guidelines committee has now classified Effient with a Class I recommendation for a larger population of ACS-PCI patients, including those with unstable angina, severe and non-severe heart attacks -- all of whom may be at increased risk of future cardiovascular events after undergoing coronary intervention,” said Paul Vaitkus, M.D., senior medical director, thrombosis, Daiichi Sankyo. “The guidelines are now in line with the FDA-approved labeling for Effient.”
“The new guidelines issued by the ACCF and AHA recognize Effient as an important treatment option for the population of ACS patients who receive PCI with or without a stent after experiencing unstable angina or NSTEMI, which is a type of heart attack that that does not need to be treated with emergent opening of blocked coronary artery,” said LeRoy LeNarz, M.D., senior medical director, cardiovascular, Eli Lilly. “This updated clinical guidance offers alternative treatment options for cardiologists when they are considering appropriate oral antiplatelet therapy for patients with different forms of ACS.”
In November 2009, prasugrel also was added as a Class I recommended treatment in AHA/ACC/SCAI clinical guidelines for patients with UA or NSTEMI receiving PCI and for patients with ST elevation myocardial infarction (STEMI), which is a severe heart attack.
For more information: www.daiichisankyo.com, www.lilly.com