PARSIPPANY, N.J. and INDIANAPOLIS, Nov. 18 /PRNewswire-FirstCall/ -- Effient(R) (prasugrel) tablets, a new antiplatelet medicine, was added as a treatment option in two clinical guideline updates: one for patients receiving percutaneous coronary intervention (PCI) and a second one for patients with ST elevation myocardial infarction (STEMI), or severe heart attack. The two 2009 focused updates for the clinical guidelines, jointly developed by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI), were published online today in Circulation, the Journal of the American College of Cardiology and Catheterization and Cardiovascular Interventions.
Effient received the Class I recommendation from the Guidelines Committee in both sets of the guideline updates. Class I means that a given "procedure/treatment should be performed/administered" to patients, given it was found to be "useful/ effective/beneficial". Consistent with the Effient label, both guidelines provide recommendations to avoid the use of Effient in patients with a prior history of TIA or stroke.
"The Guidelines Committee classified prasugrel, marketed in the United States as Effient, with a Class I rating," said Rogelio Braceras, M.D., senior medical director for Daiichi Sankyo, Inc. "Based on the latest clinical studies and scientific evidence, these guidelines provide clear recommendations for how Effient should be incorporated into medical practice to help reduce risk of cardiovascular events such as heart attacks and blood clots forming around stents."
Important Safety Information about Effient
Antiplatelet medicines, including Effient, can increase the risk of bleeding. If patients have unexplained or excessive bleeding while on Effient, they should contact their doctor right away as some bleeding can be serious, and sometimes may lead to death. Patients should not take Effient if they have a stomach ulcer or other conditions that cause bleeding or if they have a history of stroke or "mini-stroke" (transient ischemic attack or TIA).
If patients plan to have surgery or a dental procedure, they should tell their doctors that they are taking Effient. Patients should not stop taking Effient without first talking to the doctor who prescribed it for them, as this may result in increased risk of a clot in their stent, a heart attack or death.
For more information about Effient including prescribing information, please visit www.Effient.com.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd. For more information on Daiichi Sankyo, Inc., please visit www.dsi.com.
This press release contains certain forward-looking statements about Effient for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with percutaneous coronary intervention and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission and Daiichi Sankyo's filings with the Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no duty to update forward-looking statements.
CONTACT: Tammy Hull, Eli Lilly and Company, +1-317-651-9116 (office),
+1-317-614-5132 (cell); Kimberly Wix, Daiichi Sankyo (U.S.A.),
+1-973-944-2338 (office), +1-908-656-5447 (cell); Shigemichi Kondo, Daiichi
Sankyo (Tokyo), 81-3-6225-1126 (office)