New Updates To AHA/ACC/SCAI Clinical Guidelines Recommend Treatment With Effient(R) For Patients With Acute Coronary Syndromes Managed With PCI

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 28 Nov 2009 - 0:00 PST

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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.

Approved by the U.S. Food and Drug Administration in July 2009, Effient is indicated to lower the chance of having another thrombotic cardiovascular event such as heart attack or stent-related blood clot for patients with acute coronary syndromes (ACS) who are managed with angioplasty and stenting, also known as PCI.

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.

"It is important that the cardiology community has updated clinical guidelines that include the latest treatment options like Effient for treating ACS patients managed with angioplasty and stenting," said LeRoy LeNarz, M.D., senior medical director of cardiovascular care, Lilly USA, LLC. "By recommending Effient, these guidelines recognize an important new treatment for ACS-PCI patients, particularly for those with severe heart attacks who are at increased risk of suffering future cardiovascular events."

"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."

About Effient

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) co-developed Effient, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. Effient helps keep blood platelets from clumping together and developing a blockage in an artery. Effient is approved by the U.S. Food and Drug Administration for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes (ACS) 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.

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 are 75 or older, or if they weigh less than 132 pounds, or if they are taking anticoagulants (e.g., warfarin) or taking NSAIDs (e.g., ibuprofen or naproxen) for a long time, they should talk to their doctor, as they may be at an increased risk of bleeding.

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.

Patients should get medical attention right away if they develop any of the following unexpected symptoms: fever, weakness, yellowing of the skin or eyes, or if skin becomes very pale or dotted with purple spots. These symptoms may be signs of a rare but potentially life-threatening condition called TTP, which has been reported with other medicines in this class that are like Effient, sometimes after a short time (less than 2 weeks).

About Daiichi Sankyo

A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., was established in 2005 through the merger of two leading Japanese pharmaceutical companies. This integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. Areas of primary focus for Daiichi Sankyo research and development are thrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmune disorders. Equally important to the company are hypertension, hyperlipidemia or atherosclerosis and bacterial infections.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

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.

Effient(R) is a registered trademark of Eli Lilly and Company.

Source: Eli Lilly and Company