Eli Lilly and Company: Effient(R) Exhibited Greater Antiplatelet Activity than High Dose Clopidogrel in Type 2 Diabetes Mellitus Patients with Coronary Artery Disease

ORLANDO, Fla., Nov. 15 /PRNewswire-FirstCall/ -- Results from a new study showed patients with type 2 diabetes mellitus who also had coronary artery disease (CAD) and received a 60 mg loading dose and 10 mg maintenance dose of Effient(R) (prasugrel) achieved significantly greater platelet inhibition compared with a 600 mg loading dose and 150 mg maintenance dose of Plavix(R) (clopidogrel). These data were presented today at the American Heart Association 2009 Scientific Sessions.

“Previous research has shown that patients with type 2 diabetes mellitus have more active platelets, so might be more prone to clotting, than non-diabetics, and may have suboptimal response to therapies that reduce platelet activity,” said Dominick Angiolillo, M.D., Ph.D., assistant professor of Medicine and director of Cardiovascular Research, Division of Cardiology, University of Florida, Jacksonville, Fla. “This study was designed to compare the antiplatelet activity of prasugrel (Effient) used at standard doses with high doses of clopidogrel (Plavix) in patients with type 2 diabetes mellitus who also had coronary artery disease.”

This study was performed in patients who did not have a specific indication for clopidogrel therapy (more than 12 months after an acute coronary event or bare metal stent placement and no drug eluting stent in place). The relationship between inhibition of platelet aggregation and clinical activity has not been established.

Measurements of platelet inhibition were taken at several time periods, including baseline, one hour, four hours and 24 hours post loading dose, as well as six to eight days post maintenance dose during each period of the study. Inhibition of platelet aggregation was measured using three separate methods: VerifyNow P2Y12 assay, light transmission aggregometry, and phosphorylation of vasodilator stimulated phosphoprotein.

CAD is the chronic narrowing or hardening of the coronary arteries and is a condition linked to acute coronary syndromes (ACS). Over time, plaques build up in the arteries of patients with CAD. If a plaque ruptures and a clot forms in the artery, it may suddenly block blood supply to the heart, a condition known as ACS.(3)

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 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. For more information, visit www.daiichisankyo.com.

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. Additional information about Lilly is available at www.lilly.com.

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

VerifyNow(R) is a registered trademark of Accumetrics.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO)

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), +1-81-3-6225-1126 (office)