The EU prasugrel label includes a contraindication for patients with a history of TIA or stroke, as well as a warning for patients who weighed less than 60 kg (132 lbs) and patients who are 75 years of age or older. For the patients in TRITON-TIMI 38 without these risk factors, the efficacy of prasugrel compared with clopidogrel on the primary composite endpoint of CVD, nonfatal MI, or nonfatal stroke was 8.3 percent vs. 11.0 percent, respectively, and consistent with the significant efficacy benefit observed with prasugrel in the overall study population. In these same patients, the risk of serious bleeding was reduced but still higher with prasugrel compared with clopidogrel (2.0 percent vs. 1.5 percent, respectively).
An analysis weighing the risk of major bleeding and the reduction in heart attacks found an overall benefit favouring prasugrel compared with clopidogrel. For every 1,000 patients treated with prasugrel as compared with clopidogrel, there were 22 fewer patients with heart attacks and five more with non-CABG-related major bleeding events.
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 organisation 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 organisations. 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.
This press release contains certain forward-looking statements about Efient for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome undergoing 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 commercialisation. 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.
Efient(R) is a registered trademark of Eli Lilly and Company.
Plavix(R) is a registered trademark of Sanofi-Aventis Corp.
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(1) Mahoney EM, Wang K, et al. Cost-Effectiveness of Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes and Planned PCI: Results from the TRITON-TIMI 38 Trial. Circulation. 2010; 121: 71-79.
(2) British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, http://www.ehnheart.org/files/statistics%202008%20web-161229..., Accessed Oct. 15, 2009.
(3) American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. Dallas, TX. American Heart Association. (Pg. 14)
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Derin Denham, Eli Lilly and Company, +1-317-277-6749 (office), +1-317-370-1435 (cell); Dr. Michaela Paudler-Debus, Daiichi Sankyo Europe GmbH, +49-(0)89-78-08-685 (office), +49-(0)172-845-8974 (cell); Shigemichi Kondo, Daiichi Sankyo (Tokyo), +81-3-6225-1126 (office)