15/08/2011 18:25:39 CET
Compared with the overall study population, a higher risk of serious bleeding among prasugrel patients was most evident in three distinct patient populations that are readily identifiable: patients who weighed less than 60 kg, patients who were 75 years of age or older and patients who have had a prior transient ischemic attack (TIA) or stroke.(3) A 5 mg maintenance dose should be used for patients who weigh less than 60 kg.(2) Prasugrel is generally not recommended for use in patients 75 years or older.(2) If, after a careful individual benefit/risk evaluation by the prescribing physician treatment is deemed necessary a 5 mg maintenance dose should be prescribed.(2) Patients with prior TIA or stroke should not be treated with prasugrel.(2)
In this study, survival analysis methods were used to compare outcomes by treatment assignment (prasugrel vs. clopidogrel) and to compare outcomes by whether subjects were included in the core clinical cohort, non-core cohort or contraindicated cohort. The principal limitation of this analysis is that the subgroups examined were identified in a post-hoc fashion.
Notes to Editors
Daiichi Sankyo Company, Limited, and Eli Lilly and Company co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. Prasugrel helps keep blood platelets from clumping together and developing a blockage in an artery. The European Commission granted marketing authorization for prasugrel for the prevention of atherothrombotic events in patients with ACS undergoing PCI, in combination with ASA.(2) To date prasugrel has been approved in more than 65 countries worldwide.
About Acute Coronary Syndromes
Acute coronary syndrome includes heart attacks and unstable angina (chest pain). Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(4) Acute coronary syndrome (ACS), which includes heart attack and type of chest pain called unstable angina, affects more than 1 million people in the United States annually.(5) The annual incidence of new heart attacks is estimated to be approximately 610,000 and about 325,000 people will have a recurrent attack.(5) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot, which may partially or totally block the blood supply to portions of the heart, resulting in ACS.(6) Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit http://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 http://www.lilly.com.
This press release contains certain forward-looking statements about prasugrel 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.
(1) Wiviott, S.D. et al. Efficacy and Safety of Intensive Antiplatelet Therapy with Prasugrel from TRITON - TIMI 38 in a Core Clinical Cohort Defined by Worldwide Regulatory Agencies. The American Journal of Cardiology 2011. Published online 4 Aug 2011. Available at: http://www.ajconline.org/article/S0002-9149(11)01906-0/abstract. Accessed 8 July 2010.
(2) European Medicines Agency. Efient Summary of Product Characteristics [http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000984/WC500021971.pdf ] . Electronic Medicines Compendium website.
(3) Wiviott, S.D. et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. New England Journal of Medicine 2007 Vol 357 (20); 2001-2015.
(4) British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008 [http://www.heartstats.org/uploads/documents%5Cproof30NOV2007.pdf ]. Accessed 8 July 2010.
(5) Roger VL, Go AS, Lloyd-Jones DM et al. for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics - 2011 update. Circulation. 2011;123:e1-e192.
(6) WebMD Medical Reference in Collaboration with the Cleveland Clinic. Heart Disease: Coronary Artery Disease [http://www.webmd.com/heart-disease/guide/heart-disease-coronary-artery-disease ] . Accessed 8 July 2010.
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CONTACT: Christina D. Gaines, APR, Eli Lilly and Company, +1-317-276-3845(office), +1-317-366-2568 (cell), or Dr. Michaela Paudler-Debus, DaiichiSankyo Europe GmbH, +49-(0)89-78 08 685 (office), +49-(0)172-845 8974(cell), or Shigemichi Kondo, Daiichi Sankyo (Tokyo), +81-3-6225-1126(office)