PARSIPPANY, N.J. and INDIANAPOLIS, Jan. 5 /PRNewswire-FirstCall/ --Results from a health economic substudy of the TRITON-TIMI 38 clinical trial showed that among patients with acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI), including stenting, treatment with Effient((R)) (prasugrel) compared with branded clopidogrel (Plavix((R))) was more cost effective, and in most cases cost saving. These results were published in Circulation on January 5, 2010.(1)
The analysis also found that, including cost of the active study drugs as well as costs associated with the initial and subsequent hospitalizations, treatment with Effient compared with clopidogrel decreased cumulative medical costs by $221 per patient over the 14.7-month study. Study drug costs used in the analysis were the net wholesale price as of August 2009, which was $5.45 per day for Effient and $4.62 per day for clopidogrel.
"Dominant" is a health economics term used when a new treatment yields greater clinical effectiveness at lower costs. In TRITON-TIMI 38, Effient plus aspirin (ASA) was shown to significantly reduce the rate of a combined endpoint of cardiovascular death, nonfatal heart attack, or nonfatal stroke compared to clopidogrel plus ASA. In addition, patients treated with Effient also had significantly fewer stent thromboses (stent-related blood clots) compared to those treated with clopidogrel. These benefits were accompanied by a significantly higher risk of bleeding, which in some cases were life-threatening or even fatal in patients treated with Effient compared with clopidogrel.
"The hypothetical comparison with generic clopidogrel is important because the patent exclusivity for Plavix will expire in 2011 or 2012. Results from this comparison to generic clopidogrel will be useful information for the medical community, especially payers, in the future," said Dr. Cohen, "and suggest that the overall benefit of Effient was still favorable relative to its higher cost in this setting."
The primary endpoint of the study was the combined incidence of cardiovascular death, non-fatal heart attack or non-fatal stroke during a median period of at least 12 months following PCI. Patients were randomly assigned to one of two treatment groups and given a loading dose of either Effient 60 mg or the FDA-approved loading dose of clopidogrel 300 mg, followed by a daily maintenance dose of either Effient 10 mg or clopidogrel 75 mg. All patients also received a daily dose of aspirin (75 mg to 325 mg).
About Effient
Daiichi Sankyo Company, Limited , and Eli Lilly and Company 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 US Food and Drug Administration for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with 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 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.
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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) American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. Dallas, TX. American Heart Association. (Pg. 14).
(3) American Heart Association Heart Disease and Stroke Statistics - 2009 Updated. Dallas, TX. American Heart Association. (Pg. 2)
(4) Kolansky, D, Acute coronary syndromes: Morbidity, mortality, and pharmacoeconomic burden. Amer J of Manag Care, 2009;15:S36-S41. http://www.ajmc.com/media/pdf/A213_09mar_KolanskyS36to41.pdf. Accessed Oct. 13, 2009.
CONTACT: Tammy Hull, Eli Lilly and Company, +1-317-651-9116 (office),
+1-317-614-5132 (cell), or Kimberly Wix, Daiichi Sankyo (U.S.A.),
+1-973-944-2338 (office), +1-908-656-5447 (cell), or Shigemichi Kondo,
Daiichi Sankyo (Tokyo), 81-3-6225-1126 (office)
