BASINGSTOKE, England, November 4 /PRNewswire/ -- Results from a landmark clinical trial announced today at the American Heart Association meeting and published simultaneously in the New England Journal of Medicine(1), showed that a developmental heart drug called prasugrel, may prevent 19% fewer heart deaths, strokes and heart attacks compared to clopidogrel1 (Plavix(R)), the current 'gold standard' treatment.(2,3) The global trial demonstrated that treatment with prasugrel was shown to be significantly more effective than treatment with clopidogrel in patients who have already suffered a heart attack or have unstable angina, and have had a procedure to reopen their coronary arteries.(1)
Prasugrel and clopidogrel are both antiplatelet drugs. They prevent platelets from clumping or sticking together, which can cause formation of blood clots and lead to heart attack or stroke.
Dr Tony Gershlick, leading UK Consultant Cardiologist at the Glenfield Hospital, Leicester, welcomes the data and comments: "Prasugrel appears from this study to have the potential to move the management of patients with ACS forward, improving on the current standard of care for these high risk patients."
The head-to-head TRITON study involved 13,608 patients worldwide and was designed to study the effectiveness and safety of prasugrel versus clopidogrel in patients having suffered a heart attack or unstable angina due to total or partial blockage of a coronary artery(1) - a group of conditions known as Acute Coronary Syndrome(x) (ACS).(4) These patients had undergone a procedure called angioplasty or Percutaneous Coronary Intervention(xx) (PCI).(1)
Cardiovascular disease is the leading cause of death in the UK, killing 208,000 patients per year.(5) Around 227,000 people suffer a heart attack each year in the UK(6) - that's one heart attack every two minutes(6) and in the UK there are approximately 2.6 million people who have had either a heart attack or angina (stable or unstable).(5) Heart disease costs the UK economy GBP29 billion a year in healthcare expenditure and lost productivity with more than 69 million work days lost to heart disease in 2004.(7)
Dr Robert Storey, Senior Lecturer and Honorary Consultant in Cardiology, Cardiovascular Research Unit, University of Sheffield, commented: "Heart attacks and unstable angina are alarming conditions for people that put their lives at risk and can cause enduring ill-health. Cardiologists have been striving to improve the treatment for these conditions but need better tools in order to treat the clots in the arteries of the heart that cause most cases of ACS. TRITON shows that more effective drugs that help treat these clots may mean better outcomes for these people in the future."
Patients who participated in the TRITON study were randomly chosen to receive prasugrel (60 mg loading dose / 10 mg maintenance dose) plus aspirin or clopidogrel (300 mg loading dose / 75 mg maintenance dose) plus aspirin for 12 months. The doses for prasugrel were based on earlier study findings(8) and for clopidogrel were standard approved doses.(8,9)
As antiplatelet drugs help prevent blood from clotting too much, they can cause excess bleeding. The beneficial effects of the investigational drug prasugrel were associated with a higher risk of major bleeding (2.4% and 1.8% major for prasugrel and clopidogrel respectively).(1)
The TRITON data will be submitted to regulatory authorities as part of the drug's approval process.
(x)ACS is an umbrella term to cover any group of clinical symptoms resulting in chest pain due to insufficient blood supply to heart muscle.(4)
(xx)PCI is a therapeutic procedure to treat the narrowed coronary arteries of the heart found in coronary artery disease.(10)
Notes to Editors:
About TRITON TIMI-38
The TRITON TIMI-38 clinical trial has been conducted in conjunction with the TIMI Study Group at Harvard Medical School and Brigham and Women's Hospital in Boston. The Phase III study looked at the effectiveness and safety of prasugrel compared with clopidogrel in reducing ischemic events such as heart attacks, stroke and death in patients with acute coronary syndrome undergoing PCI, a procedure to open blockages in heart arteries that includes the use of coronary stents.
About prasugrel
Eli Lilly and Company (NYSE: LLY) and Sankyo Company Ltd., a subsidiary of Daiichi Sankyo Company, Limited (TSE: 4568) are co-developing prasugrel, an investigational oral antiplatelet agent, as a potential treatment initially for patients with acute coronary syndrome undergoing PCI.
Prasugrel was discovered by Sankyo and Ube Industries, Ltd and is designed to inhibit platelet activation and aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface. Antiplatelet agents prevent platelets from clumping or sticking together, which can cause formation of blood clots and lead to heart attack or stroke.
About Daiichi-Sankyo Company, Limited
Daiichi-Sankyo Company, Limited was established on Sept. 28, 2005, as the joint holding company of two major Japanese pharmaceutical companies - Sankyo Co., Ltd., and Daiichi Pharmaceutical Co., Ltd. Daiichi Sankyo is a global pharmaceutical innovator, continuously generating innovative drugs and services and maximizing its corporate value. Both companies have used their cumulative knowledge and expertise in the field of cardiovascular disease as a foundation for developing an abundant product lineup and R&D pipeline. For further details, please refer to the company Web site at http://www.daiichisankyo.co.jp/eng.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class 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.co.uk.
Plavix(r) is a registered trademark of Sanofi-Synthelabo Inc.
References:
1. Wiviott S, Braunwald E, McCabe C, et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. NEJM, Nov 2007;357 (20): 2001-2015.
2. National Institute for Health and Clinical Excellence. Clopidogrel in the treatment of non-ST-segment-elevation acute coronary syndrome. Technology Appraisal 80. London: July 2004.
3. The Information Centre. Hospital Prescribing 2005, England. London: NHS.
4. Fenton D. Acute Coronary Syndrome. E-medicine. http://www.emedicine.com/EMERG/topic31.htm. Date accessed 041007
5. Allender E, Peto V, Scarborough P, et al. (2007) Coronary heart disease statistics. London: BHF. http://www.heartstats.org/uploads/documents%5C48160_text_05_06_07.pdf. Date accessed 041007
6. British Heart Foundation. Heart Statistics online. http://www.heartstats.org/datapage.asp?id=6862. Date accessed 041007
7. R Luengo-Fernández, J Leal, A Gray, et al. Cost of cardiovascular diseases in the United Kingdom. Heart, Oct 2006; 92: 1384-1389.
8. Wiviott SD, Antman EM, Gibson M et al. Evaluation of prasugrel compared with clopidogrel in patients with acute coronary syndromes: design and rationale for the Trial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 (TRITON-TIMI 38). Am Heart J 2006:152;627-635.
9. Plavix(R) Summary of Product Characteristics. September 2007.
10. British Heart Foundation. Living with heart conditions. http://www.bhf.org.uk/living_with_heart_conditions/treatment/angioplasty.aspx . Date accessed 171007
