�A sub-analysis of
the TRITON-TIMI 38 clinical trial showed that treatment with prasugrel
compared with clopidogrel significantly decreased the hazard of new or
perennial heart attacks (7.4 percent vs. 9.7 percent, p
The sub-analysis assessed the effect of prasugrel on new or repeated
heart attacks, occurring in the penetrating setting and during long-run medical
discussion (up to 15 months) in 13,608 sharp coronary syndromes (ACS)
patients who were managed with PCI. New or perennial heart attacks were
classified according to the ESC Universal Definition of Myocardial
Infarction as spontaneous (Type 1) or procedure-related (Type 4 or 5).(1)
The analytic thinking showed that prasugrel systematically and significantly reduced
self-generated (Type 1) heart attacks by 29 percent compared with clopidogrel
(2.5 percent vs. 3.4 percent, p=0.0015) and procedure-related repeated
heart attacks (Type 4 or 5) 24 pct in prasugrel-treated patients
compared with those taking clopidogrel (4.9 percent vs. 6.4 percent,
p=0.0002).
Long-term treatment with prasugrel, continuing after 30 days for up to
15 months, significantly reduced the peril for patients who hurt any configuration
of spirit attack by 23 percent compared with clopidogrel (2.9 per centum vs.
3.7 percentage, p=0.01). In the sub-analysis, prasugrel was too shown to
reduce the risk of a succeeding severe substance attack (ST elevation myocardial
infarction (STEMI), a more severe form of ACS with a higher risk of infection of death)
by more than 50 percent compared with clopidogrel (p=0.0001).
The independent TRITON-TIMI 38 clinical trial, for which overall results were
antecedently published in the New England Journal of Medicine in November
2007 (Vol. 357 No.20), compared prasugrel with clopidogrel
(Plavix(R)/Iscover(R)) in patients with ACS undergoing PCI. In the primary
analysis of the trial, prasugrel reduced the risk of the composite of
cardiovascular expiry, heart attack or chance event by 19 percent, with an
increased risk of major bleeding compared with clopidogrel (2.4 percentage vs.
1.8 percentage).(2)
Heart attacks are a major manifestation of coronary ticker disease, a
global health problem. About 7.2 million people die each year from coronary
heart disease worldwide.(3) In the United States, the annual rate of philia
attack is 920,000, with 600,000 organism first-time attacks and 320,000 recapitulate
attacks.(4)
"In this new sub-analysis of TRITON-TIMI 38, we found that the
reduction of mettle attacks seen with prasugrel compared with clopidogrel
was consistent crossways the spectrum of heart attacks based on type, timing
and magnitude," aforementioned David Morrow, M.D., M.P.H., associate prof of
medicine at Harvard Medical School and the Brigham and Women's Hospital,
Boston, USA, and investigator with the Thrombolysis in Myocardial
Infarction (TIMI) Study Group.
About TRITON-TIMI 38
TRITON-TIMI 38 was a Phase III, randomized, double blind, head-to-head
clinical trial comparison the personal effects of prasugrel versus clopidogrel in
patients with ACS who were managed with PCI, a procedure to open blockages
in heart arteries including the usance of coronary thrombosis stenting. The study
enrolled 13,608 patients at 707 test sites in 30 countries.
The elemental endpoint of the study was to compare the effects of
prasugrel to clopidogrel on the combined incidence of cardiovascular last,
non-fatal heart attack and non-fatal solidus during a median full point of at
least 12 months following PCI. Patients were indiscriminately assigned to one of
two treatment groups and given a loading battery-acid of either prasugrel 60 mg or
the approved loading vD of clopidogrel 300 mg anytime between
randomization and one hour after the completion of the PCI procedure,
followed by a daily maintenance dose of either prasugrel 10 mg or
clopidogrel 75 mg. All patients also standard a everyday low dosage of aspirin.
About Acute Coronary Syndromes
Acute coronary syndromes, which is comprised of heart attacks and
unstable angina (pectus pain), affects more than 1.4 million people in the
United States annually.(5) ACS, a fatal import of coronary thrombosis heart
disease, is the single most common lawsuit of death in the European Union,
accounting for more than 741,000 deaths in the EU each year.(6) Heart
attack is a major manifestation of coronary heart disease, which occurs
when the arteries become narrowed or clogged by cholesterin and fatty
deposits and cannot supply enough blood to the heart. In some cases, a
blood clot crataegus laevigata partially or totally block the blood supply to the bosom
resulting in ACS.(7) Many ACS patients are managed with PCI, which unremarkably
includes a stent placement.
About prasugrel
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company
(NYSE: LLY) are co-developing prasugrel, an investigational oral
antiplatelet agent invented by Daiichi Sankyo and its Japanese research
pardner Ube Industries, Ltd., as a potentiality treatment, initially for
patients with penetrating coronary syndromes undergoing PCI. Prasugrel works by
inhibiting platelet activation and subsequent aggregation by blocking the
P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface.
Antiplatelet agents keep platelets from clumping or sticking together,
which can result in clogged arteries and crataegus laevigata lead to heart attack or
stroke.
About Daiichi Sankyo Company, Limited
Daiichi Sankyo Company, Limited, established in 2005 later on the merger
of two leading century-old Japanese pharmaceutic companies, is a global
pharmaceutical pioneer, continuously generating innovative drugs that
enrich the quality of life for patients around the world. The company uses
its accumulative knowledge and expertise in the fields of cardiovascular
disease, cancer, metabolic disorders, and infection as a foundation for
developing an abundant mathematical product lineup and R&D pipeline.
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.
This press release contains certain forward-looking statements about
the potential of the investigational compound prasugrel (CS-747, LY640315)
and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with
any pharmaceutical combine under evolution, there are substantial risks
and uncertainties in the process of development and regulatory brushup.
There is no insure that the compound will receive regulatory approval,
that the regulative approval will be for the reading(s) awaited by
the companies, or that later studies and patient get will be
consistent with study findings to date. There is also no guarantee that the
compound will prove to be commercially successful. For farther 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.
Plavix(R)/Iscover(R) are registered trademarks of sanofi-aventis
References
1. Type 1: Spontaneous myocardial infarction elated to ischemia due to
a primary coronary thrombosis event
Type 2: Myocardial infarction secondary to ischaemia due to either
increased oxygen ask of the heart or decreased blood supply
Type 4/Type 5: Myocardial infarct associated with PCI/CABG
Thygesen K et al. Universal Definition of Myocardial Infarction.
2. Wiviott, S, Braunwald, E, et al. Prasugrel versus Clopidogrel in
Patients with Acute Coronary Syndromes. New England Journal of Medicine.
November 2007;357:2001-15.
3. World Health Organization. The Atlas of Heart Disease and Stroke -
Deaths from Coronary Heart Disease.
4 .American Heart Association. Heart Disease and Stroke Statistics -
2008 Update.
5 .American Heart Association. Heart Disease and Stroke Statistics -
2008 Update.
6. British Heart Foundation Health Promotion Research Group.
7. WebMD Medical Reference in Collaboration with the Cleveland Clinic.
Heart Disease: Coronary Artery Disease.
Eli Lilly and Company
http://www.lilly.com
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