Navigation Links
Prasugrel Head-to-Head Study Showed Reduced Cardiovascular Events in Diabetes Patients by 30 Percent Compared with Clopidogrel
Date:8/31/2008

Sub-group analysis of landmark trial showed prasugrel substantially reduced risk of heart attack and stent thrombosis compared with clopidogrel among

ACS patients with diabetes

MUNICH, Germany, Aug. 31 /PRNewswire-FirstCall/ -- Patients who were diabetic and diagnosed with acute coronary syndromes (ACS) were 40 percent less likely to suffer a heart attack if they were treated with prasugrel vs. clopidogrel, according to a sub-group analysis of the TRITON-TIMI 38 trial (8.2 percent vs. 13.2 percent, P<0.001). In addition, according to this same analysis, the combined rate of cardiovascular death, non-fatal heart attack and non-fatal stroke was reduced by 30 percent in diabetes patients treated with prasugrel compared to those treated with clopidogrel (12.2 percent vs. 17.0 percent, P<0.001). In patients without diabetes, there was also improvement in outcomes with prasugrel, with the primary endpoint occurring in 9.2 percent of patients treated with prasugrel and 10.6 percent of patients treated with clopidogrel (P=0.02).

The diabetic sub-group analysis was presented today by Stephen Wiviott, M.D., Assistant Professor of Medicine at Harvard Medical School and investigator with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham & Women's Hospital, Boston, USA, at the Congress of the European Society of Cardiology (ESC) in Munich, Germany. In addition, the manuscript was simultaneously published online in Circulation, the medical journal of the American Heart Association (AHA).

"The results observed from this sub-group analysis showed that antiplatelet therapy with prasugrel resulted in significantly greater reduction of cardiovascular events among patients with diabetes when compared to those who were treated with clopidogrel," said Wiviott.

The reduction of cardiovascular events was consistent across the sub-group of diabetes patients regardless of diabetic therapies (insulin versus no insulin). The study showed a significant relative risk reduction in the primary endpoint of cardiovascular death, non-fatal heart attack and non-fatal stroke with prasugrel, 37 percent for insulin treated and 26 percent (P=0.001) for non-insulin treated diabetics. There was also a significantly lower rate of stent thrombosis among diabetes patients treated with prasugrel, resulting in a 48 percent relative risk reduction in stent thrombosis compared with clopidogrel (3.6 percent vs. 2.0 percent, P=0.007).

"These findings are interesting in view of previous studies that showed higher levels of platelet aggregation in insulin-treated diabetes patients after dual antiplatelet therapy compared to diabetes patients not treated with insulin," said Dr. Wiviott.

The main TRITON-TIMI 38 clinical trial, previously published in the New England Journal of Medicine in November 2007 (Vol. 357, No. 20), compared prasugrel with clopidogrel in patients with ACS undergoing percutaneous coronary intervention (PCI). In the primary analysis of the trial, prasugrel reduced the risk of the composite endpoint of cardiovascular death, heart attack or stroke by 19 percent, with an increased risk of major bleeding compared with clopidogrel (2.4 percent vs. 1.8 percent).(1)

In this sub analysis, the rates of major bleeding events were similar for prasugrel (2.5 percent) and clopidogrel (2.6 percent) among patients with diabetes, regardless of diabetes therapies (insulin versus no insulin).

About Diabetes in Patients with ACS

Among patients with ACS, those with diabetes are at a higher risk for subsequent cardiovascular events, including death.(2) Several mechanisms may increase the risk of events in patients with diabetes, including greater frequency of other cardiac risk factors, a greater burden of narrowing of the arteries (atherosclerotic disease), high blood sugar (hyperglycemia), inflammation, and a greater tendency toward blood clots (thrombosis).(3,4,5)

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 partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndrome 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 prevent platelets from clumping or sticking together, which can result in clogged arteries and may lead to heart attack or stroke.

About Daiichi Sankyo

A global pharma 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. A central focus of Daiichi Sankyo's research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. Equally important to the company is the discovery of new medicines in the areas of infectious diseases, cancer, bone and joint diseases, and immune disorders. For more information, visit http://www.daiichisankyo.com.

Daiichi Sankyo, Inc. (http://www.dsus.com) headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd.

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 compound under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the compound will receive regulatory approval, that the regulatory approval will be for the indication(s) anticipated by the companies, or that later studies and patient experience will be consistent with study findings to date. There is also no guarantee that the compound will prove to 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.

Plavix(R)/Iscover(R) are registered trademarks of sanofi-aventis.

P-LLY

(1) 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.

(2) Donahoe SM et al. Diabetes and mortality following acute coronary syndromes. JAMA 2007; 298(7):765-775.

(3) Angiolillo DJ. Antiplatelet therapy in type 2 diabetes mellitus. Curr Opin Endocrinol Diabetes Obes. 2007;14(2):124-131.

(4) Sabatine MS, Braunwald E. Will diabetes save the platelet blockers? Circulation. 2001;104(23):2759-2761.

(5) Sobel BE. Optimizing cardiovascular outcomes in diabetes mellitus. Am J Med. 2007;120(9 Suppl 2):S3-11.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO )


'/>"/>
SOURCE Eli Lilly and Company
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Head-to-Head Study Showed Prasugrel Statistically Superior to Clopidogrel in Reducing Recurrent Cardiovascular Events
2. FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
3. TRITON-TIMI 38 Stent Analysis Favors Prasugrel
4. Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel
5. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
6. Study Protocols Will be Amended in Two Small Early-Phase Prasugrel Studies
7. Head-to-Head Study Demonstrates Focalin(R) XR Offers Faster and Better Symptom Control than Concerta(R)1 in Early Part of ADHD Patients Day
8. New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes
9. Cleveland Clinic to Lead First Head-to-Head Comparison of the Two Most Potent Statins
10. Two-Year Outcomes From Large Head-to-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for Cypher(R) Sirolimus-Eluting Coronary Stent and Taxus Stent
11. Variant of Mad Cow Disease May Be Transmitted by Blood Transfusions, According to Animal Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... GARDENS, N.Y. , Dec. 2, 2016  LifeVac, ... will be included in the Emergency Response Training and ... are very excited to have LifeVac become part of ... Lih , Founder and CEO of LifeVac. "Having an ... LifeVac safely and effectively will help leverage our efforts ...
(Date:12/2/2016)... 2, 2016 Research and Markets has announced ... Growth and Demand Forecast to 2022" report to their offering. ... , , ... in 2015, and it is expected to grow at a CAGR of ... to witness faster growth during the forecast period, a CAGR of 8.8% ...
(Date:12/2/2016)... , Dec. 2, 2016 Quantum Radiology,s Mobile ... expert radiologist interpretation directly to women at the workplace, ... corporations, such as Delta Air Lines and SunTrust Bank, ... as a component of wellness initiatives. "I ... SunTrust. It enables them to have a mammogram without ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... ... Lori G. Cohen and Sara K. Thompson , shareholders ... American Conference Institute’s 21st Drug & Medical Device Litigation Conference , taking place in ... , Cohen, who chairs the firm’s Pharmaceutical, Medical Device & Health Care Litigation Practice ...
(Date:12/2/2016)... ... ... For over twenty-four years, Doctors on Liens has published a directory of the ... medical care. When the company started in 1997, the directory was a single page ... the now ten-page directory features a vast array of medical specialists stretching from ...
(Date:12/2/2016)... ... December 02, 2016 , ... FlexiSpot, ... of its 60-day free trial program for all of the company’s desktop riser ... a truly hassle free experience. , FlexiSpot’s unique desktop risers use an advanced ...
(Date:12/2/2016)... ... December 02, 2016 , ... U.S. Surgeon General, Dr. Vivek Murthy, graces the ... how he was inspired to practice medicine at an early age by his father, ... than making diagnoses and prescribing medicine,” he states. “It is about building relationships with ...
(Date:12/2/2016)... , ... December 02, 2016 , ... ... Beverly Hills, California, will be included in the 2016 “Guide to America’s Top ... professionals based on the amalgamation of their education, experience, and professional associations. ...
Breaking Medicine News(10 mins):