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Edoxaban Demonstrates Superior Efficacy Compared With Enoxaparin Sodium in Preventing VTE After Total Hip Replacement
Tokyo (ots/PRNewswire) - Daiichi Sankyo Company, Limited announced that its investigational once-daily oral, direct factor Xa inhibitor, edoxaban, was shown to be superior to enoxaparin sodium in preventing venous thromboembolic (VTE) events in patients following total hip replacement (THR), a type of major orthopedic surgery. Results from the Phase III STARS J-V (Studying Thrombosis After Replacement Surgery) study were presented at the 52nd Annual Meeting of the American Society of Hematology in Orlando.
This multicentre, double-blind, double dummy, centrally randomised trial evaluated the efficacy and safety of edoxaban compared with enoxaparin sodium in patients undergoing THR in Japan. A total of 610 patients received either 30 mg once-daily oral dose of edoxaban or subcutaneous injection of enoxaparin sodium 2,000 international units (equivalent to 20 mg) twice-daily for 11 to 14 days. The primary efficacy endpoint of the trial was the incidence of symptomatic pulmonary embolism (PE) and symptomatic and asymptomatic deep vein thrombosis (DVT). The primary safety endpoint was the incidence of major bleeding and clinically relevant non-major bleeding.
Asymptomatic DVT occurred in 2.4 percent of patients receiving edoxaban once-daily compared with 6.9 percent of patients who received enoxaparin sodium (relative risk reduction of 65.7 percent; p=0.016). There were no PE events observed in either treatment group. There was no statistically significant difference in major and clinically relevant non-major bleeding (p=0.475). There were no cases of intracranial hemorrhage or death in either treatment group.
Indicators for potential liver damage in both treatment groups were carefully monitored during this trial by measuring bilirubin and serum aminotransferase levels. Elevations greater than three times the upper limit of the normal range of serum aminotransferase levels occurred in 2.6 percent of patients taking edoxaban compared with 10 percent of those taking enoxaparin sodium.
In March 2010, Daiichi Sankyo submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan seeking approval of edoxaban for the prevention of VTE after major orthopedic surgery.
Edoxaban is a once-daily oral anticoagulant that directly inhibits factor Xa, an important factor in the coagulation process. Edoxaban was discovered by Daiichi Sankyo and is currently in phase III of clinical development. Daiichi Sankyo is developing edoxaban as a potential new treatment for the prevention of both arterial and venous thromboembolism. Notably, Daiichi Sankyo has more than 25 years experience conducting research in the area of factor Xa inhibition, and was the first company to study these compounds in humans. Edoxaban is being developed solely by Daiichi Sankyo.
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 optimise growth opportunities across the value chain. For more information, please visit http://www.daiichisankyo.com
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO, Co. Ltd, DAIICHI SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO, Co. Ltd, DAIICHI SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
 T. Fuji et al.,Efficacy and Safety of Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism Following Total Hip Arthroplasty: STARS J-V trial, December 4-7 2010, Orlando, Florida.
 52nd ASH Annual Meeting and Exposition. Available at http://a sh.confex.com/ash/2010/webprogram/start.html#srch=words%7CEDOXABAN%20 %7Cmethod%7Cand%7Cpge%7C1 Accessed December 3, 2010
 Medline Bilirubin. Available at http://www.nlm.nih.gov/medlineplus/ency/article/003479.htm Accessed December 3, 2010
 Liver Blood Tests. Available at: http://www.medicinenet.com/liver_blood_tests/page2.html Accessed June 18, 2010.
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For more information, please contact:
Toshiaki Sai Daiichi Sankyo, Co., Ltd. (Japan) +81-3-6225-1126 (office) Dr. Michaela Paudler-Debus Daiichi Sankyo Europe GmbH +49-(0)89-78-08-685 (office) +49-(0)172-845-8974 (mobile)
CONTACT: Toshiaki Sai, Daiichi Sankyo, Co., Ltd., (Japan),
+81-3-6225-1126(office); Dr. Michaela Paudler-Debus, Daiichi Sankyo
Europe GmbH,+49-(0)89-78-08-685 (office), +49-(0)172-845-8974