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VTE Prevention After Hip Replacement Surgery:
Head-to-Head Study Demonstrates Similar and Low Rate of Bleeding for Both Drugs
Abstract # 6
Leverkusen, December 8, 2007 - The oral, once-daily, investigational
anticoagulant rivaroxaban (Xarelto®) is significantly more effective than
enoxaparin, the standard of care, in preventing venous thromboembolism (VTE) in
patients undergoing total hip replacement surgery. Data from the RECORD1 study
show a 70% relative risk reduction (RRR) for rivaroxaban in total VTE when
compared with enoxaparin (p<0.001) and an 88% RRR (p<0.001) in major VTE.
Rivaroxaban and enoxaparin had similar low bleeding rates. These data were
released today at an official press conference during the 49th Annual Meeting
of the American Society of Hematology (ASH) and will be presented at the major
plenary session on Sunday, December 9, 2007.
"The results of this pivotal trial are very exciting for physicians who are
eagerly awaiting an improved oral anticoagulant therapy that is not associated
with an increased risk of bleeding," said Dr. Bengt Eriksson, Orthopaedic
Surgeon at the Sahlgrenska University Hospital/Östra, Gothenburg, Sweden,
Principal Investigator of the RECORD1 clinical trial. "For years, the research
on antithrombotic agents has been making advances, but these data suggest we
may be close to a breakthrough in how we treat patients after major orthopaedic
surgery."
Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced
clinical development for a wide range of indications to prevent and treat blood
clots. Rivaroxaban works at a pivotal stage in the coagulation process to
directly inhibit the enzyme Factor Xa.
The RECORD1 (REgulation of Coagulation in major Orthopaedic surgery reducing
the Risk of DVT and PE) clinical trial compared the safety and efficacy of
rivaroxaban with enoxaparin in patients undergoing total hip replacement
surgery. The duration of thromboprophylaxis in both treatments was five weeks.
The primary endpoint was total VTE (composite of deep vein thrombosis,
non-fatal pulmonary embolism and all-cause mortality) and the main secondary
endpoint was major VTE (composite of proximal deep vein thrombosis, non-fatal
pulmonary embolism and VTE-related death).
Further Phase III data evaluating rivaroxaban in major orthopaedic surgery -
including results from the RECORD2 and RECORD3 trials - will be presented
during oral sessions on Monday, December 10, 2007 at the ASH meeting in
Atlanta. The corresponding abstracts (#307 and #308) can be viewed online at
the ASH website at www.hematology.org/meetings/abstracts.cfm.
About Rivaroxaban
To date, rivaroxaban is the most studied oral, direct Factor Xa inhibitor in
development. More than 20,000 patients have been evaluated in the completed
Phase II programs or enrolled thus far in the Phase III programs. Almost 50,000
patients are expected to be evaluated in the total clinical development
program. Rivaroxaban is being jointly developed by Bayer HealthCare AG and
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bayer HealthCare submitted a regulatory filing to the European Agency for the
Evaluation of Medicinal Products (EMEA) at the end of October 2007 for approval
to market rivaroxaban in the EU for the prevention of VTE in patients
undergoing major orthopaedic surgery of the lower limbs. Upon regulatory
approval, rivaroxaban will be commercialized in Europe by Bayer Schering
Pharma. A filing for rivaroxaban for a similar indication in the United States
is planned in 2008, where upon approval, it will be commercialized by Scios
Inc. and Ortho-McNeil, Inc., both of which are wholly-owned subsidiaries of
Johnson & Johnson.
The trade name of rivaroxaban is expected to be Xarelto®, pending health
authority approval.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized
Therapeutics and Women's Healthcare. With innovative products, Bayer Schering
Pharma aims for leading positions in specialized markets worldwide. Using new
ideas, Bayer Schering Pharma aims to make a contribution to medical progress
and strives to improve the quality of life. Find more information at
www.bayerscheringpharma.de.
