The Lancet Publishes RECORD4 Study Demonstrating Xarelto(R) Provides Superior Efficacy to Enoxaparin for the Prevention of Venous Blood Clots



    
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    -   Head-to-head study shows once-daily Xarelto(R) is the only oral
        anticoagulant to significantly reduce venous thromboembolism (VTE)
        event rates compared to twice-daily injectable enoxaparin, while
        maintaining a low rate of major bleeding

    -   VTE is one of the most preventable post-surgical events; it is
        estimated that there are between 15,000 to 20,000 cases of VTE in
        Canada every year
    -------------------------------------------------------------------------
    

    TORONTO, May 19 /CNW/ - Data from the pivotal Phase III RECORD4
(REgulation of Coagulation in major Orthopedic surgery reducing the risk of
Deep Vein Thrombosis and Pulmonary Embolism) clinical trial, published May 16
in The Lancet, demonstrate that Bayer's novel anticoagulant Xarelto(R)
(rivaroxaban), taken as a once-daily tablet, was significantly more effective
in reducing the occurrence of venous blood clots following elective total knee
replacement surgery (TKR) than the current standard of care, twice-daily
injectable, enoxaparin.(1)
    The results from RECORD4 make Xarelto the only oral anticoagulant to have
demonstrated superior efficacy compared to enoxaparin at its dosing regimen of
30mg twice-daily for venous thromboembolism (VTE) prevention in patients
undergoing TKR.(1) In addition, the study demonstrated that Xarelto maintained
a similar low rate of major bleeding as seen with enoxaparin.
    RECORD4 forms part of the RECORD clinical trial program, which involved
more than 12,700 total hip or knee replacement surgery patients. RECORD4 was a
multicenter, randomized, double-blind trial that compared Xarelto (10 mg
tablet once-daily) with the Health Canada-approved treatment regimen for the
prevention of VTE following TKR surgery of enoxaparin (30 mg injection
twice-daily) in 3,148 patients.(1)

    
    Xarelto provided patients with the following benefits over enoxaparin(1):

    -   A statistically significant reduction in total VTE event rates,
        6.9 % vs. 10.1 %,
        (p = 0.012)
    -   A relative risk reduction (RRR) of 31 % in total VTE rates (composite
        of deep vein thrombosis, non-fatal pulmonary embolism and all-cause
        mortality)
    

    Furthermore, Xarelto maintained a low rate of major bleeding that was not
statistically different to the rate of major bleeding in the
enoxaparin-treated patients, (0.7 % and 0.3 % respectively; p = 0.110).(1)
    "Rivaroxaban is the first oral anticoagulant to demonstrate superiority
over the current standard treatment, and as such it has the potential to
become a new clinical standard for the prevention of serious blood clots
following elective hip replacement surgery or elective knee replacement
surgery," said Dr. A.G.G. Turpie, Professor of Medicine, McMaster University,
Hamilton and Principal Investigator for the RECORD program. "It is well
documented that many patients find the regimen of self-injection associated
with current anticoagulation therapies difficult to comply with. Rivaroxaban,
as a once-daily tablet could significantly increase patient compliance and
reduce the incidence of, and costs associated with, treating post-surgical
blood clots."

    Developments in Thrombophrophylaxis Treatments

    Venous blood clots are serious complications that can impact patients
undergoing major orthopedic surgery due to vascular damage and reduced
mobility.(2) If prophylactic measures are not taken, VTE can occur in up to 60
per cent of these patients and cause death in 7.5 per cent.(3) Current
treatments, such as vitamin K antagonists and heparins, have been the
foundation of anticoagulation treatment for years. However, they have
significant disadvantages both in the outpatient setting and for long-term
use. This highlights the need for development of new anticoagulants that are
well tolerated and effective, but do not require regular injections or routine
blood monitoring. Xarelto is taken as one tablet, once-daily (at home and in
hospital), and requires no routine coagulation monitoring.(4) It works by
targeting a pivotal stage in the blood clotting process and directly inhibits
the enzyme Factor Xa to ensure the natural healing process can occur.(4,5)
    The efficacy of Xarelto and the statistically similar low risk of
bleeding to enoxaparin demonstrated in the RECORD4 trial results were also
seen in the RECORD1, RECORD2 and RECORD3 studies that compared Xarelto against
enoxaparin (40 mg injected once-daily) after elective hip replacement surgery
or elective knee replacement surgery.(6,7,8)
    "The publication of the RECORD4 data highlights again how Xarelto
continues to exceed our expectations, and is a testament to the consistently
strong results generated across the full RECORD program," said Dr. Shurjeel
Choudhri, Senior Vice President, Medical and Scientific Affairs, Bayer Inc.
"With its unique targeted inhibition of Factor Xa and robust safety profile,
Xarelto could transform treatment approaches for the prevention of potentially
life-threatening blood clots following elective hip or knee replacement
surgery."

    RECORD4 Study Details(1)

    RECORD4 compared Xarelto with enoxaparin for the prevention of VTE
following TKR surgery in 3,148 patients. In Canada, there were 18
participating sites and 332 subjects who entered the trial, of which 310
entered treatment. Xarelto (10 mg tablet once-daily) was administered 6-8
hours post surgery, compared to enoxaparin (30 mg injection twice-daily) which
was administered 12-24 hours post surgery for 10-14 days, in accordance with
the Health Canada approved regimen. The study demonstrated a 31 % RRR in total
VTE, the primary endpoint of this trial for patients treated with Xarelto
compared with those treated with enoxaparin (6.9 % and 10.1 %, respectively; p
= 0.012). The rate of major bleeding in the Xarelto-treated patients was low
and not statistically different to the rate of major bleeding in the
enoxaparin-treated patients, (0.7 % and 0.3 % respectively; p = 0.110)

    Unmet Needs in Venous Thromboembolism (VTE)

    Blood clots can break apart and travel through the bloodstream, blocking
blood flow to vital organs. VTE, which annually impacts an estimated 6.5
million people worldwide,(9) includes deep vein thrombosis (DVT), a blood clot
in a deep vein (usually in the leg), and pulmonary embolism (PE), a blood clot
in the lung, both of which are serious, life-threatening - but often
preventable - conditions.(10) Blood clots are a major global health problem
causing more deaths than breast cancer, prostate cancer, HIV/AIDS and road
traffic accidents combined.(11,12) Patients undergoing major orthopedic
surgery are at high risk for VTE because during hip or knee replacement
procedures, the large veins of the leg that carry blood back to the heart can
be damaged, significantly increasing the risk of developing a clot.(10) In
fact, venous blood clots occur in up to 60 per cent of patients undergoing
major orthopedic surgery who do not receive preventive care.(13)
    In 2005-2006, there were nearly 69,000 hospitalizations for hip and knee
replacements in Canada.13 Overall, it is estimated that there are between
15,000 to 20,000 VTE cases in Canada annually.

    About Xarelto

    Xarelto was invented in Bayer's Wuppertal laboratories in Germany, and is
being jointly developed by Bayer HealthCare and Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. Xarelto is approved in Canada
for the prevention of venous thromboembolic events (VTE) in patients
undergoing elective hip or knee replacement surgery, where it is marketed
under the brand name Xarelto. Additional approvals have been granted in other
countries, including the European Union, Australia, China, Mexico and
Singapore. To date, Xarelto has been launched in more than 25 countries around
the world by Bayer HealthCare.
    The extensive clinical trial program supporting Xarelto makes it the most
studied oral, direct Factor Xa inhibitor in the world today. More than 60,000
patients are expected to be enrolled into the Xarelto clinical development
program, which will evaluate the product in the prevention and treatment of a
broad range of acute and chronic blood-clotting disorders, including VTE
treatment, stroke prevention in patients with atrial fibrillation, secondary
prevention of acute coronary syndrome, and VTE prevention in hospitalized,
medically ill patients.
    Xarelto is contraindicated in patients with hepatic disease (including
Child-Pugh Class B and C) associated with coagulopathy and a clinically
relevant bleeding risk; with clinically significant active bleeding, including
hemorrhagic manifestations, and bleeding diathesis; with lesions at increased
risk of clinically significant bleeding, e.g., cerebral infarction
(hemorrhagic or ischemic) within the last 6 months, and patients with
spontaneous impairment of hemostasis; receiving concomitant systemic treatment
with strong inhibitors of both CYP3A4 and P-gp; who are pregnant; who are
nursing; or who are hypersensitive to Xarelto or to any ingredient in the
formulation.
    The use of Xarelto is not recommended in patients with severe renal
impairment. Patients who develop acute renal failure while on Xarelto(R)
should discontinue such treatment.
    Please see Xarelto Product Monograph for complete prescribing
information.
    To learn more about thrombosis, please visit www.thrombosisadviser.com

    About Bayer Inc.

    Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international
research-based group with core businesses in health care, crop science and
innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates
the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer
Crop Science Inc., headquartered in Calgary, Alberta operates as a separate
legal entity in Canada. Together, the companies play a vital role in improving
the quality of life for Canadians - producing products that fight diseases,
protecting crops and animals, and developing high-performance materials for
applications in numerous areas of daily life. Canadian Bayer facilities
include the Toronto headquarters and offices in Montréal and Calgary.
    Bayer Inc. has approximately 900 employees across Canada and had sales of
$908 million CDN in 2008. Globally, the Bayer Group had sales of over 32
billion Euro in 2008. Bayer Inc. invested approximately $36 million CDN in
research and development in 2008. Worldwide, the Bayer Group spent the
equivalent of over 2.6 billion Euro in 2008 in R&D. For more information, go
to www.bayer.ca.


    
    References:
    (1)  Turpie AGG, Lassen MR, Davidson BL et al. Rivaroxaban versus
         enoxaparin for thromboprophylaxis after total knee arthroplasty
         (RECORD4): a randomised controlled trial. The Lancet 2009
    (2)  Di Minno G, Agnes R; Tufano A. Venous thromboembolism: which
         patients are truly at risk? Acta Biomed 2005; 76 (Suppl 1): 31-2.
    (3)  Geerts WH, Pineo GF, Heit JA et al. Prevention of venous
         thromboembolism. The seventh ACCP conference on antithrombotic and
         thrombolytic therapy. Chest. 2004; 126 Suppl.3:338S-400S.
    (4)  Turpie AGG. Oral, direct factor Xa inhibitors in development for the
         prevention and treatment of thromboembolic diseases. Arterioscler
         Thromb Vasc Biol. 2007;27:1238-47.
    (5)  Perzborn E, Strassburger J, Wilmen A, et al. In vitro and in vivo
         studies of the novel antithrombotic agent BAY 59-7939-an oral,
         direct Factor Xa inhibitor. J Thromb Haemost. 2005;3:514-21.
    (6)  Eriksson BI, Borris LC, Friedman RJ, et al. Oral rivaroxaban
         compared with subcutaneous enoxaparin for extended
         thromboprophylaxis after total hip arthroplasty: the RECORD1 trial.
         Abstract 2367 presented at American Society of Hematology 49th
         Annual Meeting in Atlanta, Georgia, 8-11 December 2007.
    (7)  Kakkar AK, Brenner B, Dahl OE, et al. Extended thromboprophylaxis
         with rivaroxaban compared with short-term thromboprophylaxis with
         enoxaparin after total hip arthroplasty: the RECORD2 trial. Abstract
         307 presented at American Society of Hematology 49th Annual Meeting
         in Atlanta, Georgia, 8-11 December 2007.
    (8)  Lassen MR, Turpie AG, Rosencher N, et al. Rivaroxaban - an oral,
         direct Factor Xa inhibitor - for thromboprophylaxis after total knee
         arthroplasty: the RECORD3 trial. Abstract 308 presented at American
         Society of Hematology 49th Annual Meeting in Atlanta, Georgia, 8-11
         December 2007.
    (9)  Heit JA. Poster 68 presented at: American Society of Hematology,
         47th Annual Meeting, Atlanta, GA, December 10-13, 2005.
    (10) Turpie AG, Chin BS, Lup GY. Venous Thromboembolism: pathophysiology,
         clinical features, and prevention. BMJ. 2002;325(7369):887-890.
    (11) Cohen AT, Agnelli G, Anderson FA, et al. Venous thromboembolism
         (VTE) in Europe. The number of VTE events and associated morbidity
         and mortality. Thromb Haemost. 2007;98:756-64.
    (12) Heit JA. Cohen AT, Anderson FA, on behalf of the VTE Impact
         Assessment Group. Estimated annual number of incident and recurrent,
         non-fatal and fatal venous thromboembolism (VTE) events in the US.
         Abstract 68 presented at American Society of Hematology 47th Annual
         Meeting in Atlanta, Georgia, 10-13 December 2005.
    (13) Canadian Institute for Health Information. Canadian Joint
         Replacement Registry (CJRR) 2007Annual Report on Hip and Knee
         Replacements in Canada. Accessed at:
   
<a href="http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=PG_835_E&cw_topic=835&cw_rel=AR_30_E">http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=PG_835_E&cw_topic=835&cw_re</a>
<a href="http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=PG_835_E&cw_topic=835&cw_rel=AR_30_E">l=AR_30_E</a>
    (14) Choi BY. J Surg Orthop Adv 2007; 16: 31-5.
    

    Forward-Looking Statements

    This press release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead to
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development or performance of the company and the estimates given here. These
factors include those discussed in Bayer's public reports which are available
on the Bayer website at www.bayer.ca. The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments.





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For further information: or to arrange an interview, please contact:
Fiona Robinson, Senior Consultant, Hill and Knowlton Canada, (416) 413-4737,
Fiona.robinson@hillandknowlton.ca; Laura Burns, Business Communications
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