Leading the way in new
ORAL anticoagulation
More than 75 000
patients enrolled
The most extensive Phase III Clinical Trial Programme of any new
oral anticoagulant
**
Study Programme
Dosage
n
Main Outcome Measures
Outcome
Venous thromboembolism (VTE) prevention in total
hip replacements.
Rivaroxaban
10
mg OD
4,541
Efficacy:
Composite of deep vein thrombosis (DVT),
non-fatal pulmonary embolism (PE),
and all-cause mortality
Safety:
Major bleeding
Superior efficacy
vs enoxaparin,
comparable safety.
Venous thromboembolism prevention in total hip
replacements - extended prophylaxis.
Rivaroxaban
10
mg OD
2,509
Superior efficacy
of long
term (5 week) prophylaxis
with rivaroxaban vs short
term (2 week) prophylaxis
with enoxaparin,
comparable safety.
Venous thromboembolism prevention in total knee
replacements.
Rivaroxaban
10
mg OD
2,531
Superior efficacy
vs enoxaparin,
comparable safety.
Venous thromoboembolism prevention in total knee
replacements - compared to enoxaparin 30mg BD.
Rivaroxaban
10
mg OD
3,148
Superior efficacy
vs enoxaparin,
comparable safety.
◆
Xarelto
®
10
OD is approved for clinical use for VTE prevention in adult patients undergoing major orthopaedic surgery of the lower limbs. OD = once daily.
Study Programme
Dosage
n
Main Outcome Measures
Outcome
Prevention of venous thromboembolism in
hospitalised medically ill patients.
Rivaroxaban
10
mg OD
~8,000
Efficacy:
Composite of VTE (DVT and/or PE) and VTE
related death
Safety:
Major and clinically relevant non-major
bleeding
Study completed
Treatment of acute symptomatic deep vein
thrombosis.
Rivaroxaban 15 mg BID,
first 3 weeks
Continue with
Rivaroxaban 20 mg OD
3,464
Efficacy:
Symptomatic recurrent VTE
Safety:
Major and clinically relevant non-major
bleeding
Study completed
Treatment of acute pulmonary embolism with or
without symptomatic DVT.
4,300
Study completed
Continued treatment of deep vein thrombosis or
pulmonary embolism.
Rivaroxaban
20
mg OD
1,197
Efficacy:
Symptomatic recurrent VTE
Safety:
Major bleeding
Study completed
Prevention of stroke and embolism in atrial
fibrillation.
Rivaroxaban
20
mg OD or
Rivaroxaban 15 mg
OD 30-49 ml/min CrCl
14,269
Efficacy:
Composite of stroke and non-CNS
systemic embolism
Safety:
Composite of major and clinically relevant
non-major bleeding
Study completed
Rivaroxaban 15 mg OD
1,280
Study completed
Anti-Xa therapy to lower cardiovascular events in
addition to Aspirin with or without thienopyridine
therapy in subjects with acute coronary syndrome.
Rivaroxaban 2.5 mg BID
Rivaroxaban 5 mg BID
~16,000
Efficacy:
Composite of CV death, MI and stroke
Safety:
Major bleeding events not associated with
CABG surgery
Study completed
2010
NEJM
PRESENTED
2011
ACC
2010
NEJM
201
NEJM
1
OD = once daily BID = twice daily CrCl = creatinine clearance. Rivaroxaban 2.5 mg, Rivaroxaban 5 mg, Rivaroxaban 15 mg and Rivaroxaban 20 mg are in Clinical Development;
and thus not recommended for clinical use in all Indications under investigation.
Clinical Trial Programme
2008
NEJM
2008
THE LANCET
2008
NEJM
2009
THE LANCET
PRESENTED
ISTH
2011
NEJM
2011
More than
1
million patients
worldwide treated
with Xarelto
®
10
in
THR and TKR
*
.
*
THR - total hip replacement.TKR - total knee replacement. **
RECORD1:
Eriksson BI,
et al. N Engl J Med.
2008; 358(26):2765-2775.
RECORD2:
Kakkar AK,
et al. Lancet.
2008; 372(9632):29-37.
RECORD3:
Lassen MR,
et al. N Engl J Med.
2008; 358(26):2776-2786.
RECORD4:
Turpie AGG,
et al. Lancet.
2009; 373(9676):1673-1680.
MAGELLAN:
EINSTEIN DVT and EXT:
Einstein Investigators.
N Engl J Med.
2010.
EINSTEIN PE:
ROCKET AF:
Patel, et al. N Engl J Med.
2011.
J-ROCKET AF:
ATLAS
ACS TIMI 51:
. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority (MCC) S4 XARELTO
®
10 (
Film-coated tablets). Reg.No.: 42/8.2/1046. Each film-coated tablet contains rivaroxaban 10 mg.
PHARMACOLOGICAL CLASSIFICATION:
A.8.2Anticoagulants.
INDICATION:
Prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery of the lower limbs.
HCR:
Bayer (Pty) Ltd,Reg.No.:1968/011192/07,27Wrench Road, Isando,1609.Tel:011 921 5044
Fax: 011 921 5041
DATE:
February 2012 L.ZA.GM.02.2012.0377
201
NEJM
2
