CARDIOVASCULAR JOURNAL OF AFRICA • Volume 25, No 2, March/April 2014
90
AFRICA
Advertorial
Bayer’s Xarelto
®
is approved in South Africa across five additional indications
Xarelto 15 and 20 for the prevention of stroke in patients with non-valvular atrial fibrillation, treatment of
deep-vein thrombosis and pulmonary embolism, and the prevention of recurrent deep-vein thrombosis and
pulmonary embolism.
Johanesburg, South Africa, February 2014
Bayer HealthCare’s oral anticoagulant
Xarelto
®
15 and 20 (rivaroxaban) has
been approved by the Medicines Control
Council of SouthAfrica for use in five new
indications, making it the only new oral
anticoagulant approved in six indications
across the world.
•
New indications: 15 and 20 mg
–
– Prevention of stroke and systemic
embolism in patients with non-
valvular atrial fibrillation
–
– Treatment of deep-vein thrombosis
–
– Prevention of recurrent deep-vein
thrombosis
–
– Treatment of pulmonary embolism
–
– Prevention of recurrent pulmonary
embolism.
•
Current indication: 10 mg
–
– The prevention of venous thrombo-
embolism in patients undergoing
major orthopaedic surgery of the
lower limbs.
‘The approval in these new indications by the
Medicines Control Council of South Africa
marks the culmination of years of intensive
research, and underscores Bayer’s innovative
strength’, said Frans Labuschagne, CDH
of Bayer HealthCare South Africa. ‘We are
delighted to bring the benefits of rivaroxaban
to patients and physicians in South Africa in
need of a highly effective and convenient
therapy against blood clots to prevent
strokes and treat deep-vein thrombosis and
pulmonary embolism.’
The approval of rivaroxaban for the
prevention of atrial fibrillation-related
stroke is based on the important clinical
benefits demonstrated in ROCKET AF,
a rigorous, double-blind global phase
III study that compared once-daily
rivaroxaban with warfarin in more than
14 000 patients. The results from the
ROCKET AF trial were published in
the
New England Journal of Medicine
(
NEJM
) in August 2011.
The approval of rivaroxaban for the
treatment of deep-vein thrombosis and
pulmonary embolism, and the prevention of
recurrent deep-vein thrombosis and pulmo-
nary embolism, following an acute deep-
vein thrombosis and pulmonary embo-
lism, follows submission of data from the
phase III EINSTEIN-DVT study, phase III
EINSTEIN-PE study as well as data from the
phase III EINSTEIN-Extension study. The
EINSTEIN-DVT and EINSTEIN-Extension
studies were published in the
NEJM
in
December 2010 and the EINSTEIN-PE was
published in
NEJM
in April 2012.
About venous and arterial
thromboembolism
Thrombosis is the formation of a blood
clot inside a blood vessel, blocking
a vein (venous thrombosis) or artery
(arterial thrombosis). Venous and arterial
thromboembolism (VAT) is caused when
a clot becomes loose and is moved by the
blood stream to obstruct another vessel,
which can cause damage to vital organs.
VAT encompasses two serious conditions:
•
Venous thromboembolism (VTE)
occurs when part of a clot formed
in a deep vein, for example in the
leg (known as deep-vein thrombosis or
DVT), is carried to another vessel which
delivers blood to an organ. If this occurs
in a vessel supplying blood to the lungs,
it is known as a pulmonary embolism
(PE), which can be rapidly fatal.
•
Arterial thromboembolism (ATE)
occurs when oxygenated blood flow
from the heart to another part of the
body (via an artery) is interrupted by
a blood clot. If this occurs in a vessel
supplying the brain, this can lead to a
stroke, which can be severely debilitat-
ing or fatal. If it occurs in a coronary
artery, it can lead to acute coronary
syndrome (ACS), a complication of
coronary heart disease, which includes
conditions such as myocardial infarc-
tion (heart attack) and unstable angina.
VAT is an important cause of morbidity
and mortality across a broad range of acute
and chronic blood-clotting disorders and
requires active or preventative treatment
to avoid potentially serious or fatal patient
outcomes.
About atrial fibrillation
Atrial fibrillation (AF) is themost common
sustained arrhythmia in clinical practice
and is associated with an increased risk of
stroke, heart failure, dementia and death.
1
AF confers a five-fold risk of stroke, and
one in five of all strokes is attributed
to this arrhythmia. Ischaemic strokes in
association with AF are often fatal, and
those patients who survive are left more
disabled by their stroke and more likely
to suffer a recurrence than patients with
other causes of stroke. In consequence,
the risk of death fromAF-related stroke is
doubled and the cost of care is increased
1.5-fold.
2
About deep-vein thrombosis
Venous thromboembolism is caused by
the obstruction of a blood vessel by a
blood clot. In the EU there are approxi-
mately 540 000 VTE-related deaths each
year and it is estimated to be the third
most common cardiovascular disease
after myocardial infarction and stroke.
3,4
Indeed, venous blood clots kill more
people in Europe each year than breast
cancer, prostate cancer, HIV/AIDS and
transport accidents combined.
3
DVT is the formation of a blood clot
in a deep vein that partially or totally
blocks the flow of blood. However, DVT
can progress to become a potentially fatal
PE if the blood clot breaks apart and
travels to the lungs, ultimately blocking
a blood vessel there. Even in the absence
of a PE, DVT alone can have devastating
and costly consequences such as post-
thrombotic syndrome and an increased
risk of recurring blood clots, and
therefore the achievement of treatment
goals is critically important. The current
treatment standard for DVT includes two
