CARDIOVASCULAR JOURNAL OF AFRICA • Vol 21, No 6, November/December 2010
AFRICA
343
inferior to warfarin (albeit with TTR
=
57%) for the prevention of stroke in
AF patients.
•
The difference between the ITT and
per protocol analysis may be account-
ed for by poor adherence. This raises
concerns about the relevance of the PP
analysis to real-world practice, particu-
larly for a drug with a half-life of 5–13
hours vs 20–60 hours for warfarin.
•
The ITT result showing no significant
superiority is more likely to reflect
the actual difference in effectiveness
between these treatments.
•
Importantly, there were fewer intra-
cranial bleeds on rivaroxaban and
fewer deaths from bleeding. However,
there were more haemorrhages requir-
ing transfusions, and drops in haem-
atocrit, rendering the overall safety
profile less clear.
Additional comments from an
interview with Dr Jonathan
Halperin, Mount Sinai School of
Medicine, NewYork, USA, who
attended the hot line session
It is very hard to draw comparisons
between the two trials, ROCKET-AF and
RELY, as ROCKET enrolment specifi-
cally stipulated the inclusion of high-risk
patients – hence the difference in mean
CHADS
2
risk scores between ROCKET
(
∼
3.5) and RELY (2.1). In addition,
methodological differences confound
comparison: ROCKET was a double-
blind study while RELY was an open
study with blinded endpoint assessment
(probe design).
There was great anticipation about
this study, particularly as a press release
from Europe indicated that the study had
reached its primary objective to demon-
strate the non-inferiority of rivaroxaban
compared to warfarin. The lead organisa-
tion, the Duke Clinical Trials Institute,
has done a remarkable job in analysing
and organising these data just a few weeks
after closure of the trial database. This
means, however, that the results presented
at this congress are top-line findings, and
we certainly anticipate and perhaps even
hunger for more detail.
One of the surprising findings of the
trial is that warfarin did not perform as
well in this double-blind trial (achiev-
ing a TTR below 60%) as in the North
American SPORTIF-V trial of another
anticoagulant, later abandoned due to
liver toxicity, in which warfarin’s TTR
was 68%. The reasons for the poorer
warfarin control in ROCKET-AF could
include the high-risk patient profile or
the inclusion of geographically diverse
centres, some of which may have more
experience with vitamin K antagonists
other than warfarin.
The good news is the development of
another effective anticoagulant, one that
inhibits activated factor X, demonstrating
non-inferior efficacy compared to warfa-
rin, with lower rates of intra-cerebral
haemorrhage. Concern remains about
whether the results may have been differ-
ent if the quality of warfarin control had
been better, and about higher bleeding
rates outside the central nervous system
with rivaroxaban, leading to comparable
rates of major bleeding with both treat-
ments overall.
J Aalbers, Special Assignment Editor
1. Camm AJ. The RE-LY study: Randomised
Evalution of Long-term anticoagulant ther-
apY.
Eur Heart J
: doi 10.1093/euroheartj/
ehp34.
2. Consolidated standards of reporting trials.
J
Am Med Assoc
2006.
Development of new anticoagulant highly honoured: Bayer’s
Xarelto
®
recognised with 2010 international Prix Galien award
The highly distinguished Awards
Committee of the Galien Foundation has
honoured Bayer’s Xarelto
®
(rivaroxaban)
with the Prix Galien International 2010
in the category Best Pharmaceutical
Agent. Xarelto
®
had previously already
been recognised with national Prix
Galien awards in Belgium, France and
Switzerland.
The Prix Galien award recognises
outstanding achievements in improv-
ing health through the development of
innovative therapies, and is regarded as
the equivalent of the Nobel Prize in
biopharmaceutical research. The Awards
Committee of the PrixGalien International
2010, including many Nobel Prize laure-
ates, was chaired by Gerald Weissmann,
MD, professor of Rheumatology and
director of Biotechnology Study Centre,
NewYork University School of Medicine.
The award ceremony was hosted at the
American Museum of Natural History in
NewYork, USA.
‘We are very excited about the award
and honoured by the recognition of this
globally renowned committee. Being
awarded the International Prix Galien for
Best Pharmaceutical Agent underscores
the drive for innovation that character-
ises the focus of our company, and our
continuing ambition to improve the qual-
ity of life of patients’, commented Dr
Marijn Dekkers, chairman of the Board
of Management of Bayer AG. ‘Xarelto
®
has consistently demonstrated superior
efficacy compared to current standard
therapy for the prevention of venous
thromboembolism in patients undergoing
total hip- or knee-replacement surgery
and has become the market leader among
the new oral anticoagulants.’
About rivaroxaban
Rivaroxaban is a novel oral anticoagu-
lant that was invented in Bayer Schering
Pharma’s Wuppertal laboratories in
Germany, and is being jointly devel-
oped by Bayer HealthCare and Johnson
& Johnson Pharmaceutical Research &
Development, LLC. In clinical studies,
rivaroxaban has consistently shown supe-
rior efficacy to enoxaparin in preventing
venous thromboembolism (VTE) in adult
patients following elective hip- or knee-
replacement surgery. It has a rapid onset
of action with a predictable dose response
and high bioavailability, no requirement
for coagulation monitoring, and a limited
