CARDIOVASCULAR JOURNAL OF AFRICA • Vol 21, No 1, January/February 2010
60
AFRICA
safe as (non-inferior to) warfarin (INR
2.0–3.0) for six months’ treatment of
acute symptomatic venous thromboem-
bolism, following initial treatment (5–11
days) with a parenteral anticoagulant. The
study involved 2 539 patients.
The primary efficacy endpoint was a
composite of recurrent symptomatic VTE
and deaths related to VTE. The second-
ary efficacy endpoints were: composite
of recurrent symptomatic VTE and all
deaths, symptomatic DVT, symptomatic
PE, deaths related to VTE, and all deaths.
Safety endpoints included: incidence of
bleeding events, adverse events, vital
signs, laboratory measures especially liver
function tests (LFT), and acute coronary
syndrome (ACS).
About RE-LY
®
: the largest atrial
fibrillation outcome trial to
date
5,14
The global, phase III, randomised RE-LY
®
study involving 18 113 patients in over
900 centres across 44 countries showed
that dabigatran 150 mg BID significantly
reduced the risk of stroke and systemic
embolism by 34% (
p
<
0.001) in patients
with atrial fibrillation (AF) compared to
well-controlled warfarin, without increas-
ing the risk of major bleeding. Dabigatran
110 mg BID clearly demonstrated similar
reductions in stroke and systemic embo-
lism compared to well-controlled warfa-
rin while delivering an impressive 20%
reduction (
p
=
0.003) in major bleeding
rates compared to warfarin.
Similarly impressive were the results
in key secondary and other outcomes,
including superior reduction in haemor-
rhagic strokes with both 150 and 110 mg
BID doses (RRR 74%,
p
<
0.001 and
RRR 69%,
p
<
0.001, respectively), and
a reduction in vascular mortality with the
150 mg BID dose (RRR 15%,
p
=
0.04).
For safety, both doses showed a superior
reduction in life-threatening, intracranial
and total bleeding. Importantly, these
benefits occurred without hepatotoxicity.
The RE-LY
®
study aimed to investigate
whether dabigatran (two blinded doses)
was as effective as well-controlled warfa-
rin [INR 2.0–3.0 (open label)] for stroke
prevention. Patients with non-valvular AF
and at least one other risk factor for stroke
(i.e. previous ischaemic stroke, transient
ischaemic attack, or systemic embolism,
left ventricular dysfunction, age 75 years,
age 65 years with either diabetes mellitus,
history of coronary artery disease, or
hypertension) were enrolled in the study
for two years with a minimum of one year
follow up.
The primary endpoint of the trial was
incidence of stroke (including haemor-
rhagic) and systemic embolism. Secondary
outcome measures included all-cause
death, incidenceof stroke (includinghaem-
orrhagic), systemic embolism, pulmonary
embolism, acute myocardial infarction,
and vascular death (including death from
bleeding). Additional safety endpoints
included major and minor bleeding
events, intracranial bleeding, intracerebral
haemorrhage, elevation in liver transami-
nases, bilirubin and hepatic dysfunction.
About RE-VOLUTION
®
RE-COVER™ is part of Boehringer
Ingelheim’s extensive RE-VOLUTION
®
clinical trial programme evaluating
the efficacy and safety of dabigatran
against current standard therapy in over
38 000 patients. Beyond RE-COVER™,
the RE-VOLUTION
®
trial programme
encompasses studies in:
primary prevention of VTE –
●●
RE-NOVATE
®
, RE-NOVATE
®
II,
RE-MODEL
®
and RE-MOBILIZE
®
treatment of VTE in RE-COVER™ II
●●
prevention of stroke in AF – results of
●●
RE-LY
®
were presented at the ESC in
August 2009
secondary prevention of ACS – results
●●
of the phase II RE-DEEM were
presented at the AHA in November
2009
secondary prevention of VTE in the
●●
RE-MEDY™ and RE-SONATE™
trials.
Please be advised, dabigatran is not yet
registered in South Africa.
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