NPS takes on rivaroxaban
December 13, 2012
THERE is no evidence that people
with non-valvular atrial fibrillation
(NVAF) who are well controlled on
warfarin will benefit clinically from
a switch to rivaroxaban, according
to NPS.
The comments come from an
article in the latest edition of NPS
Radar which reviewed the new oral
anticoagulant rivaroxaban, now
available as an alternative to
warfarin.
Currently the drug is TGA
approved for use in stroke
prevention in NVAF, however it is
not PBS listed for this indication
and is currently only available on
private prescription for stroke
prevention in atrial fibrillation.
In analysing the data surrounding
the drug, NPS looked at the recent
pivotal clinical trial ROCKET-AF,
which found that rivaroxaban 20mg
once daily is no worse than
warfarin for reducing the incidence
of stroke in people with NVAF.
Interestingly the ROCKET-AF trial
did find that rivaroxaban showed a
significantly lower incidence of
intracranial bleeding but
significantly more gastrointestinal
bleeds.
“If a patient is able to tolerate
warfarin then keeping them at their
optimal warfarin dose with regular
monitoring is the best way to
prevent a stroke,” said NPS
MedicineWise clinical adviser Dr
Philippa Binns.
“If people at risk of stroke are not
able to maintain a therapeutic INR
(International Normalised Ratio) on
warfarin because of food or drug
interactions, or regular monitoring
of INR is difficult or impractical,
rivaroxaban may be an alternative,”
Binns added.
In addition, Binns said that due to
the fact that there is a lack of long
term safety data for rivaroxaban
with regards to its safety profile in
people at high risk of bleeding, the
drug should be avoided in people
who have, or are at risk of, active
bleeding, such as those with
intracranial or gastrointestinal
bleeding.
“It should also be avoided in people
with significant hepatic disease or
renal impairment,” she said.
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