Boehringer Ingelheim has today announced that it has updated the US
prescribing information for Pradaxa® (dabigatran etexilate)
in alignment with the US Food and Drug Administration (FDA) to affirm
that "Pradaxa® 150mg twice daily was superior in reducing
ischemic and hemorrhagic strokes relative to warfarin." This
positive change to the US label is based upon the results of the pivotal
RE-LY® trial conducted in 18,000 patients with non-valvular
atrial fibrillation, which demonstrated unequivocally the superior
benefits offered by Pradaxa® in terms of effective prevention
of stroke. In addition, RE-LY® demonstrated a significant
benefit versus well controlled warfarin in life-threatening bleeding
events, and major reductions in intracranial bleeding.
"Ischaemic strokes account for up to 92% of strokes suffered by patients
with atrial fibrillation, often leading to severe debilitation and poor
prognosis," said Hans-Christoph Diener, M.D., Ph.D., Professor and
Chairman, Department of Neurology, University Duisburg-Essen, Germany.
"For patients with atrial fibrillation, reducing the risk of stroke,
especially ischaemic stroke, is the primary goal of anticoagulation
treatment. It is important for both physicians and patients to have a
treatment option that offers this decisive clinical benefit over
warfarin when considering long term prevention from stroke."
Pradaxa® 150mg bid is the only novel oral anticoagulant to
have shown in a major study a significant reduction of both ischaemic
and haemorrhagic strokes in patients with non-valvular atrial
fibrillation when compared to warfarin. The RE-LY®
trial showed that Pradaxa® 150mg bid reduced the risk of
stroke and systemic embolism by 35% compared to well-controlled warfarin
(INR 2-3, median TTR 67%). Furthermore, Pradaxa®
110mg bid, which is indicated for certain patients, was shown to be as
effective as well-controlled warfarin in the prevention of stroke and
systemic embolism, while being associated with significantly lower major
bleeding events in patients with non-valvular AF. RE-LY® was
a PROBE trial (prospective, randomized, open-label with blinded endpoint
evaluation), comparing two fixed doses of the oral direct thrombin
inhibitor dabigatran etexilate (110mg and 150mg bid) each administered
in a blinded manner, with open label warfarin.
"We welcome this update to the US prescribing information for Pradaxa®
which clearly demonstrates the unique benefit offered by this novel
treatment to patients and physicians worldwide," said Professor Klaus
Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.
"By significantly reducing both ischaemic and haemorrhagic strokes, and
at the same time providing significant reductions in intracranial
bleeding, Pradaxa® 150mg twice daily has the potential to
protect patients from catastrophic events better than warfarin."
The effectiveness and favourable safety profile of Pradaxa®
has been well documented in an extensive clinical trial programme,
passing independent regulatory scrutiny and approval worldwide. Clinical
experience of Pradaxa® is already well established and
continues to grow, equating to over 780,000 patient years in over 70
countries and exceeding that of all other novel oral
anticoagulants. The launch of Pradaxa® has been
the most successful in the history of Boehringer Ingelheim and is among
the pharmaceutical industry's top launches in the last decade.
Boehringer Ingelheim remains focused on both patient benefit and safety
and is further investigating the profile of Pradaxa® in the
long-term safety study RELY-ABLE®, the results of which will
be presented later this year. Additionally, Boehringer Ingelheim
recently launched Phase II of the GLORIA-AFTM patient
registry, which is designed to gain insights into the use of
antithrombotic treatments in clinical practice to reduce the risk of
stroke in patients with non-valvular atrial fibrillation.
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