INGELHEIM, Germany - Tuesday, December 17th 2013 [ME NewsWire]
New safety data consistently favour Pradaxa® (dabigatran etexilate)
over warfarin for the treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE)1
Pooled analysis of two phase III trial
data shows significantly lower clinically relevant bleeding rates for
Pradaxa® vs. warfarin1
Findings support previous data, confirming efficacy of Pradaxa® in the treatment of DVT and PE 2,3
(BUSINESS WIRE)-- For media outside of the US, the UK & Canada only
New
pooled safety data from the RE-COVERTM and RE-COVERTM II phase III
trials in acute deep vein thrombosis (DVT) and pulmonary embolism (PE)
consistently favour treatment with Pradaxa® 150mg bid over treatment
with warfarin. The data are published online today in Circulation.1
Vitamin
K antagonists (VKAs), the current standard of care in DVT and PE
patients after an initial course of parenteral anticoagulation, are
associated with multiple limitations and treatment challenges including
inconvenience to both patients and physicians.4,5 Currently, warfarin is
implicated in one third of all emergency hospitalisations for adverse
drug events and there is a need for alternative, safer and simpler
treatment options.6
RE-COVERTM and RE-COVERTM II, both global
phase III randomised double-blind parallel-group studies, investigated
the efficacy and safety of Pradaxa® versus warfarin for the treatment of
acute DVT or PE.1,2 Primary efficacy outcomes were recurrent
symptomatic venous thromboembolism (VTE) and related deaths with a
safety endpoint of major bleeding measured during six months of
therapy.1,2 The combined studies enrolled 5,107 patients who were all
initially treated with parenteral heparin therapy and then randomised to
receive warfarin or Pradaxa®.1
When looking at the total
treatment period including initial heparin treatment, the pooled data
show a statistically significantly lower incidence of clinically
relevant bleeding events (Pradaxa® 150mg vs. warfarin, HR 0.62) and
total bleeding (Pradaxa® 150mg vs. warfarin, HR 0.70) for patients
treated with heparin followed by Pradaxa® compared to patients receiving
heparin followed by warfarin.1 These data also show a trend towards
reduction of major bleeding for Pradaxa® (Pradaxa® 150mg 1.4% vs.
warfarin 2.0%).1 The primary efficacy endpoint of VTE or related death
was comparable between the two treatments (Pradaxa® 150mg 2.4% vs.
warfarin 2.2%).1
Importantly, pooled data for the treatment
period after the end of the heparin treatment when patients were
receiving only the oral study drugs (Pradaxa® or warfarin) show that
versus warfarin, patients treated with Pradaxa® have statistically
significantly lower rates of: 1
Major bleeding events (Pradaxa® 150mg vs. warfarin, HR 0.60, CI 0.36-0.99)
Major or clinically relevant bleeding (Pradaxa® 150mg vs. warfarin, HR 0.56, CI 0.45-0.71)
Total bleeding events (Pradaxa® 150mg vs. warfarin, HR 0.67, CI 0.59-0.77)
“These
latest results from the pooled analysis of the phase III trials
RE-COVERTM and RE-COVERTM II reinforce that dabigatran etexilate is an
effective treatment with a favourable safety profile in DVT and PE. The
pooled data favour dabigatran treatment over warfarin and provide
further reassurance to both physicians and patients especially regarding
the safety of the treatment”, commented Sam Schulman, Professor of
Hematology and Thromboembolism, Department of Medicine, McMaster
University, Hamilton, Canada.
Existing data show that in the
acute treatment and prevention of recurrent DVT and PE, Pradaxa® 150mg
bid offers an effective and well-tolerated treatment.2,3 Pradaxa®’s fast
onset of action, providing maximal effectiveness in less than two
hours, allows for an easy transition from initial heparin treatment with
no overlap in treatment required.7 Due to one fixed-dose treatment with
Pradaxa® from the beginning, patient management is simplified, as there
is no need to titrate or adjust once prescribed.7
Pradaxa® is
already widely approved for stroke prevention in atrial fibrillation and
for primary prevention of VTE following total hip replacement or total
knee replacement surgery.7 Collective clinical experience exceeds six
years, with two million patient-years in all licensed indications
placing Pradaxa® first among the novel oral anticoagulants.8,9
Important note: Pradaxa® (dabigatran etexilate) is currently not approved for the acute treatment of DVT or PE.
~ENDS~
Please click on the link for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/17_december_2013dabigatranetexilate.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Sara McClelland
Phone: +49 6132 – 77 8271
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
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