Munich (ots/PRNewswire) - - Daiichi Sankyo presented five abstracts
from the Global and European ETNA-VTE registry studies at ISTH 2020
- Data are from 4,595 VTE patients (mean age 64) from 583 sites
across Europe, Japan and other East and South-east Asian countries
- Real-world study adds to the growing body of evidence supporting
edoxaban-use in the ageing and elderly populations
Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today
announced results from five analyses of 12-month data from ETNA-VTE
(Edoxaban Treatment in routiNe clinical prActice in patients with
Venous ThromboEmbolism), a non-interventional, post-authorisation
safety study (PASS) evaluating edoxaban (known by the brand name
LIXIANA®), the direct oral anticoagulant (DOAC). In routine clinical
practice in 4,595 (mean age 64) venous thromboembolism (VTE)
patients, overall rates of bleeding and VTE recurrence were
considered low by the study investigators' assessment in a range of
VTE sub-populations. Findings were presented during the International
Society on Thrombosis and Haemostasis (ISTH) 2020 Virtual
VTE is a major cause of morbidity and mortality globally. Every
year in Europe more than 1.5 million people experience a VTE event,
with the risk of occurrence increasing exponentially with age
(doubling every 10 years after the age of 50),, making the
elderly most vulnerable. A prior incidence of a VTE is the most
significant risk factor of a second occurrence. Reducing the risk
of VTE recurrence and bleeding is the cornerstone of current
interventions in this patient group.
"These real-world findings provide clinicians with additional
evidence of edoxaban's safety in specific VTE patient populations
that are considered high-risk for bleeding, recurrent VTE or other
cardiovascular events, or who have comorbidities," said Dr. Alexander
T. Cohen, MBBS, MSc, MD, FRACP, FESC, Vascular Physician and
Epidemiologist at Guy's and St. Thomas' Hospital, King's College,
London and study investigator. "This is of particular significance
for ageing patients and those who treat them, as the elderly are at
greatest risk due to the high prevalence of predisposing
comorbidities and acute illnesses, making edoxaban a viable treatment
option for this population."
Global ETNA-VTE results
A global sub-analysis suggested that at 12 months, rates of recurrent
VTE were not associated with increasing age, while major bleeding and
all-cause mortality increased with age, as would be expected.
However, most of the mortalities were not cardiovascular
(CV)-related. Per year, globally:
* VTE recurrence occurred in 3.65% of patients aged <65, 2.83% of
those aged >=65-<75, 2.30% of those aged >=75-<85 and 3.07% of
those aged >=85.
* ISTH-defined major bleeding occurred in 1.34% of patients aged
<65, 3.16% of patients aged >=65-<75, 2.97% of patients aged
>=75-<85 and 5.72% of patients aged >=85.
* CV-related mortality occurred in 0.35% of patients aged <65,
of patients aged >=65-<75, 1.96% of patients aged >=75-<85 and
3.04% of patients aged >=85.
ETNA-VTE Europe results
In the first of two European sub-analyses rates of major bleeding and
VTE recurrence were considered to be low by the authors' assessment
in both patients with pulmonary embolism (PE), with or without deep
vein thrombosis (DVT), and patients with DVT alone. Of note,
patients with PE, with or without DVT, had a tendency towards a
higher risk of mortality and bleeding events than those with DVT
alone, but they also had higher risk baseline characteristics. Per
year, in the European index VTE event group:
* Major bleeding occurred in 2.39% of patients with PE, with or
without DVT, and 1.57% of patients with DVT alone.
* VTE recurrence of any kind occurred in 2.89% of patients with PE,
with or without DVT, and 2.78% of those with DVT alone.
The second European sub-analysis, which stratified patients by body
mass index (BMI) (BMI 18.5-<25 kg/m2 [normal weight], BMI 25-<30
kg/m2 [overweight], BMI >=30 kg/m2 [obese]), showed that obesity did
not substantially affect the risks of recurrent VTE and other
bleeding complications. Per year, in the European BMI group:
* VTE recurrence occurred in 2.67% of patients overall (2.44%,
and 2.71% respectively).
* Major bleeding occurred in 1.69% of patients overall (1.75%,
and 1.11% respectively).
* All-cause mortality occurred in 2.16% of patients overall (2.97%,
1.77% and 2.39% respectively).
"These are important new real-world data, which add to edoxaban's
growing knowledge base supporting its use in a range of VTE
patients," said Wolfgang Zierhut MD, Head Antithrombotic and
Cardiovascular Therapeutic Area at Daiichi Sankyo Europe. "At Daiichi
Sankyo, we are committed to continuing the evaluation of safety and
efficacy of edoxaban in a broad range of cardiovascular patients
through ETNA-VTE and other studies included in the Edoxaban Clinical
Additional findings from two further Global and European ETNA-VTE
showed that high versus low bleeding risk (as identified by the
VTE-BLEED score) was associated with similar VTE recurrence risk but
higher all-cause and cardiovascular mortality and incidences of any
bleeding type or category, and that edoxaban is largely used
adequately in real-world practice in Europe, respecting the
recommendations for treatment initiation, dosing, and dose
adjustments in special patient populations.,
ETNA-VTE is part of the global ETNA programme, which is the largest
and most comprehensive repository of routine clinical practice data
on the use, safety and effectiveness of a single DOAC in patients
with VTE. This study is also one of more than 10 randomised,
controlled trials (RCTs), registries and non-randomised clinical
studies that comprise the Edoxaban Clinical Research Programme.
About ETNA-VTE: https://www.daiichi-sankyo.eu/media/about-etna-vte
About Venous Thromboembolism:
About Edoxaban: https://www.daiichi-sankyo.eu/media/about-etna-vte
About The Edoxaban Clinical Research Programme:
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical therapies to improve standards of care and
address diversified, unmet medical needs of people globally by
leveraging our world-class science and technology. With more than 100
years of scientific expertise and a presence in more than 20
countries, Daiichi Sankyo and its 15,000 employees around the world
draw upon a rich legacy of innovation and a robust pipeline of
promising new medicines to help people. In addition to a strong
portfolio of medicines for cardiovascular diseases, under the Group's
2025 Vision to become a "Global Pharma Innovator with Competitive
Advantage in Oncology," Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders. For more
information, please visit: www.daiichisankyo.com.
 Agnelli, G. et al. Edoxaban Treatment of Venous Thromboembolism
in Routine Clinical Practice in the Non-Interventional Global
ETNA-VTE Program: A Sub-analysis by Age Groups. Poster presented at
the International Society on Thrombosis and Haemostasis (ISTH) 2020
 Schindewolf, M. et al. ETNA-VTE Europe: The Effect of Body Mass
Index on 12-Month Outcomes in VTE Patients with Edoxaban. Poster
presented at the International Society on Thrombosis and Haemostasis
(ISTH) 2020 Virtual Congress.
 Coppens, M. et al. Association between index venous
thromboembolism (VTE) event and 12-months outcomes for patients in
routine clinical practice enrolled in the Edoxaban Treatment in
routine cliNical prActice for patients with acute VTE in Europe
(ETNA-VTE-Europe) registry. Poster presented at the International
Society on Thrombosis and Haemostasis (ISTH) 2020 Virtual Congress.
 ISTH Steering Committee for World Thrombosis Day. Thrombosis: A
major contributor to global disease burden. J Thromb Haemost. 2014
 The Coalition to Prevent VTE. Available at:
D/DCD0A03F_1422_16B3_78E0B9EB0571.HTM. Last accessed June 2020.
 Zagaria, M. Venous Thrombosis: Pathogenesis and Potential for
Embolism. US Pharm. 2009;34:22-24.
 Cohen, A. et al. ETNA-VTE Global: Evaluation of Bleeding Risk
Based on VTE-BLEED Score on 12-month Outcomes in a Population Treated
with Edoxaban. Poster presented at the International Society on
Thrombosis and Haemostasis (ISTH) 2020 Virtual Congress.
 Cohen, A. et al. ETNA VTE Europe: A Contemporary Snapshot of VTE
Patients Treated with Edoxaban in Clinical Practice across Eight
European Countries. Poster presented at the International Society on
Thrombosis and Haemostasis (ISTH) 2020 Virtual Congress.
EDX/20/0641, Date of preparation: July 2020
Dr. Wolfgang Schiessl
Daiichi Sankyo Europe GmbH
Director Product PR and Communications
Digital press kit: http://www.ots.at/pressemappe/PR62920/aom
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