New 12-month analysis data from ETNA-AF non-interventional study show low bleeding and ICH rates in frail and elderly AF patients on LIXIANA (edo

- Newly presented data provide reassurance around edoxaban use in vulnerable populations of frail, elderly and renally impaired patients

- Clinician's perception of frailty found to potentially be a better marker of clinical outcomes than age

- The global ETNA-AF programme, which includes ETNA-AF-Europe, is the largest prospective, non-interventional study investigating a single NOAC to date

MUNICH, Aug. 31, 2020 /PRNewswire/ -- Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced one-year results of four sub-analyses from the European and global ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) programme, a non-interventional safety study evaluating edoxaban (known by the brand name LIXIANA(®)) treatment in routine clinical practice in >26,000 patients around the world with atrial fibrillation (AF).([1],[2],[3],[4]) New 12-month data from the European and global ETNA-AF registries showed rates of bleeding and intracranial haemorrhage (ICH) were considered low by the authors' assessment in frail and elderly patients in routine clinical care.([1],[2],[3]) Findings are available virtually at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, 29 August - 01 September, and are part of the largest prospective, non-interventional study programme investigating a single non-vitamin K antagonist oral anticoagulant (NOAC) in patients with non-valvular atrial fibrillation (NVAF) to date.

In vulnerable populations such as the elderly, frail and those with renal impairment - a common comorbidity for people with AF - anticoagulation for stroke prevention is often not prescribed due to the risk of bleeding, despite these patients being among those most at risk for ischaemic events like stroke.([5]) However, outcomes from ETNA-AF reinforce the effectiveness and safety of edoxaban in these populations.

"Elderly and frail patients have been underrepresented in certain AF stroke prevention trials, leaving a lack of evidence to support routine NOAC use in these patients," said Dr Ameet Bakhai, Consultant Cardiologist & Cardiovascular R&D Director Royal Free London NHS Trust, UK. "However, these new data should provide clinicians with some confidence of edoxaban's efficacy and safety profile to reduce the risk of stroke for the elderly and frail AF populations."

ETNA-AF-Europe Registry Outcomes: Frailty and renal function

Anticoagulation presents multiple challenges in patients who are frail, as well as those with both frailty and renal impairment.([5]) The first of the two data analyses from the 13,092 patient-wide ETNA-AF-Europe registry, assessed key clinical outcomes and risk scores in frail and elderly patients versus non-frail or younger patients correspondingly.([1]) Frailty - commonly defined as those at increased risk of disability, hospitalisation, and mortality([6]) - was determined by physician perception.([1])

Results from 1,392 patients, who were considered frail, showed:([1])


-- Rates of intracranial haemorrhage (ICH) remained low by the
investigators' assessment, regardless of frailty status or age, despite
frail patients being four times more likely to suffer mortality and
presenting with higher rates of major bleeding compared to the non-frail
cohort
-- Per year, ICH occurred in 0.15% of patients in the frail cohort,
compared to 0.27% of those in the non-frail cohort
-- Per year, major bleeding occurred in 2.18% of patients in the frail
cohort, compared to 0.95% of those in the non-frail cohort
-- Per year, total mortality occurred in 10.43% of patients in the frail
cohort, compared to 2.49% of those in the non-frail cohort
In addition, the analysis suggested that clinician's perception of frailty appeared to be a better marker of clinical outcomes than age.([1])

In the second analysis from the ETNA-AF-Europe registry, 13,021 patients with renal impairment were observed to evaluate baseline characteristics and assess follow-up outcomes at one-year.([2]) The presence of AF is linked with a greater risk of developing moderate and severe renal impairment, and clinically, anticoagulation presents multiple challenges in patients with impaired renal function because the pharmacokinetic properties and bioavailability of the treatment are often altered in those patients.([7],[8]) Findings of this analysis indicated that across the three groups, who were categorised according to their creatinine clearance (CrCl) levels, those treated with edoxaban had low rates of ICH and haemorrhagic stroke, by the investigators' assessment, and these results were similar in patients across all groups studied.([2]) Regarding renal function, ICH occurred in 0.18%, 0.32% and 0.17% of patients annually, while haemorrhagic stroke occurred in 0.04%, 0.17% and 0.10% of patients in the group with moderate to severe renal disease (CrCl <=50 mL/min), mild renal disease (CrCl (50-80) mL/min ) and normal renal function (CrCl >=80 mL/min), respectively.([2])

Global ETNA-AF: Treatment of elderly patients

Findings from one of two global sub-analyses showed that at 12 months, rates of ICH were consistently low across all age groups, while CV mortality increased numerically with age, but to a lower extent than all-cause mortality.([3]) Additional findings from the global registry, assessing the safety and effectiveness of edoxaban given at the recommended or non-recommended dose in AF patients during one-year observation in routine clinical practice, showed that edoxaban is being prescribed at the label recommended dose in the vast majority of patients, but that non-recommended edoxaban dosage tends to occur more frequently when the CrCl or body weight was closer to the threshold of dose reduction.([4])

"AF is common in the elderly population as are comorbidities and higher rates of CV events, including bleeding, which all need to be managed with a great deal of consideration for the challenges they present for both clinicians and patients," said Wolfgang Zierhut MD, Executive Director Medical Affairs and Head Thrombosis and Cardiovascular at Daiichi Sankyo Europe. "These latest data show the consistency of edoxaban treatment in providing benefits to a wide range of patients."

ETNA-AF is one of more than 10 randomised, controlled trials (RCTs), registries and non-randomised clinical studies that comprise the Edoxaban Research Programme, EDOSURE.

All of the ETNA-AF non-interventional study data presented at ESC Congress 2020 can be found here [https://programme.escardio.org/ESC2020/On-Demand?s=$expression=etna-af].

Additional edoxaban data presented

In addition to ETNA-AF, data from multiple clinical studies from EDOSURE were also presented.


Serial measurement of biomarkers and the
risk of stroke or systemic embolism and
bleeding in patients with atrial
fibrillation in ENGAGE AF-TIMI 48
(link to
data

ENGAGE AF - here
)
Oyama et al
TIMI 48


Is there a role for half-
dose anticoagulation in
atrial fibrillation?
Randomized comparison of
2 doses of edoxaban in
14,014 patients in ENGAGE
AF-TIMI 48
(link to
data

here
)
Steffel et al


Edoxaban in atrial fibrillation with PCI
by ACS or stable CAD presentation: a
pre-specified analysis of the ENTRUST-
AF PCI trial (
l
ink
to data

ENTRUST-AF here

)
Vranckx et al
PCI


Risk factors associated with stroke/
systemic embolic events in elderly non-
valvular atrial fibrillation patients
in the ANAFIE registry, the largest
real-world elderly AF registry (
l
ink to data here

ANAFIE )
Inoue et al


Risk factors of major
bleeding in elderly
atrial fibrillation
patients from the ANAFIE
registry (
l
ink to data
here
)
Inoue et al


Real-world effectiveness
and the safety of
)
anticoagulant treatment
in elderly non-valvular
atrial fibrillation in
the ANAFIE registry, the
largest real-world
elderly AF registry (
l
ink to
data

here

Yamashita et al

Comparison of clinical outcomes with
edoxaban versus apixaban, dabigatran,
rivaroxaban, and vitamin K antagonist
in patients with atrial fibrillation in
Germany: a real-world cohort study (
l
ink to data here

Gesundheitsforen )
Marston et al
Leipzig database


Improved adherence to
anticoagulant therapy
with once-daily
regimen: a real-world
study in patients with
atrial fibrillation in
Germany (
l
ink to data

here
)
Yeh et al


About ETNA-AF: https://www.daiichi-sankyo.eu/media/about-etna-af [https://us-east-2.protection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW5reW8uZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw==&t=RE5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd458ba438f01802c15e38]

About AF: https://www.daiichi-sankyo.eu/media/about-etna-af [https://us-east-2.protection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW5reW8uZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw==&t=RE5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd458ba438f01802c15e38]

About Edoxaban: https://www.daiichi-sankyo.eu/media/about-etna-af [https://us-east-2.protection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW5reW8uZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw==&t=RE5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd458ba438f01802c15e38]

About the Edoxaban Clinical Research Programme: https://www.daiichi-sankyo.eu/media/about-etna-af [https://us-east-2.protection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW5reW8uZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw==&t=RE5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd458ba438f01802c15e38]

Media Contact
Dr. Wolfgang Schiessl
Daiichi Sankyo Europe GmbH
Director Product PR and Communications
Cardiovascular Europe
+49 151 1714 7317

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 [http://www.daiichisankyo.com/].

Forward-looking statements: https://www.daiichi-sankyo.eu/media/about-etna-af [https://us-east-2.protection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW5reW8uZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw==&t=RE5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd458ba438f01802c15e38]

References


1. Bakhai A, et al. Still on 'aspirin or nothing' for AF patients with
frailty? ETNA-AF-Europe shows frailty corresponds to higher mortality but
not neurological bleeding with edoxaban anticoagulation in routine care.
Poster presented at ESC Congress 2020.
2. de Caterina R, et al. Baseline characteristics and follow-up outcomes in
routine clinical practice patients categorised by renal function in the
ETNA-AF-Europe registry. Poster presented at ESC Congress 2020.
3. Yamashita T, et al. Edoxaban Treatment of Elderly Patients with Atrial
Fibrillation in Routine Clinical Practice: 1-Year Results of the
Non-interventional Global ETNA-AF Program. Rapid Fire Abstract presented
at ESC Congress 2020.
4. Chao T-F, et al. Recommended and non-recommended edoxaban dosing in
patients with atrial fibrillation: one-year clinical events from the
Global ETNA-AF non-interventional study. Rapid Fire Abstract presented at
ESC Congress 2020.
5. Seelig J, et al. When to withhold oral anticoagulation in atrial
fibrillation - an overview of frequent clinical discussion topics. Vasc
Health Risk Manag. 2019;15:399-408.
6. Pritchard, J.M., et al. Measuring frailty in clinical practice: a
comparison of physical frailty assessment methods in a geriatric
out-patient clinic. BMC Geriatr 17, 264 (2017).
7. Soliman, et al. Chronic Kidney Disease and Prevalent Atrial Fibrillation:
The Chronic Renal Insufficiency Cohort (CRIC). Am Heart J. 2010 Jun;
159(6): 1102-1107.
8. Sciascia, et al. Chronic kidney disease and anticoagulation: from vitamin
K antagonists and heparins to direct oral anticoagulant agents. Intern
Emerg Med. 2017:12;1101-8.
Web site: https://www.daiichisankyo.com/

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