ETNA-AF Registry Data Provide Real-world Evidence of the Efficacy and Safety Profile of LIXIANA®▼ (edoxaban) in Elderly NVAF Patients

- Global and European real-world outcome analyses in non-selected atrial fibrillation (AF) patients on edoxaban, including those who are elderly with comorbidities, were reported at ESC Congress 2019

- At present, the Global ETNA-AF programme is the largest and most comprehensive repository of routine clinical practice data on the use, effectiveness, and safety profile of a single non-vitamin K antagonist oral anticoagulant (NOAC) in patients with non-valvular atrial fibrillation (NVAF)

- One-year follow-up data from the ETNA-AF global registry showed low rates of major bleeding (including haemorrhagic stroke and intracranial haemorrhage [ICH]) in edoxaban-treated elderly and very elderly AF patients with comorbidities in routine clinical care([1])

- European specific findings from ETNA-AF demonstrate that Phase III efficacy and safety results from ENGAGE AF-TIMI-48 are being confirmed in regular routine clinical care across the region([2])

MUNICH, Sept. 2, 2019 /PRNewswire/ -- Daiichi Sankyo Europe GmbH (hereafter, "Daiichi Sankyo") today announced one-year outcomes results from a study of 24,962 patients with NVAF treated with edoxaban (known by the brand name LIXIANA(®)▼), including elderly NVAF patients and those with and without a history of intracranial haemorrhage (ICH). One-year follow up data from the ETNA-AF (Edoxaban Treatment in routiNe clinical prActice) study were presented today at ESC Congress 2019 in Paris, France, reporting the effectiveness and safety of edoxaban in patients with NVAF.

Global ETNA-AF analyses

A new analysis, which reported the outcomes of 24,962 edoxaban-treated patients with NVAF at one year follow up supports the treatment's safety and efficacy profile in elderly and very elderly AF patients. The majority of these patients were aged 65 years or over.([1]) Results showed that:([1])


-- Rates of major bleeding (MB), as defined by the International Society on
Thrombosis and Haemostasis (ISTH), including ICH and ischaemic stroke
were generally low amongst all patient groups. Per year, ISTH-defined MB
occurred in 0.6% of patients aged <65, 0.9% patients aged >=65-<75, 1.2%
patients aged >=75-< 85 and 1.8% patients aged >=85. ICH occurred in
0.2% patients aged <65, 0.3% patients aged >=65-<75, 0.3% patients aged
>=75-< 85 and 0.3% patients aged >=85. Ishaemic stroke occurred in 0.6%
of patients aged <65, 0.7% patients aged >=65-<75, 0.9% patients aged
>=75-< 85 and 1.3% patients aged >=85.
-- Whilst all-cause and CV mortality was shown to increase with age, as
would be expected, CV mortality was a minor proportion of all-cause
mortality in all age groups. There was also no increase in the rate of
ICH with age. Per year, all-cause mortality/CV mortality occurred in 35
(1.1%)/18 (0.5%) of patients aged <65, 136 (1.8%)/62 (0.8%) of those
aged >=65-<75, 275 (3.3%)/116 (1.4%) of those aged >=75-<85 and 196
(8.7%)/76 (3.4%) of those aged >=85.
"These findings are important because the prevalence of NVAF and stroke risk, and therefore the need for oral anticoagulation, all increase with age," said Professor Raffaele De Caterina, Professor of Cardiology, Institute of Cardiology at the University of Pisa, Italy. "Additionally, elderly patients are more likely to have other comorbidities and to be on various medications that may interfere with treatment. The data from this set of unselected patients support edoxaban's growing evidence of safety profile and its use as an effective treatment for elderly, and very elderly, AF patients in regular clinical care. Of particular interest is the set of data showing no apparent increase in the rate of intracranial haemorrhage in edoxaban-treated patients as a function of age, while a high rate of this occurrence and its increasing prevalence as a function of age was shown in warfarin-treated patients."

Additionally, a further 1-year follow-up analysis of the difference in outcomes between edoxaban-treated AF patients with history of ICH (i.e. those at higher risk of stroke, death and recurrent haemorrhage) and those without a history of ICH, showed that:([3])


-- Incidences of ISTH-defined MB (including ICH) and clinically relevant
non-major bleeding (CRNMB) were generally low in both groups.
-- ICH occurred in 3 (1.2%) patients with history of ICH and 56 (0.3%)
patients without history of ICH, per year. The rate of ischaemic stroke
was higher in patients with history of ICH (6 [2.4%]) than in those
without (165 [0.8%]), per year.
These new data suggest that edoxaban is an effective treatment option for patients with or without prior ICH, whilst also demonstrating the need for effective stroke prevention in NVAF patients with a history of ICH.([3])

Wolfgang Zierhut, MD, Executive Director Medical Affairs and Head Thrombosis and Cardiovascular at Daiichi Sankyo Europe commented: "The wealth of new data we have shared at ESC Congress 2019 comes from the largest and most comprehensive repository of real-world data on edoxaban use. These new findings will feed into the ongoing Edoxaban Clinical Research Programme, helping to expand the strong evidence-base for the efficacy and safety of this important therapy in patients with AF."

Further new European analyses at ESC 2019

Echoing the Global registry outcomes data, additional one-year follow up analyses of 12,574 unselected elderly AF patients with comorbidities, from ten European countries, showed that the incidence of clinical events for both bleeding and stroke rates were low. Per year, MB occurred in 1.05% (n=125), ICH occurred in 0.23% (n=28) and any stroke or systemic embolic events occurred in 0.82% (n=98) of cases.([2]) All-cause mortality occurred in 3.55% of patients per year, which can be rated as low in a high-risk context.([2])

This snapshot real-world analysis compared the baseline and first year outcomes data from 12,574 patients (mean age of 73.6 years) with the outcome data of the European cohort from the clinical Phase III ENGAGE AF-TIMI 48 study,([2]) which investigated the safety and efficacy of edoxaban compared to warfarin, for the prevention of stroke or stroke and systemic embolic events in patients with AF.([4] )In ETNA-AF, edoxaban was used in a broad range of elderly NVAF patients. Additionally, dose reduction at baseline between the ETNA-AF and ENGAGE AF-TIMI 48 was similar and overall there was a good adherence (84%) to the European label.([5])

"It is interesting to note that the higher HAS-BLED score in ETNA-AF compared to ENGAGE AF-TIMI 48 suggests that in real-world clinical settings physicians are more comfortable using edoxaban in patients with higher bleeding risk," said Raffaele De Caterina, Professor of Cardiology, Institute of Cardiology at the University of Pisa, Italy. "This new analysis reinforces the safety profile and effectiveness of edoxaban in elderly NVAF patients at high CV risk, but also suggest that the ENGAGE AF-TIMI 48 study efficacy results are being largely confirmed in general practice."

About ETNA-AF

ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) is a global programme that combines data from distinct non-interventional studies in Europe, East Asia, and Japan in a single database. A total of more than 28,000 patients will be included in the ETNA-AF registries and followed for two years (patients in Europe will be followed for four years). The primary objective of ETNA-AF is to collect information on the use of edoxaban in routine clinical practice, including the safety and efficacy profile in non-preselected patients with NVAF.([6],[7],[8],[9],[10] )

About Atrial Fibrillation

AF is a condition where the heart beats irregularly and rapidly. When this happens, blood can pool and thicken in the chambers of the heart causing an increased risk of blood clots. These blood clots can break off and travel through the blood stream to the brain (or sometimes to another part of the body), where they have the potential to cause a stroke.([11])

AF is the most common type of heart rhythm disorder and is associated with substantial morbidity and mortality.[12] More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years.([13],[14] )Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.([15]) One in five of all strokes are as a result of AF.([12] )

About Edoxaban

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Edoxaban is currently marketed by Daiichi Sankyo and its partners in more than 30 countries and regions around the world.

About the Edoxaban Clinical Research Programme

More than 10 studies, more than 100,000 patients worldwide

Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through research programmes evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE) designed to further build on the results of the pivotal ENGAGE-AF and Hokusai-VTE studies. More than 100,000 patients worldwide are expected to participate in the Edoxaban Clinical Research Programme, which is comprised of more than 10 RCTs (randomised, controlled trials), registries and non-randomised clinical studies, including completed, ongoing and future research. Our goal is to generate new edoxaban clinical and real-world-data regarding its use in AF and VTE populations, providing physicians and patients worldwide with greater treatment assurance.

The RCTs include:

- ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation), in AF patients at moderate-to-high risk of thromboembolic events

- Hokusai VTE (Edoxaban in Venous Thromboembolism), in patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both

- ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation), in AF patients undergoing electrical cardioversion

- ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI), in AF patients undergoing percutaneous coronary intervention

- Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism Associated with Cancer), in patients with cancer and an acute VTE event

- ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in elderly AF patients in Japan

- ELIMINATE-AF (EvaLuatIon of edoxaban coMpared with VKA IN subjects undergoing cAThEter ablation of non-valvular Atrial Fibrillation)

- ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation (TAVI) - Atrial Fibrillation)

- STABLED Study (STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation) in Japan

- ENRICH-AF (EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation, an investigator initiated phase III study)

In addition, global and regional registry and non-randomised clinical studies provide important real-world and clinical data about the use of edoxaban and other oral anticoagulants in everyday practice; these include:

- ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation)

- ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in patients with Venous ThromboEmbolism)

- EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE)

- Prolongation PREFER in AF (PREvention oF thromboembolic events - European Registry) in patients with AF

- ANAFIE (All Nippon AF In Elderly) Registry in Japan

- Cancer-VTE Registry in Japan

- RYOUMA (Real world ablation therapY with anti-cOagUlants in Management of Atrial fibrillation) Registry in Japan

- KYU-RABLE (Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation) in Japan

- BPV-AF (Atrial Fibrillation with BioProsthetic valve) Registry in Japan

Through the Edoxaban Clinical Research Programme, we are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.

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

This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

Contact
Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Communications & Product PR Europe
+49-(89)-7808751

References:

[1] Wang, CC. et al. One-year outcomes of elderly patients with atrial fibrillation: snapshot data from the Global Noninterventional Program on Edoxaban Treatment in Routine Clinical Practice in Atrial Fibrillation. Poster presented at ESC Congress 2019.

[2] De Caterina, R. et al. ETNA-AF Europe: First 1-year follow-up snapshot analysis of more than 7,500 AF patients treated with edoxaban in routine clinical practice. Poster presented at ESC Congress 2019.

[3] Kirchhof, P. et al. Clinical characteristics and 1-year outcomes in atrial fibrillation patients with or without history of intracranial haemorrhage treated with edoxaban: data from the Global ETNA-AF program. Poster presented at ESC Congress 2019.

[4] Giugliano, RP. et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2013; 369:2093-2104.

[5] De Caterina, R. et al. Characteristics of patients initiated on edoxaban in Europe: baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe). BMC Cardiovasc Disord. 2019;19:165.

[6] Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (ETNA-AF-EU). Available at: https://clinicaltrials.gov/ct2/show/NCT02944019 [https://clinicaltrials.gov/ct2/show/NCT02944019]. [Last accessed: August 2019].

[7] Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN). Available at: https://clinicaltrials.gov/ct2/show/NCT02951039 [https://clinicaltrials.gov/ct2/show/NCT02951039]. [Last accessed: August 2019].

[8] Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong). Available at: https://clinicaltrials.gov/ct2/show/NCT03247582 [https://clinicaltrials.gov/ct2/show/NCT03247582]. [Last accessed: August 2019].

[9] Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF). Available at: https://clinicaltrials.gov/ct2/show/NCT03247569 [https://clinicaltrials.gov/ct2/show/NCT03247569]. [Last accessed: August 2019].

[10] ETNA-AF-Japan. Available at: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019728 [https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019728] [Last accessed: August 2019].

[11] National Heart, Lung and Blood Institute - What is Atrial Fibrillation. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html [http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html]. [Last accessed: August 2019].

[12] Iqbal, MB. et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485):238-43.

[13] Camm, A. et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31(19):2369-2429.

[14] Krijthe, BP. et al. Projections on the number of individuals with atrial fibrillation in the European Union, from+- 2000 to 2060. Eur Heart J. 2013;34(35):2746-2751.

[15] Ball, J. et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Card. 2013;167:1807-1824.

Date of preparation: August 2019, EDX/19/0505

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