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 (edoxaban) during routine clinical care

Munich (ots/PRNewswire) - - 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

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.

ENGAGE AF - TIMI 48 Serial measurement of Oyama et al biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in ENGAGE AF-TIMI 48 (link to data here (https://programme.escardio.or g/ESC2020/Channels-by-Topic/30 325-young-investigator-award-s ession-thrombosis?r=/ESC2020/F ull-Programme?s%3D%24expressio n%3DSerial%20measurement%20of% 20biomarkers%20and%20the%20ris k%20of%20stroke%20or%20systemi c%20embolism%20and%20bleeding% 20in%20patients%20with%20atria l%20fibrillation%20in%20ENGAGE %20AF-TIMI%2048) )

Is there a role for half-dose Steffel et al anticoagulation in atrial fibrillation? Randomized comparison of 2 doses of edoxaban in 14,014 patients in ENGAGE AF-TIMI 48 (link to data https://programme.escardio.org/E SC2020/Full-Programme?s=$express ion=Is%20there%20a%20role%20for% 20half-dose%20anticoagulation%20 in%20atrial%20fibrillation?%20Ra ndomized%20comparison%20of%202%2 0doses%20of%20edoxaban%20in%2014 ,014%20patients%20in%20ENGAGE%20 AF-TIMI%2048 )

ENTRUST-AF PCI Edoxaban in atrial Vranckx et al fibrillation with PCI by ACS or stable CAD presentation: a pre-specified analysis of the ENTRUST-AF PCI trial (link to data here (https://programme.e scardio.org/ESC2020/Full-Progr amme?s=$expression=Edoxaban%20 in%20atrial%20fibrillation%20w ith%20PCI%20by%20ACS%20or%20st able%20CAD%20presentation:%20a %20pre-specified%20analysis%20 of%20the%20ENTRUST-AF%20PCI%20 trial) )

ANAFIE Risk factors associated with Inoue et al 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 (https://p rogramme.escardio.org/ESC2020/ Full-Programme?s=$expression=R isk%20factors%20associated%20w ith%20stroke/systemic%20emboli c%20events%20in%20elderly%20no n-valvular%20atrial%20fibrilla tion%20patients%20in%20the%20A NAFIE%20registry,%20the%20larg est%20real-world%20elderly%20A F%20registry) )

Risk factors of major bleeding Inoue et al in elderly atrial fibrillation patients from the ANAFIE registry (l ink to data here (ht tps://programme.escardio.org/ESC 2020/Full-Programme?s=$expressio n=Risk%20factors%20of%20major%20 bleeding%20in%20elderly%20atrial %20fibrillation%20patients%20fro m%20the%20ANAFIE%20registry) )

Real-world effectiveness and the Yamashita et al safety of anticoagulant treatment in elderly non-valvular atrial fibrillation in the ANAFIE registry, the largest real-world elderly AF registry (link to data here (htt ps://programme.escardio.org/ESC2 020/Full-Programme?s=$expression =Real-world%20effectiveness%20an d%20the%20safety%20of%20anticoag ulant%20treatment%20in%20elderly %20non-valvular%20atrial%20fibri llation%20in%20the%20ANAFIE%20re gistry,%20the%20largest%20real-w orld%20elderly%20AF%20registry) )

Gesundheitsforen Leipzig Comparison of clinical Marston et al database 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 (htt ps://programme.escardio.org/ES C2020/Full-Programme?s=$expres sion=Comparison%20of%20clinica l%20outcomes%20with%20edoxaban %20versus%20apixaban,%20dabiga tran,%20rivaroxaban,%20and%20v itamin%20K%20antagonist%20in%2 0patients%20with%20atrial%20fi brillation%20in%20Germany:%20a %20real-world%20cohort%20study ) )

Improved adherence to Yeh et al anticoagulant therapy with once-daily regimen: a real-world study in patients with atrial fibrillation in Germany (link to data https://programme.escardio. org/ESC2020/Full-Programme?s=$ex pression=Improved%20adherence%20 to%20anticoagulant%20therapy%20w ith%20once-daily%20regimen:%20a% 20real-world%20study%20in%20pati ents%20with%20atrial%20fibrillat ion%20in%20Germany )

About ETNA-AF: https://www.daiichi-sankyo.eu/media/about-etna-af (https://us-eas t-2.protection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW5 reW8uZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw== &t=RE5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd45 8ba438f01802c15e38)

About AF: https://www.daiichi-sankyo.eu/media/about-etna-af (https://us-east-2.p rotection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW5reW8u ZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw==&t=RE 5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd458ba43 8f01802c15e38)

About Edoxaban: https://www.daiichi-sankyo.eu/media/about-etna-af (https://us-ea st-2.protection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW 5reW8uZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw= =&t=RE5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd4 58ba438f01802c15e38)

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=aHR0cHM6Ly93d3cuZGFpaWNoaS1zYW5reW8uZXUvbWVkaW EvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZmlubi5jby51aw==&t=RE5xeGRKbXE1 TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a735062dc3cd458ba438f01802c15 e38)

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: http://www.daiichisankyo.com/ .

Forward-looking statements: https://www.daiichi-sankyo.eu/media/about-etna-af (h ttps://us-east-2.protection.sophos.com/?d=daiichi-sankyo.eu&u=aHR0cHM6Ly93d3cuZG FpaWNoaS1zYW5reW8uZXUvbWVkaWEvYWJvdXQtZXRuYS1hZg==&e=cmYtb2FjZXVyb3BlQHJ1ZGVyZml ubi5jby51aw==&t=RE5xeGRKbXE1TFhUK2dGK0w4cnVmMmJSbDlUZTZqY25xMXZmMzA1SW4vVT0=&h=a 735062dc3cd458ba438f01802c15e38)

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.

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