New data further strengthens important role of LIXIANA® (edoxaban) in managing complex patient populations with atrial fibrillation (AF)

Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced new edoxaban data being presented at The European Society of Cardiology Congress 2022. These include insights from routine clinical practice via the ETNA-AF Registry, adding to the growing body of evidence reaffirming the efficacy and safety profile of edoxaban seen in randomised clinical trials across a range of atrial fibrillation (AF) patient populations.^1,2,3 The data, focusing on AF patient groups with complex needs who experience worse outcomes, may have implications for how clinicians manage these groups in the future.^1,2,3

ETNA-AF Europe registry outcomes

Data from a multivariate analysis of the ETNA-AF registry show that for AF patients with diabetes mellitus (DM) treated with edoxaban, the insulin treated DM patients were associated with an increased risk of ischaemic stroke, transient ischaemic attack (TIA), or systemic embolic event (SEE). The increased risk was not observed in patients with DM not treated with insulin.¹

The researchers found that those patients with AF who were insulin dependent experienced worse outcomes, including higher risk of stroke, TIA and SEE (HbA1c adjusted HR [95%CI]: 2.13 [1.12–4.05], p=0.0205) and all-cause death (1.83 [1.35–2.49], p=0.0001) than those with non-insulin-treated diabetes.¹

The sub-analysis assessed the safety and effectiveness outcomes in AF patients (N= 13,167) on edoxaban treatment for two years, exploring three subgroups: 1) those with insulin treated diabetes (n=605); 2) those with non-insulin treated diabetes (n=2,151) ; 3) those without concomitant diabetes (n=10,248).¹

Heart failure is another well-known risk factor for stroke and SEE in patients with AF, but it has not been established whether this risk varies according to left ventricular ejection fraction (LVEF).² LVEF can be a measure of severity of heart failure: an LVEF of less than 40% indicates more severe heart failure.² A sub-analysis investigated the impact of LVEF and heart failure on patients being treated for AF with edoxaban.² Of the 13,133 patients, 1,854 (14.1%) had diagnosed heart failure; and LVEF was available for 1,489 (80.3%), and was <40% in 671(43.9%) and ≥40% in 857 (56.1%).² Patients with HF were more often men and slightly older than those without, (54% male, 73.5 years vs 74.6 years, respectively), and had more cardiovascular co-morbidities.² At the end of the two-year follow-up, the data showed that patients with HF had higher rates of ischemic stroke/TIA, major bleeding, ICH, CV death and all-cause death, with worst events outcomes; major bleeding (HR 2.01, 95% CI [1.49-2.71]) and all-cause death (HR 2.62 [2.28–3.02]) being significant.² Therefore, HF is a predictor of worse outcome in AF.² These findings were consistent when LVEF was taken into account.²

Frail patients are also especially vulnerable to stroke in the presence of AF; however, they are often undertreated due to increased bleeding risk.³ Many clinicians estimate the frailty of patients using their clinical expertise rather than validated scores.³ In a sub-analysis of men and women with AF treated with edoxaban, a two-year follow up of perceived frailty and clinical outcomes found that, for both sexes calculated separately, the risk of any stroke or SEE, major bleeding, or all-cause death was higher in the frail than in the non-frail patients.³ The difference in risk of stroke or SEE between frail and non-frail patients was greater for men (HR 3.77, 95% CI [2.25–6.31]) than for women (HR 2.18, 95% CI [1.34–3.55]).³ This data, taken alongside the revised EHRA definition of frailty, highlight the importance of using a scoring system in clinical practice to identify and manage frail patients, especially as AF could worsen the frail state of a patient.^3,5

The EHRA Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) in Patients with Atrial Fibrillation (AF), which was published in 2021, recommends the use of NOACs as first-line treatment of patients with AF and includes specific guidance around treating complex AF patient populations, such as those with different levels of frailty.⁵ NOACs are considered by AF guidelines as the preferred choice of anticoagulants, as they have an improved efficacy/safety ratio and a predictable anticoagulant effect in comparison to warfarin, without the need for routine coagulation monitoring.⁵

The data presented at the ESC Congress this week further underscores the recommendations of the Practical Guide for the treatment of AF patients using NOACs.

“These new data on AF populations with diabetes, heart failure or frailty confirm the vulnerability of these key risk populations,” said Raffaele De Caterina, Professor of Cardiology at the University of Pisa, and Director, University Cardiology Division, at Pisa University Hospital. “More than ever, we need to consider how AF patients with co-morbidities can be better supported in their care and personalised treatment. NOACs are a well-established treatment option for these specific patient populations but it is reassuring to have this additional data to guide clinicians in developing treatment plans.”

ETNA-AF Global Registry outcomes

In addition to data from the European cohort of patients, data from three abstracts of sub-analyses from the ETNA-AF global programme add to the wealth of safety and efficacy data for edoxaban. These include:

• Two-year effectiveness and safety outcomes in 27,333 edoxaban-treated patients with and without a history of major bleeding from the Global ETNA-AF programme
• Real-world effectiveness and safety of edoxaban treatment in 27,333 Global ETNA-AF programme patients with and without a history of heart failure
• Real-world effectiveness and safety of edoxaban in patients with and without a history of ischaemic stroke: Results from the ETNA-AF programme.

“The wealth of data presented at ESC reaffirms the well-established safety and efficacy profile for edoxaban and provides additional insights into the management of comorbid patients.” said Dr Stefan Seyfried, Vice President, Medical Affairs, Specialty Medicines, Daiichi Sankyo Europe GmbH. “Insights from a range of randomized controlled trials among different groups in both the ETNA-AF Europe and Global registry outcomes help us further understand the needs of the most at-risk patient populations with AF, including the frail and those with diabetes and heart failure. We are pleased to be able to provide clinicians with further data to help inform their clinical practice and best manage their patients with complex needs.”

-ENDS-

About ETNA-AF: https://www.daiichi-sankyo.eu/media/about-etna-af

About AF: https://www.daiichi-sankyo.eu/media/about-etna-af

About Edoxaban: https://www.daiichi-sankyo.eu/media/about-etna-af

About the Edoxaban Clinical Research Programme: https://www.daiichi-sankyo.eu/media/about-etna-af

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”

For more information, please visit www.daiichisankyo.com

Forward-looking statements: https://www.daiichi-sankyo.eu/media/about-etna-af

References

¹ Patti, G., et al. Clinical outcomes in patients with atrial fibrillation with or without concomitant diabetes after two years of edoxaban treatment: ETNA-AF-Europe registry. Abstract- 82516. Presented at ESC Congress 2022.

² Ameri, P., et al. Two-year outcomes of patients with atrial fibrillation and heart failure: the ETNA-AF-Europe registry. Poster- 82529. Presented at ESC Congress 2022

³ De Vries, TAC., et al. Perceived frailty and clinical outcomes in men and women with atrial fibrillation treated with edoxaban: insights from the 2-year follow-up of ETNA-AF-Europe. Poster- 82523. Presented at ESC Congress 2022

⁴ De Caterina, R., et al. Design and rationale of the Exodaban Treatment in routine clinical proactive for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study. J Cardiovasc Med. 20(2):97–104.

⁵ Steffel, J., et al. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Europace. 2021; 23: 1612–1676.

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Contact information

Media Contact
Dr. Wolfgang Schiessl
Daiichi Sankyo Europe GmbH
PR & Portfolio Communication Lead, Specialty Medicines
+49 151 1714 7317