Rates of Bleeding and Venous Thromboembolism (VTE) Events Reported After 12 Months of Edoxaban ▼ Treatment Considered Low by Real-world ETNA-VTE Study Investigators

MUNICH, July 14, 2020 /PRNewswire/ -- 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 Congress.^[1],[2],[3]

VTE is a major cause of morbidity and mortality globally.^[4] 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),^[5],[6] making the elderly most vulnerable. A prior incidence of a VTE is the most significant risk factor of a second occurrence.^[6] 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.^[1] Per year, globally:^[1]

• 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, 1.08% 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.^[3] 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.^[3] Per year, in the European index VTE event group:^[3]

• 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.^[2] Per year, in the European BMI group:^[2]

• VTE recurrence occurred in 2.67% of patients overall (2.44%, 2.83% and 2.71% respectively).
• Major bleeding occurred in 1.69% of patients overall (1.75%, 2.00% 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 Research Programme."

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.^[7],[8]

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: https://www.daiichi-sankyo.eu/media/about-etna-vte

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

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

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.

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

References:

^[1] 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 Virtual Congress. 

^[2] 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.

^[3] 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.

^[4] ISTH Steering Committee for World Thrombosis Day. Thrombosis: A major contributor to global disease burden. J Thromb Haemost. 2014 Oct;12(10):1580-90.

^[5] The Coalition to Prevent VTE. Available at: http://www.coalitiontopreventvte.org/INDEX_CFM/T/THE_BURDEN_OF_VTE/VID/DCD0A03F_1422_16B3_78E0B9EB0571.HTM. Last accessed June 2020.

^[6] Zagaria, M. Venous Thrombosis: Pathogenesis and Potential for Embolism. US Pharm. 2009;34:22-24.

^[7] 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.

^[8] 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  

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