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
Pubblicato il: 31/08/2020 09:01
- 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
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.
"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.
Results from 1,392 patients, who were considered frail, showed:
In addition, the analysis suggested that clinician's perception of frailty appeared to be a better marker of clinical outcomes than age.
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.
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.
"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
Additional edoxaban data presented
In addition to ETNA-AF, data from multiple clinical studies from EDOSURE were also presented.
About the Edoxaban Clinical Research Programme:
Media Contact Dr. Wolfgang SchiesslDaiichi 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: