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European Results From Global ETNA-AF Registry Show Low Bleeding and Low Cardiovascular Event Rates in Elderly NVAF Patients on LIXIANA® (edoxaban)

Nachrichtenagentur: news aktuell
12.10.2019, 12:50  |  444   |   |   
- One-year outcomes of real-world edoxaban-treated European
patients from the Global ETNA-AF registry showed low rates of
potentially life-threatening bleeding and low CV events in elderly
NVAF patients1

- The Global ETNA-AF programme is currently the largest and most
comprehensive repository of routine clinical practice data on the
use, effectiveness, and safety of a single NOAC in AF patients

- Real-world Europe-specific findings demonstrate effectiveness
and safety of edoxaban in routine clinical care across Europe1

Munich (ots/PRNewswire) - -- Daiichi Sankyo Europe GmbH
(hereafter, "Daiichi Sankyo") today announced one-year follow-up
results from an analysis of 12,574 European non-valvular atrial
fibrillation (NVAF) patients, mostly elderly, treated with edoxaban
(known by the brand name LIXIANA®). One-year results from the ongoing
Global ETNA-AF (Edoxaban Treatment in routiNe clinical prActice)
registry, providing a snapshot of characteristics and outcomes from a
broad range of NVAF patients receiving edoxaban in routine clinical
care, were presented today at the Great Wall International Congress
of Cardiology (GW-ICC) 2019, in Beijing, China.

Overall, results from ETNA-AF at one year showed low rates of
bleeding (major and gastrointestinal [GI]), intracranial haemorrhage
(ICH) and ischaemic events during the first year of edoxaban
therapy.1 Per year, in the 12,574 patients from 825 sites2 in

- ISTH-defined major bleeding occurred in only 125 (1.05%) patients,
ICH occurred in 28 (0.23%) patients, and major GI bleeding occurred
in 47 (0.39%) patients
- Ischaemic stroke occurred in 65 (0.54%) patients, transient
ischaemic attack (TIA) occurred in 44 (0.37%) patients, and
haemorrhagic stroke occurred in 13 (0.11%) patients.

Rates of systemic embolic events (SEE) and myocardial infarction
(MI) were generally low. Per year in Europe:1

- SEE occurred in 13 (0.11%) patients
- MI occurred in 63 (0.53%) patients.

Additionally, mortality rates were low. In total, per year in

- All-cause mortality occurred in 425 (3.55%) patients and
cardiovascular mortality occurred in 200 (1.67%) patients.

While rates of stroke, bleeding and all-cause and cardiovascular
mortality increased with age, an age-related increase in ICH was not
apparent and rates were low in each age group.

"In routine clinical practice, the rates of major and
clinically-relevant non-major (CRNM) bleeding in elderly
edoxaban-treated patients were lower than those observed in clinical
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