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Daiichi Sankyo Presents First Snapshot Analyses from Global ETNA-AF Programme of Oral, Once-daily edoxaban (LIXIANA®) in Patients with Nonvalvular Atrial Fibrillation in Routine Clinical Practice #EscCongress #ESC2018

Daiichi Sankyo Europe GmbH  today announced results from three analyses of baseline data from patients in the Global ETNA-AF programme describing the use of oral, once-daily edoxaban (known by the brand name LIXIANA®) in routine clinical care. 

The data from 24,431 patients treated with edoxaban, representing 87% of total planned enrolled patients from more than 1,800 centers across 13 countries globally, highlight the broad range of cardiovascular risk factors and patient types being assessed to collect robust information on how edoxaban is being used in patients with nonvalvular atrial fibrillation (NVAF) in real-world settings. The data were presented at the ESC Congress 2018 in Munich.

“Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban through ETNA-AF, which is part of EDOSURE, our robust clinical research programme comprised of more than 10 studies and more than 100,000 patients worldwide,” said Hans Lanz, MD, Vice President, Head, Global Medical Affairs, Edoxaban. “The Global ETNA-AF programme will provide valuable information on edoxaban use, safety and effectiveness in a real-world setting that is being collected from these non-interventional studies. This will ultimately enable healthcare professionals to make best use of edoxaban in routine clinical practice.”

The Global ETNA-AF programme combines information from non-interventional studies conducted in Europe, East Asia, and Japan, regarding the safety and effectiveness of edoxaban. The regional patient registries were designed to reflect regional needs and local clinical practice, and data were harmonised, transformed, and integrated into a single database. A total of more than 28,000 patients will be included in the Global ETNA-AF non-interventional studies and followed for two years (patients in Europe will be followed for four years). The Global ETNA programme will serve as a large and comprehensive single NOAC repository of real-world data on the use, effectiveness, and safety of patients with NVAF or venous thromboembolism (VTE).

The first snapshot analysis presented at ESC, which reported baseline demographics and patient characteristics in the Global ETNA-AF programme, showed that overall patients were older than those in the ENGAGE AF-TIMI 48 clinical trial of edoxaban but had fewer stroke risk factors and more often presented with paroxysmal NVAF.1The percentages of patients treated with edoxaban 60 mg once-daily and 30 mg once-daily in Europe were 76.7% and 23.3% respectively (N = 13,474).1  The distribution of the edoxaban 60 mg and 30 mg QD dosing was largely consistent with the distribution in corresponding countries from ENGAGE AF-TIMI 48. Patient demographics were similar to ENGAGE AF-TIMI 48 in the European region.

The second analysis, which reported on baseline stroke and bleeding risks in the Global ETNA-AF programme, showed that across all regions, the population had a lower stroke risk and higher bleeding risk overall than those recorded in the corresponding countries in the ENGAGE AF-TIMI 48 trial.2Within non-interventional studies, physicians make clinical judgments to treat patients as appropriate. The EMA label requires only one risk factor for treatment and therefore differs from the inclusion criteria of ENGAGE AF-TIMI 48 that requires at least two major risk factors for enrolment. Global ETNA-AF enrolled a large proportion of high-risk patients including those with prior stroke, major bleed, intracranial hemorrhage, or CHA2DS2-VASc score ≥4; these high-risk patients comprised 38.2% of patients enrolled from Europe.2In addition, the mean recalculated HAS-BLED score overall in Global ETNA-AF was 2.5 ± 1.13 (Europe: 2.6 ± 1.13).2In ENGAGE AF-TIMI 48, the mean HAS-BLED score in patients from countries corresponding to Global ETNA-AF was 1.8 ± 1.0.2

The third analysis, which reported on the use of antithrombotic therapy before initiation of edoxaban in the Global ETNA-AF programme, showed that more than two-thirds of patients treated with edoxaban were naïve to anticoagulant use before starting edoxaban (17,740, 72.6%).3In Europe, 17.5% (2,364/13,474) were previously treated with a vitamin K antagonist (VKA) and 8.4% (1,138/13,474) were on another NOAC before starting edoxaban.3

“In comparison to corresponding countries in ENGAGE AF-TIMI 48, patients enrolled in Global ETNA-AF had lower stroke risk scores, and higher HAS-BLED scores,” said Raffaele De Caterina, Professor of Cardiology and Director of the Cardiology Institute at G. d’Annunzio University, Chieti, Italy. “This may indicate a shift in the willingness of physicians to treat patients who have a higher bleeding risk, reflecting an evolution in the use of NOACs. Building on the results from ENGAGE AF-TIMI 48, which included patients with moderate to high risk of stroke, these data provide real-world evidence regarding the use of edoxaban for patients with low risk of stroke.”

 

References

  1. Koretsune, Y. et al. The Global ETNA-AF registry programme: Snapshot baseline demographics and patient characteristics from 24,431 atrial fibrillation patients on edoxaban. Presented at the European Society of Cardiology Congress, Munich, 2018.
  2. De Caterina, R. et al. Baseline stroke and bleeding risks in the Global Edoxaban Treatment in Routine Clinical Practice in Patients with Nonvalvular Atrial Fibrillation programme (Global ETNA-AF): First snapshot analysis. Presented at the European Society of Cardiology Congress, Munich, 2018.
  3. De Caterina, R. et al. Prior antithrombotic therapy: A snapshot of 24,431 patients from the Global Edoxaban Treatment in Routine Clinical Practice in Patients with Nonvalvular Atrial Fibrillation programme (Global ETNA-AF). Presented at the European Society of Cardiology Congress, Munich, 2018.

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