Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) announced that the first patient has been enrolled in ETNA-AF-Europe (Edoxaban Treatment in routiNe clinical prActice – Atrial Fibrillation – Europe), as well as the commencement of ETNA-VTE-Europe (Edoxaban Treatment in routiNe clinical prActice – Venous ThromboEmbolism – Europe).
The European ETNA registries are part of the global ETNA initiative which is comprised of regional patient registries designed to reflect regional needs and local clinical practice. The objective of ETNA is to collect a robust set of information on how once-daily LIXIANA® (edoxaban) is being used in real world settings. This will include safety and efficacy parameters as well as other important data that can help to guide best use of edoxaban. In Europe, ETNA will be conducted across 12 countries and will collect data from up to 15,700 patients.
“ETNA will provide important information on how this new once-daily oral anticoagulant is being used in patients in real world settings,” said Dr. Juan-Carlos Jaramillo, Head of Market Access and Medical Affairs at Daiichi Sankyo Europe GmbH. “Daiichi Sankyo is investing in the late phase programme for edoxaban to answer customer’s question on the use of LIXIANA® (edoxaban), and ETNA is an exciting opportunity to provide further information enabling healthcare systems to make best use of this important medicine.”
In Europe, the two non-interventional ETNA registries are being conducted in patients who are already receiving once-daily edoxaban for its licenced indications. In ETNA-AF-Europe, data from approximately 13,000 patients will be collected from 1,450 sites across 12 countries. In ETNA-VTE-Europe, data from approximately 2,700 patients will be collected from 660 sites, across 11 European countries.
In June 2015 the European Commission (EC) granted Marketing Authorisation for LIXIANA®, an oral, once-daily selective factor Xa-inhibitor, for the prevention of stroke and systemic embolism (SE) in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
In the ENGAGE AF-TIMI 48 study, once-daily edoxaban showed comparable efficacy (stroke or SEEs) in comparison to warfarin (1.18% vs. 1.50% per year, edoxaban 60 mg vs. warfarin respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001) and superior safety and significantly reduced major bleeding (2.75% vs. 3.43% per year, edoxaban 60 mg vs. warfarin respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001), in a broad range of patients with NVAF.1
The Hokusai-VTE study demonstrated that once-daily edoxaban effectively reduces symptomatic recurrent VTE, including DVT and fatal and non-fatal PE risk across a broad range of patients (3.2% vs. 3.5% of patients, edoxaban 60 mg vs. warfarin respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). Once-daily edoxaban also showed a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively; HR, 0.81; 95% CI, 0.71 to 0.94, p=0.004).2