Daiichi Sankyo Europe GmbH announced enrollment of the first patient in the ETNA-AF-Europe (Edoxaban Treatment in routine clinical prActice – Atrial Fibrillation – Europe) registry, and the official launch of the ETNA-VTE-Europe (Edoxaban Treatment in routine clinical prActice – Venous ThromboEmbolism – Europe) registry. The new studies could lead to improved therapeutic developments for a number of diseases, including pulmonary embolism.
The new patient registries fall under the worldwide ETNA initiative, which is made up of regional patient registries that help indicate specific areas’ needs and local clinical practices. ETNA aims to put together a comprehensive source of information on how once-a-day LIXIANA® (edoxaban) is being used throughout the world. Not only will these registries include patient data, but also safety and efficacy parameters and other important data to serve as a guide on how and when LIXIANA is best utilized. Data gathering in Europe will be conducted across 12 countries and will attempt to obtain 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.”
A pair of non-interventional ETNA registries are currently underway in Europe, involving patients who are already being treated with LIXIANA. In ETNA-AF-Europe, data will be obtained from about 13,000 patients from 1,450 sites across 12 countries, while data from 2,700 patients from 660 sites, across 11 countries will be obtained for the ETNA-VTE-Europe registry.
LIXIANA received Marketing Authorization from the European Commission in June 2015 as an oral, once-a-day preventive medication for stroke and systemic embolism in 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 LIXIANA® showed comparable efficacy (stroke or SEs) in comparison to warfarin (1.18% vs. 1.50% per year, LIXIANA® 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, LIXIANA® 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.
The Hokusai-VTE study demonstrated that once-daily LIXIANA® 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, LIXIANA® 60 mg vs. warfarin respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). Once-daily LIXIANA® 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).