Daiichi Sankyo show positive results for atrial fibrillation treatment Lixiana
pharmafile | March 18, 2019 | News story | Manufacturing and Production, Research and Development | Daiichi Sankyo, Lixiana, pharma, vitamin K antagonist
Japanese firm Daiichi Sankyo has announced positive results of the first randomised controlled trial of uninterrupted Lixiana (edoxoban) in atrial fibrillation patients undergoing catheter ablation.
The study showed the uninterrupted anticoagulation regimen with 60mg edoxaban versus uninterrupted vitamin K antagonists, in patients undergoing catheter ablation resulted in low event rates for both thromboembolic and bleeding events.
The incident of the primary endpoint was 0.3% (1 in 316) in the Lixinia (edoxaban) group, versus 2.0% (2 in 101) in the Vitamin K antagonist group.
“Catheter ablation is a common and effective procedure for rhythm control in patients with symptomatic AF. However, the procedure is associated with a significant thromboembolic risk during and shortly after the procedure, requiring systemic anticoagulation before, during, and after ablation,” said Dr Stefan Hohnloser, Professor of Medicine and Cardiology, Head, Department of Electrophysiology, Johann Wolfgang Goethe University in Frankfurt, Germany, and principal study investigator.
“These results provide evidence that uninterrupted edoxaban treatment represents an alternative to continuous anticoagulation with VKA in patients undergoing catheter ablation of AF. This is significant for this complex patient population and physicians because the management of anticoagulation around ablation is much easier with once-daily edoxaban, with low potential of interaction with concomitant drugs.”
The trial ELIMINATE-AF sought to compare the time to first all-cause death, stroke, or International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding, assessed in the per-protocol population from the end of ablation procedure to the end of treatment
“We are encouraged by these results, which represent an important potential advancement in the way we manage thromboembolic risk surrounding catheter ablation,” said Dr Hans Lanz, Vice President, Head, Global Medical Affairs Edoxaban, Daiichi Sankyo Europe GmbH. “ELIMINATE-AF will help define the role of uninterrupted therapy with edoxaban in the clinical setting of catheter ablation of AF. These results are the first of a broad set of data to be presented in 2019 supporting the use of edoxaban in specific clinical situations and the real-world setting.”
Louis Goss
Related Content
FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment
AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan …
EMA validates two applications for datopotamab deruxtecan for cancer treatments
AstraZeneca has announced that the European Medicines Agency (EMA) has validated to marketing authorisation applications …
Daiichi Sankyo shares results for Ezharmia as lymphoma treatment
Daiichi Sankyo has announced results from the phase 2 VALENTINE-PTCL01 trial of Ezharmia (valemetostat tosilate), …
