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Korea BMS Pharmaceuticals and Pfizer Korea announced that an oral anticoagulant Elyquis has been approved for use in remedies for the treatment of critically ill patients with atrial fibrillation requiring conversion to cardioversion on July 18 . [19659002] In addition to this authorization from the Food and Drug Administration, patients with non-valvular atrial fibrillation (NVAF) who require cardioversion can now receive new or continued Eliquis. 19659002] Cardioversion is a procedure that reduces the heart rate of patients with atrial fibrillation to normal, and the risk of causing a cerebrovascular accident or systemic embolism if thrombi generated in the heart during cardioversion is transferred to the brain or heart. another area There is. The American Heart Association (AHA), the American Heart Association (ACC), and the American Society of Cardiology (HRS) guidelines recommend that patients taking a sympathetic conversion treatment take Oral anticoagulants for more than three weeks.
The addition of this authorization was based on the results of a non-random, randomized, phase 4 clinical trial, EMANATE (Eliquis evaluated in acute cardioversion compared to usual treatments for anticoagulation in subjects with NVAF)
The efficacy and safety of Eliquis 5 mg twice daily have been evaluated in patients with atrial fibrillation and having no experience of treatment anticoagulant, or having been treated by cardioversion before 48 hours of treatment (two of the following treatments) Patients were randomly badigned to either the Eliquiz group or standard treatments (eg, placebo or placebo). Patients were badigned to randomly to one of two treatment regimens: (Warfarin / heparin), and the risk of acute stroke, systemic embolism, major bleeding, hemorrhage ie non-major clinically significant and all-cause mortality in patients with non-cardiac atrial fibrillation undergoing cardioversion
As a result, no stroke or systemic embolism occurred in all patients in the Eliquiz group ( 1,500, Eliquis 753, warfarin / heparin 747) who participated in the clinical trial. On the other hand, in the standard treatment group, there were 6 strokes (1 bleeding, 5 ischemia) and no systemic embolism. All patients who received only one anticoagulant therapy (1436, 735 of Eliquis and 721 of warfarin / heparin) were badyzed for safety and there was no difference in the incidence of bleeding. major and non-major compared to the standard treatment group (3 vs. 6, 11 vs. 13), respectively.
Hong Jinsu, general manager of BMS Pharmaceutical Innovative Drug Business, Korea, said: "Patients who have not experienced atrial fibrillation or anticoagulant therapy within 48 hours despite the higher risk of bleeding / thrombosis , the EMANATE study showed that the Eliquis group had the same safety as warfarin, but no stroke, In addition to the progression of cardioversion in experienced patients, a new study of the use of NOAC has been added to the progression of a new heart rate trap without experience of anticoagulant therapy
On the other hand, the update of the label for the treatment of patients with fibrillation Seriously ill auricular requiring conversion of cardioversion of Eliquis was approved by the European Commission in April It was approved first.
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