Bristol-Myers Squibb and Pfizer said Wednesday their blood thinner drug Eliquis proved to be as safe as standard therapy for non-valvular atrial fibrillation (NVAF) patients undergoing cardioversion.
Cardioversion is a procedure that aims to restore normal health rhythm in patients with atrial fibrillation – a quivering or irregular heartbeat that can lead to blood clots, stroke, and heart failure. It is conducted either pharmacologically or through electric shock which can potentially lead to stroke or embolism.
The standard of treatment to prevent this occurrence has been heparin and/or vitamin K antagonist such as warfarin for three weeks before the procedure, the companies said.
The EMANATE phase 4 clinical study was a descriptive, randomized, open-label trial that set out to prove Eliquis (ingredient: apixaban) as safe as the standard therapy in reducing the risk of stroke for these patients.
“The EMANATE trial exemplifies the Bristol-Myers Squibb-Pfizer Alliance’s commitment to expanding understanding of Eliquis’ utility across broad NVAF patient populations and clinical settings,” said Rory O’Connor, CMO of Pfizer화이자 Innovative Health.
The study divided 1,500 patients recently diagnosed with NVAF who received less than 48 hours of anticoagulation into two groups with 753 patients taking Eliquis and 747 receiving the standard of care.
Results showed no strokes or systemic emboli in the Eliquis group versus six strokes (one hemorrhagic and five ischemic) and no systemic emboli in the other. Results also showed the Eliquis group had fewer major bleeding events (three patients vs. six patients) as well as less clinically relevant non-major bleeding events (11 patients vs. 13 patients).
However, there were two deaths in the Eliquis group and one in the standard of care group, the company noted.
“These exploratory data offer preliminary insights into the potential effects of Eliquis in this high-risk clinical setting. Further investigation is needed to understand anticoagulation for early cardioversion better,” said Christoph Koenen, who leads Eliquis development at BMS.
The findings for the oral anticoagulant were presented at the European Society of Cardiology’s ESC Congress 2017 on Aug. 28.
Eliquis treats atrial fibrillation, deep vein thrombosis and pulmonary embolism in particular settings. It recorded the sales of $1.2 billion in the second quarter, according to BMS.