Bristol-Myers Squibb Company and Pfizer have announced that they have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending an addition to the current Summary of Product Characteristics (SmPC) for apixaban stating that ‘Patients can stay on apixaban while being cardioverted.’
The CHMP’s positive opinion was based on a post-hoc analysis of the outcomes of the ARISTOTLE study. ARISTOTLE was designed to evaluate the efficacy and safety of apixaban compared to warfarin for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). In ARISTOTLE, 540 patients underwent 743 cardioversions for non valvular atrial fibrillation. The outcomes of patients treated with apixaban (n=265) compared to those treated with warfarin (n=275) were assessed in the 30 days following cardioversion attempts. Adverse clinical events occurring after cardioversion were found to be comparable between the warfarin and apixaban groups with no reported stroke or systemic emboli in either group and low observed rates of myocardial infarction, major bleeding or death.
“The SmPC update is significant because it means that non valvular atrial fibrillation patients will no longer have to change anticoagulation therapy prior to cardioversion, and apixaban therapy can now be continued without interruption,” says professor John Camm, clinical cardiologist, St George’s Hospital, London, UK.
“The fact that this ARISTOTLE analysis showed that there were no strokes or systemic emboli in the apixaban group, and that adverse events were low and balanced between the treatment arms, provides reassurance that patients already taking apixaban who need cardioversion can continue to take this oral anticoagulant while they are being cardioverted.”