Bristol/Pfizer: Eliquis Safe, Effective in Real-life Atrial Fibrillation Study

The Bristol-Myers Squibb-Pfizer Alliance today announced findings from NAXOS (EvaluatioN of ApiXaban in strOke and Systemic embolism prevention in patients with nonvalvular atrial fibrillation in the real-life setting in France), the largest real-world data analysis on oral anticoagulant (OAC) effectiveness and safety in Europe among patients with non-valvular atrial fibrillation (NVAF). NAXOS is a retrospective cohort analysis including nearly all patients in France aged 18 years or older with NVAF newly initiating one of the OACs between 2014 and 2016 (n=321,501). In this analysis, Eliquis^® (apixaban) use was associated with a lower rate of major bleeding compared to a vitamin K antagonist (VKA) (hazard ratio [HR]: 0.49, 95% confidence interval [CI]: 0.46-0.52), rivaroxaban (HR: 0.63, 95% CI: 0.58-0.67) and dabigatran (HR: 0.85, 95% CI: 0.76-0.95). These data were featured as a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2019 in Paris, France (Abstract 1362). Anticoagulants, including Eliquis, increase the risk of bleeding and can cause serious, potentially fatal bleeding. Please see important safety information below for Eliquis, including BOXED WARNINGS.

In this analysis, Eliquis was also associated with lower rates of stroke and systemic thromboembolic events compared to VKA (HR: 0.67, 95% CI: 0.62-0.72) and rates similar to rivaroxaban (HR: 0.97, 95% CI: 0.89-1.05) or dabigatran (HR: 0.92, 95% CI: 0.81-1.06). Eliquis was associated with a lower rate of all-cause mortality compared to VKA (HR: 0.56, 95% CI: 0.54-0.58) and rivaroxaban (HR: 0.89, 95% CI: 0.85-0.93) and rates similar to dabigatran (HR: 0.94, 95% CI: 0.87-1.01). It is important to note that there are no head-to-head clinical trials comparing non-vitamin K antagonist OACs.

‘The large-scale NAXOS retrospective observational analysis is significant because it included nearly the entire French population with NVAF and is the first nationwide analysis that has evaluated the effectiveness and safety of all available OACs in France,’ said Professor Philippe Gabriel Steg, M.D., FESC, FACC, Head of Cardiology Department at Hôpital Bichat, Assistance Publique-Hôpitaux de Paris and Professor at Université de Paris. ‘Being able to analyze data from routine clinical practice from a large patient population may help characterize the effectiveness and safety of available anticoagulants.’

https://www.marketscreener.com/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-Findings-Released-from-NAXOS-a-French-Real-World-Data-Analysis-and-the-Large-29144419/