Real-World Data Demonstrates Efficacy of OAC in Patients with NVAF

September 3, 2019

Findings from a real-world data analysis have been released from the Bristol-Myers Squibb-Pfizer Alliance, demonstrating that Eliquis is associated with lower rate of major bleeding compared with vitamin K antagonist, dabigatran or rivaroxaban.

Findings from a vast real-world data analysis have been released from the Bristol-Myers Squibb-Pfizer Alliance, demonstrating that Eliquis (apixaban), an oral anticoagulant (OAC), is associated with lower rate of major bleeding compared with vitamin K antagonist (VKA), dabigatran or rivaroxaban.

The evaluation of apixaban in stroke and systemic embolism (NAXOS) prevention in patients with nonvalvular atrial fibrillation (NVAF) study is the largest real-world data analysis to date on OAC effectiveness and safety in Europe. Patients in France, aged 18 years and older, who had newly initiating NVAF between the years of 2014 and 2016 have been included in the retrospective cohort analysis. 

Although no direct head-to-head clinical trials comparing the various treatments for NVAF are available, the real-world data from the NAXOS study have shown that Eliquis was associated with a lower rate of major bleeding, stroke, and systemic thromboembolic events when compared with VKA. When compared with dabigatran and rivaroxaban, Eliquis was found to be associated with a lower rate of major bleeding and comparable rates of stroke and systemic thromboembolic events.

“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, head of Cardiology Department at Hôpital Bichat, Assistance Publique-Hôpitaux de Paris and professor at Université de Paris in a Sep. 1, 2019 press release. “Being able to analyze data from routine clinical practice from a large patient population may help characterize the effectiveness and safety of available anticoagulants.” 

“Results from the NAXOS real-world data analysis of NVAF patients in France add to the growing body of real-world evidence for Eliquis, which now includes a sample size of over two million lives globally,” added Rory O’Connor, chief medical officer, Pfizer Internal Medicine. “We are committed to gaining additional insights about how a treatment performs in the real world to help practicing physicians around the world make informed decisions.”

“As the real-world evidence landscape continues to advance, we are able to provide additional insights from a growing amount of patient data from around the world,” said Mary Beth Harler, head of Innovative Medicines Development, Bristol-Myers Squibb. “Healthcare practices and patient demographics can differ across geographies, and real-world data from the French NAXOS analysis can help provide healthcare practitioners in the region with relatable insights for their patients with NVAF.”

Source: BMS