Bristol-Myers Squibb and Pfizer announce results from subanalysis of Phase III Aristotle trial of Eliquis

4th September 2013 (Last Updated September 4th, 2013 18:30)

Bristol-Myers Squibb and Pfizer have reported consistent results from a post-hoc subanalysis of the Phase III Aristotle trial of Eliquis (apixaban), an oral direct Factor Xa inhibitor.

Bristol-Myers Squibb and Pfizer have reported consistent results from a post-hoc subanalysis of the Phase III Aristotle trial of Eliquis (apixaban), an oral direct Factor Xa inhibitor.

The study was designed to demonstrate the efficacy and safety of Eliquis compared with warfarin for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) or atrial flutter.

Patients with clinically significant mitral stenosis or a mechanical prosthetic heart valve were not included in the trial.

Patients with mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or valve surgery were eligible for testing.

Compared with warfarin, Eliquis reduced stroke or systemic embolism, caused less major bleeding events and reduced all-cause mortality in NVAF patients with or without valvular heart disease (VHD), according to the subanalysis.

"These patients are generally older and considered to be at greater risk for clinical events than NVAF patients without VHD."

Dante Pazzanese Institute of Cardiology lead author of study Alvaro Avezum said the subanalysis offers better insight into the efficacy and safety of apixaban in nonvalvular atrial fibrillation patients with certain types of valvular heart disease, which are common in an elderly population.

"These patients are generally older and considered to be at greater risk for clinical events than NVAF patients without VHD," Avezum said.

Evaluated data from the subanalysis was secured from 26.4% of the Aristotle trial population of 4,808 NVAF patients who had both VHD and NVAF.

In Aristotle trial, 18,201 patients were randomised, 9,120 patients treated with Eliquis 5mg orally twice daily and 9,081 with warfarin.

In patients treated with Eliquis, the rates of post-procedural stroke or systemic embolism and major bleeding were similar whether Eliquis was interrupted or continued.

The rates of post-procedure major bleeding and death appeared higher when warfarin was continued in patients compared with when it was interrupted.

The subanalysis results, which were presented in an oral session at the ESC Congress 2013 in Amsterdam, The Netherlands, were consistent with the results of the overall Aristotle trial.