Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in patients with nonvalvular atrial fibrillation (NVAF). Eliquis (apixaban) is an oral direct Factor Xa inhibitor, a key blood clotting protein, that prevents thrombin generation and blood clot formation.
ARISTOTLE was designed to evaluate the efficacy and safety of Eliquis compared to warfarin for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation. Although the ARISTOTLE trial was neither designed nor powered to investigate the differences for safety and efficacy of Eliquis compared to warfarin for individual age groups, a pre-specified subanalysis of the ARISTOTLE trial was performed according to age. The efficacy and safety of Eliquis compared with warfarin were assessed according to age during the 1.8 years median follow-up. Of the trial population, 30% were <65 years old, 39% were 65–74 years old and 31% were ≥75 years old.
The subanalysis found consistent results across age groups for reducing the risk of stroke and systemic embolism and reducing the risk of all-cause death with fewer bleeding events. The absolute benefit to patients with NVAF was greater with Eliquis than warfarin in the older population.
Eliquis was more effective than warfarin in reducing the risk of stroke and reducing mortality across age groups. It was also associated with less major bleeding, less total bleeding, and less intracranial hemorrhage, regardless of age. The p-value for interaction across age groups was non-significant (P>0.11 for all) for the major outcomes of stroke and systemic embolism, major bleeding, and death, meaning that the results of this subanalysis were consistent with the overall results of the ARISTOTLE trial.
Eliquis is already approved to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).