Results Announced for Eliquis in Nonvalvular Atrial Fibrillation Trial
Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis (apixaban) compared to warfarin to blood pressure control 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 (n=9,120) vs. warfarin (n=9,081) for the prevention of stroke or systemic embolism. ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5mg orally twice daily (or 2.5mg twice daily in selected patients, representing 4.7% of all patients) or warfarin (target INR range 2.0–3.0), and followed for a median of 1.8 years.
The results showed that poor blood pressure control was associated with a substantially higher risk of stroke or systemic embolism, independent of Eliquis or warfarin treatment. However, this subanalysis found that Eliquis was consistent in reducing the risk of stroke or systemic embolism vs. warfarin in patients with and without poor blood pressure control during the trial (p for interaction =0.97). The effect of Eliquis in reducing the risk of stroke and systemic embolism versus warfarin was also consistent with the results of the ARISTOTLE trial in previously published subanalyses of other comorbidities, including congestive heart failure, advanced age, renal impairment and prior stroke.
Eliquis is already approved to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).