ARISTOTLE® was a Phase III, double-blind, randomized trial designed to determine whether ELIQUIS (5 mg twice daily¶) was effective [noninferior to
warfarin] (target INR range: 2.0-3.0) in reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and ≥1 additional
risk factor for stroke: prior stroke or transient ischemic attack (TIA), prior systemic embolism, age ≥75 years, arterial hypertension requiring treatment,
diabetes mellitus, heart failure ≥New York Heart Association (NYHA) Class 2, or left ventricular ejection fraction (LVEF) ≤40%. A total of 18,201 patients were
randomized to ELIQUIS (n=9120) or warfarin (n=9081), and followed for a median of ≈1.7 years. The 2 treatment groups were well balanced with respect to
baseline characteristics, including age, stroke risk at entry as measured by CHADS2 score,# and prior vitamin K antagonist (VKA) experience.1,2
AVERROES® was a Phase III, double-blind, randomized trial designed to compare the effects of ELIQUIS (5 mg twice daily¶), n=2807, and aspirin (81
mg–324 mg once daily), n=2791, in reducing the risk of stroke and systemic embolism in 5598 patients with nonvalvular atrial fibrillation thought not
to be candidates for warfarin therapy, and with ≥1 additional risk factor for stroke: prior stroke or TIA, age ≥75 years, arterial hypertension (receiving
treatment), diabetes mellitus (receiving treatment), heart failure (≥NYHA Class 2 at the time of enrollment), LVEF ≤35%, or documented peripheral artery
disease. Patients could not be receiving VKA therapy (eg, warfarin), either because it had already been demonstrated to be or because it was expected to be
unsuitable for them. The 2 treatment groups were well balanced with respect to baseline characteristics, including age, stroke risk at entry as measured by
CHADS2 score, and prior use of a VKA within 30 days before screening. The mean follow-up period was approximately 1.1 years.1,3
A dose of 2.5 mg twice daily was assigned to patients with at least 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, or serum
creatinine ≥1.5 mg/dL.
¶
Scale from 0 to 6 to estimate stroke risk; higher scores predict greater risk.
#
INDICATION
• ELIQUIS® (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
SELECTED IMPORTANT SAFETY INFORMATION
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
(A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If
anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy,
consider