CardioSource WorldNews December 2014 - Page 9

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. SELECTED IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS (contd) • Bleeding Risk: ELIQUIS increases the risk of bleeding, and can cause serious, potentially fatal bleeding. – Concomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs. – Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage. – There is no established way to reverse the anticoagulant effect of apixaba