ELIQUIS is indicated for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥II)2
Please click here to access the ELIQUIS Patient Information Leaflet.
* The ARISTOTLE clinical trial was a randomised, double-blind, double-dummy, non-inferiority trial in 18,201 patients with NVAF. A 5 mg BD dose was used in 95.3% of ELIQUIS patients.1 A 2.5 mg BD dose of ELIQUIS was used in patients who met two of the following criteria: ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dl (133 µmol/l).1 Patients with the exclusive criteria of severe renal impairment (creatinine clearance 15–29 ml/min) should also receive a lower dose of 2.5 mg twice daily.2 Stroke / systemic embolism, including haemorrhagic, ischaemic or undetermined stroke, was the primary efficacy endpoint, major bleeding according to ISTH criteria was the primary safety outcome and all-cause mortality was a key secondary endpoint.1 Pre-specified hierarchical sequential testing was performed first on stroke / systemic embolism (primary efficacy endpoint) for non-inferiority, then for superiority, then on major bleeding, and finally, on death from any cause (secondary endpoint).1
ARISTOTLE = Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ARR = Absolute Risk Reduction BD = Twice Daily CI = Confidence Interval HR = Hazard Ratio N = Total number of patients in either the ELIQUIS group or the warfarin group n = Number of patients with event NVAF = Non-Valvular Atrial Fibrillation ISTH = International Society on Thrombosis and Haemostasis RRR = Relative Risk Reduction
Granger CB et al. N Engl J Med 2011; 365: 981–992.
ELIQUIS® (apixaban) Summary of Product Characteristics.
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