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ARISTOTLE clinical trial

In ARISTOTLE, ELIQUIS (apixaban) demonstrated superior risk reduction in
stroke / systemic embolism with significantly less major bleeding vs. warfarin in patients with NVAF1*

† 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 or more 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

Diagnosemethoden

ELIQUIS 5 mg BD: simple dosing for stroke prevention in NVAF, with or without food

Dosing could differ for some patients with renal or hepatic impairment2

It’s simple to switch your patients to ELIQUIS2


ELIQUIS (apixaban) SmPC

Please click here to access the ELIQUIS SmPC.

ELIQUIS (apixaban) Patient Information Leaflet

Please click here to access the ELIQUIS Patient Information Leaflet.

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   
NOAC = Non-vitamin K antagonist Oral Anticoagulant   
NVAF = Non-Valvular Atrial Fibrillation   
ISTH = International Society on Thrombosis and Haemostasis   
RRR = Relative Risk Reduction

* Stroke or systemic embolism was the primary efficacy endpoint, major bleeding was the primary safety endpoint, and all-cause mortality was a key secondary endpoint.1 Haemorrhagic stroke and ischaemic or undetermined stroke were components of stroke.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

‡ Intracranial bleeding and major bleeding at other locations including gastrointestinal bleeding were components of major bleeding.1

§ No statistical analysis for HR / RRR is available on this endpoint.2

References

  1. Granger CB et al. N Engl J Med 2011; 365: 981–992.
  2. ELIQUIS® (apixaban) Summary of Product Characteristics.