Eliquis (apixiban) is indicated for the prevention of stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation (NVAF) who have one or more of the following risk factors: prior stroke or transient ischaemic attack; age ≥75 years; hypertension; diabetes; or symptomatic heart failure (NYHA class ≥II).
The licensed dose is 5mg twice daily but this is reduced to 2.5mg twice daily for patients with two or more of the following criteria: ≥80 years, bodyweight ≤60kg or serum creatinine ≥133 micromole/L.
Clinical study design
The extension follows the results of two double-blind, randomised clinical studies in patients with NVAF and at least one additional risk factor for stroke: the ARISTOTLE study compared apixaban with warfarin, and the AVERROES study compared apixaban with aspirin in patients unsuitable for treatment with a vitamin K antagonist.
Superior to warfarin
In the ARISTOTLE study (n=18,201), patients were randomised to received the licensed dose of apixaban or dose-adjusted warfarin to achieve a target INR 2.0–3.0.
Apixaban displayed significantly superior efficacy to warfarin in preventing stroke and systemic embolism, with rates of 1.3% and 1.6% per year, respectively (hazard ratio 0.79, 95% CI 0.66–0.95, p<0.01 for superiority). The secondary endpoints, including rates of major bleeding and all-cause death, also favoured apixaban over warfarin.
Study terminated early
The AVERROES trial enrolled 5,599 patients who were randomised to receive the licensed dose of apixaban or aspirin 81mg, 162mg, 243mg or 324mg once daily (dose allocated at investigator discretion).
Rates of stroke and systemic embolism were 1.6% per year for apixaban vs 3.7% for aspirin (hazard ratio 0.45, 95% CI 0.32–0.62, p<0.001). The study was terminated early because of a clear benefit in favour of apixaban. Similar rates of major bleeding were observed in the apixaban and aspirin groups.
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Further information: Bristol-Myers Squibb Pharmaceuticals Ltd