Apixaban Clinical Guidelines
Primary Indications
- The American Heart Association recommends apixaban to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with a hazard ratio of 0.79 (95% CI, 0.66–0.95) compared to warfarin 1
- Apixaban has demonstrated a 49% reduction in hemorrhagic stroke and an 8% reduction in ischemic stroke compared to warfarin in patients with nonvalvular atrial fibrillation 2
Dosing Considerations
- The standard dose of apixaban for atrial fibrillation is 5 mg twice daily, with a dose reduction to 2.5 mg twice daily recommended for patients meeting at least two of the following criteria: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL 1
- For VTE prophylaxis after orthopedic surgery, the recommended dose is 2.5 mg twice daily 3
Clinical Evidence and Efficacy
- The ARISTOTLE trial demonstrated apixaban's superiority over warfarin in preventing stroke or systemic embolism (1.27% vs 1.60% per year) in 18,201 patients with atrial fibrillation 2
- Apixaban also reduced major bleeding (2.13% vs 3.09%) and mortality (3.52% vs 3.94%) compared to warfarin in the ARISTOTLE trial 2
Safety Considerations
- The risk of bleeding with apixaban is increased when used with other medications that affect hemostasis, including aspirin or aspirin-containing products 2 and NSAIDs 4
- Discontinuation of apixaban at least 3 days before procedures with high bleeding risk is recommended if CrCl >30 mL/min 5
Special Populations
- Apixaban should be used with caution in patients with hepatic impairment (transaminases >2 times upper limit of normal or total bilirubin >1.5 times upper limit of normal) 5, 4
- Avoid use in patients with severe renal impairment (CrCl <15 mL/min) 5, 4
Apixaban Indications and Usage
Clinical Evidence and Guideline Recommendations
- The American Heart Association/American Stroke Association gives apixaban a Class I, Level of Evidence B recommendation for stroke prevention in nonvalvular atrial fibrillation, with selection based on risk factors, cost, tolerability, patient preference, potential drug interactions, and clinical characteristics 6
- Apixaban demonstrated superiority over aspirin in patients unsuitable for warfarin therapy, with a 55% risk reduction in stroke/systemic embolism, in a study published in Stroke in 2014 7
- The black box warning for apixaban indicates that discontinuation increases stroke risk, and ensuring coverage with another anticoagulant when stopping apixaban is crucial, as stated in a 2014 publication in Stroke 7