Is it safe to increase apixaban to 5mg BID in an 82-year-old patient with afib and impaired renal function?

From the Guidelines

Increasing apixaban to 5mg twice daily in an 82-year-old patient with atrial fibrillation and impaired renal function is generally not recommended without careful evaluation. For elderly patients (≥80 years) with impaired renal function, the standard dose reduction to 2.5mg twice daily is typically appropriate, as suggested by the guidelines 1. This dose adjustment is necessary because age and decreased kidney function both independently increase bleeding risk with apixaban.

Key Considerations

• The patient's renal function should be assessed with serum creatinine and creatinine clearance measurements before considering any dose increase.
• The patient's weight should be checked, as patients weighing less than 60kg may require the lower dose, according to the guidelines 1.
• If the patient has experienced a thromboembolic event while on the reduced dose, only then might a dose increase be considered, but this should involve consultation with both cardiology and nephrology specialists.
• The decision requires balancing stroke prevention benefits against heightened bleeding risks, particularly intracranial hemorrhage, which carries higher mortality in elderly patients with compromised renal function, as highlighted in the studies 1.

Dosing Recommendations

• The guidelines suggest using apixaban 2.5 mg BID if any 2 patient characteristics are present: Cr ≥1.5 mg/dL, ≥80 years of age, body weight ≤60 kg 1.
• Apixaban is not recommended in patients with severe hepatic impairment, as stated in the guidelines 1.
• For patients with end-stage CKD on stable hemodialysis, prescribing information indicates the use of apixaban 5 mg BID with dose reduction to 2.5 mg BID if the patient is either ≥80 years of age or body weight <60 kg, as mentioned in the study 1.

Conclusion is not allowed, so the response ends here.

From the FDA Drug Label

The recommended dose is 2.5 mg twice daily in patients with at least two of the following characteristics [see Dosage and Administration (2.1)]:

• age greater than or equal to 80 years
• body weight less than or equal to 60 kg
• serum creatinine greater than or equal to 1.5 mg/dL

For an 82-year-old patient with afib and a recent creatinine of 115, which is approximately 1.3 mg/dL (assuming 1 mg/dL = 88.4 μmol/L), it is not safe to increase apixaban to 5 mg BID because the patient's age and renal function meet one of the criteria for a reduced dose of 2.5 mg twice daily. Increasing the dose may increase the risk of bleeding. 2

From the Research

Apixaban Dosing in Patients with Atrial Fibrillation and Impaired Renal Function

• The patient in question is an 82-year-old with atrial fibrillation (afib) and a recent creatinine level of 115, indicating impaired renal function.
• According to the study by 3, reduced-dose apixaban is recommended in patients fulfilling 2 of 3 criteria: age ≥80 years, body weight ≤60 kg, and serum creatinine ≥1.5 mg/dL.
• Given the patient's age and creatinine level, they may be eligible for a reduced dose of apixaban.
• However, the study by 4 suggests that apixaban dose adjustment criteria may need to be re-evaluated, as clinical data show that among patients >75 years, <60 kg, and with estimated glomerular filtration rate <50 mL/min, including those on dialysis, there is no reduction in apixaban safety or efficacy.

Considerations for Dose Adjustment

• The study by 5 found that variations in serum creatinine and creatinine clearance can lead to changes in the recommended dosage of apixaban, particularly in patients with advanced age (≥ 75 years) and renal impairment.
• The study by 6 reports a case of a patient with end-stage renal disease on hemodialysis who experienced an elevated international normalized ratio (INR) due to apixaban use, highlighting the need for careful monitoring in patients with renal impairment.
• The review by 7 summarizes the effectiveness and safety of apixaban use in patients with renal dysfunction, concluding that apixaban has a favorable clinical efficacy and safety profile compared with vitamin K antagonists for patients with AF or VTE and comorbid kidney impairment.

Increasing Apixaban to 5 mg BID

• Based on the available evidence, increasing apixaban to 5 mg BID in an 82-year-old patient with afib and impaired renal function may not be necessary, as the patient's age and creatinine level may warrant a reduced dose.
• However, the decision to increase the dose should be made on a case-by-case basis, taking into account the patient's individual characteristics, laboratory results, and clinical status, as well as the potential risks and benefits of apixaban therapy, as suggested by the studies 4, 3, 5, 6, 7.