Author + information
- Donald F. Brophy, PharmD, MSc∗ ()
- ↵∗Department of Pharmacotherapy & Outcomes Science, Virginia Commonwealth University, 410 North 12th Street, Richmond, Virginia 23298-0533
The recent State-of-the-Art Review paper by Lau et al. (1) was exceptional. I commend the authors on presenting a timely and cogent discussion of the pros and cons of antithrombotic therapy in chronic kidney disease (CKD) patients with atrial fibrillation. As the authors point out, even at baseline (i.e., before drug therapy), there is a fine line between thrombosis and bleeding in CKD patients. Consequently, clinicians are often faced with difficult antithrombotic dosing considerations to strike the appropriate balance between efficacy and bleeding.
My specific comment is in regard to the Central Illustration (Proposed Algorithm for Oral Anticoagulant Choices in Patients With Atrial Fibrillation and CKD). For apixaban, at creatinine clearance rate of 15 ml/min to 29 ml/min, the authors recommend an apixaban dose of 2.5 mg twice daily. The collaborating authors, all of whom are from European countries, are correct in their dosing recommendations. This dose, however, illustrates the difference between the U.S.- and European Union (E.U.)–approved labeling. For example, the U.S. Food and Drug Administration–approved label for apixaban (2) states that the 2.5 mg twice daily dose is indicated, not on a specific creatinine clearance rate, but rather when 2 of the following 3 criteria are met (age ≥80 years; body weight ≤60 kg; serum creatinine level ≥1.5 mg/dl [133 μmol/l]). Conversely, the E.U. Summary of Product Characteristics leaflet (3) for apixaban does recommend the 2.5 mg twice daily dose based on a creatinine clearance between 15 ml/min and 29 ml/min.
Thus, clinicians should be aware of the differences in apixaban dosing recommendations between the U.S. and E.U, specifically in patients with compromised renal function. Hopefully this letter provides some clarification. Again, congratulations to Dr. Lau and colleagues for publishing an excellent paper.
Please note: Dr. Brophy has reported that he has no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
- Lau Y.C.,
- Proietti M.,
- Guiducci E.,
- Blann A.D.,
- Lip G.Y.H.
- ↵Eliquis [Package insert, p6]. Princeton, NJ: Bristol-Myers Squibb; 2016.
- ↵Eliquis [Summary of Product Characteristics]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf. Accessed September 28, 2016.