Population Pharmacokinetic Modelling of Apixaban in End-Stage Kidney Disease Patients with Atrial Fibrillation Receiving Haemodialysis

Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics-2019 update: a report from the American Heart Association. Circulation. 2019;139:e56-528.

Article  PubMed  Google Scholar 

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, et al. 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2021;42:373–498.

Article  PubMed  Google Scholar 

Zimmerman D, Sood MM, Rigatto C, Holden RM, Hiremath S, Clase CM. Systematic review and meta-analysis of incidence, prevalence and outcomes of atrial fibrillation in patients on dialysis. Nephrol Dial Transplant. 2012;27:3816–22.

Article  CAS  PubMed  Google Scholar 

Wizemann V, Tong L, Satayathum S, Disney A, Akiba T, Fissell RB, et al. Atrial fibrillation in hemodialysis patients: clinical features and associations with anticoagulant therapy. Kidney Int. 2010;77:1098–106.

Article  CAS  PubMed  Google Scholar 

De Vriese AS, Heine G. Anticoagulation management in haemodialysis patients with atrial fibrillation: evidence and opinion. Nephrol Dial Transplant. 2022;37:2072–9.

Article  PubMed  Google Scholar 

Chang M, Yu Z, Shenker A, Wang J, Pursley J, Byon W, et al. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of apixaban. J Clin Pharmacol. 2016;56:637–45.

Article  CAS  PubMed  Google Scholar 

Pokorney SD, Chertow GM, Al-Khalidi HR, Gallup D, Dignacco P, Mussina K, et al. Apixaban for patients with atrial fibrillation on hemodialysis: a multicenter randomized controlled trial. Circulation. 2022;146:1735–45.

Article  PubMed  Google Scholar 

Tseng CI, Roddick AJ, Bottomley MJ, Shapiro S, Udayaraj U. Safety and pharmacokinetic profile of apixaban in end-stage renal disease: a real-world analysis. EJHaem. 2023;4:291–3.

Article  CAS  PubMed  Google Scholar 

Van den Bosch I, Bouillon T, Verhamme P, Vanassche T, Jacquemin M, Coemans M, et al. Apixaban in patients on haemodialysis: a single-dose pharmacokinetics study. Nephrol Dial Transplant. 2021;36:884–9.

Article  PubMed  Google Scholar 

Wang X, Tirucherai G, Marbury TC, Wang J, Chang M, Zhang D, et al. Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis. J Clin Pharmacol. 2016;56:628–36.

Article  CAS  PubMed  Google Scholar 

Leven C, Ménard P, Gouin-Thibault I, Ballerie A, Lacut K, Ollier E, et al. Transferability of published population pharmacokinetic models for apixaban and rivaroxaban to subjects with obesity treated for venous thromboembolism: a systematic review and external evaluations. Pharmaceutics. 2023;15:665.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Albaladejo P, Bonhomme F, Blais N, Collet JP, Faraoni D, Fontana P, et al. Management of direct oral anticoagulants in patients undergoing elective surgeries and invasive procedures: updated guidelines from the French Working Group on Perioperative Hemostasis (GIHP)-September 2015. Anesth Réanim. 2016;2:414–20.

Article  Google Scholar 

Sunkara T, Ofori E, Zarubin V, Caughey ME, Gaduputi V, Reddy M. Perioperative management of direct oral anticoagulants (DOACs): a systemic review. Health Serv Insights. 2016;9s1:HIS.S407101.

Google Scholar 

Godier A, Dincq A-S, Martin A-C, Radu A, Leblanc I, Antona M, et al. Predictors of pre-procedural concentrations of direct oral anticoagulants: a prospective multicentre study. Eur Heart J. 2017;38:2431–9.

Article  CAS  PubMed  Google Scholar 

Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, et al. 2023 ACC/AHA/ACCP/HRS guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Circulation. 2024;149:e1-156.

Article  PubMed  Google Scholar 

Mavrakanas TA, Samer CF, Nessim SJ, Frisch G, Lipman ML. Apixaban pharmacokinetics at steady state in hemodialysis patients. J Am Soc Nephrol. 2017;28:2241–8.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Murakami M, Narita Y, Urata M, Ichigi M, Nakatani S, Kondo Y, et al. Improved formula for predicting hemodialyzability of intravenous and oral drugs. Blood Purif. 2021;50:865–75.

Article  CAS  PubMed  Google Scholar 

Tatarinova T, Neely M, Bartroff J, van Guilder M, Yamada W, Bayard D, et al. Two general methods for population pharmacokinetic modeling: non-parametric adaptive grid and non-parametric Bayesian. J Pharmacokinet Pharmacodyn. 2013;40:189–99.

Article  PubMed  PubMed Central  Google Scholar 

Neely MN, van Guilder MG, Yamada WM, Schumitzky A, Jelliffe RW. Accurate detection of outliers and subpopulations with Pmetrics, a nonparametric and parametric pharmacometric modeling and simulation package for R. Ther Drug Monit. 2012;34:467–76.

Article  PubMed  PubMed Central  Google Scholar 

Geoffroy M, Gozalo C, Konecki C, Pauvele L, Hittinger A, Pastorel N, et al. A new pharmacokinetic model of urinary methotrexate to assess adherence in rheumatoid arthritis. Biomed Pharmacother. 2023;168: 115620.

Article  CAS  PubMed  Google Scholar 

Merli GJ, Kraft WK, Eraso LH, Galanis T, Thomson LJ, Ouma GO, et al. Apixaban Discontinuation for Invasive Or major Surgical procedures (ADIOS): a prospective cohort study. Vasc Med. 2022;27:269–76.

Article  CAS  PubMed  Google Scholar 

Levy JH, Ageno W, Chan NC, Crowther M, Verhamme P, Weitz JI. When and how to use antidotes for the reversal of direct oral anticoagulants: guidance from the SSC of the ISTH. J Thromb Haemost. 2016;14:623–7.

Article  CAS  PubMed  Google Scholar 

Cirincione B, Kowalski K, Nielsen J, Roy A, Thanneer N, Byon W, et al. Population pharmacokinetics of apixaban in subjects with nonvalvular atrial fibrillation. CPT Pharmacomet Syst Pharmacol. 2018;7:728–38.

Article  CAS  Google Scholar 

Bristol-Myers Squibb/Pfizer. Eliquis product information. Available from: https://www.ema.europa.eu/fr/documents/product-information/eliquis-epar-product-information_fr.pdf. Accessed 8 Jan 2025.

Leil TA, Frost C, Wang X, Pfister M, LaCreta F. Model-based exposure-response analysis of apixaban to quantify bleeding risk in special populations of subjects undergoing orthopedic surgery. CPT Pharmacomet Syst Pharmacol. 2014;3: e136.

Article  CAS  Google Scholar 

Byon W, Sweeney K, Frost C, Boyd RA. Population pharmacokinetics, pharmacodynamics, and exploratory exposure-response analyses of apixaban in subjects treated for venous thromboembolism. CPT Pharmacomet Syst Pharmacol. 2017;6:340–9.

Article  CAS  Google Scholar 

Ueshima S, Hira D, Kimura Y, Fujii R, Tomitsuka C, Yamane T, et al. Population pharmacokinetics and pharmacogenomics of apixaban in Japanese adult patients with atrial fibrillation. Br J Clin Pharmacol. 2018;84:1301–12.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Goto E, Horinaka S, Ishimitsu T, Kato T. Factor Xa inhibitors in clinical practice: comparison of pharmacokinetic profiles. Drug Metab Pharmacokinet. 2020;35:151–9.

Article  CAS  PubMed  Google Scholar 

Andrews L, Benken S, Tan X, Wenzler E. Pharmacokinetics and dialytic clearance of apixaban during in vitro continuous renal replacement therapy. BMC Nephrol. 2021;22:45.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Leil TA, Feng Y, Zhang L, Paccaly A, Mohan P, Pfister M. Quantification of apixaban’s therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose. Clin Pharmacol Ther. 2010;88:375–82.

Article  CAS  PubMed  Google Scholar 

Stanifer JW, Pokorney SD, Chertow GM, Hohnloser SH, Wojdyla DM, Garonzik S, et al. Apixaban versus warfarin in patients with atrial fibrillation and advanced chronic kidney disease. Circulation. 2020;141:1384–92.

Article  CAS  PubMed  Google Scholar 

Société Française de Médecine d’Urgence, Société Française d’Anesthésie-Réanimation et médecine péri-opératoire, Groupe d’Intérêt en Hémostase Péri-opératoire, Société Française de Thrombose et d’Hémostase. Guidelines on the management of anticoagulant in emergency setting. 2024. Available from: https://sfar.org/gestion-de-lanticoagulation-dans-un-contexte-durgence/. Accessed 29 Apr 2024.

Gibert A, Lanoiselée J, Janisset L, Pernod G, Ollier E, Delavenne X. Development of a Bayesian estimation tool to determine the optimal duration of apixaban discontinuation before a high-bleeding risk procedure. Fundam Clin Pharm. 2022;36:898–907.

Comments (0)

No login
gif