Population pharmacokinetics of edoxaban and its main metabolite in a dedicated renal impairment study

Journal of Clinical Pharmacology

Volumn 55, Issue 11, 2015, Pages 1268-1279

  Jönsson, Siv ^a   Simonsson, Ulrika S H ^a   Miller, Raymond ^b   Karlsson, Mats O ^a  

^a UPPSALA UNIVERSITY   (Sweden)

^b DAIICHI SANKYO INC   (United States)

Author keywords

edoxaban; metabolite; NONMEM; pharmacokinetic; renal impairment

Indexed keywords

DRUG METABOLITE; EDOXABAN; BLOOD CLOTTING FACTOR 10A INHIBITOR; PYRIDINE DERIVATIVE; THIAZOLE DERIVATIVE;

ABSORPTION RATE CONSTANT; ADULT; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; COMPARTMENT MODEL; CREATININE CLEARANCE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG URINE LEVEL; END STAGE RENAL DISEASE; FEMALE; HUMAN; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MILD RENAL IMPAIRMENT; MODERATE RENAL IMPAIRMENT; PERIPHERAL VOLUME OF DISTRIBUTION; PREDICTION; RENAL CLEARANCE; SEVERE RENAL IMPAIRMENT; SINGLE DRUG DOSE; AGED; BIOLOGICAL MODEL; BLOOD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; KIDNEY FAILURE; METABOLISM; MIDDLE AGED; URINE;

ADULT; AGED; DOSE-RESPONSE RELATIONSHIP, DRUG; FACTOR XA INHIBITORS; FEMALE; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; PYRIDINES; RENAL INSUFFICIENCY; THIAZOLES;

EID: 84942986160     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.541     Document Type: Article

References (32)

1. Furugohri T, Isobe K, Honda Y, et al., DU-176b, a potent and orally active factor Xa inhibitor: in vitro and in vivo pharmacological profiles. J Thromb Haemost. 2008; 6 (9): 1542-1549.
2. Giugliano RP, Ruff CT, Braunwald E, et al., Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013; 369 (22): 2093-2104.
3. Buller HR, Decousus H, Grosso MA, et al., Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013; 369 (15): 1406-1415.
4. Ogata K, Mendell-Harary J, Tachibana M, et al., Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol. 2010; 50 (7): 743-753.
5. Matsushima N, Lee F, Sato T, Weiss D, Mendell J., Bioavailability and safety of the factor Xa inhibitor edoxaban and the effects of quinidine in healthy subjects. Clin Pharmacol Drug Dev. 2013; 2 (4): 358-366.
6. Mendell J, Tachibana M, Shi M, Kunitada S., Effects of food on the pharmacokinetics of edoxaban, an oral direct factor Xa inhibitor, in healthy volunteers. J Clin Pharmacol. 2011; 51 (5): 687-694.
7. Mendell J, Chen S, He L, Parasrampuria D., Abstracts of the 60th Annual Meeting of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis June 23-26, 2014. J Thromb Haemost. 2009; 12 (abstract COA26): 17.
8. Mendell J, Zahir H, Matsushima N, et al., Drug-drug interaction studies of cardiovascular drugs involving P-glycoprotein, an efflux transporter, on the pharmacokinetics of edoxaban, an oral factor Xa inhibitor. Am J Cardiovasc Drugs. 2013; 13 (5): 331-342.
9. Mikkaichi T, Yoshigae Y, Masumoto H, et al., Edoxaban transport via P-glycoprotein is a key factor for the drug's disposition. Drug Metab Dispos. 2014; 42 (4): 520-528.
10. Bathala MS, Masumoto H, Oguma T, He L, Lowrie C, Mendell J., Pharmacokinetics, biotransformation, and mass balance of edoxaban, a selective, direct factor Xa inhibitor, in humans. Drug Metab Dispos. 2012; 40 (12): 2250-2255.
11. Mendell J, Johnson L, Ridout G, He L, Chen S,. An open-label, phase 1 study to evaluate the effects of hepatic impairment on edoxaban pharmacokinetics. Eur Heart J. 2012; 33 (Suppl 1, abstract 2024): 343.
12. Ridout G, de la Motte S, Niemczyk S, et al., Abstracts: Thirty-Eighth Annual Meeting American College of Clinical Pharmacology September 13-15, 2009, San Antonio, Texas. J Clin Pharmacol. 2009; 49 (abstract 144): 1091-1130.
13. Salazar DE, Mendell J, Kastrissios H, et al., Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012; 107 (5): 925-936.
14. Cockcroft DW, Gault MH., Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16 (1): 31-41.
15. NONMEM User's Guides. (1989-2009) [computer program]. Ellicott City, Maryland: Icon Development Solutions; 2009.
16. R Core Team. R: A Language and Environment for Statistical Computing [computer program]. Vienna, Austria: R Foundation for Statistical Computing; 2014.
17. Keizer RJ, Karlsson MO, Hooker A., Modeling and simulation workbench for NONMEM: tutorial on Pirana, PsN, and Xpose. CPT Pharmacometrics Syst Pharmacol. 2013; 2: e50.
18. Lindbom L, Pihlgren P, Jonsson EN., PsN-Toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005; 79 (3): 241-257.
19. Lindbom L, Ribbing J, Jonsson EN., Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed. 2004; 75 (2): 85-94.
20. Savic RM, Jonker DM, Kerbusch T, Karlsson MO., Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J Pharmacokinet Pharmacodyn. 2007; 34 (5): 711-726.
21. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO,. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011; 13 (2): 143-151.
22. Holford N., The Visual Predictive Check-Superiority to Standard Diagnostic (Rorschach) Plots. Abstract 738. http://www.page-meeting.org/?abstract=738. Accessed November 26, 2014.
23. Karlsson MO, Holford N., A Tutorial on Visual Predictive Checks. Abstract 1434. http://www.page-meeting.org/?abstract=1434. Accessed November 26, 2014.
24. Savic RM, Karlsson MO., Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J. 2009; 11 (3): 558-569.
25. Anderson BJ, Holford NH., Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008; 48: 303-332.
26. Yin OQ, Miller R., Population pharmacokinetics and dose-exposure proportionality of edoxaban in healthy volunteers. Clin Drug Investig. 2014; 34 (10): 743-752.
27. Yin OQ, Tetsuya K, Miller R., Edoxaban population pharmacokinetics and exposure-response analysis in patients with non-valvular atrial fibrillation. Eur J Clin Pharmacol. 2014; 70 (11): 1339-1351.
28. Rohatagi S, Mendell J, Kastrissios H, et al., Characterisation of exposure versus response of edoxaban in patients undergoing total hip replacement surgery. Thromb Haemost. 2012; 108 (5): 887-895.
29. Song S, Kang D, Halim AB, Miller R., Population pharmacokinetic-pharmacodynamic modeling analysis of intrinsic FXa and bleeding from edoxaban treatment. J Clin Pharmacol. 2014; 54 (8): 910-916.
30. Savaysa (edoxaban tosylate monohydrate) Capsules [package insert]. Tokyo, Japan: Daiichi Sankyo Co., Inc.; 2015.
31. Ahn JE, Karlsson MO, Dunne A, Ludden TM., Likelihood based approaches to handling data below the quantification limit using NONMEM VI. J Pharmacokinet Pharmacodyn. 2008; 35 (4): 401-421.
32. Beal SL,. Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn. 2001; 28 (5): 481-504.