Measurement of the direct oral anticoagulants apixaban, dabigatran, edoxaban, and rivaroxaban in human plasma using turbulent flow liquid chromatography with high-resolution mass spectrometry

Therapeutic Drug Monitoring

Volumn 36, Issue 5, 2014, Pages 597-605

  Gous, Tracey ^a   Couchman, Lewis ^a,b   Patel, Jignesh P ^b,c   Paradzai, Chitongo ^c   Arya, Roopen ^c   Flanagan, Robert J ^a  

^a KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^b KING'S COLLEGE LONDON   (United Kingdom)

^c KING S COLLEGE HOSPITAL   (United Kingdom)

Author keywords

apixaban; dabigatran; direct oral anticoagulants; edoxaban; liquid chromatography high resolution mass spectrometry; rivaroxaban; therapeutic drug monitoring

Indexed keywords

ACETONITRILE; AMMONIUM ACETATE; APIXABAN; DABIGATRAN ETEXILATE; EDOXABAN; METHANOL; RIVAROXABAN; ANTICOAGULANT AGENT; BENZIMIDAZOLE DERIVATIVE; BETA ALANINE; DABIGATRAN; MORPHOLINE DERIVATIVE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE; PYRIDONE DERIVATIVE; THIAZOLE DERIVATIVE; THIOPHENE DERIVATIVE;

AGED; ARTICLE; CALIBRATION; CENTRIFUGATION; CLINICAL ARTICLE; DRUG ABSORPTION; DRUG HALF LIFE; FEMALE; HUMAN; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PLASMA; PRIORITY JOURNAL; QUALITY CONTROL; ROOM TEMPERATURE; STANDARD; STORAGE; SUPERNATANT; TIME TO MAXIMUM PLASMA CONCENTRATION; TURBULENT FLOW; VERY ELDERLY; ANALOGS AND DERIVATIVES; BLOOD; CHEMICAL STRUCTURE; CHEMISTRY; PROCEDURES;

ANTICOAGULANTS; BENZIMIDAZOLES; BETA-ALANINE; CHROMATOGRAPHY, LIQUID; HUMANS; MASS SPECTROMETRY; MOLECULAR STRUCTURE; MORPHOLINES; PYRAZOLES; PYRIDINES; PYRIDONES; THIAZOLES; THIOPHENES;

EID: 84930183306     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0000000000000059     Document Type: Article

References (34)

1. Kuruvilla M, Gurk-Turner C. A review of warfarin dosing and monitoring. Proc (Bayl Univ Med Cent). 2001;14:305-306.
2. Royal Pharmaceutical Society of Great Britain and British Medical Association. British National Formulary. 66th ed. London: Pharmaceutical Press; 2013.
3. Holford NH. Clinical pharmacokinetics and pharmacodynamics of warfarin. Clin Pharmacokinet. 1986;11:483-504.
4. Baglin T, Keeling D, Kitchen S. Effects on routine coagulation screens and assessment of anticoagulant intensity in patients taking oral dabigatran or rivaroxaban: guidance from the British Committee for Standards in Haematology. Br J Haematol. 2012;159:427-429.
5. Schulman S. Advantages and limitations of the new anticoagulants. J Intern Med. 2014;275:1-11.
6. Ten Cate H. New oral anticoagulants: discussion on monitoring and adherence should start now! Thromb J. 2013;11:8-12.
7. MHRA. Drug safety update-dabigatran. 2011;5:A2. Available at: http:// www. mhra. gov. uk/Safetyinformation/DrugSafetyUpdate/CON137771. Accessed June 24, 2013.
8. Harper P, Young L, Merriman E. Bleeding risk with dabigatran in the frail elderly. N Engl J Med. 2012;366:864-866.
9. Pernod G, Albaladejo P, Godier A, et al. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors. Proposals of the Working Group on Perioperative Haemostasis (GIHP). Ann Fr Anesth Reanim. 2013;32:691-700.
10. Gong IY, Kim RB. Importance of pharmacokinetic profile and variability as determinants of dose and response to dabigatran, rivaroxaban, and apixaban. Can J Cardiol. 2013;29(7 suppl):S24-S33.
11. 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;13:331-342.
12. van Ryn J, Strangler J, Haertter S, et al. Dabigatran etexilate-a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemostas. 2010;103:1116-1127.
13. Douxfils J, Mullier F, Loosen C, et al. Assessment of the impact of rivaroxaban on coagulation assays: laboratory recommendations for the monitoring of rivaroxaban and review of the literature. Thromb Res. 2012;130:956-966.
14. Douxfils J, Muller F, Robert S, et al. Impact of dabigatran on a large panel of routine or specific coagulation assays-laboratory recommendations for monitoring of dabigatran etexilate. Thromb Haemostas. 2012;107:985-997.
15. Samama MM, Amiral J, Guinet C, et al. Monitoring plasma levels of factor Xa inhibitors: how, why and when? Expert Rev Hematol. 2013;6:155-164.
16. Douxfils J, Chatelain C, Chatelain B, et al. Impact of apixaban on routine and specific coagulation assays: A practical laboratory guide. Thromb Haemost. 2013;110:283-294.
17. Rohde G. Determination of rivaroxaban-a novel, oral, direct factor Xa inhibitor-in human plasma by high performance liquid chromatography-tandem mass spectrometry. J Chromatogr B. 2008;872:43-50.
18. Blech S, Ebner T, Ludwig-Schwellinger E, et al. The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran, in humans. Drug Metab Dispos. 2008;36:386-399.
19. Antovic JP, Skeppholm M, Eintrei J, et al. Evaluation of coagulation assays versus LC-MS/MS for determinations of dabigatran concentrations in plasma. Eur J Clin Pharmacol. 2013;69:1875-1881.
20. Douxfils J, Dogne JM, Mullier F, et al. Comparison of calibrated dilute thrombin time and aPTT tests with LC-MS/MS for the therapeutic drug monitoring of patients treated with dabigatran etexilate. Thromb Haemost. 2013;110:543-549.
21. Douxfils J, Tamigniau A, Chatelain B, et al. Comparison of calibrated chromogenic anti-Xa assay and PT tests with LC-MS/MS for the therapeutic drug monitoring of patients treated with rivaroxaban. Thromb Haemost. 2013;110:723-731.
22. Bathala MS, Masumoto H, Oguma T, et al. Pharmacokinetics, biotransformation, and mass balance of edoxaban, a selective, direct factor Xa inhibitor, in humans. Drug Metab Dispos. 2012;40:2250-2255.
23. Delavenne X, Mismetti P, Basset T. Rapid determination of apixaban concentration in human plasma by liquid chromatography/tandem mass spectrometry: Application to pharmacokinetic study. J Pharm Biomed Anal. 2013;78-79:150-153.
24. Palladino M, Merli G, Thomson L. Evaluation of the oral direct factor Xa inhibitor-betrixaban. Expert Opin Investig Drugs. 2013;22:1465-1472.
25. Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER). Guidance for industry. Bioanal Method Validation. 2001. Available at: http://www. fda. gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070107. pdf. Accessed September 1, 2013.
26. Polettini A. Applications of LC-MS in Toxicology. London: Pharmaceutical Press; 2006.
27. Bonfiglio R, King RC, Olah TV, et al. The effects of sample preparation on the variability of electrospray ionization response for model drug compounds. Rapid Commun Mass Spectrom. 1999;13:1175-1185.
28. Frost C, Wang J, Nepal S, et al. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol. 2013;75:476-487.
29. Mani H, Hesse C, Stratmann G, et al. Rivaroxaban differentially influences ex vivo coagulation assays based on the administration time. Thromb Haemost. 2011;106:156-164.
30. Ebner T, Wagner K, Wienen W. Dabigatran acylglucuronide, the major human metabolite of dabigatran: in vitro formation, stability, and pharmacological activity. Drug Metab Dispos. 2010;38:1567-1575.
31. Herman JL. Generic approach to high throughput ADME screening for lead candidate optimization. Int J Mass Spectrom. 2004;238:107-117.
32. Couchman L. Turbulent flow chromatography in bioanalysis: A review. Biomed Chromatogr. 2012;26:892-905.
33. He X, Kozak M. Development of a liquid chromatography-tandem mass spectrometry method for plasma-free metanephrines with ion-pairing turbulent flow online extraction. Anal Bioanal Chem. 2012;403:3003-3010.
34. Couchman L, Belsey SL, Handley SA, et al. A novel approach to quantitative LC-MS/MS: Therapeutic drug monitoring of clozapine and norclozapine using isotopic internal calibration. Anal Bioanal Chem. 2013; 405:9455-9466.