Effects of the oral, direct factor Xa inhibitor apixaban on routine coagulation assays and anti-FXa assays

Journal of Thrombosis and Haemostasis

Volumn 12, Issue 9, 2014, Pages 1545-1553

  Hillarp, A ^a   Gustafsson, K M ^b   Faxalv L ^b   Strandberg, K ^a   Baghaei, F ^c,d   Fagerberg Blixter, I ^c,d   Berndtsson, M ^e   Lindahl, T L ^b  

^a Lund University   (Sweden)

^b LINKÖPING UNIVERSITY   (Sweden)

^c SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^d UNIVERSITY OF GOTHENBURG   (Sweden)

^e KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

Analysis; Anticogaulants; Apixaban; Blood coagulation tests; Factor Xa

Indexed keywords

ANTITHROMBIN; APIXABAN; PROTEIN C; PROTEIN S; RIVAROXABAN; BLOOD CLOTTING FACTOR 10A; BLOOD CLOTTING FACTOR 10A INHIBITOR; LUPUS ANTICOAGULANT; MORPHOLINE DERIVATIVE; PHOSPHOLIPID; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE; THIOPHENE DERIVATIVE;

ANTICOAGULATION; ARTICLE; BLOOD SAMPLING; DOSE RESPONSE; DRUG DETERMINATION; DRUG EFFECT; FEMALE; HUMAN; IN VITRO STUDY; MALE; NORMAL HUMAN; PARTIAL THROMBOPLASTIN TIME; PHASE 3 CLINICAL TRIAL; PROTHROMBIN TIME; BLOOD CLOTTING; CALIBRATION; CHEMISTRY; DRUG EFFECTS; INTERNATIONAL NORMALIZED RATIO; LABORATORY DIAGNOSIS; ORAL DRUG ADMINISTRATION; REPRODUCIBILITY;

ADMINISTRATION, ORAL; BLOOD COAGULATION; CALIBRATION; FACTOR XA; FACTOR XA INHIBITORS; FALSE POSITIVE REACTIONS; HEALTHY VOLUNTEERS; HUMANS; INTERNATIONAL NORMALIZED RATIO; LUPUS COAGULATION INHIBITOR; MORPHOLINES; PARTIAL THROMBOPLASTIN TIME; PHOSPHOLIPIDS; PROTEIN C; PROTEIN S; PROTHROMBIN TIME; PYRAZOLES; PYRIDONES; REPRODUCIBILITY OF RESULTS; THIOPHENES;

EID: 84908499973     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.12649     Document Type: Article

References (24)

1. Harder S, Graff J. Novel oral anticoagulants: clinical pharmacology, indications and practical considerations. Eur J Clin Pharmacol 2013; 69: 1617-33.
2. 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: S24-33.
3. Turpie AG. Oral, direct factor Xa inhibitors in development for the prevention and treatment of thromboembolic diseases. Arterioscler Thromb Vasc Biol 2007; 27: 1238-47.
4. Pinto DJ, Orwat MJ, Koch S, Rossi KA, Alexander RS, Smallwood A, Wong PC, Rendina AR, Luettgen JM, Knabb RM, He K, Xin B, Wexler RR, Lam PY. Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1Hpyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation factor Xa. J Med Chem 2007; 50: 5339-56.
5. de Souza Brito F, Lopes RD, Alexander JH. The safety and efficacy of apixaban: where do we stand in 2013? Expert Opin Drug Saf 2013; 12: 559-67.
6. Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013; 369: 799-808.
7. Becker RC, Alexander JH, Newby LK, Yang H, Barrett Y, Mohan P, Wang J, Harrington RA, Wallentin LC. Effect of apixaban, an oral and direct factor Xa inhibitor, on coagulation activity biomarkers following acute coronary syndrome. Thromb Haemost 2010; 104: 976-83.
8. Becker RC, Yang H, Barrett Y, Mohan P, Wang J, Wallentin L, Alexander JH. Chromogenic laboratory assays to measure the factor Xa-inhibiting properties of apixaban - an oral, direct and selective factor Xa inhibitor. J Thromb Thrombolysis 2011; 32:183-7.
9. Douxfils J, Chatelain C, Chatelain B, Dogne JM, Mullier F. Impact of apixaban on routine and specific coagulation assays: a practical laboratory guide. Thromb Haemost 2013; 110: 283-94.
10. Gouin-Thibault I, Flaujac C, Delavenne X, Quenet S, Horellou M-H, Laporte S, Siguret V, Lecompte T. Assessment of apixaban plasma levels by laboratory tests: suitability of three anti-Xa assays. A multicentre French GEHT study. Thromb Haemost 2014; 111: 240-8.
11. Lindahl TL, Baghaei F, Fagerberg Blixter I, Gustafsson KM, Stigendal L, Sten-Linder M, Strandberg K, Hillarp A. Effects of the oral, direct thrombin inhibitor dabigatran on five common coagulation assays. Thromb Haemost 2011; 105: 371-8.
12. Hillarp A, Baghaei F, Fagerberg Blixter I, Gustafsson KM, Stigendal L, Sten-Linder M, Strandberg K, Lindahl TL. Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays. J Thromb Haemost 2011; 9: 133-9.
13. Barrett YC, Wang J, Song Y, Pursley J, Wastall P, Wright R, Lacreta F, Frost C. A randomised assessment of the pharmacokinetic, pharmacodynamic and safety interaction between apixaban and enoxaparin in healthy subjects. Thromb Haemost 2012; 107: 916-24.
14. Frost C, Wang J, Nepal S, Schuster A, Barrett YC, Mosqueda-Garcia R, Reeves RA, LaCreta F. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol 2013; 75: 476-87.
15. Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation 2009; 119: 2877-85.
16. 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 a phase III trial dose. Clin Pharmacol Ther 2010; 88: 375-82.
17. Lindahl TL, Egberg N, Hillarp A, Odegaard OR, Edlund B, Svensson J, Sandset PM, Ranby M. INR calibration of Owrentype prothrombin time based on the relationship between PT% and INR utilizing normal plasma samples. Thromb Haemost 2004; 91: 1223-31.
18. Mani H, Rohde G, Stratmann G, Hesse C, Herth N, Schwers S, Perzborn E, Lindhof-Last E. Accurate determination of rivaroxaban levels requires different calibrator sets but not addition of antithrombin. Thromb Haemost 2012; 108: 191-8.
19. Jiang X, Crain EJ, Luettgen JM, Schumacher WA, Wong PC. Apixaban, an oral direct factor Xa inhibitor, inhibits human clot-bound factor Xa activity in vitro. Thromb Haemost 2009; 101: 780-2.
20. Wong PC, Crain EJ, Watson CA, Xin B. Favorable therapeutic index of the direct factor Xa inhibitors, apixaban and rivaroxaban, compared with the thrombin inhibitor dabigatran in rabbits. J Thromb Haemost 2009; 7: 1313-20.
21. Merriman E, Kaplan Z, Butler J, Malan E, Gan E, Tran H. Rivaroxaban and false positive lupus anticoagulant testing. Thromb Haemost 2011; 105: 385-6.
22. Halbmayer WM, Weigel G, Quehenberger P, Tomasits J, Haushofer AC, Aspoeck G, Loacker L, Schnapka-Koepf M, Goebel G, Griesmacher A. Interference of the new oral anticoagulant dabigatran with frequently used coagulation tests. Clin Chem Lab Med 2012; 50: 1601-5.
23. Martinuzzo ME, Barrera LH, D'adamo MA, Otaso JC, Gimenez MI, Oyhamburu J. Frequent false-positive results of lupus anticoagulant tests in plasmas of patients receiving the new oral anticoagulants and enoxaparin. Int J Lab Hematol 2014; 36:144-50.
24. Perzborn E, Strassburger J, Wilmen A, Pohlmann J, Roehrig S, Schlemmer KH, Straub A. In vitro and in vivo studies of the novel antithrombotic agent BAY 59-7939 - an oral, direct factor Xa inhibitor. J Thromb Haemost 2005; 3: 514-21.