Comparison between the impact of morning and evening doses of rivaroxaban on the circadian endogenous coagulation rhythm in healthy subjects

Journal of Thrombosis and Haemostasis

Volumn 14, Issue 2, 2016, Pages 316-323

  Brunner Ziegler, S ^a   Jilma, Bernd ^a   Schorgenhofer C ^a   Winkler, F ^a   Jilma Stohlawetz, P ^a   Koppensteiner, R ^a   Quehenberger, P ^a   Seger, C ^b   Weigel, G ^b   Griesmacher, A ^b   Brunner, M ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b Central Institute for Medical and Chemical Laboratory Diagnostics   (Austria)

Author keywords

Blood coagulation; Chronotherapy; Circadian rhythm; Prothrombin activation fragment F1+2; Rivaroxaban

Indexed keywords

BLOOD CLOTTING FACTOR 10A; RIVAROXABAN; BLOOD CLOTTING FACTOR 10A INHIBITOR;

ADULT; ANTICOAGULATION; ARTICLE; CIRCADIAN RHYTHM; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; DRUG RESPONSE; DRUG TOLERABILITY; EVENING DOSAGE; FEMALE; FIBRINOLYSIS; HUMAN; HUMAN EXPERIMENT; HYPOFIBRINOLYSIS; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MORNING DOSAGE; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; THROMBOCYTE VOLUME; TREATMENT OUTCOME; YOUNG ADULT; BLOOD; BLOOD CLOTTING; BLOOD CLOTTING TEST; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG ADMINISTRATION; DRUG EFFECTS; DRUG MONITORING; PREDICTIVE VALUE; PROCEDURES; TIME FACTOR;

ADULT; BLOOD COAGULATION; BLOOD COAGULATION TESTS; CHROMATOGRAPHY, LIQUID; CIRCADIAN RHYTHM; DRUG ADMINISTRATION SCHEDULE; DRUG MONITORING; FACTOR XA INHIBITORS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; MALE; MASS SPECTROMETRY; PREDICTIVE VALUE OF TESTS; RIVAROXABAN; TIME FACTORS; YOUNG ADULT;

EID: 84958259596     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.13213     Document Type: Article

References (34)

1. 1+2, and plasmin-plasmin inhibitor complex. Circulation 1997; 96: 19-21.
2. Rosing DR, Brakman P, Redwood DR, Goldstein RE, Beiser GD, Astrup T, Epstein SE. Blood fibrinolytic activity in man. Diurnal variation and the response to varying intensities of exercise. Circ Res 1970; 27: 171-84.
3. Fearnly G, Balmforth G, Fearnley E. Evidence of a diurnal fibrinolytic rhythm; with a simple method of measuring natural fibrinolysis. Clin Sci 1957; 16: 645-50.
4. Andreotti F, Kluft C. Circadian variation of fibrinolytic activity in blood. Chronobiol Int 1991; 8: 336-51.
5. Pinotti M, Bertolucci C, Portaluppi F, Colognesi I, Frigato E, Foà A, Bernardi F. Daily and circadian rhythms of tissue factor pathway inhibitor and factor VII activity. Arterioscler Thromb Vasc Biol 2005; 25: 646-9.
6. Angleton P, Chandler WL, Schmer G. Diurnal variation of tissue-type plasminogen activator and its rapid inhibitor (PAI-1). Circulation 1989; 79: 101-6.
7. Haus E. Chronobiology of hemostasis and inferences for the chronotherapy of coagulation disorders and thrombosis prevention. Adv Drug Deliv Rev 2007; 59: 966-84.
8. Broze GJ Jr. Tissue factor pathway inhibitor and the revised theory of coagulation. Annu Rev Med 1995; 46: 103-12.
9. Blombäck M, Konkle BA, Manco-Johnson MJ, Bremme K, Hellgren M, Kaaja R; ISTH SSC Subcommittee on Women's Health Issues. Preanalytical conditions that affect coagulation testing, including hormonal status and therapy. J Thromb Haemost 2007; 5: 855-8.
10. Bleske BE, Welage LS, Warren EW, Brown MB, Shea MJ. Variations in prothrombin time and international normalized ratio over 24 hours in warfarin-treated patients. Pharmacotherapy 1995; 15: 709-12.
11. Kubitza D, Becka M, Mueck W, Zuehlsdorf M. Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban-an oral, direct factor Xa inhibitor-are not affected by aspirin. J Clin Pharmacol 2006; 46: 981-90.
12. Lai A, Davidson N, Galloway SW, Thachil J. Perioperative management of patients on new oral anticoagulants. Br J Surg 2014; 101: 742-9.
13. Hollenstein U, Homoncik M, Knöbl P, Pernerstorfer T, Graggaber J, Eichler HG, Handler S, Jilma B. Acenocoumarol decreases tissue factor-dependent coagulation during systemic inflammation in humans. Clin Pharmacol Ther 2002; 71: 368-74.
14. Schmitz EM, Boonen K, van den Heuvel DJ, van Dongen JL, Schellings MW, Emmen JM, van der Graaf F, Brunsveld L, van de Kerkhof D. Determination of dabigatran, rivaroxaban and apixaban by ultra-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) and coagulation assays for therapy monitoring of novel direct oral anticoagulants. J Thromb Haemost 2014; 12: 1636-46.
15. Douxfils J, Tamigniau A, Chatelain B, Chatelain C, Wallemacq P, Dogné JM, Mullier F. Comparison of calibrated chromogenic anti-Xa assay and PT tests with LC-MS/MS for the therapeutic monitoring of patients treated with rivaroxaban. Thromb Haemost 2013; 110: 723-31.
16. Königsbrügge O, Quehenberger P, Belik S, Weigel G, Seger C, Griesmacher A, Pabinger I, Ay C. Anti-coagulation assessment with prothrombin time and anti-Xa assays in real-world patients on treatment with rivaroxaban. Ann Hematol 2015; 94: 1463-71.
17. Derhaschnig U, Reiter R, Knöbl P, Baumgartner M, Keen P, Jilma B. Recombinant human activated protein C (rhAPC; drotrecogin alfa [activated]) has minimal effect on markers of coagulation, fibrinolysis, and inflammation in acute human endotoxemia. Blood 2003; 102: 2093-8.
18. Hollenstein U, Pernerstorfer T, Homoncik M, Hansen JB, Finzen H, Handler S, Jilma B. Effect of factor X inhibition on coagulation activation and cytokine induction in human systemic inflammation. J Infect Dis 2002; 186: 1270-6.
19. Stampfuss J, Kubitza D, Becka M, Mueck W. The effect of food on the absorption and pharmacokinetics of rivaroxaban. Int J Clin Pharmacol Ther 2013; 51: 549-61.
20. Ohno M, Yamaguchi I, Ito T, Saiki K, Yamamoto I, Azuma J. Circadian variation of the urinary 6beta-hydroxycortisol to cortisol ratio that would reflect hepatic CYP3A activity. Eur J Clin Pharmacol 2000; 55: 861-5.
21. Freyburger G, Macouillard G, Labrouche S, Sztark F. Coagulation parameters in patients receiving dabigatran etexilate or rivaroxaban: two observational studies in patients undergoing total hip or total knee replacement. Thromb Res 2011; 127: 457-65.
22. Perera V, Gross AS, McLachlan AJ. Diurnal variation in CYP1A2 enzyme activity in South Asians and Europeans. J Pharm Pharmacol 2013; 65: 264-70.
23. Graff J, Harder S. Anticoagulant therapy with the oral direct factor Xa inhibitors rivaroxaban, apixaban and edoxaban and the thrombin inhibitor dabigatran etexilate in patients with hepatic impairment. Clin Pharmacokinet 2013; 52: 243-54.
24. Yamazaki S, Numano R, Abe M, Hida A, Takahashi R, Veda M, Block GD, Sakaki Y, Menaker M, Tei H. Resetting central and peripheral circadian oscillators in transgenic rats. Science 2000; 288: 682-5.
25. Sakamoto K, Ishida N. Light-induced phase-shifts in the circadian expression rhythm of mammalian period genes in the mouse heart. Eur J Neurosci 2000; 12: 4003-6.
26. Damiola F, Le Minh N, Preitner N, Kornmann B, Fleury-Olela F, Schibler U. Restricted feeding uncouples circadian oscillators in peripheral tissues from the central pacemaker in the suprachiasmatic nucleus. Genes Dev 2000; 14: 2950-61.
27. Krulder JW, de Boer A, van den Besselaar AM, Cohen AF, Schoemaker HC, Briët E, Meinders AE. Diurnal rhythm in anticoagulant effect of heparin during a low dose constant rate infusion. A study in healthy volunteers. Thromb Haemost 1992; 6: 68.
28. Eberlin M, Otto G, Krämer I. Increased medication compliance of liver transplant patients switched from a twice-daily to a once-daily tacrolimus-based immunosuppressive regimen. Transplant Proc 2013; 45: 2314-20.
29. Smolensky MH, Hermida RC, Ayala DE, Tiseo R, Portaluppi F. Administration-time-dependent effect of blood pressure-lowering medications: basis for the chronotherapy of hypertension. Blood Press Monit 2010; 15: 173-80.
30. Hermida RC, Ayala DE, Mojón A, Fernández JR. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int 2010; 27: 1629-51.
31. Salles GF, Cardoso CR, Muxfeldt ES. Prognostic influence of office and ambulatory blood pressures in resistant hypertension. Arch Intern Med 2008; 168: 2340-6.
32. de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallarés V, Sarría A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension 2009; 53: 466-72.
33. Gheorghiade M, Thyssen A, Zolynas R, Nadar VK, Greenberg BH, Mehra M, Sun X, Tian H, Plotnikov AN, Burton P. Pharmacokinetics and pharmacodynamics of rivaroxaban and its effect on biomarkers of hypercoagulability in patients with chronic heart failure. J Heart Lung Transplant 2011; 30: 218-26.
34. European Medicines Agency. Evaluation of Medicines for Human Use, CHMP assessment report for xarelto; Doc. Ref.: EMEA/543519/2008.