On the monitoring of dabigatran treatment in "real life" patients with atrial fibrillation

Thrombosis Research

Volumn 134, Issue 4, 2014, Pages 783-789

  Skeppholm, Mika ^a,b,c   Hjemdahl, Paul ^a   Antovic, Jovan P ^a,c   Muhrbeck, Josephine ^b,c   Eintrei, Jaak ^a,c   Rönquist Nii, Yuko ^a   Pohanka, Anton ^a   Beck, Olof ^a   Malmström, Rickard E ^a  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b DANDERYD HOSPITAL   (Sweden)

^c KAROLINSKA INSTITUTE   (Sweden)

Author keywords

aPTT; Dabigatran; Drug concentration; ECA; Hemoclot; LC MS MS

Indexed keywords

DABIGATRAN; ANTITHROMBIN; BENZIMIDAZOLE DERIVATIVE; BETA ALANINE;

ACCURACY; AGED; ANALYTIC METHOD; ARTICLE; BLEEDING; BLOOD CLOTTING TEST; BODY WEIGHT; CHADS2 SCORE; CREATININE CLEARANCE; DRUG BLOOD LEVEL; DRUG MONITORING; FEMALE; HEART ATRIUM FIBRILLATION; HEMATOLOGY TEST KIT; HUMAN; INTERNATIONAL NORMALIZED RATIO; KIDNEY FUNCTION; LIQUID CHROMATOGRAPHY; MAJOR CLINICAL STUDY; MALE; PARTIAL THROMBOPLASTIN TIME; RISK ASSESSMENT; TANDEM MASS SPECTROMETRY; ANALOGS AND DERIVATIVES; ATRIAL FIBRILLATION; BLOOD; MIDDLE AGED;

AGED; ANTITHROMBINS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; BETA-ALANINE; BLOOD COAGULATION TESTS; CHROMATOGRAPHY, LIQUID; DRUG MONITORING; FEMALE; HUMANS; MALE; MIDDLE AGED; TANDEM MASS SPECTROMETRY;

EID: 84908138564     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2014.06.016     Document Type: Article

References (24)

1. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146:857-67.
2. European Heart Rhythm Association, European Association for Cardio-Thoracic Surgery, Camm AJ, Kirchhof P, Lip GY, Schotten U, et al. ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace 2010;12:1360-420.
3. Agarwal S, Hachamovitch R, Menon V. Current trial-associated outcomes with warfarin in prevention of stroke in patients with nonvalvular atrial fibrillation. Arch Intern Med 2012;172:623-31.
4. Morgan CL, McEwan P, Tukiendorf A, Robinson PA, Clemens A, Plumb JM. Warfarin treatment in patients with atrial fibrillation: observing outcomes associated with varying levels of INR control. Thromb Res 2009;124:37-41.
5. ten Cate Hugo. Monitoring new oral anticoagulants, managing thrombosis, or both? Thromb Haemost 2012;107:803-5.
6. Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, et al. 2012 focused update of the ESC Guidelinel European Heart Rhythm Association. Eur Heart J 2012;33:2719-47.
7. Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013;15:625-51.
8. Stangier J, Clemens A. Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost 2009;15(Suppl. 1):9S-16S.
9. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51.
10. Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010;376:975-83.
11. F.D.A. SUMMARY REVIEW for PRADAXA; 2010.
12. Reilly PA, Lehr T, Haertter S, Connolly SJ, Yusuf S, Eikelboom JW, et al. The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients in the RE-LY Trial. J Am Coll Cardiol 2014;63:321-8.
13. Antovic JP, Skeppholm M, Eintrei J, Boija EE, Söderblom L, Norberg EM, et al. Evaluation of coagulation assays versus LC-MS/MS for determinations of dabigatran concentrations in plasma. Eur J Clin Pharmacol 2013;69:1875-81.
14. Douxfils J, Dogné JM, Mullier F, Chatelain B, Rönquist-Nii Y, Malmström RE, et al. Comparison of calibrated dilute thrombin time and aPTT tests with LC-MS/MS for the therapeutic monitoring of patients treated with dabigatran etexilate. Thromb Haemost 2013;110:543-9.
15. E.M.A.. EU - Summary of Product Characteristic: PRADAXA. http://www.emea.europa.eu/docs/en-GB/document-library/EPAR---Product-Information/human/000829/WC500041059.pdf.
16. Stangier J, Rathgen K, Stahle H, Gansser D, Roth W. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 2007;64:292-303.
17. Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med 2013;369:1206-14.
18. Stangier J, Rathgen K, Stahle H, Mazur D. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study. Clin Pharmacokinet 2010;49:259-68.
19. Olesen JB, Lip GY, Kamper AL, Hommel K, Køber L, Lane DA, et al. Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med 2012;367:625-35.
20. Hijazi Z, Hohnloser SH, Oldgren J, Andersson U, Connolly SJ, Eikelboom JW, et al. Efficacy and Safety of Dabigatran Compared with Warfarin in Relation to Baseline Renal Function in Patients with Atrial Fibrillation: A RE-LY Trial Analysis. Circulation 2014;129:961-70.
21. Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, et al. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation 2012;126:343-8.
22. van Ryn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, et al. Dabigatran etexilate-a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010;103:1116-27 [Review].
23. Garcia D, Barrett YC, Ramaciotti E, Weitz Ji. Laboratory assessment of the anticoagulant effects of the next generation of oral anticoagulants. J Thromb Haemost 2013;11:245-52.
24. Helin TA, Pakkanen A, Lassila R, Joutsi-Korhonen L. Laboratory assessment of novel oral anticoagulants: method suitability and variability between coagulation laboratories. Clin Chem 2013;59:807-14.