Dabigatran Concentration: Variability and Potential Bleeding Prediction In "Real-Life" Patients With Atrial Fibrillation

Basic and Clinical Pharmacology and Toxicology

Volumn 117, Issue 5, 2015, Pages 323-329

  Šinigoj, Petra ^a   Malmström, Rickard E ^b   Vene, Nina ^a   Rönquist Nii, Yuko ^b   Božič Mijovski, Mojca ^a   Pohanka, Anton ^b   Antovic, Jovan P ^b   Mavri, Alenka ^a  

^a UNIVERSITY MEDICAL CENTRE LJUBLJANA   (Slovenia)

^b KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN; ANTITHROMBIN;

AGED; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; BLOOD CLOTTING TEST; CHADS2 SCORE; CLINICAL ARTICLE; CONTROLLED STUDY; CREATININE CLEARANCE; CYSTITIS; DRUG BLOOD LEVEL; EPISTAXIS; FEMALE; FOLLOW UP; HUMAN; LIQUID CHROMATOGRAPHY; MALE; MUCOSAL BLEEDING; OUTCOME ASSESSMENT; PARTIAL THROMBOPLASTIN TIME; PREDICTION; PREDICTIVE VALUE; PRIORITY JOURNAL; PROTHROMBIN TIME; RECTUM HEMORRHAGE; SKIN BLEEDING; TANDEM MASS SPECTROMETRY; TREATMENT RESPONSE; BLOOD; BLOOD CLOTTING; CHEMICALLY INDUCED; DRUG EFFECTS; DRUG MONITORING; MIDDLE AGED; PROCEDURES; REPRODUCIBILITY; RISK ASSESSMENT; RISK FACTOR; TIME FACTOR; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTITHROMBINS; ATRIAL FIBRILLATION; BLOOD COAGULATION; BLOOD COAGULATION TESTS; CHROMATOGRAPHY, LIQUID; DABIGATRAN; DRUG MONITORING; FEMALE; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; RISK FACTORS; TANDEM MASS SPECTROMETRY; TIME FACTORS; TREATMENT OUTCOME;

EID: 84943350695     PISSN: 17427835     EISSN: 17427843     Source Type: Journal    
DOI: 10.1111/bcpt.12417     Document Type: Article

References (20)

1. Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation - developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 2012;33:2719-47.
2. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 2008;47:285-95.
3. Stangier J, Clemens A. Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost 2009;15:9S-16S.
4. 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 (2014, December 1)
5. Baglin T, Hillarp A, Tripodi A, Elalamy I, Buller H, Ageno W. Measuring Oral Direct Inhibitors (ODIs) of thrombin and factor Xa: a recommendation from the Subcommittee on Control of Anticoagulation of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2013;11:756-60.
6. Antovic JP, Skeppholm M, Eintrei J, Boija EE, Soderblom 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.
7. vanRyn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M et al. Dabigatranetexilate - a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010;103:1116-27.
8. 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: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol 2014;63:321-8.
9. Katoh H, Nozue T, Asada T, Nakashima K, Kimura Y, Ito S et al. Frequency and predictors of bleeding complications associated with anti-coagulant therapy using dabigatran in Japanese patients with atrial fibrillation. Am J Cardiovasc Dis 2014;4:70-8.
10. Chan NC, Coppens M, Hirsh J, Ginsberg JS, Weitz JI, Vanassche T et al. Real-world variability in dabigatran levels in patients with atrial fibrillation. J Thromb Haemost 2015;13:353-9.
11. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro Heart Survey on Atrial Fibrillation. Chest 2010;137:263-72.
12. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess one-year risk of major bleeding in atrial fibrillation patients: the Euro Heart Survey. Chest 2010;138:1093-100.
13. Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in nonsurgical patients. J Thromb Haemost 2005;3:692-4.
14. Mehran R, Rao SV, Bhat DL, Gibson CM, Caixeta A, Eikelboom J et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011;123:2736-47.
15. Skeppholm M, Hjemdahl P, Antovic JP, Muhrbeck J, Eintrei J, Rönquist-Nii Y et al. On the monitoringofdabigatrantreatment in "real life" patients withatrialfibrillation. Thromb Res 2014;134:783-9.
16. Owada S, Tomita H, Kinjo T, Ishida Y, Itoh T, Sasaki K et al. CHA2DS2-VASc and HAS-BLED scores and activated partial thromboplastin time for prediction of high plasma concentration of dabigatran at trough. Thromb Res 2015;135:62-7.
17. Lip GY, Clemens A, Noack H, Ferreira J, Connolly SJ, Yusuf S. Patient outcomes using the European label for dabigatran. A post-hoc analysis from the RE-LY database. Thromb Haemost 2014;111:933-42.
18. Amin AP, Bachuwar A, Reid KJ, Chhatriwalla AK, Salisbury AC, Yeh RW et al. Nuisance bleeding with prolonged dual antiplatelet therapy after acute myocardial infarction and its impact on health status. J Am Coll Cardiol 2013;61:2130-8.
19. Roy P, Bonello L, Torguson R, de Labriolle A, Lemesle G, Slottow TL et al. Impact of "nuisance" bleeding on clopidogrel compliance in patients undergoing intracoronary drug-eluting stent implantation. Am J Cardiol 2008;102:1614-7.
20. Armero S, Bonello L, Berbis J, Camoin-Jau L, Lemesle G, Jacquin L et al. Rate of nuisance bleedings and impact on compliance to prasugrel in acute coronary syndromes. Am J Cardiol 2011;108:1710-3.