title: Monitoring of dabigatran therapy using Hemoclot(®) Thrombin Inhibitor assay in patients with atrial fibrillation.
abstract: Dabigatran, a new direct thrombin inhibitor, achieves strong anticoagulation that is more predictable than warfarin. Nevertheless, a patient on dabigatran therapy (DT) may suffer from thrombotic or bleeding events. The routine monitoring of DT is not recommended, and standard coagulation tests are not sensitive enough for the assessment of DT activity. The aim of this study was to examine the clinical usefulness of the Hemoclot(®) Thrombin Inhibitor (HTI) assay in the assessment of dabigatran plasma levels in patients with non-valvular AF. Nineteen patients (12 men, 7 women) on DT were included in this preliminary prospective observational study. Dabigatran was administrated twice daily in a two dose regimens: 150 mg (5 patients) and 110 mg (14 patients). Blood samples were taken for the assessment of trough and peak levels of dabigatran. Dabigatran concentrations were measured with the HTI assay. The average dabigatran trough level was 69.3 ± 55.5 ng/ml and the average dabigatran peak level was 112.7 ± 66.6 ng/ml. The dabigatran trough plasma concentration was in the established reference range in 15 patients and the dabigatran peak plasma concentration was in the established reference range in 9 patients, respectively. Despite the fact that the activated partial thromboplastin and thrombin times were generally changed (prolonged), these tests failed to identify the patients with too low or too high dabigatran concentrations. The study confirmed the high sensitivity of the HTI assay for the assessment of dabigatran plasma levels. When compared to standard coagulation tests, the HTI is a more suitable assay for the monitoring of patients treated with dabigatran. Monitoring of DT may be beneficial in selected patients; however, further studies will be needed for the final clarification of this issue.
authors.affiliation: Department of Internal Medicine I, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, Kollárova 2, 036 59, Martin, Slovak Republic, matej.samos@gmail.com.
authors.forename: Matej
authors.initials: M
authors.lastname: Samoš
authors.forename: Lucia
authors.initials: L
authors.lastname: Stančiaková
authors.forename: Jela
authors.initials: J
authors.lastname: Ivanková
authors.forename: Ján
authors.initials: J
authors.lastname: Staško
authors.forename: František
authors.initials: F
authors.lastname: Kovář
authors.forename: Miroslava
authors.initials: M
authors.lastname: Dobrotová
authors.forename: Peter
authors.initials: P
authors.lastname: Galajda
authors.forename: Peter
authors.initials: P
authors.lastname: Kubisz
authors.forename: Marián
authors.initials: M
authors.lastname: Mokáň
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000991:Antithrombins / Q000008:administration & dosage / Q000493:pharmacokinetics; D001281:Atrial Fibrillation / Q000097:blood / Q000188:drug therapy; D001562:Benzimidazoles / Q000008:administration & dosage / Q000493:pharmacokinetics; D000069604:Dabigatran; D016903:Drug Monitoring / Q000295:instrumentation / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D015091:beta-Alanine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics
chemical_list: D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D000069604:Dabigatran
references.citation: Cerebrovasc Dis Extra. 2013 May 03;3(1):78-80
references.pmid: 23687505
references.citation: Thromb Haemost. 2012 May;107(5):838-47
references.pmid: 22318514
references.citation: Thromb Haemost. 2010 Jun;103(6):1116-27
references.pmid: 20352166
references.citation: Eur J Clin Pharmacol. 2013 Nov;69(11):1875-81
references.pmid: 23784008
references.citation: Circulation. 2011 Apr 5;123(13):1436-50
references.pmid: 21464059
references.citation: Blood Coagul Fibrinolysis. 2012 Mar;23(2):138-43
references.pmid: 22227958
references.citation: Eur Heart J. 2012 Nov;33(21):2719-47
references.pmid: 22922413
references.citation: Thromb Res. 2013 Oct;132(4):433-6
references.pmid: 24050826
references.citation: J Pharm Pract. 2013 Jun;26(3):264-9
references.pmid: 23160864
references.citation: Am J Clin Pathol. 2014 Feb;141(2):262-7
references.pmid: 24436275
references.citation: Ann Pharmacother. 2013 Oct;47(10):1368-71
references.pmid: 24259703
references.citation: J Am Coll Cardiol. 2014 Feb 4;63(4):321-8
references.pmid: 24076487
references.citation: Thromb Haemost. 2013 Aug;110(2):308-15
references.pmid: 23783268
references.citation: Am J Health Syst Pharm. 2014 Mar 1;71(5):360
references.pmid: 24534590
references.citation: Thrombosis. 2012;2012:867121
references.pmid: 22645678
references.citation: Am J Clin Pathol. 2012 Oct;138(4):551-8
references.pmid: 23010710
references.citation: N Engl J Med. 2009 Sep 17;361(12):1139-51
references.pmid: 19717844
references.citation: Int J Clin Pract. 2013 Jul;67(7):603-5
references.pmid: 23758442