22. European Stroke Conference 9 Heart and brain 9:50 - 10:00 Minimal plasmatic concentration of dabigatran in stroke patients A. Tomek1, V. Matoska2, I. Sarbochova3, M. Sramek4, P. Ptacek5, J. Klima6 Neurology Department of Charles University, 2nd School of Medicine and University Hospital Motol, Prague, CZECH REPUBLIC1,Molecular Genetics Laboratory, Hospital Na Homolce, Prague, CZECH REPUBLIC2, Neurology Department of Charles University, 2nd School of Medicine and University Hospital Motol, Prague, CZECH REPUBLIC3, Neurolo-gy Department of Charles University, 2nd School of Medicine and University Hospital Motol, Prague, CZECH REPUBLIC4, Pharmakl spol. s.r.o., Prague, CZECH REPUBLIC5, Pharmakl spol. s.r.o., Prague, CZECH REPUBLIC6 Introduction: Dabigatran etexilate is direct thrombin inhibitor approved in the prevention of stroke and systemic embolism in patients with atrial fibrillation. Clinical use of dabigatran spread quickly after its approval. One of the marketed advantages compared to warfarin is the fact that monitoring is not routinely recommended. It is advised only in cases of adverse events (e.g. bleeding, urgent surgery). Aim of study: The aim of the study was to determine minimal plasmatic concentration (through, Cmin) of dabigatran in cardioembolic stroke patients. Methods: Minimal plasmatic concentration (Through, Cmin) of dabigatran was quantified with liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Isotopically labeled internal standard was used for quantification (d3-dabigatran), method is validated for range 19- 1900 ng/ml. Results: 38 patients, mean age 72,3 (56-89) years, 20 (56.2%) men were enrolled. 23 (60.5%) were treated with 150 mg b.i.d. and 15 (39.5%) with 110 mg b.i.d. All had good renal functions; mean creatinine clearance (CrCl) was 84.8 mL/min (44-175). 21 (55,3%) patients were in ther-apeutical range (50-200 ng/ml), their mean minimal plasmatic concentration of dabigatran was 111.6 ng/ml (51.5-184.3). 10 (26,3%) patients were were in subtherapeutical range (mean 35.4, 15-45.6) and 7 (18,4%) patients were above 200 ng/ml (mean 299.1, 206.8-455). There was no statistically significant correlation of cmin with CrCl; in-range patients had mean CrCl 87.95 mL/min, above-range 67.42 mL/min and bellow-range 90.7 mL/min. There was a trend for cor-relation of cmin with age (Spearman’s rho 0.32, p=0.051). Conclusion: Due to low bioavailability and interindividual variability, monitoring of dabigatran may be required in specific patients (e.g. older, low/high body weight, impaired renal functions) to prevent the risk of complications. Personalized dosing strategies based on monitoring cmin should be studied in future clinical trials. 26 © 2013 S. Karger AG, Basel Scientific Programme
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