Drug-drug interactions of non-vitamin K oral anticoagulants

References

• Keeling D, Baglin T, Tait C, et al. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol. 2011;154(3):311–324.
   PubMed Web of Science ®Google Scholar
• De Caterina R, Husted S, Wallentin L, et al. General mechanisms of coagulation and targets of anticoagulants (Section I). Thromb Haemost. 2013 Apr;109(4):569–579.
   PubMed Web of Science ®Google Scholar
• Heidbuchel H, Verhamme P, Alings M, et al. Updated European Heart Rhythm Association Practical Guide on the use of non-Vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace. 2015 Aug;17(10):1467–1507.
   PubMed Web of Science ®Google Scholar
• Camm AJ, Lip GYH, De Caterina R, 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(21):2719–2747.
   PubMed Web of Science ®Google Scholar
• Konstantinides S, Torbicki A, Agnelli G, et al. 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. Nov;35(43):3033–3069.
   PubMed Web of Science ®Google Scholar
• Ageno W, Gallus AS, Wittkowsky A, et al. Oral anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2):e44S–88S.
   PubMed Web of Science ®Google Scholar
• Ahrens I, Peter K, Lip GY, et al. Development and clinical applications of novel oral anticoagulants. Part I. Clinically approved drugs. Discov Med. 2012 Jun;13(73):433–443.
   PubMed Web of Science ®Google Scholar
• Gnoth MJ, Buetehorn U, Muenster U, et al. In vitro and in vivo P-glycoprotein transport characteristics of rivaroxaban. J Pharmacol Exp Ther. 2011 Jul;338(1):372–380.
   PubMed Web of Science ®Google Scholar
• Raub TJ. P-glycoprotein recognition of substrates and circumvention through rational drug design. Mol Pharm. 2006 Jan;3(1):3–25.
   PubMed Web of Science ®Google Scholar
• Zhou SF. Structure, function and regulation of P-glycoprotein and its clinical relevance in drug disposition. Xenobiotica. 2008 Jul;38(7–8):802–832.
   PubMed Web of Science ®Google Scholar
• Denisov IG, Grinkova YV, Baylon JL, et al. Mechanism of drug-drug interactions mediated by human cytochrome P450 CYP3A4 monomer. Biochemistry. 2015 May;54(13):2227–2239.
   PubMed Web of Science ®Google Scholar
• Giacomini KM, Huang S-M, Tweedie DJ, et al. Membrane transporters in drug development. Nat Rev Drug Discov. 2010 Mar;9(3):215–236.
   PubMed Web of Science ®Google Scholar
• Wessler JD, Grip LT, Mendell J, et al. The P-glycoprotein transport system and cardiovascular drugs. J Am Coll Cardiol. 2013 Jun;61(25):2495–2502.
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Dahl OE, Buller HR, et al. A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial. J Thromb Haemost. 2005 Jan;3(1):103–111.
   PubMed Web of Science ®Google Scholar
• Stangier J, Eriksson BI, Dahl OE, et al. Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement. J Clin Pharmacol. 2005 May;45(5):555–565.
   PubMed Web of Science ®Google Scholar
• Härtter S, Yamamura N, Stangier J, et al. Pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects after oral administration of dabigatran etexilate. Thromb Haemost. 2012 Feb;107(2):260–269.
   PubMed Web of Science ®Google Scholar
• Liesenfeld K-H, Lehr T, Dansirikul C, et al. Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with non-valvular atrial fibrillation from the RE-LY trial. J Thromb Haemostasis. 2011;9(11):2168–2175.
   PubMed Web of Science ®Google Scholar
• Blech S, Ebner T, Ludwig-Schwellinger E, et al. The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran, in humans. Drug Metab Dispos. 2008 Mar;36(2):386–399.
   PubMed Web of Science ®Google Scholar
• Stangier J, Stähle H, Rathgen K, et al. Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, with coadministration of digoxin. J Clin Pharmacol. 2012;52(2):243–250.
   PubMed Web of Science ®Google Scholar
• Stangier J, Stähle H, Rathgen K, et al. Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, are not affected by moderate hepatic impairment. J Clin Pharmacol. 2008 Dec;48(12):1411–1419.
   PubMed Web of Science ®Google Scholar
• Stangier J, Rathgen K, Stähle H, et al. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol. 2007;64(3):292–303.
   PubMed Web of Science ®Google Scholar
• Dansirikul C, Lehr T, Liesenfeld KH, et al. A combined pharmacometric analysis of dabigatran etexilate in healthy volunteers and patients with atrial fibrillation or undergoing orthopaedic surgery. Thromb Haemost. 2012;107(4):775–785.
   PubMed Web of Science ®Google Scholar
• Eriksson BI, Dahl OE, Ahnfelt L, et al. Dose escalating safety study of a new oral direct thrombin inhibitor, dabigatran etexilate, in patients undergoing total hip replacement: BISTRO I. J Thromb Haemostasis. 2004 Sep;2(9):1573–1580.
   PubMed Web of Science ®Google Scholar
• Kishimoto W, Ishiguro N, Ludwig-Schwellinger E, et al. In vitro predictability of drug-drug interaction likelihood of P-glycoprotein-mediated efflux of dabigatran etexilate based on [I]2/IC50 threshold. Drug Metab Dispos. 2013 Mar;42(2):257–263.
   PubMed Web of Science ®Google Scholar
• Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep;361(12):1139–1151.
   PubMed Web of Science ®Google Scholar
• Pradaxa, INN-dabigatran etexilate - WC500041059.pdf. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf
   Google Scholar
• CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW – DABIGATRAN; [cited 2016 Jan 23]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022512Orig1s000ClinPharmR_Corrrected 3.11.2011.pdf
   Google Scholar
• Legrand M. The use of dabigatran in elderly patients. Arch Intern Med. 2011 Jul;171(14):1285–1286.
   PubMed Web of Science ®Google Scholar
• Okubo K, Kuwahara T, Takagi K, et al. Relation between dabigatran concentration, as assessed using the direct thrombin inhibitor assay, and activated clotting time/activated partial thromboplastin time in patients with atrial fibrillation. Am J Cardiol. 2015 Jun;115(12):1696–1699.
   PubMed Web of Science ®Google Scholar
• Härtter S, Sennewald R, Nehmiz G, et al. Oral bioavailability of dabigatran etexilate (Pradaxa(®)) after co-medication with verapamil in healthy subjects. Br J Clin Pharmacol. 2013 Apr;75(4):1053–1062.
   PubMed Web of Science ®Google Scholar
• Nguyen C, Christensen JM, Ayres JW. Verapamil sustained release: new formulation and convolution. Pharm Dev Technol. 2012 Jan;17(2):148–157.
   PubMed Web of Science ®Google Scholar
• Delavenne X, Ollier E, Basset T, et al. A semi-mechanistic absorption model to evaluate drug-drug interaction with dabigatran: application with clarithromycin. Br J Clin Pharmacol. 2013 Jul;76(1):107–113.
   PubMed Web of Science ®Google Scholar
• Pfeilschifter W, Luger S, Brunkhorst R, et al. The gap between trial data and clinical practice – an analysis of case reports on bleeding complications occurring under dabigatran and rivaroxaban anticoagulation. Cerebrovasc Dis. 2013 Jan;36(2):115–119.
   PubMed Web of Science ®Google Scholar
• Härtter S, Koenen-Bergmann M, Sharma A, et al. Decrease in the oral bioavailability of dabigatran etexilate after co-medication with rifampicin. Br J Clin Pharmacol. 2012 Sep;74(3):490–500.
   PubMed Web of Science ®Google Scholar
• Wiggins BS, Northup A, Johnson D, et al. Reduced anticoagulant effect of Dabigatran in a patient receiving concomitant phenytoin. Pharmacotherapy. 2016 Feb;36(2):e5–7.
   PubMed Web of Science ®Google Scholar
• Stangier J, Stähle H, Rathgen K, et al. Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, with coadministration of digoxin. J Clin Pharmacol. 2012 Feb;52(2):243–250.
   PubMed Web of Science ®Google Scholar
• Dans AL, Connolly SJ, Wallentin L, et al. Concomitant use of antiplatelet therapy with dabigatran or warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Circulation. 2013 Feb;127(5):634–640.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration – FDA Briefing Information. Dabigatran etexilate mesylate capsules, for the September 20, 2010. In: Meeting of the Cardiovascular and Renal Drugs Advisory Committee; 2010 Oct 19.
   Google Scholar
• Majeed A, Goldhaber SZ, Kakkar A, et al. Bleeding events with dabigatran or warfarin in patients with venous thromboembolism. Thromb Haemost. 2015 Jan;115(2):291–298.
   PubMed Web of Science ®Google Scholar
• Ezekowitz MD, Reilly PA, Nehmiz G, et al. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). Am J Cardiol. 2007 Nov;100(9):1419–1426.
   PubMed Web of Science ®Google Scholar
• Stangier J, Rathgen K, Stähle H, et al. Coadministration of dabigatran etexilate and atorvastatin: assessment of potential impact on pharmacokinetics and pharmacodynamics. Am J Cardiovasc Drugs. 2009 Jan;9(1):59–68.
   PubMed Web of Science ®Google Scholar
• Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of bleeding with 2 doses of Dabigatran compared with warfarin in older and younger patients with atrial fibrillationclinical perspective. Circulation. 2011 May;123(21):2363–2372.
   PubMed Web of Science ®Google Scholar
• Stangier J, Stähle H, Rathgen K, et al. Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects. Clin Pharmacokinet. 2008 Jan;47(1):47–59.
   PubMed Web of Science ®Google Scholar
• Ollier E, Hodin S, Basset T, et al. In vitro and in vivo evaluation of drug-drug interaction between dabigatran and proton pump inhibitors. Fundam Clin Pharmacol. 2015 Dec;29(6):604–614.
   PubMed Web of Science ®Google Scholar
• Friedman RJ, Kurth A, Clemens A, et al. Dabigatran etexilate and concomitant use of non-steroidal anti-inflammatory drugs or acetylsalicylic acid in patients undergoing total hip and total knee arthroplasty: no increased risk of bleeding. Thromb Haemost. 2012 Jul;108(1):183–190.
   PubMed Web of Science ®Google Scholar
• Ahrens I, Peter K, Lip GY, et al. Development and clinical applications of novel oral anticoagulants. Part I. Clinically approved drugs. Discov Med. 2012 Jun;13(73):433–443.
   PubMed Web of Science ®Google Scholar
• Mann KG, Jenny RJ, Krishnaswamy S. Cofactor proteins in the assembly and expression of blood clotting enzyme complexes. Annu Rev Biochem. 1988 Jan;57:915–956.
   PubMed Web of Science ®Google Scholar
• Perzborn E, Roehrig S, Straub A, et al. Rivaroxaban: a new oral factor Xa inhibitor. Arterioscler Thrombosis Vasc Biol. 2010 Mar;30(3):376–381.
   PubMed Web of Science ®Google Scholar
• Colman E. U. S. food and drug administration notice: archived document [Internet]. [cited 2016 Jan 23]. Available from: http://www.fda.gov/downloads/AdvisoryCom....e/UCM225627.pdf
   Google Scholar
• Weinz C, Schwarz T, Kubitza D, et al. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Dispos. 2009 May;37(5):1056–1064.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Wensing G, et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939–an oral, direct Factor Xa inhibitor–after multiple dosing in healthy male subjects. Eur J Clin Pharmacol. 2005 Dec;61(12):873–880.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Roth A, et al. Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr Med Res Opin. 2008 Oct;24(10):2757–2765.
   PubMed Web of Science ®Google Scholar
• Stampfuss J, Kubitza D, Becka M, et al. The effect of food on the absorption and pharmacokinetics of rivaroxaban. IntJournal Clin Pharmacol Ther. 2013 Jul;51(7):549–561.
   PubMed Web of Science ®Google Scholar
• Jiang J, Hu Y, Zhang J, et al. Safety, pharmacokinetics and pharmacodynamics of single doses of rivaroxaban - an oral, direct factor Xa inhibitor - in elderly Chinese subjects. Thromb Haemost. 2009 Jan;103(1):234–241.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Mueck W, et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol. 2010 Nov;70(5):703–712.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Roth A, Becka M, et al. Effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of a single dose of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol. 2013 Jul;76(1):89–98.
   PubMed Web of Science ®Google Scholar
• Douxfils J, Mullier F, Loosen C, et al. Assessment of the impact of rivaroxaban on coagulation assays: laboratory recommendations for the monitoring of rivaroxaban and review of the literature. Thromb Res. 2012 Dec;130(6):956–966.
   PubMed Web of Science ®Google Scholar
• Mueck W, Kubitza D, Becka M. Co-administration of rivaroxaban with drugs that share its elimination pathways: pharmacokinetic effects in healthy subjects. Br J Clin Pharmacol. 2013 Sep;76(3):455–466.
   PubMed Web of Science ®Google Scholar
• Elikowski W, Małek M, Skowroński M, et al. Hemoptysis during concomitant treatment with rivaroxaban and amiodarone in a patient with a history of pulmonary disease. Pol Merkur Lekarski. 2015 Oct;39(232):227–230.
   PubMedGoogle Scholar
• Xarelto, INN-rivaroxaban - WC500057108.pdf [Internet]; [cited 2016 Jan 23]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf
   Google Scholar
• Bates D, Dalton B, Gilmour J, et al. Venous thromboembolism due to suspected interaction between rivaroxaban and nevirapine. Can J Hosp Pharm. 2013 Mar;66(2):125–129.
   PubMedGoogle Scholar
• Egan G, Hughes CA, Ackman ML. Drug interactions between antiplatelet or novel oral anticoagulant medications and antiretroviral medications. Ann Pharmacother. 2014 Jun;48(6):734–740.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Roth A, et al. Absence of clinically relevant interactions between rivaroxaban — an oral, direct factor Xa inhibitor — and digoxin or atorvastatin in healthy subjects. J Int Med Res. 2012 Jan;40(5):1688–1707.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Schwers S, et al. Investigation of pharmacodynamic and pharmacokinetic interactions between rivaroxaban and enoxaparin in healthy male subjects. Clin Pharmacol Drug Dev. 2013 Jul;2(3):270–277.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Mück W, et al. Pharmacodynamics and pharmacokinetics during the transition from warfarin to rivaroxaban: a randomized study in healthy subjects. Br J Clin Pharmacol. 2014 Aug;78(2):353–363.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Mueck W, et al. Rivaroxaban (BAY 59-7939) ? an oral, direct Factor Xa inhibitor? Has no clinically relevant interaction with naproxen. Br J Clin Pharmacol. 2007 Apr;63(4):469–476.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Mueck W, et al. Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban–an oral, direct factor Xa inhibitor–are not affected by aspirin. J Clin Pharmacol. 2006 Sep;46(9):981–990.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Mück W, et al. Effect of co-administration of rivaroxaban and clopidogrel on bleeding time, pharmacodynamics and pharmacokinetics: a phase I study. Pharmaceuticals (Basel). 2012 Jan;5(12):279–296.
   PubMedGoogle Scholar
• Mega JL, Braunwald E, Mohanavelu S, et al. Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial. Lancet (London, England). 2009 Jul;374(9683):29–38.
   PubMed Web of Science ®Google Scholar
• Mega JL, Braunwald E, Wiviott SD, et al. Comparison of the efficacy and safety of two rivaroxaban doses in acute coronary syndrome (from ATLAS ACS 2-TIMI 51). Am J Cardiol. 2013 Aug;112(4):472–478.
   PubMed Web of Science ®Google Scholar
• Kubitza D, Becka M, Zuehlsdorf M, et al. Effect of food, an antacid, and the H2 antagonist ranitidine on the absorption of BAY 59-7939 (rivaroxaban), an oral, direct factor Xa inhibitor, in healthy subjects. J Clin Pharmacol. 2006 May;46(5):549–558.
   PubMed Web of Science ®Google Scholar
• FDA U.S. Food and Drug Administration – Rivaroxaban; [cited 2016 Jan 23]. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM181524.pdf
   Google Scholar
• Raghavan N, Frost CE, Yu Z, et al. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos. 2009 Jan;37(1):74–81.
   PubMed Web of Science ®Google Scholar
• Frost C, Wang J, Nepal S, et al. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol. 2013 Mar;75(2):476–487.
   PubMed Web of Science ®Google Scholar
• He K, Luettgen JM, Zhang D, et al. Preclinical pharmacokinetics and pharmacodynamics of apixaban, a potent and selective factor Xa inhibitor. Eur J Drug Metab Pharmacokinet. 2011 Sep;36(3):129–139.
   PubMed Web of Science ®Google Scholar
• Raghavan N, Frost CE, Yu Z, et al. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos. 2009 Jan;37(1):74–81.
   PubMed Web of Science ®Google Scholar
• Wang L, Zhang D, Raghavan N, et al. In vitro assessment of metabolic drug-drug interaction potential of apixaban through cytochrome P450 phenotyping, inhibition, and induction studies. Drug Metab Dispos. 2010 Mar;38(3):448–458.
   PubMed Web of Science ®Google Scholar
• Zhang D, He K, Herbst JJ, et al. Characterization of efflux transporters involved in distribution and disposition of apixaban. Drug Metab Dispos. 2013 Apr;41(4):827–835.
   PubMed Web of Science ®Google Scholar
• 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 Apr;52(4):243–254.
   PubMed Web of Science ®Google Scholar
• Chang M, Yu Z, Shenker A, et al. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of apixaban. J Clin Pharmacol. 2015 Sep;56(5):637–645.
   Google Scholar
• Cuker A, Siegal DM, Crowther MA, et al. Laboratory measurement of the anticoagulant activity of the non-vitamin K oral anticoagulants. J Am Coll Cardiol. 2014 Sep;64(11):1128–1139.
   PubMed Web of Science ®Google Scholar
• Blann AD, Lip GY. Laboratory monitoring of the non-vitamin K oral anticoagulants. J Am Coll Cardiol. 2014 Sep;64(11):1140–1142.
   PubMed Web of Science ®Google Scholar
• Frost CE, Byon W, Song Y, et al. Effect of ketoconazole and diltiazem on the pharmacokinetics of apixaban, an oral direct factor Xa inhibitor. Br J Clin Pharmacol. 2015 May;79(5):838–846.
   PubMed Web of Science ®Google Scholar
• Eliquis II-14 Summary of opinion - WC500169373.pdf; [cited 2016 Jan 18]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002148/WC500169373.pdf
   Google Scholar
• EVALUATION and RESEARCH. Center for drug evaluation and clinical pharmacology and biopharmaceutics review (S) [Internet]. 2009. p. 1–5. [cited 2016 Jan 23]. Available from http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527orig1s000clinpharmr.pdf
   Google Scholar
• PRODUCT INFORMATION-apixaban-ELIQUIS®; [cited 2016 Jan 23]. Available from: http://secure.healthlinks.net.au/content/bms/pi.cfm?product=bqpeliqu11112
   Google Scholar
• Alexander JH, Lopes RD, Thomas L, et al. Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur Heart J. 2014 Jan;35(4):224–232.
   PubMed Web of Science ®Google Scholar
• Barrett YC, Wang J, Song Y, et al. A randomised assessment of the pharmacokinetic, pharmacodynamic and safety interaction between apixaban and enoxaparin in healthy subjects. Thromb Haemost. 2012 May;107(5):916–924.
   PubMed Web of Science ®Google Scholar
• Alexander JH, Becker RC, Bhatt DL, et al. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun;119(22):2877–2885.
   PubMed Web of Science ®Google Scholar
• Frost C, Shenker A, Gandhi MD, et al. Evaluation of the effect of naproxen on the pharmacokinetics and pharmacodynamics of apixaban. Br J Clin Pharmacol. 2014 Oct;78(4):877–885.
   PubMed Web of Science ®Google Scholar
• Upreti VV, Song Y, Wang J, et al. Effect of famotidine on the pharmacokinetics of apixaban, an oral direct factor Xa inhibitor. Clin Pharmacol. 2013;5:59–66.
   PubMedGoogle Scholar
• Vakkalagadda B, Frost C, Byon W, et al. Effect of rifampin on the pharmacokinetics of apixaban, an oral direct inhibitor of Factor Xa. Am J Cardiovasc Drugs. 2016 Jan;16:119–127.
   PubMed Web of Science ®Google Scholar
• Zafar MU, Vorchheimer DA, Gaztanaga J, et al. Antithrombotic effects of factor Xa inhibition with DU-176b: Phase-I study of an oral, direct factor Xa inhibitor using an ex-vivo flow chamber. Thromb Haemost. 2007 Oct;98(4):883–888.
   PubMed Web of Science ®Google Scholar
• Bounameaux H, Camm AJ. Edoxaban: an update on the new oral direct factor Xa inhibitor. Drugs. 2014 Jul;74(11):1209–1231.
   PubMed Web of Science ®Google Scholar
• Bathala MS, Masumoto H, Oguma T, et al. Pharmacokinetics, biotransformation, and mass balance of edoxaban, a selective, direct factor Xa inhibitor, in humans. Drug Metab Dispos. 2012 Dec;40(12):2250–2255.
   PubMed Web of Science ®Google Scholar
• Mendell J, Zahir H, Matsushima N, et al. Drug-drug interaction studies of cardiovascular drugs involving P-glycoprotein, an efflux transporter, on the pharmacokinetics of edoxaban, an oral factor Xa inhibitor. Am J Cardiovasc Drugs. 2013 Oct;13(5):331–342.
   PubMed Web of Science ®Google Scholar
• Moore KT, St-Fleur D, Marricco NC, et al. A randomized study of the effects of food on the pharmacokinetics of once-daily extended-release hydromorphone in healthy volunteers. J Clin Pharmacol. 2011 May;51(11):1571–1579.
   PubMed Web of Science ®Google Scholar
• Mikkaichi T, Yoshigae Y, Masumoto H, et al. Edoxaban transport via P-glycoprotein is a key factor for the drug’s disposition. Drug Metab Dispos. 2014 Apr;42(4):520–528.
   PubMed Web of Science ®Google Scholar
• Mendell J, Johnson L, Chen S. An open-label, phase 1 study to evaluate the effects of hepatic impairment on edoxaban pharmacokinetics and pharmacodynamics. J Clin Pharmacol. 2015 Dec;55(12):1395–1405.
   PubMed Web of Science ®Google Scholar
• Ruff CT, Giugliano RP, Antman EM, et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: Design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial fibrillation–thrombolysis in myocardial infarction study 48 (ENGAGE AF–TIMI 48). Am Heart J. 2010 Oct;160(4):635–641.
   PubMed Web of Science ®Google Scholar
• Raskob G, Büller H, Prins M, et al. Edoxaban for the long-term treatment of venous thromboembolism: rationale and design of the Hokusai-venous thromboembolism study–methodological implications for clinical trials. J Thromb Haemost. 2013 Jul;11(7):1287–1294.
   PubMed Web of Science ®Google Scholar
• Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov;369(22):2093–2104.
   PubMed Web of Science ®Google Scholar
• Weitz JI, Eikelboom J. Incorporating edoxaban into the choice of anticoagulants for atrial fibrillation. Thromb Haemost. 2015 Oct;115(2):257–270.
   PubMed Web of Science ®Google Scholar
• Mendell J, Noveck RJ, Shi M. Pharmacokinetics of the direct factor Xa inhibitor edoxaban and digoxin administered alone and in combination. J Cardiovasc Pharmacol. 2012 Oct;60(4):335–341.
   PubMed Web of Science ®Google Scholar
• LIXIANA, INN-EDOXABAN - SUMMARY OF PRODUCT CHARACTERISTICS; [cited 2016 Jan 31]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf
   Google Scholar
• Mendell J, Chen S, He L, et al. The effect of rifampin on the pharmacokinetics of edoxaban in healthy adults. Clin Drug Investig. 2015 Jul;35(7):447–453.
   PubMed Web of Science ®Google Scholar
• Mendell J, Lee F, Chen S, et al. The effects of the antiplatelet agents, aspirin and naproxen, on pharmacokinetics and pharmacodynamics of the anticoagulant edoxaban, a direct factor Xa inhibitor. J Cardiovasc Pharmacol. 2013 Aug;62(2):212–221.
   PubMed Web of Science ®Google Scholar
• Büller HR, Décousus H, Grosso MA, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct;369(15):1406–1415.
   PubMed Web of Science ®Google Scholar
• Zahir H, Matsushima N, Halim A-B, et al. Edoxaban administration following enoxaparin: a pharmacodynamic, pharmacokinetic, and tolerability assessment in human subjects. Thromb Haemost. 2012 Jul;108(1):166–175.
   PubMed Web of Science ®Google Scholar
• Hylek EM, Ko D, Cove CL. Gaps in translation from trials to practice: non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation. Thromb Haemost. 2014 May;111(5):783–788.
   PubMed Web of Science ®Google Scholar
• Black SA, Cohen AT. Anticoagulation strategies for venous thromboembolism: moving towards a personalised approach. Thromb Haemost. 2015 Oct;114(4):660–669.
   PubMed Web of Science ®Google Scholar
• Kralev S, Schneider K, Lang S, et al. Incidence and severity of coronary artery disease in patients with atrial fibrillation undergoing first-time coronary angiography. PLoS One. 2011 Jan;6(9):e24964.
   PubMed Web of Science ®Google Scholar
• Lip GY, Windecker S, Huber K, et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on. Eur Heart J. 2014 Dec;35(45):3155–3179.
   PubMed Web of Science ®Google Scholar
• Roffi M, Patrono C, Collet J-P, et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2015 Aug;37(3):ehv320.
   Web of Science ®Google Scholar
• Steg PG, James SK, Atar D, et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC). Eur Heart J. 2012 Oct;33(20):2569–2619.
   PubMed Web of Science ®Google Scholar
• Lamberts M, Gislason GH, Olesen JB, et al. Oral anticoagulation and antiplatelets in atrial fibrillation patients after myocardial infarction and coronary intervention. J Am Coll Cardiol. 2013 Sep;62(11):981–989.
   PubMed Web of Science ®Google Scholar
• Oldgren J, Wallentin L, Alexander JH, et al. New oral anticoagulants in addition to single or dual antiplatelet therapy after an acute coronary syndrome: a systematic review and meta-analysis. Eur Heart J. 2013 Jun;34(22):1670–1680.
   PubMed Web of Science ®Google Scholar
• Apostolakis S, Lane DA, Buller H, et al. Comparison of the CHADS2, CHA2DS2-VASc and HAS-BLED scores for the prediction of clinically relevant bleeding in anticoagulated patients with atrial fibrillation: the AMADEUS trial. Thromb Haemost. 2013;110(5):1074–1079.
   PubMed Web of Science ®Google Scholar
• Apostolakis S, Lane DA, Guo Y, et al. Performance of the HEMORR2HAGES, ATRIA, and HAS-BLED bleeding risk-prediction scores in nonwarfarin anticoagulated atrial fibrillation patients. J Am Coll Cardiol. 2013;61(3):386–387.
   PubMed Web of Science ®Google Scholar
• Smith JG, Wieloch M, Koul S, et al. Triple antithrombotic therapy following an acute coronary syndrome: prevalence, outcomes and prognostic utility of the HAS-BLED score. EuroIntervention J Eur Collab with Work Gr Interv Cardiol Eur Soc Cardiol. 2012;8(6):672–678.
   Google Scholar