The factor xa inhibitor edoxaban for the prevention of stroke and systemic embolism in patients with atrial fibrillation

References

• Camm AJ, Lip GY, De Caterina R, et al. 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
• Krijthe BP, Kunst A, Benjamin EJ, et al. Projections on the number of individuals with atrial fibrillation in the European union, from 2000 to 2060. Eur Heart J. 2013;34(35):2746–2751.
   PubMed Web of Science ®Google Scholar
• Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics–2015 update: a report from the American heart association. Circulation. 2015;131(4):e29–322.
   PubMed Web of Science ®Google Scholar
• Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the framingham study. Stroke. 1991;22(8):983–988.
   PubMed Web of Science ®Google Scholar
• January CT, Wann LS, Alpert JS, et al. AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American college of cardiology/American heart association task force on practice guidelines and the heart rhythm society. J Am Coll Cardiol. 2014;64(21):2246–2280.
   Web of Science ®Google Scholar
• Fitzmaurice DA, Blann AD, Lip GY. Bleeding risks of antithrombotic therapy. Bmj. 2002;325(7368):828–831.
   PubMed Web of Science ®Google Scholar
• Hylek EM, Skates SJ, Sheehan MA, et al. An analysis of the lowest effective intensity of prophylactic anticoagulation for patients with nonrheumatic atrial fibrillation. N Engl J Med. 1996;335(8):540–546.
   PubMed Web of Science ®Google Scholar
• Shields AM, Lip GY. Choosing the right drug to fit the patient when selecting oral anticoagulation for stroke prevention in atrial fibrillation. J Intern Med. 2015;278(1):1–18.
   PubMed Web of Science ®Google Scholar
• Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981–992.
   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;361(12):1139–1151.
   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;369(22):2093–2104.
   PubMed Web of Science ®Google Scholar
• Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883–891.
   PubMed Web of Science ®Google Scholar
• Mega JL, Walker JR, Ruff CT, et al. Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015;385(9984):2280–2287.
   PubMed Web of Science ®Google Scholar
• O’Donoghue ML, Ruff CT, Giugliano RP, et al. Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillationdagger. Eur Heart J. 2015;36(23):1470–1477.
   PubMed Web of Science ®Google Scholar
• Ruff CT, Giugliano RP, Braunwald E, et al. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015;385(9984):2288–2295.
   PubMed Web of Science ®Google Scholar
• Steffel J, Giugliano RP, Braunwald E, et al. Edoxaban vs. warfarin in patients with atrial fibrillation on amiodarone: a subgroup analysis of the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2015;36(33):2239–2245.
   PubMed Web of Science ®Google Scholar
• Bohula EA, Giugliano RP, Ruff CT, et al. Impact of renal function on outcomes with edoxaban in the ENGAGE AF-TIMI 48 trial. Circulation. 2016;134(1):24–36.
   PubMed Web of Science ®Google Scholar
• Eisen A, Giugliano RP, Ruff CT, et al. Edoxaban vs warfarin in patients with nonvalvular atrial fibrillation in the US food and drug administration approval population: an analysis from the effective anticoagulation with factor xa next generation in atrial fibrillation-thrombolysis in myocardial infarction 48 (ENGAGE AF-TIMI 48) trial. Am Heart J. 2016;172:144–151.
   PubMed Web of Science ®Google Scholar
• Kato ET, Giugliano RP, Ruff CT, et al. Efficacy and safety of edoxaban in elderly patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. J Am Heart Assoc. 2016;5:5.
   Web of Science ®Google Scholar
• Magnani G, Giugliano RP, Ruff CT, et al. Efficacy and safety of edoxaban compared with warfarin in patients with atrial fibrillation and heart failure: insights from ENGAGE AF-TIMI 48. Eur J Heart Fail. 2016;18(9):1153–1161.
   PubMed Web of Science ®Google Scholar
• Plitt A, Ezekowitz MD, De Caterina R, et al. Cardioversion of atrial fibrillation in ENGAGE AF-TIMI 48. Clin Cardiol. 2016;39(6):345–346.
   PubMed Web of Science ®Google Scholar
• Rost NS, Giugliano RP, Ruff CT, et al. Outcomes with edoxaban versus warfarin in patients with previous cerebrovascular events: findings from ENGAGE AF-TIMI 48 (effective anticoagulation with factor xa next generation in atrial fibrillation-thrombolysis in myocardial infarction 48). Stroke. 2016;47(8):2075–2082.
   PubMed Web of Science ®Google Scholar
• Steffel J, Giugliano RP, Braunwald E, et al. Edoxaban versus warfarin in atrial fibrillation patients at risk of falling: ENGAGE AF-TIMI 48 analysis. J Am Coll Cardiol. 2016;68(11):1169–1178.
   PubMed Web of Science ®Google Scholar
• Xu H, Ruff CT, Giugliano RP, et al. Concomitant use of single antiplatelet therapy with edoxaban or warfarin in patients with atrial fibrillation: analysis from the ENGAGE AF-TIMI48 trial. J Am Heart Assoc. 2016;5:2.
   Web of Science ®Google Scholar
• Yamashita T, Koretsune Y, Yang Y, et al. Edoxaban vs. Warfarin in East Asian Patients With Atrial Fibrillation- An ENGAGE AF-TIMI 48 Subanalysis. Circ J. 2016;80(4):860–869.
   PubMed Web of Science ®Google Scholar
• Lip GY, Mitchell SA, Liu X, et al. Relative efficacy and safety of non-Vitamin K oral anticoagulants for non-valvular atrial fibrillation: network meta-analysis comparing apixaban, dabigatran, rivaroxaban and edoxaban in three patient subgroups. Int J Cardiol. 2016;204:88-94.
   Web of Science ®Google Scholar
• Fernandez MM, Wang J, Ye X, et al. Systematic review and network meta-analysis of the relative efficacy and safety of edoxaban versus other nonvitamin K antagonist oral anticoagulants among patients with nonvalvular atrial fibrillation and CHADS2 score 2. SAGE Open Med. 2015;3:2050312115613350.
   Google Scholar
• Sherrill B, Fernandez M, Wang J, et al. Network meta-analysis of relative efficacy and safety of edoxaban versus other novel oral anticoagulants (NOACs) among atrial fibrillation patients with CHADS2 score ≥ 2. J Am Coll Cardiol. 2015;65(10_S):A346.
   Web of Science ®Google Scholar
• Tereshchenko LG, Henrikson CA, Cigarroa J, et al. Comparative effectiveness of interventions for stroke prevention in atrial fibrillation: a network meta-analysis. J Am Heart Assoc. 2016;5:5.
   Web of Science ®Google Scholar
• Morimoto T, Crawford B, Wada K, et al. Comparative efficacy and safety of novel oral anticoagulants in patients with atrial fibrillation: A network meta-analysis with the adjustment for the possible bias from open label studies. J Cardiol. 2015;66(6):466–474.
   PubMed Web of Science ®Google Scholar
• Tornyos A, Kehl D, D’Ascenzo F, et al. Risk of myocardial infarction in patients with long-term non-vitamin K antagonist oral anticoagulant treatment. Prog Cardiovasc Dis. 2016;58(5):483–494.
   PubMed Web of Science ®Google Scholar
• Harenberg J, Weiss C, Marx S, et al. Clinical trials with new direct oral anticoagulants: additive value of indirect comparisons also named network meta-analyses. Phlebologie. 2013;42:143–152.
   Google Scholar
• PRADAXA- dabigatran etexilate mesylate capsule package insert. Ridgefield, CT 06877 USA: Boehringer Ingelheim Pharmaceuticals Inc.; updated 2015 Nov 30th; Cited 2015 Aug 24th. Available from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s032lbl.pdf
   Google Scholar
• XARELTO® (rivaroxaban) tablets, for oral use package insert. Titusville, NJ 08560: Janssen Pharmaceuticals, Inc; cited 2016 May; cited 2016 Aug 24th. Available from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s017lbl.pdf
   Google Scholar
• ELIQUIS® (apixaban) tablets package insert. Princeton, New Jersey 08543 USA: Bristol-Myers Squibb Company and Pfizer Inc.; updated Jul 2016; Cited 2016 Aug 24th. Available from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202155s012lbl.pdf
   Google Scholar
• Ministry of health, labour and welfare report on the deliberation results: edoxaban tosilate hydrate [press release]. Japan: Pharmaceuticals and Medical Devices Agency (PMDA); 2011 Mar 1st. www.pmda.go
   Google Scholar
• SAVAYSA (edoxaban) tablets for oral use package insert. Daiichi Sankyo Co., LTD: Parsippany, NJ 07054 USA; updated sep 2016; cited 2015 Nov 2nd. Available from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206316s004lbl.pdf
   Google Scholar
• European public assessment report for Lixiana - annex 1: summary of product characteristics. European Medicines Agency (EMA); Cited 2015 Oct 4th. Available from www.ema.europa.eu http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf
   Google Scholar
• Furugohri T, Isobe K, Honda Y, et al. DU-176b, a potent and orally active factor Xa inhibitor: in vitro and in vivo pharmacological profiles. J Thromb Haemost. 2008;6(9):1542–1549.
   PubMed Web of Science ®Google Scholar
• Ogata K, Mendell-Harary J, Tachibana M, et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol. 2010;50(7):743–753.
   PubMed Web of Science ®Google Scholar
• Mendell J, Noveck RJ, Shi M. A randomized trial of the safety, pharmacokinetics and pharmacodynamics of edoxaban, an oral factor Xa inhibitor, following a switch from warfarin. Br J Clin Pharmacol. 2013;75(4):966–978.
   PubMed Web of Science ®Google Scholar
• Weitz JI, Connolly SJ, Patel I, et al. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost. 2010;104(3):633–641.
   PubMed Web of Science ®Google Scholar
• Yamashita T, Koretsune Y, Yasaka M, et al. Randomized, multicenter, warfarin-controlled phase II study of edoxaban in Japanese patients with non-valvular atrial fibrillation. Circ J. 2012;76(8):1840–1847.
   PubMed Web of Science ®Google Scholar
• Stacy ZA, Call WB, Hartmann AP, et al. Edoxaban: a comprehensive review of the pharmacology and clinical data for the management of atrial fibrillation and venous thromboembolism. Cardiol Ther. 2016;5:1–18.
   PubMed Web of Science ®Google Scholar
• Mani H, Lindhoff-Last E. New oral anticoagulants in patients with nonvalvular atrial fibrillation: a review of pharmacokinetics, safety, efficacy, quality of life, and cost effectiveness. Drug Des Devel Ther. 2014;8:789–798.
   PubMed Web of Science ®Google Scholar
• COUMADIN (warfarin sodium) for oral use/injection package insert: Revisited December 2015. Princeton, New Jersey 08543 USA: Bristol-Myers Squibb Company; Cited 2015 Oct 4th. Available from http://packageinserts.bms.com/pi/pi_coumadin.pdf
   Google Scholar
• Cabral KP, Ansell J. Oral direct factor Xa inhibitors for stroke prevention in atrial fibrillation. Nat Rev Cardiol. 2012;9(7):385–391.
   PubMed Web of Science ®Google Scholar
• Masotti LCM. Pharmacology of new oral anticoagulants: Mechanism of action, pharmacokinetics, pharmacodynamics. Italian J Med. 2013;7:(s8):1-7.
   Google Scholar
• Cuker A. Laboratory measurement of the non-vitamin K antagonist oral anticoagulants: selecting the optimal assay based on drug, assay availability, and clinical indication. J Thromb Thrombolysis. 2016;41(2):241–247.
   PubMed Web of Science ®Google Scholar
• Matsushima NLF, Sato T, Weiss D, et al. Bioavailability and safety of the factor Xa inhibitor edoxaban and the effects of quinidine in healthy subjects. Clin Pharmacol Drug Dev. 2013;2(4):358–366.
   PubMed Web of Science ®Google Scholar
• Parasrampuria DA, Weilert D, Maa JF, et al. Pharmacokinetics and pharmacodynamics of the nonvitamin K antagonist oral anticoagulant edoxaban when administered alone or after switching from rivaroxaban or dabigatran etexilate in healthy subjects. Clin Drug Investig. 2016;36(2):127–136.
   PubMed Web of Science ®Google Scholar
• Parasrampuria DA, Kanamaru T, Connor A, et al. Evaluation of regional gastrointestinal absorption of edoxaban using the enterion capsule. J Clin Pharmacol. 2015;55(11):1286–1292.
   PubMed Web of Science ®Google Scholar
• Mendell J, Tachibana M, Shi M, et al. Effects of food on the pharmacokinetics of edoxaban, an oral direct factor Xa inhibitor, in healthy volunteers. J Clin Pharmacol. 2011;51(5):687–694.
   PubMed Web of Science ®Google Scholar
• Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011;71(12):1503–1526.
   PubMed Web of Science ®Google Scholar
• Reilly PA, Lehr T, Haertter S, 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(4):321–328.
   PubMed Web of Science ®Google Scholar
• Xarelto: Clinical Pharmacology & Biopharmaceutical Review(s): Food and Drug Administration.; 2009 [ Cited 2nd Nov]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022406Orig1s000ClinPharmR.pdf.
   Google Scholar
• Eliquis: Clinical Pharmacology & Biopharmaceutical Review(s) 2012: Food and drug Administration; 2012 [ Cited 2nd Nov]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202155Orig1s000ClinPharmR.pdf.
   Google Scholar
• Salazar DE, Mendell J, Kastrissios H, et al. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012;107(5):925–936.
   PubMed Web of Science ®Google Scholar
• Niebecker R, Jonsson S, Karlsson MO, et al. Population pharmacokinetics of edoxaban in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism–the Hokusai-VTE phase 3 study. Br J Clin Pharmacol. 2015;80(6):1374–1387.
   PubMed Web of Science ®Google Scholar
• Krekels EH, Niebecker R, Karlsson MO, et al. Population pharmacokinetics of edoxaban in patients with non-valvular atrial fibrillation in the ENGAGE AF-TIMI 48 study, a phase III clinical trial. Clin Pharmacokinet. 2016;55(9):1079–1090.
   PubMed Web of Science ®Google Scholar
• Parasrampuria DA, Mendell J, Shi M, et al. Edoxaban drug-drug interactions with ketoconazole, erythromycin, and cyclosporine. Br J Clin Pharmacol. 2016. doi:10.1111/bcp.13092
   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;40(12):2250–2255.
   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;55(12):1395–1405.
   PubMed Web of Science ®Google Scholar
• Jonsson S, Simonsson US, Miller R, et al. Population pharmacokinetics of edoxaban and its main metabolite in a dedicated renal impairment study. J Clin Pharmacol. 2015;55(11):1268–1279.
   PubMed Web of Science ®Google Scholar
• Giugliano RP, Ruff CT, Wiviott SD, et al. Mortality in patients with atrial fibrillation randomized to edoxaban or warfarin: insights from the ENGAGE AF-TIMI 48 trial. Am J Med. 2016;129(8):850–7.e2.
   PubMed Web of Science ®Google Scholar
• Gosselin R, Grant RP, Adcock DM. Comparison of the effect of the anti-Xa direct oral anticoagulants apixaban, edoxaban, and rivaroxaban on coagulation assays. Int J Lab Hematol. 2016;38(5):505–513.
   PubMed Web of Science ®Google Scholar
• Lip GY, Brechin CM, Lane DA. The global burden of atrial fibrillation and stroke: a systematic review of the epidemiology of atrial fibrillation in regions outside North America and Europe. Chest. 2012;142(6):1489–1498.
   PubMed Web of Science ®Google Scholar
• Crowther M, Crowther MA. Antidotes for novel oral anticoagulants: current status and future potential. Arterioscler Thromb Vasc Biol. 2015;35(8):1736–1745.
   PubMed Web of Science ®Google Scholar
• Perzborn E, Heitmeier S, Laux V, et al. Reversal of rivaroxaban-induced anticoagulation with prothrombin complex concentrate, activated prothrombin complex concentrate and recombinant activated factor VII in vitro. Thromb Res. 2014;133(4):671–681.
   PubMed Web of Science ®Google Scholar
• Zahir H, Brown KS, Vandell AG, et al. Edoxaban effects on bleeding following punch biopsy and reversal by a 4-factor prothrombin complex concentrate. Circulation. 2015;131(1):82–90.
   PubMed Web of Science ®Google Scholar
• Brown KS, Wickremasingha P, Parasrampuria DA, et al. The impact of a three-factor prothrombin complex concentrate on the anticoagulatory effects of the factor Xa inhibitor edoxaban. Thromb Res. 2015;136(4):825–831.
   PubMed Web of Science ®Google Scholar
• Siegal DM, Curnutte JT, Connolly SJ, et al. Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med. 2015;373:2413–2424.
   PubMed Web of Science ®Google Scholar
• Crowther M, Levy GG, Lu G, et al. A phase 2 randomized, double-blind, placebo-controlled trial demonstrating reversal of edoxaban-induced anticoagulation in healthy subjects by andexanet alfa (PRT064445), a universal antidote for factor Xa (fXa) inhibitors. Blood. 2014;124(21):4269.
   Web of Science ®Google Scholar
• Ansell JE, Bakhru SH, Laulicht BE, et al. Use of PER977 to reverse the anticoagulant effect of edoxaban. New England J Med. 2014;371(22):2141–2142.
   PubMed Web of Science ®Google Scholar
• Halim AB, Samama MM, Mendell J. Ex vivo reversal of the anticoagulant effects of edoxaban. Thromb Res. 2014;134(4):909–913.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Summary of the risk management plan (RMP) for Lixiana (edoxaban) 2015 [cited 2016 May]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Risk-management-plan_summary/human/002629/WC500186050.pdf.
   Google Scholar
• Study of DU-176b Aged 80 Years or Older (clinicaltrial.gov identifier: NCT02801669). Daiichi Sankyo Co., Ltd; cited 2016 Aug 25th. Available from https://clinicaltrials.gov/ct2/show/NCT02801669?term=%22edoxaban%22+AND+%22atrial+fibrillation%22&rank=8
   Google Scholar
• Pazdur R Department of health and human services nda approval: food and drug administration (Silver Spring MD 20993); 2015 [cited 2015 Aug 01] Available from: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf.
   Google Scholar
• Major R&D Pipeline. Daiichi Sankyo Co., Ltd; [cited 2016 Jul]. Press release. Available from: http://www.daiichisankyo.com/rd/pipeline/pdf/20160729_Pipeline_EN.pdf.
   Google Scholar
• Daiichi Sankyo Launches Once-Daily LIXIANAⓇ Sales Alliance in Europe. Daiichi sankyo co., Ltd. [cited 2016 Feb 17]. Press release. Available from: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006406/160217_631_E.pdf.
   Google Scholar
• Late-stage Products. Daiichi Sankyo Co., Ltd; [cited 2016 Oct 4]. Available from www.daiichisankyo.com file:///D:/14-Projects-ongoing/OWN-Edoxaban%20review-August%202016%20update/ERCP-rev1/Late-stage%20Products%20-%20R&D%20-%20Daiichi%20Sankyo.html.
   Google Scholar
• Daiichi Sankyo Enters Into Agreement with Servier Canada For Factor Xa Inhibitor Edoxaban. Daiichi-Sankyo Co.,Ltd. [cited 2016 Jun 27]. Press release. Available from: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006469/160627_659_E.pdf.
   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: executive summary. Eur Heart J. 2016;ehw058. doi:10.1093/eurheartj/.
   Google Scholar
• A study in patients with acute major bleeding to evaluate the ability of andexanet alfa to reverse the anticoagulation effect of direct and indirect oral anticoagulants (ClinicalTrials.gov Identifier: NCT02329327). U.S. National Institutes of Health; updated 2015 Oct; cited 2016 Oct 4th. Available from https://clinicaltrials.gov/ct2/show/NCT02329327?term=Andexanet+alfa&rank=3
   Google Scholar