Abstract
Target specific anticoagulants (TSOACs) have recently been introduced to the US market for multiple indications including venous thromboembolism (VTE) prevention in total hip and knee replacement surgeries, VTE treatment and reduction in the risk of stroke in patients with non-valvular atrial fibrillation (NVAF). Currently, three TSOACs are available including rivaroxaban, apixaban, and dabigatran with edoxaban currently under Food and Drug Administration review for VTE treatment and stroke prevention in NVAF. The introduction of these agents has created a paradigm shift in anticoagulation by considerably simplifying treatment and anticoagulant initiation for patients by giving clinicians the opportunity to use a rapid onset, rapid offset, oral agent. The availability of these rapid onset TSOACs is allowing for outpatient treatment of low risk pulmonary embolism and deep vein thrombosis which can greatly reduce healthcare costs by avoiding inpatient hospitalizations and treatment for the disease. Additionally with this practice, the complications of an inpatient hospitalization may also be avoided such as nosocomial infections. Single-agent approaches with TSOACs represent a paradigm shift in the treatment of VTE versus the complicated overlap of a parenteral agent with warfarin. Transitions between anticoagulants, including TSOACs, are a high-risk period for the patient, and clinicians must carefully consider patient characteristics such as renal function as well as the agents that are being transitioned. TSOAC use appears to be growing slowly with improved payment coverage throughout the US.
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References
Lu G, DeGuzman FR, Hollenbach SJ, Karbarz MJ, Abe K, Lee G, Luan P, Hutchaleelaha A, Inagaki M, Conley PB, Phillips DR, Sinha U (2013) A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med 19(4):446–451. doi:10.1038/nm.3102
Schiele F, van Ryn J, Canada K, Newsome C, Sepulveda E, Park J, Nar H, Litzenburger T (2013) A specific antidote for dabigatran: functional and structural characterization. Blood 121(18):3554–3562. doi:10.1182/blood-2012-11-468207
Mahan CE, Fanikos J (2011) New antithrombotics: the impact on global health care. Thromb Res 127(6):518–524. doi:10.1016/j.thromres.2011.03.022
Weitz JI, Eikelboom JW, Samama MM, American College of Chest P (2012) New antithrombotic drugs: antithrombotic therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 141(2 Suppl):e120S–e151S. doi:10.1378/chest.11-2294
http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf-zoom=100. Xarelto Package Insert. Accessed 12 Feb 2014
http://packageinserts.bms.com/pi/pi_eliquis.pdf. Eliquis Package Insert. Accessed 12 Feb 2014
http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/PrescribingInformation/PIs/Pradaxa/Pradaxa.pdf. Pradaxa Package Insert. Accessed 12 Feb 2014
http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006065.html. Edoxaban FDA submission. Accessed 12 Feb 2014
http://www.portola.com/clinical-development/andexanet-alfa-prt4445-fxa-inhibitor-antidote/. Andexanet Alpha Xa Reversal Agent. Accessed 12 Feb 2014
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/19_november_2014dabigatranetexilateaha.html. Idarucizumab–Pradaxa Reversal Agent. Accessed 12 Feb 2014
http://www.jnj.com/news/all/Janssen-Expands-EXPLORER-Global-Cardiovascular-Research-Program-to-Evaluate-the-Role-of-XARELTO-in-Addressing-Critical-Medical-Needs. Rivaroxaban research programs. Accessed 12 Feb 2014
http://clinicaltrials.gov/ct2/results?term=apixaban&Search=Search. Apixaban clinical trials. Accessed 12 Feb 2014
http://clinicaltrials.gov/ct2/results?term=rivaroxaban&Search=Search. Rivaroxaban clinical research. Accessed 12 Feb 2014
Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P, European Heart Rhythm A (2013) European heart rhythm association practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 15(5):625–651. doi:10.1093/europace/eut083
Hokusai VTEI, Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P (2013) Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 369(15):1406–1415. doi:10.1056/NEJMoa1306638
Bang OY, Hong KS, Heo JH, Koo J, Kwon SU, Yu KH, Bae HJ, Lee BC, Yoon BW, Kim JS (2014) New oral anticoagulants may be particularly useful for asian stroke patients. J Stroke 16(2):73–80. doi:10.5853/jos.2014.16.2.73
Source: IMS Health National Prescription Audit, data through 11/14/14. Courtesy Janssen Pharmaceuticals 12/1/2014
http://www.eliquis.com/eliquis/support-coverage-assistance. Apixaban coverage. Accessed 12 March 2014
http://www.xareltohcp.com/formulary-map.html. Xarelto formulary map. Accessed 12 March 2014
http://www.xareltohcp.com/access-affordability/access-affordability.html. Xarelto Access and Affordability. Accessed 12 March 2014
http://www.pradaxapro.com/pradaxalink/dabigatran-coverage-affordability. Pradaxa coverage. Accessed 12 March 2014
http://www.fingertipformulary.com/drugs/Eliquis/. Eliquis Coverage by State. Accessed 12 March 2014
http://www.xareltocarepath.com/reducing-stroke-risk/xarelto-savings-programs. Xarelto savings programs. Accessed 12 March 2014
http://www.eliquis.com/eliquis/support-offers. Eliquis support programs. Accessed 12 March 2014
http://www.pradaxa.com/patient-support/pradaxalink.html. Pradaxa support programs. Accessed 12 March 2014
http://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/SAB_Copayment_Coupons.pdf. Office of inspector general special advisory bulletin. Accessed 12 March 2014
Abo-Salem E, Becker R (2014) Transitioning to and from the novel oral anticoagulants: a management strategy for clinicians. J Thromb Thrombolysis 37(3):372–379. doi:10.1007/s11239-014-1060-y
Atay JK, Fiumara K, Piazza G, Fanikos J, Goldhaber SZ (2012) Hospital budget implications of substituting dabigatran for warfarin in an anticoagulation service. Clin Appl Thromb/Hemost 18(2):181–184. doi:10.1177/1076029611416642
Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK, Eckman MH, Dunn AS, Kunz R, College American, Chest P (2012) Perioperative management of antithrombotic therapy: antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 141(2 Suppl):e326S–e350S. doi:10.1378/chest.11-2298
Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM, Investigators EA-T (2013) Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 369(22):2093–2104. doi:10.1056/NEJMoa1310907
Dawes J, Prowse CV, Pepper DS (1986) Absorption of heparin, LMW heparin and SP54 after subcutaneous injection, assessed by competitive binding assay. Thromb Res 44(5):683–693
Mahan CE, Borrego ME, Woersching AL, Federici R, Downey R, Tiongson J, Bieniarz MC, Cavanaugh BJ, Spyropoulos AC (2012) Venous thromboembolism: annualised United States models for total, hospital-acquired and preventable costs utilising long-term attack rates. Thromb Haemost 108(2):291–302. doi:10.1160/TH12-03-0162
http://www.health.gov/hai/prevent_hai.asp. Nosocomial infections. Accessed 12 May 2014
Acknowledgments
Charles Mahan has received investigator-initiated grants from Sanofi-Aventis and funding from the North American Thrombosis Forum Traveling Fellowship Award, served as a consultant for Point of Care Software Solutions, Sanofi-Aventis, Boehringer-Ingelheim, Johnson & Johnson, Polymedix Inc., Leo, Eisai, and Daiichi Sankyo. He has served as a speaker for Janssen, Bristol Myers Squibb, Phizer, Sanofi-Aventis, and Boehringer Ingelheim.
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Mahan, C.E. Practical aspects of treatment with target specific anticoagulants: initiation, payment and current market, transitions, and venous thromboembolism treatment. J Thromb Thrombolysis 39, 295–303 (2015). https://doi.org/10.1007/s11239-014-1164-4
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DOI: https://doi.org/10.1007/s11239-014-1164-4