243
Views
79
CrossRef citations to date
0
Altmetric
Review

New oral anticoagulants in patients with nonvalvular atrial fibrillation: a review of pharmacokinetics, safety, efficacy, quality of life, and cost effectiveness

&
Pages 789-798 | Published online: 17 Jun 2014

References

  • Virchow RLK Thrombosis und Emboli (1846–1856) Klassiker der Medizin Karl Sudhoff Von Johann Ambrosius Barth V. 1910 Leipzig Matzdorff AC Bell WR Canton, Science History Publications 1998 32 49 50 53 56 62 110 169
  • Albers GW Dalen JE Laupacis A Manning WJ Petersen P Singer DE Antithrombotic therapy in atrial fibrillation Chest 2001 119 Suppl 1 194S 206S 11157649
  • Go AS Hylek EM Phillips KA Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study JAMA 2001 285 2370 2375 11343485
  • Naccarelli GV Panaccio MP Cummins G Tu N CHADS2 and CHA2DS2-VASc risk factors to predict first cardiovascular hospitalization among atrial fibrillation/atrial flutter patients Am J Cardiol 2012 109 10 1526 1533 22360819
  • Friberg L Rosenqvist M Lip GY Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study Eur Heart J 2012 33 12 1500 1510 22246443
  • European Heart Rhythm Association European Association for Cardio-Thoracic Surgery Camm AJ Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Eur Heart J 2010 31 2369 2429 20802247
  • Ansell J Hirsh J Poller L Bussey H Jacobson A Hylek E The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy Chest 2004 126 Suppl 3 204S 233S 15383473
  • You JJ Singer DE Howard PA Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 141 Suppl 2 e531S e575S 22315271
  • Hirsh J Dalen J Anderson DR Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range Chest 2001 119 Suppl 1 8S 21S 11157640
  • Mueck W Lensing AW Agnelli G Decousus H Prandoni P Misselwitz F Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention Clin Pharmacokinet 2011 50 10 675 686 21895039
  • Perzborn E Roehrig S Straub A Kubitza D Mueck W Laux V Rivaroxaban: a new oral factor Xa inhibitor Arterioscler Thromb Vasc Biol 2010 30 3 376 381 20139357
  • Mueck W Schwers S Stampfuss J Rivaroxaban and other novel oral anticoagulants: pharmacokinetics in healthy subjects, specific patient populations and relevance of coagulation monitoring Thromb J 2013 11 1 10 23809871
  • Ogata K Mendell-Harary J Tachibana M Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers J Clin Pharmacol 2010 50 7 743 753 20081065
  • Stangier J Clemens A Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor Clin Appl Thromb Hemost 2009 15 Suppl 1 9S 16S 19696042
  • Clemens A Haertter S Friedman J Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification Curr Med Res Opin 2012 28 2 195 201 22208675
  • Healey JS Eikelboom J Douketis J Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial Circulation 2012 126 3 343 348 22700854
  • Patel MR Mahaffey KW Garg J Rivaroxaban versus warfarin in nonvalvular atrial fibrillation N Engl J Med 2011 365 10 883 891 21830957
  • Flaker GC Eikelboom JW Shestakovska O Bleeding during treatment with aspirin versus apixaban in patients with atrial fibrillation unsuitable for warfarin: the apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment (AVERROES) trial Stroke 2012 43 12 3291 3297 23033347
  • Wallentin L Lopes RD Hanna M Efficacy and safety of apixaban compared with warfarin at different levels of predicted international normalized ratio control for stroke prevention in atrial fibrillation Circulation 2013 127 22 2166 2176 23640971
  • Giugliano RP Ruff CT Braunwald E Edoxaban versus warfarin in patients with atrial fibrillation N Engl J Med 2013 369 22 2093 2104 24251359
  • Kalus JS Antithrombotic alternatives for stroke prevention in atrial fibrillation: critical differences and remaining questions Drugs Context 2013 2013 212251 24432039
  • Bloomfield HE Taylor BC Krause A Safe and Effective Anticoagulation in the Outpatient Setting: A Systematic Review of the Evidence Washington (DC) Department of Veterans Affairs (US) 2011 VA Evidence-based Synthesis Program Reports
  • Samsa GP Matchar DB Relationship between test frequency and outcomes of anticoagulation: a literature review and commentary with implications for the design of randomized trials of patient self-management J Thromb Thrombolysis 2000 9 283 292 10728029
  • Silva de Assis MC Nascimento Cruz L Zuchinali P Rohde LE Rejane Rabelo E Does treatment guided by vitamin K in the diet alter the quality of life of anticoagulated patients? Nutr Hosp 2012 27 4 1328 1333 23165582
  • Matchar DB Samsa GP Cohen SJ Oddone EZ Jurgelski AE Improving the quality of anticoagulation of patients with atrial fibrillation in managed care organizations: results of the managing anticoagulation services trial Am J Med 2002 113 1 42 51 12106622
  • Cromheecke ME Levi M Colly LP Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomized cross-over comparison Lancet 2000 356 8 97 102 10963245
  • Gadisseur AP Breukink-Engbers WG van der Meer FJ van den Besselaar AM Sturk A Rosendaal FR Comparison of the quality of oral anticoagulant therapy through patient self management and management by specialized anticoagulation clinics in the Netherlands Arch Intern Med 2003 163 2639 2646 14638565
  • Casais P Meschengieser SS Sanchez-Luceros A Lazzari MA Patients’ perceptions regarding oral anticoagulation therapy and its effect on quality of life Curr Med Res Opin 2005 21 7 1085 1090 16004677
  • Gadisseur AP Kaptein AA Breukink-Engbers WG van der Meer FJ Rosendaal FR Patient self-management of oral anticoagulant care vs management by specialized anticoagulation clinics: positive effects on quality of life J Thromb Haemost 2004 2 4 584 591 15102012
  • Davis NJ Billett HH Cohen HW Arnsten JH Impact of adherence, knowledge, and quality of life on anticoagulation control Ann Pharmacother 2005 39 4 632 636 15713790
  • Mani H Kasper A Lindhoff-Last E Measuring the anticoagulant effects of target specific oral anticoagulants-reasons, methods and current limitations J Thromb Thrombolysis 2013 36 2 187 194 23512159
  • Mismetti P Laporte S New oral antithrombotics: a need for laboratory monitoring. For J Thromb Haemost 2010 8 4 621 626 20102486
  • European Medicines Agency Xarelto-Summary of Product Characteristics London European Medicines Agency 2013 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000944/WC500057109.pdf Accessed April 24, 2014
  • European Medicines Agency Eliquis-Summary of Product Characteristics London European Medicines Agency 2013 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002148/WC500107773.pdf Accessed April 24, 2014
  • Upreti VV Wang J Barrett YC Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects Br J Clin Pharmacol 2013 76 6 908 916 23488672
  • European Medicines Agency Pradaxa-Summary of Product Characteristics London European Medicines Agency 2013 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000829/WC500041060.pdf Accessed April 24, 2014
  • Reilly PA Lehr T Haertter S RE-LY Investigators 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 24076487
  • Harper P Young L Merriman E Bleeding risk with dabigatran in the frail elderly N Engl J Med 2012 366 9 864 866 22375994
  • Legrand M Mateo J Aribaud A The use of dabigatran in elderly patients Arch Intern Med 2011 171 14 1285 1286 21788545
  • Garcia DA Crowther MA Reversal of warfarin: case-based practice recommendations Circulation 2012 125 23 2944 2947 22689931
  • Bershad EM Suarez JI Prothrombin complex concentrates for oral anticoagulant therapy-related intracranial hemorrhage: a review of the literature Neurocrit Care 2010 12 3 403 413 19967567
  • Lauritzen B Hedner U Johansen PB Tranholm M Ezban M Recombinant human factor VIIa and a factor VIIa-analogue reduces heparin and low molecular weight heparin (LMWH)-induced bleeding in rats J Thromb Haemost 2008 6 5 804 811 18315554
  • Lu G DeGuzman FR Hollenbach SJ A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa Nat Med 2013 19 4 446 451 23455714
  • Schiele F van Ryn J Canada K A specific antidote for dabigatran: functional and structural characterization Blood 2013 121 18 3554 3562 23476049
  • Laulicht B Bakhru S Lee C Small Molecule Antidote for Anticoagulants Los Angeles AHA 2012 Available from: http://www.perosphere.com/content/presentations/documents/Perosphere_ISTH_Talk.pdf Accessed April 24, 2014
  • Ogilvie IM Newton N Welner SA Cowell W Lip GY Underuse of oral anticoagulants in atrial fibrillation: a systematic review Am J Med 2010 123 7 638 645. e4 20609686
  • Connolly SJ Pogue J Eikelboom J Benefit of oral anticoagulant over antiplatelet therapy in atrial fibrillation depends on the quality of international normalized ratio control achieved by centers and countries as measured by time in therapeutic range Circulation 2008 118 20 2029 2037 18955670
  • Ageno W Gallus AS Wittkowsky A Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 2012 141 Suppl 2 e44S e88S 22315269
  • Wienen W Stassen JM Priepke H Ries UJ Hauel N In-vitro profile and ex-vivo anticoagulant activity of the direct thrombin inhibitor dabigatran and its orally active prodrug, dabigatran etexilate Thromb Haemost 2007 98 155 162 17598008
  • Samama MM Martinoli JL LeFlem L Assessment of laboratory assays to measure rivaroxaban-an oral, direct factor Xa inhibitor Thromb Haemost 2010 103 4 815 825 20135059
  • van Ryn J Stangier J Haertter S Dabigatran etexilate-a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity Thromb Haemost 2010 103 6 1116 1127 20352166
  • Tripodi A Chantarangkul V Guinet C Samama MM The International Normalized Ratio calibrated for rivaroxaban has the potential to normalize prothrombin time results for rivaroxaban-treated patients: results of an in vitro study J Thromb Haemost 2011 9 1 226 228 20942848
  • Samama MM Guinet C Laboratory assessment of new anticoagulants Clin Chem Lab Med 2011 49 5 761 772 21288169
  • Mani H Hesse C Stratmann G Lindhoff-Last E Rivaroxaban differentially influences ex vivo global coagulation assays based on the administration time Thromb Haemost 106 1 156 164 21655672
  • Samama MM Contant G Spiro TE Evaluation of the prothrombin time for measuring rivaroxaban plasma concentrations using calibrators and controls: results of a multicenter field trial Clin Appl Thromb Hemost 2012 18 2 150 158 22387577
  • Douxfils J Mullier F Robert S Chatelain C Chatelain B Dogné JM Impact of dabigatran on a large panel of routine or specific coagulation assays. Laboratory recommendations for monitoring of dabigatran etexilate Thromb Haemost 2012 107 5 985 997 22438031
  • Asmis LM Alberio L Angelillo-Scherrer A Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories Thromb Res 2012 129 4 492 498 21840043
  • Mani H Rohde G Stratmann G Accurate determination of rivaroxaban levels requires different calibrator sets but not addition of antithrombin Thromb Haemost 2012 108 1 191 198 22534775
  • Harenberg J Krämer R Giese C Marx S Weiss C Wehling M Determination of rivaroxaban by different factor Xa specific chromogenic substrate assays: reduction of interassay variability J Thromb Thrombolysis 2011 32 3 267 271 21811937
  • Samama MM Contant G Spiro TE Evaluation of the anti-factor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls Thromb Haemost 2012 107 2 379 387 22187012
  • Stangier J Feuring M Using the HEMOCLOT direct thrombin inhibitor assay to determine plasma concentrations of dabigatran Blood Coagul Fibrinolysis 2012 23 2 138 143 22227958
  • Curvers J van de Kerkhof D Stroobants AK van den Dool EJ Scharnhorst V Measuring direct thrombin inhibitors with routine and dedicated coagulation assays: which assay is helpful? Am J Clin Pathol 2012 138 4 551 558 23010710
  • Hickey K Anticoagulation management in clinical practice: preventing stroke in patients with atrial fibrillation Heart Lung 2012 41 2 146 156 22047781
  • Harrington AR Armstrong EP Nolan PE Malone DC Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation Stroke 2013 44 1676 1681 23549134
  • Krejczy M Harenberg J Marx S Obermann K Frölich L Wehling M Comparison of cost-effectiveness of anticoagulation with dabigatran, rivaroxaban and apixaban in patients with non-valvular atrial fibrillation across countries J Thromb Thrombolysis Epub 9 25 2013
  • Regier DA Sunderji R Lynd LD Gin K Marra CA Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy CMAJ 2006 174 13 1847 1852 16785459