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References

  • 1
    Weitz JI, Hirsh J, Samama MM. New antithrombotic drugs: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 234S256.
  • 2
    Hawkins D. Limitations of traditional anticoagulants. Pharmacotherapy 2004; 24: 62S65.
  • 3
    Harris JE. Interaction of dietary factors with oral anticoagulants: review and applications. J Am Diet Assoc 1995; 95: 580584.
  • 4
    Rewinkel JB, Adang AE. Strategies and progress towards the ideal orally active thrombin inhibitor. Curr Pharm Des 1999; 5: 10431075.
  • 5
    Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 160S198.
  • 6
    Weitz JI. Emerging anticoagulants for the treatment of venous thromboembolism. Thromb Haemost 2006; 96: 274284.
  • 7
    Ieko M, Tarumi T, Takeda M, Naito S, Nakabayashi T, Koike T. Synthetic selective inhibitors of coagulation factor Xa strongly inhibit thrombin generation without affecting initial thrombin forming time necessary for platelet activation in hemostasis. J Thromb Haemost 2004; 2: 612618.
  • 8
    Wong PC, Crain EJ, Watson CA, Wexler RR, Lam PY, Quan ML, Knabb RM. Razaxaban, a direct factor Xa inhibitor, in combination with aspirin and/or clopidogrel improves low-dose antithrombotic activity without enhancing bleeding liability in rabbits. J Thromb Thrombolysis 2007; 24: 4351.
  • 9
    Wong PC, Crain EJ, Xin B, Wexler RR, Lam PY, Pinto DJ, Luettgen JM, Knabb RM. Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies. J Thromb Haemost 2008; 6: 820829.
  • 10
    Wong PC, Watson CA, Crain EJ. Arterial antithrombotic and bleeding time effects of apixaban, a direct factor Xa inhibitor, in combination with antiplatelet therapy in rabbits. J Thromb Haemost 2008; 6: 17361741.
  • 11
    Wong PC, Crain EJ, Watson CA, Xin B. Favorable therapeutic index of the direct factor Xa inhibitors, apixaban and rivaroxaban, compared with the thrombin inhibitor dabigatran in rabbits. J Thromb Haemost 2009; 7: 13131320.
  • 12
    Eriksson BI, Quinlan DJ, Weitz JI. Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor Xa inhibitors in development. Clin Pharmacokinet 2009; 48: 122.
  • 13
    Eriksson BI, Quinlan DJ, Eikelboom JW. Novel oral factor Xa and thrombin inhibitors in the management of thromboembolism. Annu Rev Med 2011; 62: 4157.
  • 14
    Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet 2010; 375: 807815.
  • 15
    Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med 2010; 363: 24872498.
  • 16
    Ufer M. Comparative efficacy and safety of the novel oral anticoagulants dabigatran, rivaroxaban and apixaban in preclinical and clinical development. Thromb Haemost 2010; 103: 572585.
  • 17
    Frost C, Yu Z, Nepal S, Bragat A, Moore K, Shenker A, Barrett YC, LaCreta F. Apixaban, a direct factor Xa inhibitor: single-dose pharmacokinetics and pharmacodynamics of an intravenous formulation [abstract]. J Clin Pharmacol 2008; 48: 1132.
  • 18
    Vakkalagadda B, Frost C, Wang J, Nepal S, Schuster A, Zhang D, Dias C, Yu Z, Shenker A, LaCreta F. Effect of rifampin on the pharmacokinetics of apixaban, an oral direct inhibitor of factor Xa [abstract]. J Clin Pharmacol 2009; 49: 10911130.
  • 19
    Jiang X, Crain EJ, Luettgen JM, Schumacher WA, Wong PC. Apixaban, an oral direct factor Xa inhibitor, inhibits human clot-bound factor Xa activity in vitro. Thromb Haemost 2009; 101: 780782.
  • 20
    Pinto DJ, Orwat MJ, Koch S, Rossi KA, Alexander RS, Smallwood A, Wong PC, Rendina AR, Luettgen JM, Knabb RM, He K, Xin B, Wexler RR, Lam PY. Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H -pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation factor Xa. J Med Chem 2007; 50: 53395356.
  • 21
    Raghavan N, Frost CE, Yu Z, He K, Zhang H, Humphreys WG, Pinto D, Chen S, Bonacorsi S, Wong PC, Zhang D. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos 2009; 37: 7481.
  • 22
    Buller H, Deitchman D, Prins M, Segers A. Efficacy and safety of the oral direct factor Xa inhibitor apixaban for symptomatic deep vein thrombosis. The Botticelli DVT dose-ranging study. J Thromb Haemost 2008; 6: 13131318.
  • 23
    Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S. Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364: 806817.
  • 24
    Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek E, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser S, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon J, Pais P, Parkhomenko A, Verheugt F, Zhu J, Wallentin L. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981992.
  • 25
    Food and Drug Administration. Guidance for Industry: food effect bioavailability and fed bioequivalence studies. Available at http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126833.pdf. 2002. FDA. Guidance for Industry. 6-5-2011.
  • 26
    Perrier D, Gibaldi M. General derivation of the equation for time to reach a certain fraction of steady state. J Pharm Sci 1982; 71: 474475.
  • 27
    Rowland M, Tozer T. Clinical Pharmacokinetics, Concepts and Applications, 3rd edn. Philadelphia, PA: Lippincott Williams & Wilkins, 1995.
  • 28
    Barrett YC, Wang Z, Knabb RM. A novel prothrombin time assay for assessing the anticoagulant activity of oral factor Xa inhibitors. Clin Appl Thromb Hemost 2012; Apr 2. [Epub ahead of print].
  • 29
    Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 1991; 29: 18.
  • 30
    Frost C, Yu Z, Moore K, Nepal S, Barrett Y, Mosqueda-Garcia R, Shenker A. Apixaban, an oral direct factor Xa inhibitor: multiple-dose safety, pharmacokinetics, and pharmacodynamics in healthy subjects. J Thromb Haemost 2007; 5: P-M-664.
  • 31
    Groen D, Harris S, Colucci S, Apseloff G. Serum transaminase levels should be measured immediately prior to dosing in early phase I clinical trials. J Clin Pharmacol 2011; 51: 252255.
  • 32
    Pettersson J, Hindorf U, Persson P, Bengtsson T, Malmqvist U, Werkstrom V, Ekelund M. Muscular exercise can cause highly pathological liver function tests in healthy men. Br J Clin Pharmacol 2008; 65: 253259.
  • 33
    Fleisher D, Li C, Zhou Y, Pao LH, Karim A. Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications. Clin Pharmacokinet 1999; 36: 233254.
  • 34
    Barrett YC, Wang Z, Frost C, Shenker A. Clinical laboratory measurement of direct factor Xa inhibitors: anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost 2010; 104: 12631271.
  • 35
    Hillarp A, Baghaei F, Fagerberg Blixter I, Gustafsson KM, Stigendal L, Sten-Linder M, Strandberg K, Lindahl TL. Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays. J Thromb Haemost 2011; 9: 133139.
  • 36
    Ford SK, Misita CP, Shilliday BB, Malone RM, Moore CG, Moll S. Prospective study of supplemental vitamin K therapy in patients on oral anticoagulants with unstable international normalized ratios. J Thromb Thrombolysis 2007; 24: 2327.
  • 37
    Franco V, Polanczyk CA, Clausell N, Rohde LE. Role of dietary vitamin K intake in chronic oral anticoagulation: prospective evidence from observational and randomized protocols. Am J Med 2004; 116: 651656.
  • 38
    Hirsch IB, Brownlee M. Beyond hemoglobin A1c – need for additional markers of risk for diabetic microvascular complications. JAMA 2010; 303: 22912292.
  • 39
    Kubitza D, Becka M, Zuehlsdorf M, Mueck W. 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; 46: 549558.
  • 40
    Kurnik D, Loebstein R, Rabinovitz H, Austerweil N, Halkin H, Almog S. Over-the-counter vitamin K1-containing multivitamin supplements disrupt warfarin anticoagulation in vitamin K1-depleted patients. A prospective, controlled trial. Thromb Haemost 2004; 92: 10181024.
  • 41
    Stangier J, Eriksson BI, Dahl OE, Ahnfelt L, Nehmiz G, Stahle H, Rathgen K, Svard R. Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement. J Clin Pharmacol 2005; 45: 555563.