A rolling-horizon pharmacokinetic pharmacodynamic model for warfarin inpatients in transient clinical states

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References

• 1 Chinitz JS, Vaishnava P, Narayan RL, Fuster V. Atrial fibrillation through the years: contemporary evaluation and management. Circulation 127(3), 408–416 (2013). • Provides a comprehensive review of the advancements in clinical evaluation, treatment and management of atrial fibrillation.
  MedlineGoogle Scholar
• 2 Kernan WN, Ovbiagele B, Black HR et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Aassociation. Stroke 45(7), 2160–2236 (2014). • Provides evidence-based guidelines for anticoagualtion and stroke prevention for clinical practitioners.
  MedlineGoogle Scholar
• 3 Cheng JW, Barillari G. Non-vitamin K antagonist oral anticoagulants in cardiovascular disease management: evidence and unanswered questions. J. Clin. Pharm. Ther. 39(2), 118–135 (2014).
  Medline CASGoogle Scholar
• 4 Visser LE, Penning-van Bees FJ, Kasbergen AA et al. Overanticoagulation associated with combined use of antibacterial drugs and acenocoumarol or phenprocoumon anticoagulants. Thromb. Haemost. 88(5), 705–710 (2002).
  Medline CASGoogle Scholar
• 5 Teichert M, van Noord C, Uitterlinden AG et al. Proton pump inhibitors and the risk of overanticoagulation during acenocoumarol maintenance treatment. Br. J. Haematol. 153(3), 379–385 (2011).
  MedlineGoogle Scholar
• 6 van Dijk KN, Plat AW, van Dijk AA et al. Potential interaction between acenocoumarol and diclofenac, naproxen and ibuprofen and role of CYP2C9 genotype. Thromb. Haemost. 91(1), 95–101 (2004).
  Medline CASGoogle Scholar
• 7 Knijff-Dutmer EA, van der Palen J, Schut G, Van de Laar MA. The influence of cyclo-oxygenase specificity of non-steroidal anti-inflammatory drugs on bleeding complications in concomitant coumarine users. QJM 96(7), 513–520 (2003).
  Medline CASGoogle Scholar
• 8 Johnson SG, Witt DM, Eddy TR, Delate T. Warfarin and antiplatelet combination use among commercially insured patients enrolled in an anticoagulation management service. Chest 131(5), 1500–1507 (2007).
  Medline CASGoogle Scholar
• 9 Johnson SG, Rogers K, Delate T, Witt DM. Outcomes associated with combined antiplatelet and anticoagulant therapy. Chest 133(4), 948–954 (2008).
  Medline CASGoogle Scholar
• 10 Shikata E, Ieiri I, Ishiguro S et al. Association of pharmacokinetic (CYP2C9) and pharmacodynamic (factors II, VII, IX, and X; proteins S and C; and gamma-glutamyl carboxylase) gene variants with warfarin sensitivity. Blood 103(7), 2630–2635 (2004).
  Medline CASGoogle Scholar
• 11 D'Andrea G, D'Ambrosio RL, Perna PD et al. A polymorphism in the VKORC1 gene is associated with an interindividual variability in the dose-anticoagulant effect of warfarin. Blood 105(2), 645–649 (2005).
  MedlineGoogle Scholar
• 12 Sconce EA, Khan TI, Wynne HA et al. The impact of CYP2C9 and VKORC1 genetic polymorphism and patient characteristics upon warfarin dose requirements: proposal for a new dosing regimen. Blood 106(7), 2329–2333 (2005).
  Medline CASGoogle Scholar
• 13 Schwarz UI, Ritchie MD, Bradford Y et al. Genetic determinants of response to warfarin during initial anticoagulation. N. Engl. J. Med. 358(10), 999–1008 (2008).
  Medline CASGoogle Scholar
• 14 Takahashi H, Wilkinson GR, Nutescu EA et al. Different contributions of polymorphisms in VKORC1 and CYP2C9 to intra- and inter-population differences in maintenance dose of warfarin in Japanese, Caucasians and African–Americans. Pharmacogenet. Genomics 16(2), 101–110 (2006).
  Medline CASGoogle Scholar
• 15 Cooper GM, Johnson JA, Langaee TY et al. A genome-wide scan for common genetic variants with a large influence on warfarin maintenance dose. Blood 112(4), 1022–1027 (2008).
  Medline CASGoogle Scholar
• 16 Wadelius M, Chen LY, Lindh JD et al. The largest prospective warfarin-treated cohort supports genetic forecasting. Blood 113(4), 784–792 (2009).
  Medline CASGoogle Scholar
• 17 Nutescu EA, Shapiro NL, Ibrahim S, West P. Warfarin and its interactions with foods, herbs and other dietary supplements. Expert Opin. Drug Saf. 5(3), 433–451 (2006).
  Medline CASGoogle Scholar
• 18 Ford SK, Moll S. Vitamin K supplementation to decrease variability of international normalized ratio in patients on vitamin K antagonists: A literature review. Curr. Opin. Hematol. 15(5), 504–508 (2008).
  Medline CASGoogle Scholar
• 19 Holbrook A, Schulman S, Witt DM et al. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141(2), e152S–e184S (2012).
  Medline CASGoogle Scholar
• 20 Wysowski DK, Nourjah P, Swartz L. Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action. Arch. Intern. Med. 167(13), 1414–1419 (2007).
  MedlineGoogle Scholar
• 21 Torn M, Cannegieter SC, Bollen WL, van der Meer FJ, van der Wall EE, Rosendaal FR. Optimal level of oral anticoagulant therapy for the prevention of arterial thrombosis in patients with mechanical heart valve prostheses, atrial fibrillation, or myocardial infarction: a prospective study of 4202 patients. Arch. Intern. Med. 169(13), 1203–1209 (2009).
  Medline CASGoogle Scholar
• 22 Gage BF, Fihn SD, White RH. Management and dosing of warfarin therapy. Am. J. Med. 109(6), 481–488 (2000).
  Medline CASGoogle Scholar
• 23 January CT, Wann LS, Alpert JS et al. AHA/ACC/HRS Guideline for the management of patients with atrial fibrillation: 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. 60, 1740–1749 (2014).
  Google Scholar
• 24 Witt DM, Delate T, Clark NP et al. Twelve-month outcomes and predictors of very stable INR control in prevalent warfarin users. J. Thromb. Haemost. 8(4), 744–749 (2010).
  Medline CASGoogle Scholar
• 25 van Walraven C, Forster AJ. Anticoagulation control in the peri-hospitalization period. J. Gen. Intern. Med. 22(6), 727–735 (2007).
  MedlineGoogle Scholar
• 26 Witt DM, Delate T, Clark NP et al. Outcomes and predictors of very stable INR control during chronic anticoagulation therapy. Blood 114(5), 952–956 (2009).
  Medline CASGoogle Scholar
• 27 Kimmel SE, Chen Z, Price M et al. The influence of patient adherence on anticoagulation control with warfarin: results from the international normalized ratio Adherence and Genetics (IN-RANGE) Study. Arch. Intern. Med. 167(3), 229–235 (2007).
  Medline CASGoogle Scholar
• 28 Platt AB, Localio AR, Brensinger CM et al. Can we predict daily adherence to warfarin? Results from the international normalized ratio Adherence and Genetics (IN-RANGE) Study. Chest 137(4), 883–889 (2010).
  MedlineGoogle Scholar
• 29 Rose AJ, Ozonoff A, Berlowitz DR, Henault LE, Hylek EM. Warfarin dose management affects INR control. J. Thromb. Haemost. 7(1), 94–101 (2009).
  Medline CASGoogle Scholar
• 30 Rose AJ, Hylek EM, Ozonoff A, Ash AS, Reisman JI, Berlowitz DR. Patient characteristics associated with oral anticoagulation control: results of the Veterans AffaiRs Study to Improve Anticoagulation (VARIA). J. Thromb. Haemost. 8(10), 2182–2191 (2010).
  Medline CASGoogle Scholar
• 31 Ansell J, Hirsh J, Hylek E et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest. 133(6), 160S–198S (2008).
  Medline CASGoogle Scholar
• 32 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. 113(1), 42–45 (2002). • Provides practical evidence on the effectiveness of the warfarin dosing protocols and methods currently used in practice.
  MedlineGoogle Scholar
• 33 Mitra R, Marciell MA, Brain C, Ahangar B, Burke DT. Efficacy of computer-aided dosing of warfarin among patients in a rehabilitation hospital. Am. J. Phys. Med. Rehabil. 84(6), 423–427 (2005).
  MedlineGoogle Scholar
• 34 Ageno W, Johnson J, Nowacki B, Turpie AG. A computer generated induction system for hospitalized patients starting on oral anticoagulant therapy. Thromb. Haemost. 83(6), 849–852 (2000).
  Medline CASGoogle Scholar
• 35 van Spall HG, Wallentin L, Yusuf S et al. Variation in warfarin dose adjustment practice is responsible for differences in the quality of anticoagulation control between centers and countries: an analysis of patients receiving warfarin in the randomized evaluation of long-term anticoagulation therapy (RE-LY) trial. Circulation 126, 2309–2316 (2012).
  Medline CASGoogle Scholar
• 36 Jones M, McEwan P, Morgan CL, Peters JR, Goodfellow J, Currie CJ. Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record linkage study in a large British population. Heart 91(4), 472–477 (2005).
  Medline CASGoogle Scholar
• 37 Wallentin L, Yusuf S, Ezekowitz MD et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 376(9745), 975–983 (2010).
  Medline CASGoogle Scholar
• 38 Reynolds KK, Valdes R, Hartung BR, Linder MW. Individualizing warfarin therapy. Pers. Med. 4, 11–31 (2007). • Provides evidence that multiple regression models with genetic information and combinations of patient's physical attributes can better explain warfarin dose variability than models with only genetic information.
  CASGoogle Scholar
• 39 Holford NHG, Sheiner LB. Understanding the dose–effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin. Pharmacokinet. 6(6), 429–453 (1981). • The first paper to study the dose–effect relationship between warfarin and international normalized ratio (INR) from a pharmacokinetic pharmacodynamic (PK/PD) perspective.
  Medline CASGoogle Scholar
• 40 Holford NHG. Clinical pharmacokinetics and pharmacodynamics of warfarin. Understanding the dose–effect relationship. Clin. Pharmacokinet. 11(6), 483–504 (1986). •• The first paper to define the four submodels for the clinical PK and PD of warfarin; it also proposes various mathematical equations suitable for each of the submodels.
  Medline CASGoogle Scholar
• 41 Wright DFB, Duffull SB. Development of a Bayesian forecasting method for warfarin dose individualization. Pharm. Res. 28(5), 1100–1111 (2011). • Reviews and compares existing PK/PD models for warfarin and INR, and proposes a Bayesian forecasting method for INR and warfarin doses.
  Medline CASGoogle Scholar
• 42 Pasterkamp E, Kruithof CJ, van der Meer FJ, Rosendaal FR, Vanderschoot JP. A model-based algorithm for the monitoring of long-term anticoagulation therapy. J. Thromb. Haemost. 3(5), 915–921 (2005). • Simplifies the model by [44] for the long-term anticoagulation treatment of outpatients with visit intervals between 1 and 6 weeks.
  Medline CASGoogle Scholar
• 43 Vadher B, Patterson DLH, Leaning M. Prediction of the international normalized ratio and maintenance dose during the initiation of warfarin therapy. Br. J. Clin. Pharmacol. 48, 63–70 (1999). • Provides a PK/PD model, which can accurately predict the INR and maintenance dose during the initiation of warfarin therapy.
  Medline CASGoogle Scholar
• 44 Carter BL, Taylor JW, Becker A. Evaluation of three dosage-prediction methods for initial in-hospital stabilization of warfarin therapy. Clin. Pharm. 6(1), 37–45 (1987).
  Medline CASGoogle Scholar
• 45 White RH, Hong R, Venook AP et al. Initiation of warfarin therapy – comparison of physician dosing with computer-assisted dosing. J. Gen. Intern. Med. 3, 141–148 (1987).
  Google Scholar
• 46 Wright DFB, Duffull SB. A Bayesian dose-individualization method for warfarin. Clin. Pharmacokinet. 52(1), 59–68 (2013). • Assesses the predictive performance of the Bayesian method by [45] on 55 warfarin patients and finds that the method can accurately predict the steady-state INR.
  Medline CASGoogle Scholar
• 47 White RH, Mungall D. Outpatient management of warfarin therapy: comparison of computer-predicted dosage adjustment to skilled professional care. Ther. Drug Monit. 13(1), 46–50 (1991).
  Medline CASGoogle Scholar
• 48 Hamberg AK, Wadelius M, Lindh JD et al. A pharmacometic model describing the relationship between warfarin dose and INR response with respect to variations in CYP2C9, VKORC1, and age. Clin. Pharmacol. Ther. 87(6), 727–734 (2010). • Develops a population PK/PD model that describes the relationship between warfarin dose and INR response and also takes into account genetic variations.
  Medline CASGoogle Scholar
• 49 Shi L, Olafsson S. Nested partitions method for global optimization. Oper. Res. 48(3), 390–407 (2000).
  Google Scholar
• 50 Shi L, Olafsson S. Nested Partitions Method, Theory and Applications. Springer Science + Business Media, NY, USA (2009).
  Google Scholar
• 51 Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J. Pharmacokinet. Biopharm. 9(4), 503–512 (1981).
  Medline CASGoogle Scholar