Laboratory and clinical outcomes of pharmacogenetic vs. clinical protocols for warfarin initiation in orthopedic patients

Journal of Thrombosis and Haemostasis

Volumn 6, Issue 10, 2008, Pages 1655-1662

  Lenzini, P A ^a   Grice, G R ^a,b   Milligan, P E ^a,b   Dowd, M B ^c   Subherwal, S ^a   Deych, E ^a   Eby, C S ^a   King, C R ^a   Porche sorbet, R M ^a   Murphy, C V ^d   Marchand, R ^b   Millican, E A ^a   Barrack, R L ^a   Clohisy, J C ^a   Kronquist, K ^c   Gatchel, S K ^a   Gage, Brian F ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ST LOUIS COLLEGE OF PHARMACY   (United States)

^c KAISER PERMANENTE   (United States)

^d BARNES JEWISH HOSPITAL   (United States)

Author keywords

Anticoagulants; Dosing algorithm; Orthopedic surgery; Pharmacogenetics; Warfarin

Indexed keywords

AMIODARONE; CYTOCHROME P450; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PRAVASTATIN; WARFARIN;

ADULT; ALGORITHM; ARTICLE; BLEEDING; CIGARETTE SMOKING; CLINICAL PROTOCOL; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DOSE CALCULATION; DOSE RESPONSE; DRUG SAFETY; FEMALE; FOLLOW UP; GENOTYPE; HUMAN; INTERNATIONAL NORMALIZED RATIO; LIVER DISEASE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; ORTHOPEDIC SURGERY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PERIOPERATIVE PERIOD; PHARMACOGENETICS; POSTOPERATIVE THROMBOSIS; PRIORITY JOURNAL; PROSPECTIVE STUDY; TREATMENT DURATION; VALIDATION PROCESS;

ADULT; AGED; ALGORITHMS; ARTHROPLASTY; CLINICAL PROTOCOLS; FEMALE; HUMANS; MALE; MIDDLE AGED; PHARMACOGENETICS; PREDICTIVE VALUE OF TESTS; PREMEDICATION; PROSPECTIVE STUDIES; RISK FACTORS; THROMBOEMBOLISM; TREATMENT OUTCOME; WARFARIN;

EID: 49849105411     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/j.1538-7836.2008.03095.x     Document Type: Article

References (36)

1. FDA Approves Updated Warfarin (Coumadin) Prescribing Information: New Genetic Information May Help Providers Improve Initial Dosing Estimates of the Anticoagulant for Individual Patients, 2007. http://www.fda.gov/ bbs/topics/news/2007/new01684.html. Accessed 12 August, 2008.
2. Higashi MK, Veenstra DL, Kondo LM, Wittkowsky AK, Srinouanprachanh SL, Farin FM, Rettie AE. Association between CYP2C9 genetic variants and anticoagulation-related outcomes during warfarin therapy. JAMA 2002; 287: 1690-8.
3. White RH, Beyth RJ, Zhou H, Romano PS. Major bleeding after hospitalization for deep-venous thrombosis. Am J Med 1999; 107: 414-24.
4. Limdi NA, McGwin G, Goldstein JA, Beasley TM, Arnett DK, Adler BK, Baird MF, Acton RT. Influence of CYP2C9 and VKORC1 1173C/T genotype on the risk of hemorrhagic complications in African-American and European-American patients on warfarin. Clin Pharmacol Ther 2008; 83: 312-21.
5. Millican E, Lenzini P, Milligan P, Grosso L, Eby C, Deych E, Grice G, Clohisy J, Barrack R, Burnett R, Voora D, Gatchel S, Tiemeier A, Gage B. Genetic-based dosing in orthopaedic patients beginning warfarin therapy. Blood 2007; 110: 1511-5.
6. Schelleman H, Chen Z, Kealey C, Whitehead AS, Christie J, Price M, Brensinger CM, Newcomb CW, Thorn CF, Samaha FF, Kimmel SE. Warfarin response and vitamin K epoxide reductase complex 1 in African Americans and Caucasians. Clin Pharmacol Ther 2007; 81: 742-7.
7. Gage BF, Eby C, Milligan PE, Banet GA, Duncan JR, McLeod HL. Use of pharmacogenetics and clinical factors to predict the maintenance dose of warfarin. Thromb Haemost 2004; 91: 87-94.
8. Linder MW, Looney S, Adams JE 3rd, Johnson N, Antonino-Green D, Lacefield N, Bukaveckas BL, Valdes R Jr. Warfarin dose adjustments based on CYP2C9 genetic polymorphisms. J Thromb Thrombolysis 2002; 14: 227-32.
9. Voora D, Eby C, Linder MW, Milligan PE, Bukaveckas BL, McLeod HL, Maloney W, Clohisy J, Burnett RS, Grosso L, Gatchel SK, Gage BF. Prospective dosing of warfarin based on cytochrome P-450 2C9 genotype. Thromb Haemost 2005; 93: 700-5.
10. Margaglione M, Colaizzo D, D'Andrea G, Brancaccio V, Ciampa A, Grandone E, Di Minno G. Genetic modulation of oral anticoagulation with warfarin. Thromb Haemost 2000; 84: 775-8.
11. Rieder MJ, Reiner AP, Gage BF, Nickerson DA, Eby CS, McLeod HL, Blough DK, Thummel KE, Veenstra DL, Rettie AE. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. N Engl J Med 2005; 352: 2285-93.
12. Wadelius M, Chen LY, Downes K, Ghori J, Hunt S, Eriksson N, Wallerman O, Melhus H, Wadelius C, Bentley D, Deloukas P. Common VKORC1 and GGCX polymorphisms associated with warfarin dose. Pharmacogenomics J 2005; 5: 262-70.
13. D'Andrea G, D'Ambrosio RL, Di Perna P, Chetta M, Santacroce R, Brancaccio V, Grandone E, Margaglione M. A polymorphism in the VKORC1 gene is associated with an interindividual variability in the dose-anticoagulant effect of warfarin. Blood 2005; 105: 645-9.
14. Yuan HY, Chen JJ, Lee MT, Wung JC, Chen YF, Charng MJ, Lu MJ, Hung CR, Wei CY, Chen CH, Wu JY, Chen YT. A novel functional VKORC1 promoter polymorphism is associated with inter-individual and inter-ethnic differences in warfarin sensitivity. Hum Mol Genet 2005; 14: 1745-51.
15. Wood S. New Warfarin Labeling Reminds Physicians About Genetic Tests to Help Guide Initial Warfarin Dosing, 2007 http://www.medscape.com/ viewarticle/561608. Accessed 4 September 2007.
16. Carlquist JF, Horne BD, Muhlestein JB, Lappe DL, Whiting BM, Kolek MJ, Clarke JL, James BC, Anderson JL. Genotypes of the cytochrome p450 isoform, CYP2C9, and the vitamin K epoxide reductase complex subunit 1 conjointly determine stable warfarin dose: A prospective study. J Thromb Thrombolysis 2006; 22: 191-7.
17. Sconce EA, Khan TI, Wynne HA, Avery P, Monkhouse L, King BP, Wood P, Kesteven P, Daly AK, Kamali F. The impact of CYP2C9 and VKORC1 genetic polymorphism and patient characteristics upon warfarin dose requirements: Proposal for a new dosing regimen. Blood 2005; 106: 2329-33.
18. Herman D, Peternel P, Stegnar M, Breskvar K, Dolzan V. The influence of sequence variations in factor VII, gamma-glutamyl carboxylase and vitamin K epoxide reductase complex genes on warfarin dose requirement. Thromb Haemost 2006; 95: 782-7.
19. Gage B, Eby C, Johnson J, Deych E, Rieder M, Ridker P, Milligan P, Grice G, Lenzini P, Rettie A, Aquilante C, Grosso L, Marsh S, Langaee T, Farnett L, Voora D, Veenstra D, Glynn R, Barrett A, McLeod H. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin Pharmacol Ther 2008; 84: 326-31.
20. Anderson JL, Horne BD, Stevens SM, Grove AS, Barton S, Nicholas ZP, Kahn SF, May HT, Samuelson KM, Muhlestein JB, Carlquist JF. Randomized trial of genotype-guided versus standard warfarin dosing in patients initiating oral anticoagulation. Circulation 2007; 116: 2563-70.
21. Caraco Y, Blotnick S, Muszkat M. CYP2C9 genotype-guided warfarin prescribing enhances the efficacy and safety of anticoagulation: A prospective randomized controlled study. Clin Pharmacol Ther 2008; 83: 460-70.
22. Schwarz UI, Ritchie MD, Bradford Y, Li C, Dudek SM, Frye-Anderson A, Kim RB, Roden DM, Stein CM. Genetic determinants of response to warfarin during initial anticoagulation. N Engl J Med 2008; 358: 999-1008.
23. Lenzini P, Grice G, Milligan P, Gatchel S, Deych E, Eby C, Burnett RS, Clohisy J, Barrack R, Gage B. Optimal dose adjustment in orthopaedic patients beginning warfarin therapy. Ann Pharmacother 2007; 41: 1798-804.
24. King C, Porche-Sorbet R, Gage B, Ridker P, Renaud Y, Phillips M, Eby C. Performance of commercial platforms for rapid genotyping of polymorphisms affecting warfarin dose. Am J Clin Pathol 2008; 129: 876-883.
25. Rosendaal FR, Cannegieter SC, van der Meer FJ, Briet E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993; 69: 236-9.
26. Cohen LH, van Leeuwen RE, van Thiel GC, van Pelt JF, Yap SH. Equally potent inhibitors of cholesterol synthesis in human hepatocytes have distinguishable effects on different cytochrome P450 enzymes. Biopharm Drug Dispos 2000; 21: 353-64.
27. Gage BF, Fihn SD, White RH. Management and dosing of warfarin therapy. Am J Med 2000; 109: 481-8.
28. Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007; 115: 2689-96.
29. Siguret V, Gouin I, Debray M, Perret-Guillaume C, Boddaert J, Mahe I, Donval V, Seux ML, Romain-Pilotaz M, Gisselbrecht M, Verny M, Pautas E. Initiation of warfarin therapy in elderly medical inpatients: A safe and accurate regimen. Am J Med 2005; 118: 137-42.
30. Fennerty A, Dolben J, Thomas P, Backhouse G, Bentley DP, Campbell IA, Routledge PA. Flexible induction dose regimen for warfarin and prediction of maintenance dose. Br Med J (Clin Res Ed) 1984; 288: 1268-70.
31. Gedge J, Orme S, Hampton KK, Channer KS, Hendra TJ. A comparison of a low-dose warfarin induction regimen with the modified Fennerty regimen in elderly inpatients. Age Ageing 2000; 29: 31-4.
32. Kovacs MJ, Rodger M, Anderson DR, Morrow B, Kells G, Kovacs J, Boyle E, Wells PS. Comparison of 10-mg and 5-mg warfarin initiation nomograms together with low-molecular-weight heparin for outpatient treatment of acute venous thromboembolism. A randomized, double-blind, controlled trial. Ann Intern Med 2003; 138: 714-9.
33. Mungall DR, Ludden TM, Marshall J, Hawkins DW, Talbert RL, Crawford MH. Population kinetics of racemic warfarin. J Pharmacokinet Biopharm 1985; 13: 213-27.
34. Sconce EA, Khan TI, Daly AK, Wynne HA, Kamali F. The impact of simvastatin on warfarin disposition and dose requirements. J Thromb Haemost 2006; 4: 1422-4.
35. Oden A, Fahlen M, Hart RG. Optimal INR for prevention of stroke and death in atrial fibrillation: A critical appraisal. Thromb Res 2006; 117: 493-9.
36. Caldwell MD, Berg RL, Zhang KQ, Glurich I, Schmelzer JR, Yale SH, Vidaillet HJ, Burmester JK. Evaluation of genetic factors for warfarin dose prediction. Clin Med Res 2007; 5: 8-16.