Effects on bleeding complications of pharmacogenetic testing for initial dosing of vitamin K antagonists: A systematic review and meta-analysis

Journal of Thrombosis and Haemostasis

Volumn 12, Issue 9, 2014, Pages 1480-1487

  Franchini, Massimo ^a   Mengoli, C ^b   Cruciani, M ^c   Bonfanti, C ^a   Mannucci, P M ^d  

^a CARLO POMA HOSPITAL   (Italy)

^b UNIVERSITY OF PADOVA   (Italy)

^c ULSS 20 Verona   (Italy)

^d FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

Author keywords

Hemorrhage; Meta analysis; Pharmacogenetics; Thromboembolism; Warfarin

Indexed keywords

ANTIVITAMIN K; CYTOCHROME P450 2C9; WARFARIN; ANTICOAGULANT AGENT; CYP2C9 PROTEIN, HUMAN; VITAMIN K EPOXIDE REDUCTASE; VITAMIN K GROUP; VKORC1 PROTEIN, HUMAN;

ARTICLE; BLEEDING; GENETIC VARIABILITY; GENOTYPE; HEMOSTASIS; HUMAN; INTERNATIONAL NORMALIZED RATIO; META ANALYSIS; PHARMACOGENETICS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; ADULT; AGED; ANTAGONISTS AND INHIBITORS; BLOOD CLOTTING; CHEMICALLY INDUCED; COMPLICATION; FEMALE; GENETICS; MALE; MIDDLE AGED; PROCEDURES; PROSPECTIVE STUDY; REPRODUCIBILITY; THROMBOEMBOLISM; TREATMENT OUTCOME;

ADULT; AGED; ANTICOAGULANTS; BLOOD COAGULATION; CYTOCHROME P-450 CYP2C9; FEMALE; GENOTYPE; HEMORRHAGE; HUMANS; INTERNATIONAL NORMALIZED RATIO; MALE; MIDDLE AGED; PHARMACOGENETICS; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; THROMBOEMBOLISM; TREATMENT OUTCOME; VITAMIN K; VITAMIN K EPOXIDE REDUCTASES; WARFARIN;

EID: 84908501011     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.12647     Document Type: Article

References (42)

1. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007; 146: 857-67.
2. Guyatt GH, Akl EA, Crowther M, Gutterman DD, Schu€unemann HJ; American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel. Executive summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 2(Suppl): 7S-47S.
3. Mannucci PM, Franchini M. Old and new anticoagulant drugs: a minireview. Ann Med 2011; 43: 116-23.
4. Franchini M, Mannucci PM. New anticoagulants for treatment of venous thromboembolism. Eur J Intern Med 2012; 23: 692-5.
5. Friberg L, Rosenqvist M, Lip GY. Net clinical benefit of warfarin in patients with atrial fibrillation: a report from the Swedish atrial fibrillation cohort study. Circulation 2012; 125: 2298-307.
6. Hylek EM, Chang YC, Skates SJ, Hughes RA, Singer DE. Prospective study of the outcomes of ambulatory patients with excessive warfarin anticoagulation. Arch Intern Med 2000; 160: 1612-7.
7. Oake N, Jennings A, Forster AJ, Fergusson D, Doucette S, van Walraven C. Anticoagulation intensity and outcomes among patients prescribed oral anticoagulant therapy: a systematic review and meta-analysis. CMAJ 2008; 179: 235-44.
8. Jonas DE, McLeod HL. Genetic and clinical factors relating to warfarin dosing. Trends Pharmacol Sci 2009; 30: 375-86.
9. Kamali F, Wynne H. Pharmacogenetics of warfarin. Annu Rev Med 2010; 61: 63-75.
10. Wang L, McLeod HL, Weinshilboum RM. Genomics and drug response. N Engl J Med 2011; 364: 1144-53.
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. 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.
13. Cooper GM, Johnson JA, Langaee TY, Feng H, Stanaway IB, Schwarz UI, Ritchie MD, Stein CM, Roden DM, Smith JD, Veenstra DL, Rettie AE, Rieder MJ. A genome-wide scan for common genetic variants with a large influence on warfarin maintenance dose. Blood 2008; 112: 1022-7.
14. 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.
15. Takeuchi F, McGinnis R, Bourgeois S, Barnes C, Eriksson N, Soranzo N, Whittaker P, Ranganath V, Kumanduri V, McLaren W, Holm L, Lindh J, Rane A, Wadelius M, Deloukas P. A genome-wide association study confirms VKORC1, CYP2C9, and CYP4F2 as principal genetic determinants of warfarin dose. PLoS Genet 2009; 5: e1000433.
16. Gong IY, Tirona RG, Schwarz UI, Crown N, Dresser GK, Larue S, Langlois N, Lazo-Langner A, Zou G, Roden DM, Stein CM, Rodger M, Carrier M, Forgie M, Wells PS, Kim RB. Prospective evaluation of a pharmacogenetics-guided warfarin load-ing and maintenance dose regimen for initiation of therapy. Blood 2011; 118: 3163-71.
17. Epstein RS, Moyer TP, Aubert RE, OKane D, Xia F, Verbrugge RR, Gage BF, Teagarden JR. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J Am Coll Cardiol 2010; 55: 2804-12.
18. Klein TE, Altman RB, Eriksson N, Gage BF, Kimmel SE, Lee MT, Limdi NA, Page D, Roden DM, Wagner MJ, Caldwell MD, Johnson JA; International Warfarin Pharmacogenetics Consortium. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med 2009; 360: 753-64.
19. Limdi NA, Wadelius M, Cavallari L, Eriksson N, Crawford DC, Lee MT, Chen CH, Motsinger-Reif A, Sagreiya H, Liu N, Wu AH, Gage BF, Jorgensen A, Pirmohamed M, Shin JG, Suarez-Kurtz G, Kimmel SE, Johnson JA, Klein TE, Wagner MJ, et al. Warfarin pharmacogenetics: a single VKORC1 polymorphism is predictive of dose across 3 racial groups. Blood 2010; 115: 3827-34.
20. Wadelius M, Chen LY, Lindh JD, Eriksson N, Ghori MJ, Bumpstead S, Holm L, McGinnis R, Rane A, Deloukas P. The largest prospective warfarin-treated cohort supports genetic forecasting. Blood 2009; 113: 784-92.
21. Verhoef TI, Ragia G, de Boer A, Barallon R, Kolovou G, Kolovou V, Konstantinides S, Le Cessie S, Maltezos E, van der Meer FJ, Redekop WK, Remkes M, Rosendaal FR, van Schie RM, Tavridou A, Tziakas D, Wadelius M, Manolopoulos VG, Maitland-van der Zee AH; EU-PACT Group. A randomized trial of genotype-guided dosing of acenocoumarol and phenprocoumon. N Engl J Med 2013; 369: 2304-12.
22. Kimmel SE, French B, Kasner SE, Johnson JA, Anderson JL, Gage BF, Rosenberg YD, Eby CS, Madigan RA, McBane RB, Abdel-Rahman SZ, Stevens SM, Yale S, Mohler E3, Fang MC, Shah V, Horenstein RB, Limdi NA, Muldowney JA 3rd, Gujral J, et al. A pharmacogenetic versus a clinical algorithm for warfarin dosing. N Engl J Med 2013; 369: 2283-93.
23. Pirmohamed M, Burnside G, Eriksson N, Jorgensen AL, Toh CH, Nicholson T, Kesteven P, Christersson C, Wahlstr€om B, Stafberg C, Zhang JE, Leathart JB, Kohnke H, Maitland-van der Zee AH, Williamson PR, Daly AK, Avery P, Kamali F, Wadelius M; EU-PACT Group. A randomized trial of genotypeguided dosing of warfarin. N Engl J Med 2013; 369: 2294-303.
24. Kangelaris KN, Bent S, Nussbaum RL, Garcia DA, Tice JA. Genetic testing before anticoagulation? A systematic review of pharmacogenetic dosing of warfarin. J Gen Intern Med 2009; 24: 656-64.
25. Lindh JD, Holm L, Andersson ML, Rane A. Influence of CYP2C9 genotype on warfarin dose requirements-a systematic review and meta-analysis. Eur J Clin Pharmacol 2009; 65: 365-75.
26. Yang J, Chen Y, Li X, Wei X, Chen X, Zhang L, Zhang Y, Xu Q, Wang H, Li Y, Lu C, Chen W, Zeng C, Yin T. Influence of CYP2C9 and VKORC1 genotypes on the risk of hemorrhagic complications in warfarin-treated patients: a systematic review and meta-analysis. Int J Cardiol 2013; 168: 4234-43.
27. Heneghan C, Tyndel S, Bankhead C, Wan Y, Keeling D, Perera R, Ward A. Optimal loading dose for the initiation of warfarin: a systematic review. BMC Cardiovasc Disord 2010; 10: 18.
28. Mahtani KR, Heneghan CJ, Nunan D, Bankhead C, Keeling D, Ward AM, Harrison SE, Roberts NW, Hobbs FD, Perera R. Optimal loading dose of warfarin for the initiation of oral anticoagulation. Cochrane Database Syst Rev 2012; 12: CD008685.
29. Johnson EG, Horne BD, Carlquist JF, Anderson JL. Genotypebased dosing algorithms for warfarin therapy: data review and recommendations. Mol Diagn Ther 2011; 15: 255-64.
30. Gage BF, Eby C, Johnson JA, Deych E, Rieder MJ, Ridker PM, Milligan PE, Grice G, Lenzini P, Rettie AE, Aquilante CL, Grosso L, Marsh S, Langaee T, Farnett LE, Voora D, Veenstra DL, Glynn RJ, Barrett A, McLeod HL. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin Pharmacol Ther 2008; 84: 326-31.
31. Verhoef TI, Redekop WK, Daly AK, van Schie RM, de Boer A, Maitland-van der Zee AH. Pharmacogenetic-guided dosing of coumarin anticoagulants: algorithms for warfarin, acenocoumarol and phenprocoumon. Br J Clin Pharmacol 2014; 77: 626-41.
32. Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G; American College of Chest Physicians. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 2(Suppl): e44S-88S.
33. Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692-4.
34. Higgins JPT, Green S (Editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1. [updated March 2011]. Available at: www.cochrane.org/training/cochrane-handbook.
35. Hillman MA, Wilke RA, Yale SH, Vidaillet HJ, Caldwell MD, Glurich I, Berg RL, Schmelzer J, Burmester JK. A prospective, randomized pilot trial of model-based warfarin dose initiation using CYP2C9 genotype and clinical data. Clin Med Res 2005; 3: 137-45.
36. Anderson JL, Horne BD, Stevens SM, Grove AS, Barton S, Nicholas ZP, Kahn SF, May HT, Samuelson KM, Muhlestein JB, Carlquist JF; Couma-Gen Investigators. Randomized trial of genotype-guided versus standard warfarin dosing in patients initiating oral anticoagulation. Circulation 2007; 116: 2563-70.
37. 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.
38. Burmester JK, Berg RL, Yale SH, Rottscheit CM, Glurich IE, Schmelzer JR, Caldwell MD. A randomized controlled trial of genotype-based Coumadin initiation. Genet Med 2011; 13: 509-18.
39. Borgman MP, Pendleton RC, McMillin GA, Reynolds KK, Vazquez S, Freeman A, Wilson A, Valdes R Jr, Linder MW. Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation. Thromb Haemost 2012; 108: 561-9.
40. Jonas DE, Evans JP, McLeod HL, Brode S, Lange LA, Young ML, Shilliday BB, Bardsley MM, Swinton-Jenkins NJ, Weck KE. Impact of genotype-guided dosing on anticoagulation visits for adults starting warfarin: a randomized controlled trial. Pharmacogenomics 2013; 14: 1593-603.
41. Gage BF, Lesko LJ. Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues. J Thromb Thrombolysis 2008; 25: 45-51.
42. Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, Bankhead C, Xu Y. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 2008; 1: 84-91.