Domača naloga 21. modularna skupina
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1 Domača naloga 21. modularna skupina Individualizacija antikoagulantnega zdravljenja glede na genetsko variabilnost v poteh presnove in delovanja varfarina prof. dr. Vita Dolžan, dr. med. Laboratorij za farmakogenetiko, Inštitut za biokemijo Medicinska fakulteta, Univerza v Ljubljani vita.dolzan@mf.uni-lj.si 1
2 1. Opis problema oz. vprašanja, vključno z opisom populacije, na katero se problem nanaša Ali je pri bolnikih z atrijsko fibrilacijo pri odmerjanju varfarina smiselno prilagajanje glede na genetske dejavnike? Katere genetske dejavnike bi bilo potrebno upoštevati?
3 2. Relevantnost problema za delo v ambulanti Varfarin je pri nas najpogosteje uporabljano antikoagulacijsko zdravilo. Čeprav se zdravljenja z varfarinom ne uvaja v ambulanti družinske medicine in zdravniki v teh ambulantah večinoma prevzamejo vodenje bolnikov na vzdrževalnem zdravljenju, se pri vodenju teh bolnikov srečujejo s težavami. Zaradi nihanj vrednosti INR lahko pride do krvavitev ali trombemboličnih zapletov. Interakcije z drugimi zdravili in/ali prehrano dodatno otežujejo vodenje bolnika na antikoagulantnem zdravljenju z varfarinom. Da bi se izognili zapletom bolnike pogosteje naročamo na kontrole in prilagajamo odmerjanje varfarina
4 3. Pregled relevantnih člankov in virov (PubMed, Medline) 3a. Izhodiščne farmakogenetske študije in študije celotnega genoma podpirajo ugotovitve, da na odmerjanje varfarina in urejenost antikoagulantnega zdravljenja najpomembneje vplivajo genetski polimorfizmi CYP2C9 in VKORC1 1. 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 Oct 1;106(7): Takeuchi F, McGinnis R, Bourgeois S, et al. A genome-wide association study confirms VKORC1, CYP2C9, and CYP4F2 as principal genetic determinants of warfarin dose. PLoS Genet Mar;5(3):e 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 Aug 15;112(4): b. Študije pri slovenskih bolnikih z atrijsko fibrilacijo 4. Herman D, Locatelli I, Grabnar I, Peternel P, Stegnar M, Mrhar A, Breskvar K, Dolzan V. Influence of CYP2C9 polymorphisms, demographic factors and concomitant drug therapy on warfarin metabolism and maintenance dose. Pharmacogenomics J. 2005;5(3): 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 May;95(5):782-7.
5 GENSKA VARIABILNOST Encimi vključeni v metabolizem zdravil Prenašalci zdravila Tarče zdravil in njihovih signalnih poti Farmakokinetika Farmakodinamika variabilnost plazemskih koncentracij variabilnost odziva na zdravilo TOKSIČNOST UČINKOVITO ZDRAVLJENJE NEODZIVNOST RAZLIČEN ODZIV NA ZDRAVILO 5
6 Presnova S-varfarina v jetrih poteka pretežno preko CYP2C9 6
7 Varfarin inhibira cikel vitamina K 7
8 GWAS: VKORC1, CYP2C9, in CYP4F2 so glavni genetski dejavniki, ki vplivajo na višino odmerka varfarina Prilagoditev po VKORC1, CYP2C9 in starosti 1053 švedskih bolnikov na vzdrževalnem zdravljenju z varfarinom 80% statistična moč da zaznajo označevalce, ki razložijo vsaj 1,5% variabilnosti višine odmerka Takeuchi et al. PLoS Genet
9 3c. Najpomembnejše klinične randomizirane študije 6. Pirmohamed M, Burnside G, Eriksson N,..in EU-PACT Group. A randomized trial of genotype-guided dosing of warfarin. N Engl J Med Dec 12;369(24): Kimmel SE, French B, Kasner SE,..in COAG Investigators. A pharmacogenetic versus a clinical algorithm for warfarin dosing. N Engl J Med Dec 12;369(24): (8. Baranova EV, Asselbergs FW, de Boer A, Maitland-van der Zee AH. The COAG and EU-PACT trials: what is the clinical benefit of pharmacogenetic-guided coumarin dosing during therapy initiation? Curr Mol Med. 2014;14(7):841-8.) 9. International Warfarin Pharmacogenetics Consortium, Klein TE, Altman RB, et al. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med Feb 19;360(8):
10 3d. Najpomembnejše meta-analize randomiziranih kliničnih študij 10. Li X, Yang J, Wang X, Xu Q, Zhang Y, Yin T. Clinical benefits of pharmacogenetic algorithm-based warfarin dosing: meta-analysis of randomized controlled trials. Thromb Res Apr;135(4): Wang ZQ, Zhang R, Zhang PP, Liu XH, Sun J, Wang J, Feng XF, Lu QF, Li YG. Pharmacogenetics-based warfarin dosing algorithm decreases time to stable anticoagulation and the risk of major hemorrhage: an updated meta-analysis of randomized controlled trials. J Cardiovasc Pharmacol Apr;65(4): Xu H, Xie X, Wang B, Chen Y, Meng T, Ma S, Wang F. Meta-analysis of efficacy and safety of genotype-guided pharmacogenetic dosing of warfarin. Int J Cardiol Dec 15;177(2): Stergiopoulos K, Brown DL. Genotype-guided vs clinical dosing of warfarin and its analogues: meta-analysis of randomized clinical trials. JAMA Intern Med Aug;174(8): e. Obstoječa priporočila in algoritmi 14. Johnson JA, Gong L, Whirl-Carrillo M,... in Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C9 and VKORC1 genotypes and warfarin dosing. Clin Pharmacol Ther Oct;90(4): Začetni odmerek varfarina je priporočeno prilagoditi bolnikovemu genotipu CYP2C9 in VKORC1. Tabela 5 navaja priporočen začetni odmerek pri različnih kombinacijah genotipov CYP2C9 in VKORC Prosto dostopen spletni algoritem za odmerjanje varfarina glede na klinične, genetske in okoljske dejavnike.
11 FDA: 16/08/ 2007 dopolnjen povzetek glavnih značilnosti zdravila za varfarin FDA: 17/09/ 2007 odobren prvi genetski test za varfarin Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test FDA: 01/22/ 2010 dopolnjen povzetek glavnih značilnosti zdravila za varfarin Genotipizacija CYP2C9 in VKORC1: priporočena, a ne zahtevana Informacija o genotipu CYP2C9 in VKORC1 pomaga pri izbiri začetnega odmerka (Tabela 5 ) Pri vseh bolnikih je potrebno nadaljnje prilagajanje odmerka glede na vrednosti PT/INR. 11
12 Prospektivne študije: genotipu prilagojeno odmerjanje v uvajalnem obdobju skrajša čas do tarčnega INR in zniža število ADR algoritmi za odmerjanje varfarina 12
13 4. Izbira enega najbolj relevantnih virov, ki bi jih priporočili kolegom 1. Li X, Yang J, Wang X, et al. Clinical benefits of pharmacogenetic algorithm-based warfarin dosing: meta-analysis of randomized controlled trials. Thromb Res Apr;135(4): Vprašanje: Ali je genotipu prilagojeno odmerjanje varfarina(pg) klinično bolj učinkovito kot zdravljenje po obstoječih kliničnih smernicah (STD) Metode: Meta analiza 10 randomiziranih kliničnih raziskav z 2601 preiskovanci ( po podatkih PUBMED, EMBASE, Cochrane Library in Web of Science databases do Junija 2014). Rezultati:Pri PG zdravljenju je v primerjavi s STD: manj velikih krvavitev (2.65% vs 4.75%; RR: 0.57, 95% CI: , P=0.02) manj tromboemboličnih zapletov (0.59% vs 1.88%; RR: 0.38, 95% CI: , P=0.02) trend da so bolniki večji procent časa znotraj terapevtskega območja (mean difference (MD) %TTR: 4.65, 95% CI: , P=0.05) ni razlik v tveganju za INR>4 Zaključek: Genotipu prilagojeno odmerjanje varfarina(pg) je povezano z manjšim tveganjem za zaplete kot standardno zdravljenje.
14 5. Priporočilo za prakso na osnovi dokazov in stanja v ambulanti Slovenija Obstoječe smernice glede antikoagulantnega zdravljenja ne priporočajo prilagajanja odmerka varfarina glede na genotip CYP2C9 in VKORC1. Bi pa bilo priporočljivo genetsko analizo opraviti pri bolnikih, ki so pogosto izven terapevtskega območja in pri bolnikih z zapleti. V svetu Raven dokazov: 1A CPIC ali strokovna združenja so sprejela priporočila glede prilagajanja odmerka genotipu; ta priporočila se že uporabljajo v smernicah nekaterih zdravstvenih sistemov
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