Prečo pouţiť rivaroxaban v liečbe HŢT? MUDr. Ivan Čupka

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1 Prečo pouţiť rivaroxaban v liečbe HŢT? MUDr. Ivan Čupka HŢT Hlboká ţilová trombóza L.SK.MA

2 Potenciálny konflikt záujmov MUDr. Ivan Čupka Konzultant farmaceutických spoločností Člen Advisory Board spoločností Iná spolupráca (konkretizovať aká) so spoločnosťami: prednášková činnosť Bayer

3 Klinické štúdie a reálna klinická prax Registračné štúdie t Viac ako 9,000 HŢT/PE pacientov zaradených do randomizovaných kontrolovaných štúdií Prvá medzinárodná, prospektívna observačná štúdia na NOAK t Viac ako 5,000 HŢT pacientov sledovaných v rutinnej klinickej praxi Hodnotené v širokom spektre pacientov v študijnom programe HŢT/PE 1 1.Prins M.H., Lensing A.W.A., Bauersachs R. et al. Thrombosis J. 2013;11(1):21., 2. Bauersachs R.M., Berkowitz S.D., Brenner B. et al. N Engl J Med. 2010;363(26): , 3. Ageno W., Mantovani L.G., Haas S., et al. Thrombosis J. 2014;12(1):16., NOAK Perorálne antikoagulanciá okrem antagonistu vitamínu K

4 Cieľ t zber reálnych dát u pacientov s akútnou HŢT liečených rivaroxabanom alebo štandardnou antikoagulačnou liečbou Pacienti s diagnostikovanou akútnou HŢT* a s indikáciou na antikoagulačnú liečbu 3 mesiace Typ, dávka a trvanie pouţívanej liečby je na zváţení ošetrujúceho lekára Rivaroxaban na 3 mesiace Investigátori zhromaţďovali dáta pri prvej návšteve, po 1. mesiaci a potom štvrťročne # (1 mesiac po ukončení liečby) Štandardná antikoagulačná liečba napr. iniciálna liečba LMWH/fondaparinuxom, pokračujúca s VKA alebo parenterálna antikoagulačná liečba na 3 mesiace Finálne hodnotenie Primárne ciele Udalosti závaţného krvácania, symptomatická recidivujúca VTE a všetky príčiny smrti HŢT hlboká ţilová trombóza, LMWH nízkomolekulový heparín, VTE venózny tromboembolizmus, VKA anatgonista vitamínu K ClinicalTrials.gov NCT ; *After PE EU licence, DVT with concomitant PE permitted; isolated PE excluded. # Data were collected at the initial visit and during routine follow-up visits or via mail, telephone, or Ageno W et al, Published online December 7, 2015.

5 Inklúzne / Exklúzne kritériá Inklúzne kritériá Muţi alebo ţeny, vek pacientov 18 rokov s akútnou HŢT s indikáciou na antikoagulačnú liečbu na 3 mesiace Po schválení rivaroxabanu pre indikáciu PE, boli zaradení pacienti s HŢT a súbeţne PE Exklúzne kritériá Pacienti s izolovanou PE Ďalšie exklúzne kritériá boli v súlade s lokálnymi indikačnými obmedzeniami 1,Ageno W et al, Published online December 7, 2015, DVT hlboká ţilová trombóza, PE pľúcna embólia.

6 Charakteristika pacientov je podobná so štúdiou EINSTEIN HŢT 1,2 Vek (roky, priemer +/- štandardná odchýlka) CrCl<30 ml/min (%) Predchádzajúca VTE, n (%) Aktívne onkologické ochorenie n (%) 55,8 +/- 16,4 57,3 +/- 16,7 (1,0) (24,0) (6,0) 993 (57,4) (55) DVT - Hlboká ţilová trombóza, VTE - Venózny tromboembolizmus, CrCL - klírens kreatinínu, n- počet 1. Ageno W et al, Thromb J. 2014;12: Bauersachs R.M., Berkowitz S.D., Brenner B. et al. N Engl J Med. 2010;363(26):

7 (%) (%) Účinnosť a výskyt závaţných krvácaní 1 Štúdia fázy III. s rivaroxabanom vs. LMWH/VKA Prospektívna, neintervančná štúdia s rivaroxabanom a štandardnou antikoagulačnou liečbou v beţnej praxi * Závaţné krvácanie Rekurencia VTE Celková mortalita Závaţné krvácanie Rekurencia VTE Celková mortalita rivaroxaban rivaroxaban DVT hlboká ţilová trombóza, VTE venózny tromboembolizmus, VKA antagonista vitamínu K *Propensity score-adjusted population. 1. Ageno W et al, Published online December 7, 2015.

8 Rekurencia symptomatického VTE (%) Účinná liečba HŢT/PE u pacientov s ľahkou a stredne ťaţkou poruchou funkcie obličiek a,1 CrCL ml/min CrCL ml/min CrCL ml/min CrCL <15 ml/min PE pľúcna embólia, DVT hlboká ţilová trombóza, VTE venózny tromboembolizmus, CrCl klírens kreatinínu,vka antagonista vitamínu K, CrCl Klírens kreatinínu, a,normálna funkcia obličiek: CrCl 80 ml/min. Ľahká porucha funkcie obličiek: CrCl ml/min. Stredne ťaţká porucha funkcie obličiek: CrCl ml/min. Ťaţká porucha funkcie obličiek: CrCl ml/min. #redukcia dávky z 20 mg jeden krát denne na 15 mg jeden krát denne by mala byť zváţená ak riziko krvácania u pacienta prevaţuje riziko rekurencie DVT and PE 1, Bauersachs R.M., Lensing A.W.A., Prins M.H. et al. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014;12:25.

9 Závaţné krvácania (%) Niţší výskyt závaţných krvácaní u pacientov a,1,4 s ľahkou a stredne ťaţkou poruchou funkcie obličiek rivaroxaban PE pľúcna embólia, DVT hlboká ţilová trombóza, RRR relatívna redukcia rizika, ARR absolútna redukcia rizika, CrCl klírens kreatinínu, VKA antagonista vitamínu K, a,normálna funkcia obličiek: CrCl 80 ml/min. Ľahká porucha funkcie obličiek: CrCl ml/min. Stredne ťaţká porucha funkcie obličiek: CrCl ml/min. 1, Bauersachs R.M., Lensing A.W.A., Prins M.H. et al. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014;12: Prins M.H., Lensing A.W.A., Bauersachs R. et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11(1):21

10 Aké máme dôkazy v liečbe DVT u pacientov s aktívnym onkologickým ochorením rivaroxaban PE pľúcna embólia, DVT hlboká ţilová trombóza, LMWH nízkomolekulový heparín, VKA antagonista vitamínu K 1. Prins M.H., Lensing A.W.A., Brighton T.A. et al. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014;1(1):e37 e36 5. Lee A.Y.,Levine M.N., Baker R.I., et al. Low molecular weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003;349(2): Agnelli G., Büller H.R., Cohen A., et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9): Büller H.R., Décousus H., Grosso M.A., et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369(15): Schulman S., Kearon C., Kakkar A.K., et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361(24): Schulman S., Kakkar A.K. Goldhaber S.Z., et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circ. 2014;129(7):

11 Rekurencia symptomatického VTE (%) Závaţné krvácanie (%) Rivaroxaban výskyt rekurencie VTE a závaţného krvácania pri liečbe DVT/PE a,1 rivaroxaban rivaroxaban PE pľúcna embólia, DVT hlboká ţilová trombóza, VTE venózny tromboembolizmus, VKA antagonista vitamínu K, RRR relatívna redukcia rizika, ARR absolútna redukcia rizika. a) Podskupina analyzovaných pacientov s aktívnym nádorom zaradených v EINSTEIN DVT a EINSTEIN PE randomizovaných kontrolovaných štúdiách 1. Prins M.H., Lensing A.W.A., Brighton T.A. et al. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014;1(1):e37 e36

12 Výskyt recidívy VTE (%)* Riziko rekurencie VTE je najvyššie v prvých 3-4 týţdňoch VTE Venózny tromboembolizmus 3,Adaptované podľa Limone B.L., et al. 2013, *príhody rekurencie VTE paciento/rok A literature search of MEDLINE, EMBASE and CENTRAL during April 2013 identified randomised trials of acute pharmacologic treatment and prevention of recurrent VTE, enrolling 200 subjects/treatment arm, requiring anticoagulation for 3 months and reporting time to objectively confirmed recurrent VTE (n=27,237).

13 Percento pacientov s kompletnou regresiou trombu Kompletná regresia trombu (USG + CT) 70% 60% Rivaroxaban Štandardná liečba Priemerná dĺţka liečby: 50% - rivaroxaban 195 dní - warfarín 200 dní 40% 30% 20% 10% 0% 20/75 (26,7%) DEŇ Day 22 3/19 (15,8%) Dĺţka terapie 44/71 (62%) EOT 6/19 (31,6%) PE pľúcna embólia, DVT hlboká ţilová trombóza, EOT end of intended treatment period na konci plánovaného liečebného obdobia Preddefinovaný výsledok zobrazovania J-Einsteinova populácie (n = 100). Zahŕňa DVT a PE, 1. Yamada N et al, Thromb J 2015;13:2.,

14 Liečba a dlhodobá ochrana pred DVT s rivaroxabanom 1 Od 22. dňa rivaroxaban 15 mg 2 x denne od stanovenia diagnózy DVT rivaroxaban Rivaroxaban 15 mg a 20 mg sa má uţívať s jedlom z dôvodu optimálnej perorálnej biologickej dostupnosti 1 Bez potreby iniciálnej liečby s heparínom 1. Rivaroxaban SPC, Súhrn charakteristických vlastností lieku, Júl 2015, DVT hlboká ţilová trombóza

15 Indikačné obmedzenie v liečbe HŢT Hradená liečba sa môţe indikovať na liečbu hlbokej ţilovej trombózy a prevenciu rekurencie hlbokej ţilovej trombózy a pľúcnej embólie u pacientov s proximálnou (lokalizovaná vo vena poplitea a proximálnejšie) hlbokou ţilovou trombózou,ktorá musí byt objektívne potvrdená (duplexným ultrazvukovým alebo venografickým vyšetrením). Doba uhrádzanej liečby je limitovaná na maximálne: a) 3 mesiace v prípade prvej vyprovokovanej hlbokej ţilovej trombózy, b) 6 mesiacov v prípade idiopatickej hlbokej ţilovej trombózy, c) 12 mesiacov v prípade opakovanej recidivujúcej hlbokej ţilovej trombózy. Pri indikácii podľa písmena c) sa vyţaduje súčasné splnenie aspoň jednej z týchto podmienok: 1. chronická liečba warfarínom nie je dostatočne kontrolovaná v terapeutickom rozmedzí INR 2-3, t.j. dve merania zo šiestich nie sú v takto uvedenom terapeutickom rozmedzí, 2. recidíva hlbokej ţilovej trombózy alebo pľúcnej embólie napriek liečbe warfarínom, 3. liečba warfarínom je kontraindikovaná. HŢT Hlboká ţilová trombóza

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18 Kumulatívna incidencia (%) Kumulatívna incidencia závaţného krvácania 4 Rivaroxaban Štandardná antikoagulácia 3 2 HR=0.41 (95% CI ) Čas do prvej udalosti (dni) 1. Ageno W., Mantovani L., Haas S. et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis (XALIA): an international prospective non-interventional study. Published online December 7, Populácia bezpečnosti, Upravené pre karcinóm pri vstupe do štúdie

19 Výsledky pre závaţné krvácanie Závaţné krvácanie (posudzované) Rivaroxaban (n=2619) n (%) Štandardná antikoagulácia (n=2149) n (%) 19 (0.7) 48 (2.3) Hazard ratio* (95% CI) 0.41 ( ) Fatálne 0 (0.0) 2 (0.1) Nefatálne do kritických orgánov Intrakraniálne (subdurálne, subarachnoidálne alebo cerebrálne) Nefatálne, iné nekritické miesta Gastrointestinálne krvácanie 8 (0.3) 12 (0.6) 6 (0.2) 5 (0.2) 11 (0.4) 34 (1.6) 3 (0.1) 18 (0.8) 1. Ageno W., Mantovani L., Haas S. et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis (XALIA): an international prospective non-interventional study. Published online December 7, Populácia bezpečnosti; * Upravené pre karcinóm pri vstupe do štúdie

20 Kumulatívna incidencia (%) 1. Ageno W., Mantovani L., Haas S. et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis (XALIA): an international prospective non-interventional study. Published online December 7, Populácia bezpečnosti; Upravené pre karcinóm pri vstupe do štúdie Kumulatívna incidencia rekurentného VTE Rivaroxaban Standard Štandardná anticoagulation antikoagulácia 4 3 HR=0.67 (95% CI ) Čas do udalosti (dni)

21 Tromboembolické príhody Rivaroxaban (n=2619) n (%) Štandardná antikoagulácia (n=2149) n (%) Hazard ratio* (95% CI) Rekurentný VTE (posudzovaný) 37 (1.4) 55 (2.6) 0.67 ( ) Fatálna PE 1 (<0.1) 1 (<0 1) Úmrtie kde sa PE nevylúčila 4 (0.2) 4 (0.2) Nefatálna PE 17 (0.6) 17 (0.8) Rekurentná DVT + PE 1 (<0.1) 4 (0.2) Rekurentná DVT 13 (0.5) 30 (1.4) Iné 1 (<0.1) 0 (0.0) 1. Ageno W., Mantovani L., Haas S. et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis (XALIA): an international prospective non-interventional study. Populácia bezpečnosti; niektorí pacienti mali > 1 tromboembolickú príhodu; * Upravené pre karcinóm pri vstupe do štúdie, VTE Venózny tromboembolizmus, PE Pľúcna embólia, DVT Hlboká ţilová trombóza

22 Kumulatívna incidencia (%) 1. Ageno W., Mantovani L., Haas S. et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis (XALIA): an international prospective non-interventional study. bezpečnosti; stratifikovaná na karcinóm pri vstupe do štúdie Celková mortalita Rivaroxaban 7 Standard Štandardná anticoagulation antikoagulácia HR=0.26 (95% CI ) Čas do udalosti (dni)

23 Celková mortalita Rivaroxaban (n=2619) n (%) Štandardná antikoagulácia (n=2149) n (%) Hazard ratio* (95% CI) Úmrtia z akýchkoľvek príčin 12 (0.5) 88 (4.1) 0.26 ( ) Súvisiace s VTE 4 (0.2) 4 (0.2) PE 1 (<0.1) 1 (<0.1) PE sa nevylúčila 3 (0.1) 3 (0.1) Súvisiace s krvácaním 0 (0.0) 0 (0.0) Súvisiace s nádorom 6 (0.2) 61 (2.8) Kardiovaskulárne ochorenie 1 (<0.1) 10 (0.5) Iné 1 (<0.1) 13 (0.6) 1. Ageno W., Mantovani L., Haas S. et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis (XALIA): an international prospective non-interventional study. bezpečnosti; *Stratifikovaná pre karcinóm pri vstupe do štúdie VTE Venózny tromboembolizmus, PE Pľúcna embólia

24 Klinické výsledky Rivaroxaban (n=2505) n (%) Štandardná antikoagulácia (n=2010) n (%) Hazard ratio (95% CI) p-value Závaţné krvácanie 19 (0.8) 43 (2.1) Rekurentný VTE 36 (1.4) 47 (2.3) 0.77 ( ) 0.91 ( ) Úmrtia z akýchkoľvek príčin 11 (0.4) 69 (3.4) 0.51 ( ) Ageno W., Mantovani L., Haas S. et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis (XALIA): an international prospective non-interventional study. Populácia propensity-skóre analýzy, VTE Venózny tromboembolizmus

25 Signifikantná redukcia dĺţky hospitalizácie 1 t Signifikantná redukcia hospitalizácie o 3 a dni Dĺţka hospitalizácie Analýza rivaroxaban štandardná antikoagulácia V prospech rivaroxabanu V prospech štandardnej antikoagulácie Pred úpravou dát * Po úprave dát * *Priemerná dĺţka pobytu vypočítaná iba z hospitalizovaných pacientov; pomer na základe analýzy ANOVA rozptylu z logaritmicky transformovaných dát LOS. a 3 dni zaokrúhlené nahor od priemerného zníţenia 2,7 dňa, * Pred štatistikcou úpravou dát - PMS propensity score matching 1. Ageno W et al, Published online December 7, 2015.

26 Závaţné krvácania (%) Niţší výskyt závaţných krvácaní u pacientov s ľahkou a stredne ťaţkou poruchou funkcie obličiek a,1,4 rivaroxaban t Celkový výskyt klinicky relevantného nezávaţného krvácania bol porovnávaný medzi rivaroxabanom a štandardnou 1,4 liečbou enoxaparínom + VKA PE pľúcna embólia, DVT hlboká ţilová trombóza, RRR relatívna redukcia rizika, ARR absolútna redukcia rizika, CrCl klírens kreatinínu, VKA antagonista vitamínu K, a,normálna funkcia obličiek: CrCl 80 ml/min. Ľahká porucha funkcie obličiek: CrCl ml/min. Stredne ťaţká porucha funkcie obličiek: CrCl ml/min. 1, Bauersachs R.M., Lensing A.W.A., Prins M.H. et al. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014;12: Prins M.H., Lensing A.W.A., Bauersachs R. et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11(1):21

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