Dott. Marco Piccininno S.C. Cardiologia Ospedale Galliera, Genova
METABOLISMO Rapido assorbimento pro-farmaco Non importanti interferenze con il cibo Concentrazioni plasmatiche stabili entro 3 giorni dall’inizio della terapia Farmacocinetica prevedibile (minima variabilità interindividuale)
18113 pz età media: 71.5 anni CHADS2: 2.1 follow-up: 2 anni
Criteri di esclusione RELY
RELY: results -Dab 110 non inferior to Warfarin SSE prevention -Dab 150 superior to Warfarin SSE prevention (-34%) -Dab 150 reduced ischemic stroke (-25%) and CV death (-15%) - Both doses reduced hemorragic stroke (-74% e – 69%) -Dab 110 caused less major bleeding (-20%) -No significant difference in CV and all-cause mortality between the 2 doses of Dab SSE= stroke & sistemic embolism
SAFETY & EFFICACY RELY
ESC Guidelines. European Heart Journal 2012; doi:10 ESC Guidelines. European Heart Journal 2012; doi:10.1093/eurheartj/ehs253
Bleeding post-marketing & Case Report
RELY ?
JACC 2013; 61:2264
CONTROINDICAZIONI ALL’UTILIZZO DEL DABIGATRAN
PAZIENTE RELY 60% 40% Follow-up visit 2 SETTIMANE 1 MESE 3 MESI 6 MESI 9 MESI 12 MESI 16 MESI 20 MESI 24 MESI 83 kg Cl creat 69 ml/min CC 71aa > 85 aa = 4 % Iperteso (80%) controllato (130/77, 60% βblock, 65% ACE/ARB, 45% stat.) 1/7 pregr. stroke (1/5 stroke+TIA), 1/6 pregr. IM, 1/4 DM, 1/3 HF
Source of bleeding Time of the last dose Measure aPTT/TT Measure creat/ cl.cr Wait at least 30’ to assess the effect aPTT and/or TT every 3 h MODERATE-SEVERE BLEEDING: reduction in hemoglobin > 2 g/dl, trasfusion of > 2 U red cells, symptomatic bleeding in critical area (intraocular, intraspiinal, intramuscolar with compartimen syndrome, retroperitoneal, intraarticular, pericardial). LIFE THREATENING BLEEDING: symptomatic intracranial bleeding, reduction in hemoglobin > 5 g/dl, trasfusion of > 4 U red cells, hypotension requiring inotropic agents, or bleeding requiring surgical interventions.