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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 - PowerPoint PPT Presentation
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Dott. Marco Piccininno
S.C. Cardiologia
Ospedale Galliera, Genova
pro-farmaco
METABOLISMO
Non importanti interferenze con il cibo Concentrazioni plasmatiche stabili entro 3 giorni dall’inizio della terapiaFarmacocinetica prevedibile (minima variabilità interindividuale)
Rapido assorbimento
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
RELY
SAFETY & EFFICACY
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 DABIGATRANCONTROINDICAZIONI ALL’UTILIZZO DEL DABIGATRAN
CC
PAZIENTE RELY60% 40%
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
Follow-up visit2 SETTIMANE1 MESE3 MESI6 MESI9 MESI12 MESI16 MESI20 MESI24 MESI
83 kg
Cl creat 69 ml/min
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.
Source of bleedingTime of the last doseMeasure aPTT/TTMeasure creat/ cl.cr
Wait at least 30’ to assess the effectaPTT and/or TT every 3 h