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