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
follow-up: 2 anni
CHADS2: 2.1
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:10.1093/eurheartj/ehs253
Bleeding post-marketing &
Case Report
RELY
?
JACC 2013; 61:2264
CONTROINDICAZIONI ALL’UTILIZZO DEL DABIGATRAN
PAZIENTE RELY
60%
40%
83 kg
CC
Cl creat 69 ml/min
71aa
Follow-up visit
2 SETTIMANE
1 MESE
3 MESI
6 MESI
9 MESI
12 MESI
16 MESI
20 MESI
24 MESI
> 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.