Dati dal mondo reale sull

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Dati dal mondo reale sulluso dei NAO...

• Dott.ssa Paola Pedrazzi

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I dati di utilizzo
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We found that prescription rates of dabigatran
were most accelerated among patients 85 or older,
a group at increased risk of bleeding who are
markedly older than the average participant in
the clinical trial in which the drug was tested
(71 yr).

• Since April 2012, the proportion of dabigatran
  prescriptions filled by patients 65 or older
  exceeded the proportion of participants in the
  same age group enrolled in dabigatran arms of the
  RE-LY trial (87.3 v. 83.2, p lt0.001).
• In September 2012, most of the dabigatran
  prescriptions were for the lower dosage (110
  mg/d) in the older groups in our study

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2011-2013
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I dati di outcome
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Warfarin D150 matched N3996 Dabigatran 150mg N2239 Warfarin D110 matched N4940 Dabigatran 110mg N2739
Emorragie intracraniche 0.7 0.1 1.0 0.3
Emorragie gastrointestinali 1.5 1.5 2.1 1.2
Emorragie maggiori 2.9 2.2 3.5 2.8
Eventi emorragici /100 anni/paz
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24 di pazienti in Dabigatran aveva gt80 anni
Larsen TB et al. Journal of the American College
of Cardiology (2013)
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Sørensen R et al. BMJ Open 20133e002758
Study population We identified all Danish
residents registered with a diagnosis of AF
(ICD-10 code I48) between 1 January 1995 and 31
December 2011 by the Danish National Patient
Register. All AF patients admitted to the
hospital with AF, managed for AF in an outpatient
clinic/ambulatory or seen at an emergency
department contact for AF were eligible for the
study. Warfarin and dabigatran therapy Patients
with a prescription claim of VKA (ATC B01AA03) or
dabigatran (ATC B01AE07) between 22 August and 31
December 2011 were included. According to their
first prescription claim in this period, patients
were stratified in three groups VKA, dabigatran
110 mg twice daily and dabigatran 150 mg twice
daily. Prescription claims of VKA from 0 to 180
days prior to baseline stratification were
registered and classified as previous VKA therapy
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Sørensen R et al. BMJ Open 20133e002758

• Primi 4 mesi di introduzione in commercio
• Pazienti naive e pazienti già in terapia con AVK

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Emorragie maggiori
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Emorragie maggiori
Registro volontario da parte di Centri
specializzati
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...a ogni paziente va cucito addosso un
vestito....il suo vestito....
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