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ARRITMIAS Ignacio Fernández Lozano.Javier Alzueta.
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FA
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CHADSFAPx 1,8FAPn 2
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End point Placebo (%/y)
Dronedarone (%/y)
HR (95% CI) p
Stroke 1.79 1.19 0.66 (0.46-0.96)
0.027
Stroke or TIA 2.05 1.37 0.67 (0.47-0.94)
0.020
Fatal stroke 0.54 0.36 0.67 (0.34-1.32)
0.247
Stroke, ACS, or CV death 5.52 3.80 0.68 (0.55-0.84)
<0.001
Stroke, ACS, or all-cause death 6.70 5.06 0.75 (0.62-0.90)
0.002
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Purpose The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
Arms Assigned Interventions
1: Experimental Drug: dronedarone (SR33589) 400mg bid
2: Active Comparator Drug: amiodarone 600mg daily for 28 days, then 200mg daily
Ages Eligible for Study: 21 Years and olderGenders Eligible for Study: BothAccepts Healthy Volunteers: No
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SINCOPE
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Estratificación de riesgo
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Incidencia de Muerte súbitaMyerburg RJ. Circulation.1998;97:1514-1521.
GROUP
>2 factores de riesgo
Pacientes con enfermedad coronaria
Pacientes con FE <35%,
e ICCPacientes con PCR previa
Pacientes con IAM FE deprimida y TV
Población global
300,000200,000100,0000
Nº. De MS anual
3025201050
Incidencia de MS(% grupo)
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High energy implant rates pmp
Avg = 160
Avg = 133
USAGermany
ItalyNetherlands
IrelandWestern Europe
DenmarkAustria
SwitzerlandBelgiumFrance
UKFinland
SwedenNorway
SpainPortugal
0 100 200 300 400 500 600 700
ICD CRT-D 2006 WE Average 2005 WE Average
Source: Eucomed
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