ARRITMIAS Ignacio Fernández Lozano.Javier Alzueta.

FA

402 PT

1.376 PT

5.700 PT

CHADSFAPx 1,8FAPn 2

627 PT

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

4.628 PT

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

504 PT

112 PT

SINCOPE

Estratificación de riesgo

504 PT

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)

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

490 PT

651 PT

206 PT

45 PT

7.001 PT