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El estudio observacional multicéntrico a largo plazo del tratamiento con Dabigatran en pacientes con fibrilación
Stuart J Connolly1, Lars Wallentin, Michael D Ezekowitz
1Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.connostu@phri.ca
Circulation
|June 18, 2013
Resumen
El uso a largo plazo de dabigatrán en pacientes con fibrilación auricular mostró tasas similares de accidente cerebrovascular y mortalidad para ambas dosis. Sin embargo, la dosis de 150 mg se relacionó con un mayor riesgo de hemorragia mayor en comparación con la dosis de 110 mg.
Área de la Ciencia:
- Cardiología Cardiología.
- Farmacología Farmacología.
- Los ensayos clínicos son ensayos clínicos.
Sus antecedentes:
- El ensayo de evaluación aleatoria de la terapia anticoagulante a largo plazo (RE-LY) estableció previamente la eficacia y seguridad del dabigatrán etexilato para la prevención del accidente cerebrovascular en pacientes con fibrilación auricular.
- Existía la necesidad de extender los datos de seguimiento del dabigatrán y de realizar comparaciones directas entre sus dos regímenes posológicos.
Objetivo del estudio:
- Evaluar la seguridad y eficacia a largo plazo de dos dosis de dabigatrán etexilato (150 mg y 110 mg dos veces al día) en pacientes con fibrilación auricular.
- Para extender el período de seguimiento más allá del ensayo inicial RE-LY en pacientes que continúan el tratamiento con dabigatrán.
Principales métodos:
- La extensión multicéntrica a largo plazo del tratamiento con dabigatrán en pacientes con fibrilación auricular (RELY-ABLE) incluyó a pacientes del ensayo RE-LY que continuaron con la dosis asignada de dabigatrán.
- El seguimiento se extendió hasta 28 meses después de RE-LY, con una mediana de seguimiento de 2,3 años para 5851 pacientes inscritos.
- Se analizaron las tasas de eventos de accidente cerebrovascular, embolia sistémica, hemorragia mayor y muerte para ambas dosis de dabigatrán.
Principales resultados:
- Las tasas de ictus o embolia sistémica fueron comparables entre las dos dosis: 1,46%/año para 150 mg y 1,60%/año para 110 mg (HR 0,91; IC 95%, 0,69-1,20).
- Las tasas de hemorragia mayor fueron más altas con dabigatrán 150 mg (3,74% / año) en comparación con 110 mg (2,99% / año) (HR 1,26; IC del 95%, 1,04-1,53).
- Las tasas de mortalidad fueron similares entre los dos grupos: 3.02%/año para 150 mg y 3.10%/año para 110 mg (HR 0.97; IC 95%, 0.80-1.19).
Conclusiones:
- El tratamiento prolongado con dabigatrán durante 2,3 años mostró tasas similares de accidente cerebrovascular y muerte tanto para las dosis de 150 mg como para las de 110 mg dos veces al día.
- Se observó una incidencia significativamente mayor de sangrado mayor con la dosis de 150 mg en comparación con la dosis de 110 mg.
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