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Tratamiento triple inhalado con extrafina versus tratamiento doble con broncodilatador en la enfermedad pulmonar

Alberto Papi¹, Jørgen Vestbo², Leonardo Fabbri³

¹Research Centre on Asthma and COPD, University of Ferrara, Ferrara, Italy.

Lancet (London, England)

|February 13, 2018

Resumen

La triple terapia inhalada con dipropionato de beclometasona, fumarato de formoterol y glicopirrónio (BDP/FF/G) redujo significativamente las exacerbaciones de EPOC de moderadas a severas en comparación con la doble broncodilatación. Este hallazgo apoya la triple terapia para pacientes con síntomas graves de EPOC y antecedentes de exacerbación.

Área de la Ciencia:

Medicina de las vías respiratorias
Farmacología

Sus antecedentes:

Existen pruebas limitadas sobre el riesgo-beneficio comparativo de la terapia triple inhalada frente a la broncodilatación dual para la EPOC.
La terapia triple combina un corticosteroide inhalado, un antagonista muscarínico de acción prolongada y un agonista β2 de acción prolongada.

Objetivo del estudio:

Para comparar una terapia triple de inhalador único (dipropionato de beclometasona/fumarato de formoterol/glicopirrónio - BDP/FF/G) con un broncodilatador dual de inhalador único (indacaterol/glicopirrónio - IND/GLY).
Evaluar la tasa de exacerbaciones de EPOC de moderadas a severas durante 52 semanas.

Principales métodos:

Un estudio aleatorizado, de grupos paralelos, doble ciego y doble simulacro en el que participaron 1532 pacientes con EPOC sintomática y limitación severa del flujo de aire.
Los pacientes recibieron BDP/ FF/ G extrafina dos veces al día o IND/ GLY una vez al día durante 52 semanas.
El criterio de valoración primario fue la tasa de exacerbaciones de EPOC de moderadas a severas.

Principales resultados:

La tasa de exacerbaciones de moderadas a severas fue menor con BDP/FF/G (0,50) en comparación con IND/GLY (0,59) por paciente-año, una diferencia estadísticamente significativa (ratio de tasa 0,848, p=0,043).
Las tasas de eventos adversos fueron similares entre los grupos (64% para BDP/FF/G frente a 67% para IND/GLY).
La incidencia de neumonía fue comparable (4% en ambos grupos).

Conclusiones:

Extrafine BDP/ FF/ G redujo significativamente las exacerbaciones de EPOC de moderadas a severas en comparación con IND/ GLY en pacientes sintomáticos con limitación severa del flujo de aire y antecedentes de exacerbaciones.
El tratamiento triple no aumentó el riesgo de neumonía.
Este estudio proporciona evidencia que apoya el uso de la terapia triple inhalada para poblaciones específicas de pacientes con EPOC.

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