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07:51
Refined Murine Model of Idiopathic Pulmonary Fibrosis
Published on: June 17, 2025
Pirfenidona en pacientes con fibrosis pulmonar idiopática (CAPACITY): dos ensayos aleatorizados en pacientes con
Paul W Noble1, Carlo Albera, Williamson Z Bradford
1Duke University School of Medicine, Durham, NC 27710, USA. paul.noble@duke.edu
Lancet (London, England)
|May 17, 2011
Resumen
La pirfenidona, un medicamento antifibrótico, se estudió en pacientes con fibrosis pulmonar idiopática. Demostró un perfil de beneficio-riesgo favorable, reduciendo el deterioro de la función pulmonar y la mortalidad, por lo que es una opción de tratamiento viable.
Área de la Ciencia:
- Pulmonología Pulmonología.
- Farmacología Farmacología.
- Los ensayos clínicos son ensayos clínicos.
Sus antecedentes:
- La fibrosis pulmonar idiopática (FIP) es una enfermedad pulmonar progresiva y fatal caracterizada por el inevitable deterioro de la función pulmonar.
- El programa CAPACITY (estudios 004 y 006) tenía como objetivo confirmar la eficacia de la pirfenidona para retrasar la progresión de la FPI.
Objetivo del estudio:
- Evaluar la eficacia y seguridad de la pirfenidona oral en pacientes con fibrosis pulmonar idiopática.
- Confirmar la capacidad de la pirfenidona para reducir el deterioro de la función pulmonar en pacientes con FPI.
Principales métodos:
- Dos ensayos aleatorizados simultáneos, controlados con placebo (estudios CAPACITY 004 y 006) en los que participaron 779 pacientes con FPI de entre 40 y 80 años.
- Los pacientes recibieron pirfenidona oral (2403 mg/día o 1197 mg/día) o placebo durante al menos 72 semanas.
- El criterio de valoración primario fue el cambio en el porcentaje previsto de capacidad vital forzada (FVC) en la semana 72; se realizó un análisis de intención de tratar.
Principales resultados:
- En el estudio 004, la pirfenidona 2403 mg / día redujo significativamente la disminución de la CVF en comparación con el placebo (diferencia del 4,4%, p = 0,001), con un menor número de pacientes que experimentaron una disminución de ≥10% (20% frente a 35%).
- El estudio 006 no mostró una diferencia estadísticamente significativa en el cambio de CVF en la semana 72, pero la pirfenidona demostró un efecto consistente hasta la semana 48.
- Pirfenidona 2403 mg / día se asoció con un aumento de eventos adversos (náuseas, dispepsia, erupción) pero menos muertes generales y relacionadas con la IPF en comparación con el placebo.
Conclusiones:
- La pirfenidona exhibe un perfil de beneficio-riesgo favorable para el tratamiento de la fibrosis pulmonar idiopática.
- La pirfenidona representa una opción de tratamiento adecuada para los pacientes diagnosticados con fibrosis pulmonar idiopática.
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