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Carvedilol para niños y adolescentes con insuficiencia cardíaca: un ensayo clínico controlado aleatorizado
Robert E Shaddy1, Mark M Boucek, Daphne T Hsu
1Department of Pediatrics, University of Utah School of Medicine and Primary Children's Medical Center, Salt Lake City, USA. shaddyr@email.chop.edu
JAMA
|September 13, 2007
Resumen
El carvedilol no mejoró significativamente los resultados de la insuficiencia cardíaca en niños y adolescentes. Se necesita más investigación debido a los posibles efectos diferenciales basados en la morfología ventricular.
Área de la Ciencia:
- Cardiología Pediátrica Cardiología pediátrica.
- Farmacología Farmacología.
- Investigación cardiovascular Investigación cardiovascular Investigación cardiovascular Investigación cardiovascular Investigación cardiovascular
Sus antecedentes:
- Se sabe que los betabloqueantes mejoran los resultados en la insuficiencia cardíaca en adultos.
- Existen datos limitados sobre la eficacia de los betabloqueantes en pacientes pediátricos con insuficiencia cardíaca.
Objetivo del estudio:
- Evaluar prospectivamente los efectos del carvedilol en niños y adolescentes con insuficiencia cardíaca sistólica sintomática.
- Evaluar el impacto del carvedilol en los resultados clínicos y la función cardíaca en pacientes pediátricos.
Principales métodos:
- Un ensayo multicéntrico, aleatorizado, doble ciego, controlado con placebo en el que participaron 161 pacientes pediátricos.
- Los pacientes recibieron terapia convencional de insuficiencia cardíaca más placebo o carvedilol en dosis baja o alta durante 8 meses.
- El resultado primario fue un compuesto de eventos de insuficiencia cardíaca; los resultados secundarios incluyeron medidas ecocardiográficas y de biomarcadores.
Principales resultados:
- No hay diferencia estadísticamente significativa en el resultado compuesto de la insuficiencia cardíaca entre los grupos de carvedilol y placebo.
- Se observaron tasas de mejora similares (56%) tanto en los grupos de carvedilol como en los de placebo.
- Una interacción significativa (P=.02) sugirió un efecto diferencial potencial del carvedilol basado en la morfología ventricular.
Conclusiones:
- El carvedilol no demostró una mejora significativa en los resultados clínicos de la insuficiencia cardíaca en pacientes pediátricos.
- El estudio puede haber sido insuficiente debido a tasas de eventos más bajas de lo esperado.
- La morfología ventricular puede influir en la eficacia del carvedilol en niños y adolescentes.
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