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Spironolactona versus placebo en pacientes sometidos a diálisis de mantenimiento (ACHIEVE): un ensayo internacional
Michael Walsh1, David Collister2, Martin Gallagher3
1Population Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, ON, Canada; Department of Medicine and Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
Lancet (London, England)
|August 16, 2025
Resumen
La espironolactona no redujo las muertes cardiovasculares ni las hospitalizaciones por insuficiencia cardíaca en pacientes en diálisis de mantenimiento. Este estudio no encontró ningún beneficio al iniciar la administración de espironolactona en esta población de alto riesgo.
Área de la Ciencia:
- Nefrología
- Cardiología
- Ensayos clínicos
Sus antecedentes:
- Los pacientes en diálisis de mantenimiento se enfrentan a riesgos cardiovasculares significativos.
- Los antagonistas de los receptores de mineralcorticoides como la espironolactona son tratamientos potenciales.
Objetivo del estudio:
- Determinar si la espironolactona reduce la mortalidad cardiovascular y las hospitalizaciones por insuficiencia cardíaca en pacientes en diálisis.
Principales métodos:
- El ensayo ACHIEVE fue un ensayo controlado aleatorio en el que participaron 2538 pacientes en 143 programas de diálisis.
- Los participantes recibieron 25 mg de espironolactona al día o un placebo.
- El resultado primario fue un compuesto de muerte cardiovascular o hospitalización por insuficiencia cardíaca.
Principales resultados:
- El juicio se detuvo temprano debido a la inutilidad después de un análisis provisional.
- La espironolactona no redujo significativamente el resultado primario compuesto en comparación con el placebo (HR 0, 92; p=0, 35).
- No se observaron diferencias significativas en la mortalidad por cualquier causa o en las hospitalizaciones entre los grupos.
Conclusiones:
- La espironolactona oral diaria (25 mg) no mejoró los resultados cardiovasculares en pacientes sometidos a diálisis de mantenimiento.
- La administración inicial de espironolactona en esta población no mostró ningún beneficio identificable.
- Las investigaciones futuras deben explorar estrategias alternativas para mitigar los riesgos cardiovasculares en pacientes en diálisis.
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