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Efecto de la metilprednisolona oral en los resultados clínicos en pacientes con nefropatía IgA: el ensayo clínico
Jicheng Lv1, Hong Zhang2, Muh Geot Wong3
1Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China2The George Institute for Global Health, University of New South Wales, Sydney, Australia.
JAMA
|August 2, 2017
Resumen
Los corticosteroides como la metilprednisolona pueden ofrecer protección renal en pacientes con nefropatía IgA, pero aumentan el riesgo de infecciones graves. El estudio se interrumpió prematuramente, lo que limitó las conclusiones definitivas sobre los beneficios del tratamiento.
Área de la Ciencia:
- Nefrología
- Inmunología
- Ensayos clínicos
Sus antecedentes:
- Las directrices sugieren corticosteroides para la nefropatía IgA (IgAN) con proteinuria persistente.
- La eficacia y la seguridad de estos tratamientos siguen siendo inciertas, lo que requiere más investigación.
Objetivo del estudio:
- Evaluar la eficacia y seguridad de los corticosteroides en pacientes con nefropatía IgA en riesgo de progresión de la enfermedad.
- Evaluación del impacto de la metilprednisolona en los resultados renales y los eventos adversos.
Principales métodos:
- Un ensayo clínico multicéntrico, doble ciego y aleatorizado (estudio TESTING) en el que participaron pacientes con IgAN y proteinuria > 1 g/ día.
- Los participantes recibieron metilprednisolona oral o placebo durante 2 meses, seguido de un período de destete.
Principales resultados:
- El ensayo se interrumpió prematuramente debido al exceso de eventos adversos graves en el grupo de metilprednisolona, principalmente infecciones graves.
- Si bien el resultado renal primario (por ejemplo, enfermedad renal terminal) se produjo con menos frecuencia en el grupo de metilprednisolona, las conclusiones definitivas son limitadas.
Conclusiones:
- El tratamiento con metilprednisolona en pacientes con IgAN se asoció con un mayor riesgo de eventos adversos graves, en particular infecciones.
- A pesar de una señal potencial de beneficio renal, la terminación temprana del ensayo impide conclusiones definitivas sobre la eficacia de los corticosteroides para IgAN.
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