Problema de salud AUGE N°01
Hemodiálisis
Recomendación de Tratamiento – Juicio del Panel y Evidencia
En personas con enfermedad renal crónica etapa 5 en hemodiálisis en tratamiento con eritropoyetina con hemoglobina mayor 12 g/dL el Ministerio de Salud SUGIERE mantener dosis quincenal por sobre suspender la administración de eritropoyetina.
Comentarios del panel:
►La dosis de eritropoyetina es de 4.000 a 6.000 UI quincenalmente, pero debe ajustarse en aquellas personas que tienen hipertensión arterial resistente y administrarse en el centro de diálisis.
►El panel de expertos consideró que la evidencia para responder esta pregunta era muy indirecta ya que los estudios compararon diferentes metas de hemoglobina.
El Panel de Expertos analizó y debatió cada uno de las preguntas de la “Tabla de la evidencia a la decisión”, considerando tanto la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de los pacientes. Una vez consensuada la postura del panel respecto a las preguntas, emitieron un juicio seleccionando la opción de respuesta que mejor representaba la opinión del conjunto (destacada con color). Finalmente cuando el panel emitió su juicio sobre todas las preguntas, se emitió la recomendación.
A continuación se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.
1.- ¿El problema es una prioridad?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
El problema ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad.
2.- ¿Qué tan significativos son los efectos deseables anticipados?
| Trivial | Pequeño | Moderado | Grande | Varía | No lo sé |
|---|
Triviales: El equipo elaborador de la Guía estimó que los efectos deseables de «suspender eritropoyetina » en comparación a «mantener dosis quincenal de eritropoyetina» son triviales o no relevantes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Consideraciones Adicionales
El panel de experto considera que los estudios encontrados no dan respuesta a la pregunta.
Evidencia de investigación
Tabla de Resumen de Resultados (Summary of Findings)
|
Suspender eritropoyetina comparado con mantener el uso quincenalmente para enfermedad renal crónica en hemodiálisis. |
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|
Pacientes |
Personas con enfermedad renal crónica etapa 5 en hemodiálisis en tratamiento con eritropoyetina con hemoglobina mayor 12 mg/dL. |
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|
Intervención |
Suspender el uso de eritropoyetina. |
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|
Comparación |
Mantener el uso de eritropoyetina quincenalmente |
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|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
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|
CON mantención |
CON suspensión |
Diferencia (IC 95%) |
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|
Mortalidad |
RR 0,98 (0,73 a 1,32) — 4 ensayos / 2319 pacientes [47, 53, 54, 96] |
192 por 1000 |
188 por 1000 |
Diferencia: 4 menos (52 menos a 61 más) |
⊕◯◯◯1,2,3 Muy baja |
Suspender la administración de eritropoyetina en enfermedad renal crónica etapa 5 en hemodiálisis con hemoglobina mayor a 12 mg/dL podría tener poco impacto en mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
|
Infarto al miocardio |
RR 0,97 (0,65 a 1,43) — 2 ensayos / 1829 pacientes [47, 96] |
53 por 1000 |
51 por 1000 |
Diferencia: 2 menos (18 menos a 23 más) |
⊕◯◯◯1,2,3 Muy baja |
Suspender la administración de eritropoyetina en enfermedad renal crónica etapa 5 en hemodiálisis con hemoglobina mayor a 12 mg/dL podría tener poco impacto en infarto al miocardio. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
|
Accidente cerebrovascular |
RR 0,65 (0,28 a 1,48) — 1 ensayo / 1233 pacientes [47] |
23 por 1000 |
15 por 1000 |
Diferencia: 8 menos (16 menos a 11 más) |
⊕◯◯◯1,2,3 Muy baja |
Suspender la administración de eritropoyetina en enfermedad renal crónica etapa 5 en hemodiálisis con hemoglobina mayor a 12 mg/dL podría disminuir el riesgo de accidente cerebrovascular. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo CON mantención está basado en el riesgo del grupo control en los estudios. El riesgo CON suspender (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
1 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo ya que la mayoría de los ensayos no está clara la generación de la secuencia de aleatorización ni el ocultamiento de ésta.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
3 Se disminuyó dos niveles de certeza de evidencia por indirecto, ya que se utilizó evidencia que proviene de la población más amplia. En el caso de mortalidad, se seleccionó la población en diálisis, por lo que sólo se disminuyó un nivel de certeza de evidencia por la diferencia de la intervención.
Fecha de elaboración de la tabla: Octubre, 2018.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
3.- ¿Qué tan significativos son los efectos indeseables anticipados?
| Grande | Moderado | Pequeño | Trivial | Varía | No lo sé |
|---|
Grandes: El equipo elaborador de la Guía estimó que los efectos indeseables de «suspender eritropoyetina » en comparación a «mantener dosis quincenal de eritropoyetina» son grandes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Evidencia de investigación
Tabla de Resumen de Resultados (Summary of Findings)
|
Suspender eritropoyetina comparado con mantener el uso quincenalmente para enfermedad renal crónica en hemodiálisis. |
||||||
|
Pacientes |
Personas con enfermedad renal crónica etapa 5 en hemodiálisis en tratamiento con eritropoyetina con hemoglobina mayor 12 mg/dL. |
|||||
|
Intervención |
Suspender el uso de eritropoyetina. |
|||||
|
Comparación |
Mantener el uso de eritropoyetina quincenalmente |
|||||
|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
||
|
CON mantención |
CON suspensión |
Diferencia (IC 95%) |
||||
|
Mortalidad |
RR 0,98 (0,73 a 1,32) — 4 ensayos / 2319 pacientes [47, 53, 54, 96] |
192 por 1000 |
188 por 1000 |
Diferencia: 4 menos (52 menos a 61 más) |
⊕◯◯◯1,2,3 Muy baja |
Suspender la administración de eritropoyetina en enfermedad renal crónica etapa 5 en hemodiálisis con hemoglobina mayor a 12 mg/dL podría tener poco impacto en mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
|
Infarto al miocardio |
RR 0,97 (0,65 a 1,43) — 2 ensayos / 1829 pacientes [47, 96] |
53 por 1000 |
51 por 1000 |
Diferencia: 2 menos (18 menos a 23 más) |
⊕◯◯◯1,2,3 Muy baja |
Suspender la administración de eritropoyetina en enfermedad renal crónica etapa 5 en hemodiálisis con hemoglobina mayor a 12 mg/dL podría tener poco impacto en infarto al miocardio. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
|
Accidente cerebrovascular |
RR 0,65 (0,28 a 1,48) — 1 ensayo / 1233 pacientes [47] |
23 por 1000 |
15 por 1000 |
Diferencia: 8 menos (16 menos a 11 más) |
⊕◯◯◯1,2,3 Muy baja |
Suspender la administración de eritropoyetina en enfermedad renal crónica etapa 5 en hemodiálisis con hemoglobina mayor a 12 mg/dL podría disminuir el riesgo de accidente cerebrovascular. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. |
Accidente cerebrovascular
IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo CON mantención está basado en el riesgo del grupo control en los estudios. El riesgo CON suspender (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
1 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo ya que la mayoría de los ensayos no está clara la generación de la secuencia de aleatorización ni el ocultamiento de ésta.
2 Se disminuyó un nivel de certeza de evidencia por imprecisión ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
3 Se disminuyó dos niveles de certeza de evidencia por indirecto, ya que se utilizó evidencia que proviene de la población más amplia. En el caso de mortalidad, se seleccionó la población en diálisis, por lo que sólo se disminuyó un nivel de certeza de evidencia por la diferencia de la intervención.
Fecha de elaboración de la tabla: Octubre, 2018.
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103. Stone WJ, Graber SE, Krantz SB, Dessypris EN, O’Neil VL, Olsen NJ, Pincus TP. Treatment of the anemia of predialysis patients with recombinant human erythropoietin: a randomized, placebo-controlled trial. The American journal of the medical sciences. 1988;296(3):171-9.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
| Muy baja | Baja | Moderada | Alta | Ningún estudio incluido |
|---|
Muy Baja: Existe considerable incertidumbre respecto del efecto de «suspender eritropoyetina » en comparación a «mantener dosis quincenal de eritropoyetina».
Evidencia de investigación
|
Desenlaces |
Importancia |
Certainty of the evidence |
|
Mortalidad |
CRÍTICO |
⨁◯◯◯ |
|
Infarto al miocardio |
CRÍTICO |
⨁◯◯◯ |
|
Accidente cerebrovascular |
CRÍTICO |
⨁◯◯◯ |
a. Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo ya que la mayoría de los ensayos no está clara la generación de la secuencia de aleatorización ni el ocultamiento de ésta.
b. Se disminuyó un nivel de certeza de evidencia por imprecisión ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
c. Se disminuyó dos niveles de certeza de evidencia por indirecto, ya que se utilizó evidencia que proviene de la población más amplia y además no todos el tratamiento fue eritropoyetina. En el caso de mortalidad, se seleccionó la población en diálisis, por lo que sólo se disminuyó un nivel de certeza de evidencia por la diferencia de la intervención.
5.- ¿Hay incertidumbre importante o variabilidad sobre qué tanto valora la gente los desenlaces principales?
| Incertidumbre o variabilidad importantes | Posiblemente hay incertidumbre o variabilidad importantes | Probablemente no hay incertidumbre ni variabilidad importantes | No hay variabilidad o incertidumbre importante |
|---|
Probablemente no hay incertidumbre ni variabilidad importantes: En función de la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud, el equipo elaborador de la Guía consideró que probablemente no hay incertidumbre o ni variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «suspender eritropoyetina » y «mantener dosis quincenal de eritropoyetina».
Evidencia de investigación
Un estudio observacional prospectivo tuvo como objetivo comprobar los efectos deseables e indeseables del medicamento (eritropoyetina) en los pacientes en diálisis domiciliaria adiestrados en la unidad de nefrología del Hospital Universitarios Virgen del Roció. Sevilla, España.(1)
Al preguntar por tres efectos positivos o negativos de la EPO que no figuraran en la encuesta cabe destacar que en los efectos positivos, según versión del paciente refirieron tener más fuerza, dolor precordial menos frecuente y menos intenso, piernas menos cansadas, más ágil, mejor apetito, más cantidad de pelo en cuero cabelludo (mujeres), más ganas de vivir, menstruación más reglada y menos abundante. Con respecto a los efectos negativos comentan la hipertensión y la taquicardia.
Otro estudio, una revisión de literatura, cuyo objetivo es analizar el impacto del tratamiento con hemodiálisis en la calidad de vida de las personas con insuficiencia renal crónica terminal
Entre los pacientes que habían recibido o estaban actualmente recibiendo hemodiálisis (n = 773), el 84% indicó que medicamentos tales como la eritropoyetina preferían que se administrara de manera endovenosa durante la diálisis mientras que solo el 5% prefirió la inyección subcutánea (2)
Referencia
1. J. Lucas Martín Espejo, Luisa Soler,, Francisco Barbosa,. Tratamiento con eritropoyetina en pacientes con diálisis domiciliaria. Encuesta de valoración de enseñanza y calidad de vida. Comunicaciones SociedadEsapañola de Enfermeria Nefrológica. 1991;101–8.
2. Claudia Pérez, Angelina Dois, Lorena Díaz, Priscila Villavicencio. Efectos de la hemodiálisis en la calidad de vida de los usuarios. Horiz Enferm. 2009;20(1):57–65.
Consideraciones Adicionales
No existe indicación de eritropoyetina endovenosa en Chile, solo está disponible la eritropoyetina subcutánea
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de valores y preferencias de los pacientes
6.- El balance entre efectos deseables e indeseables favorece la intervención o la comparación?
| Favorece la comparación | Probablemente favorece la comparación | No favorece la intervención ni la comparación | Probablemente favorece la intervención | Favorece la intervención | Varía | No lo sé |
|---|
Favorece la comparación: Considerando que la intervención es «suspender eritropoyetina » y la comparación es «mantener dosis quincenal de eritropoyetina», el equipo elaborador de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «mantener dosis quincenal de eritropoyetina».
7.- ¿Qué tan grandes son los recursos necesarios (costos)?
| Costos extensos | Costos moderados | Costos y ahorros despreciables | Ahorros moderados | Ahorros extensos | Varía | No lo sé |
|---|
Costos moderados: El equipo elaborador de la Guía consideró que los costos de «suspender eritropoyetina » son moderados si se compara con los costos de «mantener dosis quincenal de eritropoyetina», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.
Evidencia de investigación
A continuación, se muestran los precios referenciales de las prestaciones de usar eritropoyetina quincenalmente en comparación a suspender su uso en personas con enfermedad renal crónica etapa 5 en hemodiálisis en tratamiento con eritropoyetina, con hemoglobina mayor a 12mh/dL, de modo que el equipo elaborador de la Guía se pudiese pronunciar respecto a los costos de la misma.
|
Ítem |
Precio |
Suspender uso de Eritropoyetina |
|
Eritropoyetina Ampolla 2000 UI1 |
$ 1.129 x 2 veces al mes (quincenal)= $ 2.258 |
—– |
|
Eritropoyetina Ampolla 4000 UI1 |
$ 1.790 x 2 veces al mes (quincenal)= $ 3.580 |
—– |
El porcentaje de cobertura del seguro de salud sobre el precio de la(s) prestación(es) sanitaria(s), dependerá del tipo de seguro de cada paciente.
Referencias: 1 .Precio promedio compra centralizada CENABAST
Búsqueda y Síntesis de Evidencia
Búsqueda de costos
8.- ¿La costo-efectividad de la intervención beneficia la intervención o la comparación?
| Favorece la comparación | Probablemente favorece la comparación | No favorece la intervención ni la comparación | Probablemente favorece la intervención | Favorece la intervención | Varía | Ningún estudio incluido |
|---|
Favorece la comparación: Considerando que la intervención es «suspender eritropoyetina » y la comparación es «mantener dosis quincenal de eritropoyetina», el equipo elaborador de la Guía opinó que claramente la alternativa más costo-efectiva es «mantener dosis quincenal de eritropoyetina».
Consideraciones Adicionales
El panel de expertos considera que suspender la eritropoyetina significa mayor probabilidad de transfusiones, mayor gasto económico, (realización de más exámenes, mayor dosis de fármacos y aumento de hospitalizaciones)
Evidencia de investigación
No se realizó la búsqueda de estudios que abordaran la costo-efectividad de la eritropoyetina ya que no es considerada una intervención de alto costo (Anual $2.418.399 y Mensual $201.533).*
Referencia
*Ministerio de Salud. Decreto 80: Determinar umbral nacional de costo anual al que se refiere el artículo 6° de la Ley 20.850 [Internet]. Santiago; 2015 Nov.
9.- ¿Cuál sería el impacto en equidad en salud?
| Reducido | Probablemente reducido | Probablemente ningún impacto | Probablemente aumentado | Aumentado | Varía | No lo sé |
|---|
Probablemente ningún impacto: El equipo elaborador de la Guía consideró que probablemente no tendría ningún impacto en la equidad en salud si se recomendase «suspender eritropoyetina «, dado que identificó grupos o contextos que actualmente tiene barreras de acceso importantes, ya sea en términos económicos, geográficos u otros.
Consideraciones Adicionales
El panel de expertos informa que la eritropoyetina está garantizada.
10.- ¿La intervención es aceptable para las partes interesadas?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
No: El equipo elaborador de la Guía consideró que «suspender eritropoyetina » NO es aceptable para las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos de centros de salud, pacientes, cuidadores, seguros de salud, otros).
11.- ¿Es factible implementar la intervención?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
No: El equipo elaborador de la Guía consideró que «suspender eritropoyetina » NO es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.
Consideraciones Adicionales
El panel de expertos considera que la intervención se puede implementar pero no es recomendable desde el punto de vista clínico.