Revista Biomédica Revisada Por Pares
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Los trastornos minerales y óseos asociados a la enfermedad renal crónica son frecuentes. Para su tratamiento existen quelantes de fósforo en base a calcio y otros no cálcicos como el sevelamer, pero no está claro cuál constituye una mejor opción. Utilizando la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples fuentes de información, identificamos 12 revisiones sistemáticas que en conjunto incluyen 61 estudios primarios, de los cuales 41 corresponden a ensayos aleatorizados. Extrajimos los datos, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. Concluimos que el sevelamer, en comparación con los quelantes de fósforo en base a calcio, podría disminuir los eventos de hipercalcemia, pero con una mayor incidencia de efectos gastrointestinales. Por otra parte, no está claro si existen diferencias en cuanto a mortalidad porque la certeza de la evidencia es muy baja.
Una de las complicaciones de los pacientes con insuficiencia renal crónica son los trastornos minerales y óseos. Éstos incluyen tres componentes principales [1]:
La hiperfosfemia juega un rol en múltiples niveles, por lo que su adecuado manejo con quelantes de fósforo se considera fundamental. Existen dos alternativas terapéuticas principales; los quelantes de fósforo en base a calcio (por ej. acetato de calcio y carbonato de calcio) y los no cálcicos, en particular el sevelamer. Sevelamer es un polímero de clorhidrato de alilamina. Sin embargo, no está claro cuál de las alternativas constituye una mejor opción.
Utilizamos la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples fuentes de información, para identificar revisiones sistemáticas y sus estudios primarios incluidos. Con esta información generamos un resumen estructurado, siguiendo un formato preestablecido, que incluye mensajes clave, un resumen del conjunto de evidencia (presentado como matriz de evidencia en Epistemonikos), metanálisis del total de los estudios, tablas de resumen de resultados con el método GRADE, y tabla de otras consideraciones para la toma de decisión.
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Mensajes clave
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Cuál es la evidencia. |
Encontramos 12 revisiones sistemáticas en 13 referencias [2],[3],[4],[5],[6],[7],[8],[9],[10],[11],[12],[13],[14] que incluyen 61 estudios primarios en 75 referencias [15], [16],[17],[18],[19],[20],[21],[22],[23],[24],[25],[26], [27],[28],[29],[30],[31],[32],[33],[34],[35],[36],[37], [38],[39],[40],[41],[42],[43],[44],[45],[46],[47],[48], [49],[50],[51],[52],[53],[54],[55],[56],[57],[58],[59], [60],[61],[62],[63],[64],[65],[66],[67],[68],[69],[70], [71],[72],[73],[74],[75],[76],[77],[78],[79],[80],[81], [82],[83],[84],[85],[86],[87],[88],[89]. De éstos, 41 estudios en 54 referencias son ensayos aleatorizados. Esta tabla y el resumen en general se basan en estos últimos, dado que los estudios observacionales no aumentaban la certeza de la evidencia existente, ni entregaban información adicional relevante. |
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Qué tipo de pacientes incluyeron los estudios* |
Respecto a la etapa de la nefropatía, 27 ensayos [15], [18],[20],[22],[26],[33],[34],[35],[36],[37],[41],[43], [44],[47],[50],[52],[53],[54],[56],[57],[64],[68],[69], [74],[75],[81],[84] incluyeron pacientes en hemodiálisis, tres [31],[39],[61] en peritoneodiálisis, nueve [23],[27],[29],[38],[46],[63],[73],[85],[88] incluyeron pacientes en etapa III o IV sin diálisis, un ensayo [77] no especificó el tipo de diálisis, sino sólo que llevaran más de seis meses en esta terapia y un ensayo [89] sólo requirió que estuviesen en etapa V.** |
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Qué tipo de intervenciones incluyeron los estudios* |
Todos los ensayos utilizaron sevelamer como intervención en dosis ajustada según fósforo. No se logró extraer algún dato más específico de la dosis desde las revisiones sistemáticas. Seis ensayos [33],[34],[36],[47],[53],[75] utilizaron como cointervención vitamina D por cualquier vía de administración, uno [20] usó vitamina D oral, tres [18],[39],[69] usaron vitamina D endovenosa, un ensayo [68] utilizó atorvastatina y uno [77] carbonato de calcio en dosis bajas. Respecto a la comparación, 14 ensayos [18],[20],[27], [46],[47],[56],[57],[61],[63],[64],[68],[69],[88],[89] utilizaron acetato de calcio, 20 ensayos [15],[26],[29], [31],[36],[37],[38],[39],[41],[43],[50],[52],[53],[54], [73],[74],[75],[77],[84],[85] usaron carbonato de calcio, cinco [22],[33],[35],[44],[81] usaron carbonato de calcio y acetato de calcio. |
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Qué tipo de desenlaces midieron |
Los desenlaces, de acuerdo a como fueron agrupados en las revisiones sistemáticas identificadas, fueron:
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La información sobre los estudios primarios es extraída desde las revisiones sistemáticas identificadas, no directamente desde los estudios, a menos que se especifique lo contrario.
**Etapa de insuficiencia renal crónica según MDRD-4
La información sobre los efectos de sevelamer en comparación a quelantes de fósforo basados en calcio está basada en el total de ensayos identificados en este resumen, que incluyen 5928 pacientes.
Treinta y un ensayos [18],[20],[22],[23],[26],[27],[29],[33],[36],[37],[38],[39],[41],[47],[50],[53],[54],[56],[57],[61],[63],[68],[69],[73],[74],[75], [81],[84],[85],[88],[89] midieron mortalidad que incluyen 5011 pacientes. Veinte ensayos [20],[23],[27],[29],[33],[35],[39],[41],[43],[50],[53],[54],[56],[57],[63],[68],[74],[75],[81],[88] midieron eventos adversos gastrointestinales que incluyen 2863 pacientes. Diecinueve ensayos [20],[22],[23],[26],[27],[33],[36],[38],[39],[43],[47],[56],[57],[68],[69],[74],[75],[81],[88] midieron hipercalcemia que incluyen 2867 pacientes.
El resumen de los resultados es el siguiente:
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Siga el enlace para acceder a la versión interactiva de tabla SOF |
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A quién se aplica y a quién no se aplica esta evidencia |
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| Sobre los desenlaces incluidos en este resumen |
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| Balance riesgo/beneficio y certeza de la evidencia |
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| Consideraciones de recursos |
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| Qué piensan los pacientes y sus tratantes |
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| Diferencias entre este resumen y otras fuentes |
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| ¿Puede que cambie esta información en el futuro? |
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Mediante métodos automatizados y colaborativos recopilamos toda la evidencia relevante para la pregunta de interés y la presentamos en una matriz de evidencia.
Siga el enlace para acceder a la versión interactiva: Sevelamer comparado con quelantes de fósforo en base a calcio en insuficiencia renal crónica
Si con posterioridad a la publicación de este resumen se publican nuevas revisiones sistemáticas sobre este tema, en la parte superior de la matriz se mostrará un aviso de “nueva evidencia”. Si bien el proyecto contempla la actualización periódica de estos resúmenes, los usuarios están invitados a comentar en Medwave o contactar a los autores mediante correo electrónico si creen que hay evidencia que motive una actualización más rápida.
Luego de crear una cuenta en Epistemonikos, al guardar las matrices recibirá notificaciones automáticas cada vez que exista nueva evidencia que potencialmente responda a esta pregunta. El detalle de los métodos para elaborar este resumen están descritos aquí: http://dx.doi.org/10.5867/medwave.2014.06.5997.
La Fundación Epistemonikos es una organización que busca acercar la información a quienes toman decisiones en salud, mediante el uso de tecnologías. Su principal desarrollo es la base de datos Epistemonikos (www.epistemonikos.org).
Los resúmenes de evidencia siguen un riguroso proceso de revisión por pares interno.
Declaración de conflictos de intereses
Los autores declaran no tener conflictos de intereses con la materia de este artículo.
Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.
Chronic kidney disease-mineral and bone disorder is prevalent. There is controversy regarding whether calcium-based phosphate binders or sevelamer - a non-calcium phosphate binder – constitute a better therapeutic alternative. Searching in Epistemonikos database, which is maintained by screening multiple information sources, we identified 12 systematic reviews comprising 61 studies of which 41 correspond to randomized trials addressing the question of this article. We combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded sevelamer may decrease hypercalcemia, but with a higher incidence of gastrointestinal effects than calcium based phosphate binders. It is unclear if there are differences in mortality because the certainty of the evidence is very low.
Autores:
Gonzalo A Bravo-Soto[1,2], Trinidad Madrid[2,3]
Citación: Bravo-Soto GA, Madrid T. Sevelamer versus calcium-based phosphate binders for chronic kidney disease. Medwave2017;17(Suppl2):e6942 doi: 10.5867/medwave.2017.6942
Fecha de envío: 24/2/2017
Fecha de aceptación: 1/3/2017
Fecha de publicación: 12/5/2017
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