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Eventos adversos asociados a la triptorelina evaluados utilizando datos de farmacovigilancia del FAERS

Wei Jia1,2, Tiezhou Wang3

  • 1Department of Pharmacy, Tonglu branch Hospital, Hangzhou First People's Hospital, No.899 Meilin Road, Tonglu, Hangzhou, 330000, Zhejiang Province, China. weij8341@163.com.

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Este estudio analizó eventos adversos en el mundo real para la triptorelina, un agonista de la GnRH, revelando señales de seguridad inesperadas como el comportamiento desafiante y la demencia de Alzheimer. Se recomienda un seguimiento continuo para este medicamento contra el cáncer de próstata y la endometriosis.

Palabras clave:
Incidencias adversasFAERS (en inglés)Farmacovigilancia de las sustanciasLa triptorelina

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Área de la Ciencia:

  • Farmacovigilancia y seguridad de los medicamentos
  • Oncología y Endocrinología

Sus antecedentes:

  • La triptorelina, un agonista de la hormona liberadora de gonadotropina (GnRH), es un medicamento aprobado por la FDA para el cáncer de próstata avanzado, la endometriosis y la pubertad precoz central.
  • El perfil de eventos adversos en el mundo real es crucial para comprender la seguridad de los medicamentos más allá de los ensayos clínicos.

Objetivo del estudio:

  • Para caracterizar el perfil de eventos adversos en el mundo real de la triptorelina.
  • Identificar las posibles señales estadísticas de seguridad utilizando una gran base de datos de eventos adversos.

Principales métodos:

  • Estudio de farmacovigilancia retrospectivo utilizando los datos del Sistema de Notificación de Eventos Adversos (FAERS) de la FDA para el período 2004Q1 a 2024Q3.
  • Análisis de desproporcionalidad con cuatro algoritmos (ROR, PRR, BCPNN, MGPS) para detectar señales de AE.
  • Análisis de 4 018 informes de sospecha de triptorelina entre los 18,5 millones de informes de FAERS.

Principales resultados:

  • Se han identificado 102 términos preferidos estadísticamente significativos.
  • Las señales inesperadas incluyeron comportamiento desafiante y demencia de Alzheimer, cumpliendo con los criterios de la EMA para una investigación adicional.
  • Las EA mostraron un patrón de aparición bimodal, con perfiles distintos entre los géneros.

Conclusiones:

  • Los datos de FAERS revelaron señales de seguridad esperadas e inesperadas para la triptorelina.
  • El comportamiento desafiante y la demencia de Alzheimer representan importantes preocupaciones potenciales de seguridad que requieren validación clínica.
  • Se recomienda la farmacovigilancia continua para controlar el perfil de seguridad de la triptorelina.