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Patrones de eventos adversos en el mundo real de ramucirumab en la base de datos FAERS (2014-2024): un estudio de
Yi Dong1, Tianjun Feng1, Xu Zhang2
1Harbin Medical University Cancer Hospital, 150 Haping Road, Harbin, 150081, China.
Naunyn-Schmiedeberg's archives of pharmacology
|February 10, 2026
Resumen
Ramucirumab, un inhibidor de VEGFR-2, muestra toxicidades conocidas y nuevas preocupaciones de seguridad como la insuficiencia cardíaca. La vigilancia vigilante es crucial, especialmente en las primeras etapas del tratamiento de tumores sólidos.
Área de la Ciencia:
- Oncología Oncología.
- Farmacovigilancia y farmacovigilancia también.
- Farmacología clínica Farmacología clínica.
Sus antecedentes:
- Ramucirumab, un anticuerpo monoclonal dirigido a VEGFR-2, se utiliza para varios tumores sólidos.
- Su perfil de seguridad en el mundo real requiere una mayor aclaración más allá de los ensayos clínicos.
Objetivo del estudio:
- Para analizar exhaustivamente los informes de eventos adversos para ramucirumab en la práctica clínica de rutina.
- Identificar las señales de seguridad conocidas y no reconocidas previamente asociadas con el tratamiento con ramucirumab.
Principales métodos:
- Análisis de 3.435 informes desduplicados de eventos adversos de la base de datos FAERS (2014-2024).
- Se utilizaron cuatro métodos de desproporcionalidad para identificar señales de seguridad significativas (139 términos preferidos).
Principales resultados:
- Las toxicidades conocidas confirmadas: perforación gastrointestinal, hemorragia, hipertensión, proteinuria.
- Se detectaron eventos subreconocidos: insuficiencia cardíaca, quilo tórax, pseudocirrosis.
- Las perforaciones gastrointestinales fueron frecuentes, a menudo ocurriendo dentro de los primeros tres meses de tratamiento con ramucirumab.
Conclusiones:
- La fase temprana de la terapia con ramucirumab es crítica para la aparición de eventos adversos graves.
- Los hallazgos ponen de relieve la necesidad de mejorar el monitoreo de los pacientes y una mayor investigación sobre los riesgos de seguridad del ramucirumab.
- Los datos de FAERS sugieren posibles preocupaciones de seguridad poco reconocidas que requieren atención clínica.
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