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Resultados musculoesqueléticos diferentes reportados en pacientes que recibieron ácido bempedoico o atorvastatina: un
Gianluca Gazzaniga1,2, Antonio Romio1, Chiara Galuppi1
1Department of Medical Biotechnology and Translational Medicine, Postgraduate School of Clinical Pharmacology and Toxicology, University of Milano, Milano, Italy.
Frontiers in pharmacology
|February 9, 2026
Resumen
El ácido bempedoico (BA) muestra mayores probabilidades de reacciones adversas al fármaco relacionadas con el músculo (ADR) que la atorvastatina (ATO), pero estas son generalmente menos graves. Se necesita una mayor atención para los síntomas musculares con BA, especialmente cuando se combina con estatinas.
Área de la Ciencia:
- Cardiología Cardiología.
- Farmacología Farmacología.
- Seguridad de las drogas Seguridad de las drogas.
Sus antecedentes:
- El colesterol lipoproteico de baja densidad (LDL-C) elevado es un factor de riesgo clave para la enfermedad cardiovascular aterosclerótica.
- Las estatinas son medicamentos primarios que reducen el colesterol LDL, pero pueden causar trastornos musculoesqueléticos (EMS), lo que afecta la adherencia del paciente.
- El ácido bempedoico (BA) es un agente reductor de lípidos alternativo con activación muscular limitada, aunque datos recientes sugieren posibles reacciones adversas a los medicamentos relacionadas con los músculos (ADR).
Objetivo del estudio:
- Para comparar las reacciones adversas relacionadas con los músculos entre el ácido bempedoico (BA) y la atorvastatina (ATO).
- Evaluar el perfil de seguridad de BA con respecto a los eventos adversos relacionados con los músculos en un entorno real.
Principales métodos:
- Análisis de los informes de ADR del sistema europeo de notificación espontánea hasta junio de 2024.
- Análisis de desproporcionalidad utilizando ratios de probabilidades de notificación (ROR) para comparar las ADR relacionadas con el músculo entre BA y ATO.
- Categoría de las reacciones adversas por demografía del paciente y tipo de evento.
Principales resultados:
- Se analizaron un total de 78,930 informes de ADR (2,667 solo para BA, 76,137 solo para ATO).
- Los trastornos musculoesqueléticos fueron significativamente más frecuentes con BA que con ATO (ROR 2.25).
- La incomodidad muscular se asoció más con la EA, mientras que los eventos graves como la rabdomiolisis fueron más frecuentes con la ATO; las ERA musculares relacionadas con la EA fueron generalmente menos graves.
Conclusiones:
- Los receptores de ácido bempedoico (BA) mostraron mayores probabilidades de informes de ADR relacionados con el músculo en comparación con los receptores de atorvastatina (ATO).
- A pesar de las probabilidades de notificación más altas, las ERA musculares asociadas a la BA se caracterizaron por resultados clínicos más favorables y menor gravedad.
- Los médicos deben considerar los síntomas musculares inducidos por el fármaco al prescribir BA, particularmente en la terapia de combinación con estatinas.
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