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Riesgos asociados con el tratamiento con estatinas: una visión general sistemática de ensayos clínicos aleatorizados
Amir Kashani1, Christopher O Phillips, JoAnne M Foody
1Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn, USA.
Circulation
|December 13, 2006
Resumen
Las estatinas son generalmente seguras, sin un aumento significativo en los riesgos de daño muscular o hepático en comparación con el placebo. Sin embargo, la terapia con estatinas está relacionada con un pequeño aumento en las elevaciones de las transaminasas.
Área de la Ciencia:
- Medicina Cardiovascular La medicina cardiovascular es una especialidad de la salud.
- Farmacología Farmacología.
- Los ensayos clínicos son ensayos clínicos.
Sus antecedentes:
- Las estatinas reducen efectivamente el riesgo de eventos cardiovasculares.
- Las preocupaciones sobre los efectos adversos pueden limitar la prescripción de estatinas.
- Este estudio revisó sistemáticamente los ensayos con estatinas para evaluar los riesgos de complicaciones.
Objetivo del estudio:
- Para cuantificar los riesgos de complicaciones musculoesqueléticas, renales y hepáticas por el tratamiento con estatinas.
- Evaluar el perfil de seguridad de la monoterapia con estatinas frente al placebo en ensayos aleatorios.
Principales métodos:
- Una visión general sistemática de los ensayos aleatorizados de estatinas (búsqueda MEDLINE, 1966-2005).
- Se incluyeron adultos con hiperlipidemia, estatina doble ciego vs. placebo, >=100 pacientes.
- Se analizaron datos sobre mialgia, creatina quinasa, rabdomiolisis, elevaciones de las transaminasas y interrupción del evento adverso.
Principales resultados:
- 74.102 sujetos en 35 ensayos (seguimiento de 1 a 65 meses).
- No hay un aumento significativo en las mialgias, elevaciones de la creatina quinasa, rabdomiolisis o interrupción del tratamiento.
- Se observó un aumento absoluto significativo en las elevaciones de las transaminasas (RD, 4.2; IC del 95%, 1.5 a 6.9).
Conclusiones:
- La terapia con estatinas muestra un pequeño exceso de riesgo de elevaciones de las transaminasas, pero no de mialgias, elevaciones de la creatina quinasa, rabdomiolisis o abstinencia.
- Se necesita más investigación para confirmar estos hallazgos en la práctica de rutina, especialmente para los grupos de pacientes de alto riesgo.
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