Videos de Experimentos Relacionados
La rosiglitazona evaluada para los resultados cardiovasculares en la terapia de combinación de agentes orales para la
Philip D Home1, Stuart J Pocock, Henning Beck-Nielsen
1Newcastle Diabetes Centre and Newcastle University, Newcastle upon Tyne, UK. philip.home@newcastle.ac.uk
Lancet (London, England)
|June 9, 2009
Resumen
La adición de rosiglitazona a la terapia para la diabetes no aumentó los eventos cardiovasculares generales, pero aumentó los riesgos de insuficiencia cardíaca y fractura, especialmente en las mujeres. Este estudio comparó la rosiglitazona con los tratamientos estándar durante 5-7 años.
Área de la Ciencia:
- Endocrinología y Metabolismo.
- Medicina Cardiovascular La medicina cardiovascular es una especialidad de la salud.
- Farmacología Farmacología.
Sus antecedentes:
- La rosiglitazona es un sensibilizante de insulina utilizado para el tratamiento de la diabetes tipo 2.
- Su seguridad y eficacia cardiovascular en comparación con otros regímenes de reducción de la glucosa requieren evaluación.
Objetivo del estudio:
- Para evaluar los resultados cardiovasculares en pacientes con diabetes tipo 2 tratados con rosiglitazona versus una combinación de metformina y sulfonilurea.
- Evaluar el perfil de seguridad comparativa de la rosiglitazona en esta población de pacientes.
Principales métodos:
- Un ensayo multicéntrico y abierto que involucró a 4447 pacientes con diabetes tipo 2.
- Los pacientes recibieron rosiglitazona agregada a la monoterapia o una combinación de metformina y sulfonilurea (control activo).
- El criterio de valoración primario: hospitalización cardiovascular o muerte; seguimiento: 5-7 años.
Principales resultados:
- Se cumplió la no inferioridad para el criterio de valoración cardiovascular primario (HR 0,99).
- La rosiglitazona aumentó significativamente el riesgo de insuficiencia cardíaca (HR 2.10) y fracturas, principalmente en mujeres.
- La media de HbA1c fue menor en el grupo de rosiglitazona.
Conclusiones:
- La adición de rosiglitazona a la terapia para reducir la glucosa aumenta los riesgos de insuficiencia cardíaca y fracturas, especialmente en las mujeres.
- La rosiglitazona no eleva la morbilidad o mortalidad cardiovascular en general en comparación con los tratamientos estándar.
- Los datos sobre los efectos del infarto de miocardio siguen sin ser concluyentes.
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