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Riesgo cardiovascular del celecoxib en 6 ensayos aleatorizados controlados con placebo: el análisis cruzado de
Scott D Solomon1, Janet Wittes, Peter V Finn
1Cardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA. ssolomon@rics.bwh.harvard.edu
Circulation
|April 2, 2008
Resumen
El riesgo cardiovascular aumenta con la dosis de celecoxib, con el riesgo más alto en 400 mg BID. Los pacientes con mayor riesgo cardiovascular basal experimentaron eventos adversos desproporcionadamente mayores con celecoxib.
Área de la Ciencia:
- Cardiología Cardiología.
- Farmacología Farmacología.
- Los ensayos clínicos son ensayos clínicos.
Sus antecedentes:
- Estudios anteriores indicaron un mayor riesgo cardiovascular con los inhibidores de la ciclooxigenasa-2.
- Existían datos limitados sobre la dosis de celecoxib o los efectos del estado cardiovascular basal sobre el riesgo.
Objetivo del estudio:
- Para evaluar el riesgo cardiovascular asociado con celecoxib en tres regímenes de dosis.
- Evaluar la relación entre el riesgo cardiovascular basal y el efecto del celecoxib en los eventos cardiovasculares.
Principales métodos:
- Análisis agrupado a nivel de paciente de los datos de 6 ensayos controlados con placebo.
- Incluido 7950 pacientes con seguimiento planificado de al menos 3 años.
- Se evaluaron dosis de celecoxib de 400 mg QD, 200 mg BID y 400 mg BID.
Principales resultados:
- Se observó una proporción de riesgo agrupado de 1,6 (95% IC, 1.1 a 2.3) para el criterio de valoración compuesto.
- El riesgo cardiovascular aumentó significativamente con la dosis de celecoxib (P=0.0005).
- El riesgo más alto se asoció con la dosis de 400 mg BID (HR, 3.1; 95% CI, 1.5 a 6.1), y el más bajo con 400 mg QD (HR, 1.1; 95% CI, 0.6 a 2.0).
- Los pacientes con mayor riesgo cardiovascular basal mostraron eventos adversos relacionados con el celecoxib desproporcionadamente mayores (P para la interacción = 0,034).
Conclusiones:
- La evidencia sugiere un riesgo cardiovascular diferencial basado en la dosis de celecoxib y el riesgo cardiovascular basal del paciente.
- Los hallazgos pueden ayudar a orientar las decisiones de tratamiento para los pacientes que se benefician de la inhibición selectiva de la ciclooxigenasa-2.
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