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Rimonabant para la prevención de eventos cardiovasculares (CRESCENDO): un ensayo aleatorizado, multicéntrico y
Eric J Topol1, Marie-Germaine Bousser, Keith A A Fox
1Scripps Translational Science Institute, La Jolla, CA 92037, USA. etopol@scripps.edu
Lancet (London, England)
|August 17, 2010
Resumen
El rimonabant, un bloqueador de los receptores cannabinoides, no mejoró la supervivencia libre de eventos vasculares importantes en pacientes en riesgo. El ensayo se detuvo antes de tiempo debido a efectos secundarios neuropsiquiátricos inaceptables, incluidas las preocupaciones de suicidio.
Área de la Ciencia:
- Medicina Cardiovascular La medicina cardiovascular es una especialidad de la salud.
- Farmacología Farmacología.
- Trastornos metabólicos Los trastornos metabólicos son trastornos metabólicos que se producen en el cuerpo.
Sus antecedentes:
- El bloqueo del receptor endocannabinoide es prometedor para reducir la obesidad y mejorar los parámetros metabólicos.
- Investigaciones anteriores indicaron beneficios potenciales para los triglicéridos, el colesterol HDL y la glucosa en sangre en ayunas.
- El estudio tuvo como objetivo evaluar el impacto de rimonabant en la supervivencia libre de eventos vasculares importantes.
Objetivo del estudio:
- Evaluar la eficacia del rimonabant en la mejora de la supervivencia libre de eventos vasculares mayores.
- Para determinar si el rimonabant reduce la muerte cardiovascular, el infarto de miocardio o el accidente cerebrovascular en pacientes de alto riesgo.
- Investigar el perfil de seguridad del rimonabant en relación con los eventos adversos cardiovasculares y psiquiátricos.
Principales métodos:
- Un ensayo doble ciego controlado con placebo que involucró a 18.695 pacientes en 974 hospitales en 42 países.
- Los pacientes fueron asignados al azar para recibir rimonabant 20 mg o un placebo correspondiente.
- El objetivo primario fue un compuesto de muerte cardiovascular, infarto de miocardio o accidente cerebrovascular, con análisis de intención de tratar.
Principales resultados:
- El ensayo se interrumpió prematuramente debido a preocupaciones regulatorias con respecto al suicidio en el grupo de rimonabant.
- No se observó diferencia significativa en el criterio de valoración primario entre los grupos de rimonabant y placebo (3,9% vs 4,0%).
- El rimonabant aumentó significativamente los efectos secundarios gastrointestinales, neuropsiquiátricos y psiquiátricos graves en comparación con el placebo, incluidos cuatro suicidios en el grupo de rimonabant.
Conclusiones:
- El ensayo destaca lecciones críticas para el desarrollo de fármacos, particularmente con respecto a la seguridad neuropsiquiátrica.
- El rimonabant, destinado a la pérdida de peso y probado para resultados cardiovasculares, exhibió efectos neuropsiquiátricos graves inaceptables.
- Las autoridades reguladoras llevaron a la terminación abrupta tanto del medicamento como del ensayo clínico.
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