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Estudio aleatorizado de fase 1b de modulación controlada por antídoto de la actividad del factor IXa en pacientes con
Mark Y Chan1, Mauricio G Cohen, Christopher K Dyke
1Duke Clinical Research Institute, 2400 Pratt St, Terrace Level Room 0311, Durham, NC 27705, USA.
Circulation
|May 29, 2008
Resumen
REG1, una nueva terapia de ARN aptamer, inhibe efectivamente la actividad del factor IXa en pacientes con enfermedad arterial coronaria en terapia antiplaquetaria. El sistema fármaco-antídoto demostró una anticoagulación predecible y una rápida reversión sin mayores eventos de sangrado.
Área de la Ciencia:
- Medicina Cardiovascular La medicina cardiovascular es una especialidad de la salud.
- Farmacología Farmacología.
- Investigación de la trombosis.
Sus antecedentes:
- Investigando nuevos anticoagulantes para pacientes con enfermedad arterial coronaria (CAD) estable en terapia antiplaquetaria.
- Evaluación de la eficacia y seguridad de la inhibición selectiva del factor IXa en combinación con tratamientos dirigidos a las plaquetas.
Objetivo del estudio:
- Para evaluar la seguridad, tolerabilidad y farmacodinámica de REG1, un sistema de fármaco-antídoto de aptamer de ARN dirigido al factor IXa.
- Para determinar el efecto anticoagulante dependiente de la dosis y las capacidades de reversión de REG1 en pacientes con CAD.
Principales métodos:
- Un estudio aleatorizado, doble ciego, controlado con placebo que involucró a 50 pacientes con CAD que recibían aspirina y / o clopidogrel.
- Administración de REG1 (medicamento RB006, antídoto RB007) en cuatro niveles de dosis en aumento.
- Monitoreo del tiempo de tromboplastina parcial activado (aPTT) y eventos adversos.
Principales resultados:
- RB006 demostró un aumento dependiente de la dosis en aPTT, lo que indica una inhibición efectiva del factor IXa (P<0.0001).
- RB007 revirtió rápidamente aPTT a la línea de base en 1 minuto sin ningún efecto de rebote observado durante 7 días.
- No se reportaron hemorragias importantes ni eventos adversos graves, lo que sugiere una buena tolerabilidad.
Conclusiones:
- REG1 representa la primera pareja fármaco-antídoto de un aptamer de ARN que inhibe y restaura con éxito la actividad del factor IXa en pacientes con EAC que reciben terapia antiplaquetaria.
- Los efectos farmacodinámicos predecibles y el perfil de seguridad preliminar apoyan una mayor investigación en pacientes sometidos a revascularización electiva.
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