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In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
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Eficacia de la polipíldora para la prevención primaria y secundaria de las enfermedades cardiovasculares (PolyIran):
Gholamreza Roshandel1, Masoud Khoshnia1, Hossein Poustchi2
1Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran; Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran.
Lancet (London, England)
|August 27, 2019
Resumen
El estudio PolyIran demostró que una estrategia de polipíldoras redujo significativamente los eventos cardiovasculares importantes en un 34% en los participantes. La alta adherencia y los bajos eventos adversos apoyan su uso, especialmente en países de ingresos bajos y medios.
Área de la Ciencia:
- Prevención de las enfermedades cardiovasculares
- Intervenciones de salud pública
- Tratamientos farmacológicos
Sus antecedentes:
- Las enfermedades cardiovasculares (ECV) representan una carga significativa para la salud mundial, especialmente en los países de ingresos bajos y medios (PIBM).
- La terapia combinada de dosis fija, o estrategia de polipíldoras, ofrece un enfoque prometedor para simplificar los regímenes de tratamiento y mejorar la adherencia para la prevención de ECV.
- El estudio PolyIran investigó la eficacia y seguridad de una polipíldora de cuatro componentes para la prevención primaria y secundaria de ECV.
Objetivo del estudio:
- Evaluar la eficacia de una estrategia de poli píldoras en la reducción de eventos cardiovasculares importantes.
- Evaluar la seguridad y las tasas de adherencia asociadas con el régimen de polipíldoras.
- Determinar el potencial de la polipíldora como herramienta de salud pública para el control de las enfermedades cardiovasculares en los PIM.
Principales métodos:
- Un ensayo pragmático, aleatorizado por clúster, en el que participaron 6.838 participantes de entre 40 y 75 años de edad en Irán.
- Los participantes fueron asignados al azar para recibir una atención mínima (intervenciones no farmacológicas) o una atención mínima más una polipíldora diaria (aspirina, atorvastatina, hidroclorotiazida, enalapril/ valsartán).
- El resultado primario fue la aparición de eventos cardiovasculares mayores durante un período de seguimiento de 60 meses, con análisis de intención de tratar.
Principales resultados:
- El grupo de polipíldoras experimentó una reducción del 34% en los eventos cardiovasculares mayores en comparación con el grupo de tratamiento mínimo (RH ajustada 0,66; IC del 95%: 0,55 a 0,80).
- Se observó una alta mediana de adherencia al tratamiento con polipíldoras (80,5%).
- Las tasas de eventos adversos, incluida la hemorragia intracraneal y el sangrado gastrointestinal superior, fueron similares entre los grupos.
Conclusiones:
- La estrategia de la polipíldora fue eficaz en la prevención de eventos cardiovasculares importantes.
- La alta adherencia a la medicación y un perfil de seguridad favorable apoyan la utilidad de la polipíldora.
- El enfoque de la polipíldora es una estrategia viable y efectiva para el manejo de enfermedades cardiovasculares, especialmente en entornos con recursos limitados.
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