Descripción del proyecto
Mejora de la salud cardiovascular de los ancianos mediante la intervención con policápsulas
El tratamiento de las enfermedades cardiovasculares suele requerir politerapia, que se asocia a una adhesión al tratamiento subóptima. Ello reduce la eficacia y el beneficio clínico, lo que empeora los síntomas y aumenta la mortalidad. A partir de estas constataciones, el equipo del proyecto SECURE, financiado con fondos europeos, tiene el firme propósito de evaluar una policápsula combinada de dosis fija para la prevención cardiovascular secundaria en personas mayores de sesenta y cinco años. Los investigadores llevarán a cabo un ensayo clínico destinado a evaluar los beneficios potenciales de la policápsula como estrategia de tratamiento rentable y accesible en todo el mundo, comparándola con la terapia estándar. Los criterios secundarios de valoración incluyen la evaluación de la adhesión al tratamiento, el control de los factores de riesgo, el efecto farmacoeconómico, las diferencias regionales y la información sobre directrices y recomendaciones clínicas.
Objetivo
While Cardiovascular diseases (CVD) are the main cause of death worldwide, they are responsible for half of all deaths in Europe. The overall ageing of the European population and improving survival of patients with coronary heart disease has created a large population of older adults eligible for secondary prevention. Despite the established efficacy of cardiovascular medications, suboptimal adherence reduces their effectiveness and is the primary reason for suboptimal clinical benefit, contributing significantly to worsening of diseases and deaths at the population level. SECURE will be the first trial testing the efficacy of a fixed dose combination (FDC) polypill for secondary cardiovascular prevention in the elderly population (≥ 65 years old). The main objective is to evaluate the potential benefit of the FDC as a component of a cost-effective, globally available and comprehensive treatment strategy for secondary prevention of cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, stroke, and hospitalisation requiring revascularisation) as compared to standard therapy (the three components of the polypill given separately). As part of the secondary endpoints, SECURE will compare the effect of both strategies on adherence and intermediate measures of risk factor control such as lipids and blood pressure. Importantly, it will also measure the pharmacoeconomic impact of the FDC intervention as well as regional differences in all outcomes. The five-year project will thus involve subjects from seven different countries: Spain, Italy, France, Germany, Hungary, Poland and the Czech Republic. The findings and conclusions obtained in SECURE will allow the drafting of clinical guidelines and recommendations that will provide useful guidance and will serve as a reference framework for all stakeholders involved in tackling major challenges related to secondary prevention and treatment of chronic diseases in the elderly population.
Ámbito científico
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- natural sciencesbiological sciencesbiochemistrybiomoleculeslipids
- medical and health sciencesclinical medicinecardiologycardiovascular diseases
- medical and health sciencesbasic medicineneurologystroke
- social sciencespolitical sciencesgovernment systems
Palabras clave
Programa(s)
Tema(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-PHC-2014-two-stage
Régimen de financiación
RIA - Research and Innovation actionCoordinador
28029 Madrid
España