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Secondary prEvention of CardiovascUlaR disease in the Elderly trial

Descrizione del progetto

Migliorare la salute cardiovascolare negli anziani con l’intervento mediante polipillola

Il trattamento delle malattie cardiovascolari richiede spesso una combinazione di farmaci, che è associata a un’osservanza non ottimale del trattamento. Ciò riduce l’efficacia e il beneficio clinico, peggiorando i sintomi della malattia e aumentando la mortalità. Il progetto SECURE, finanziato dall’UE, intende valutare una polipillola combinata a dose fissa per la prevenzione cardiovascolare secondaria nei soggetti di età pari o superiore a 65 anni. Attraverso uno studio clinico, valuterà i potenziali benefici della polipillola come strategia di trattamento economica e accessibile a livello globale, confrontandola con la terapia standard. Gli endpoint secondari includono la valutazione dell’osservanza, il controllo dei fattori di rischio, l’impatto farmaco-economico, le differenze regionali e l’influenza su linee guida e raccomandazioni cliniche.

Obiettivo

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.

Invito a presentare proposte

H2020-PHC-2014-2015

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Bando secondario

H2020-PHC-2014-two-stage

Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III (F.S.P.)
Contribution nette de l'UE
€ 1 465 972,00
Indirizzo
CALLE MELCHOR FERNANDEZ ALMAGRO 3
28029 Madrid
Spagna

Mostra sulla mappa

Regione
Comunidad de Madrid Comunidad de Madrid Madrid
Tipo di attività
Research Organisations
Collegamenti
Costo totale
€ 1 594 375,00

Partecipanti (11)