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SECURE Report Summary

Project ID: 633765
Funded under: H2020-EU.3.1.3.

Periodic Reporting for period 1 - SECURE (Secondary prEvention of CardiovascUlaR disease in the Elderly trial)

Reporting period: 2015-05-01 to 2016-10-31

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first 18 months of the SECURE project, partners have prepared the start of the clinical trial. Study sites were selected in all 7 countries involved (Spain, Italy, France, Hungary, Poland, Germany and the Czech Republic). The required documents and the clinical protocol were finalised and submitted to the Ethics Committees and Competent Authorities. The first major achievement of this period was to obtain the necessary approvals in all countries. In parallel, partners have been preparing contracts with the hospitals selected to recruit patients, activating the sites and training the investigators. A secure database was also set up for the collection of the study data. In addition, the polypill to be used as treatment was produced, labelled, packaged and shipped to the study centres. In August 2016, the clinical trial was officially open/able to start the recruitment of patients. Since then, all national coordinators of the study in the 7 countries have been performing the required monitoring activities and ensuring the follow-up visits of patients and the data management procedures are carried out as planned.
While the scientific activities of the project were progressing, the SECURE partners have also initiated many dissemination activities to raise awareness of the project. A public website was set up at the beginning and a brochure was produced one year later. This leaflet was also translated into the 7 languages of the countries where the study takes place. The project was presented during many international events in the field of cardiovascular diseases and prevention, notably during the last 2 ESC (European Society of Cardiology) Congresses, that the consortium attended. In addition to 3 peer-reviewed publications, the partners published several articles on their websites and in relevant journals. The internal management of the project was also ensured through the set-up of the necessary collaboration tools and frequent telephone meetings.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The results of the SECURE trial could potentially have profound impact on secondary cardiovascular prevention in the elderly population in different EU countries as it will provide:
• The proof of concept of the efficacy and cost-effectiveness of an FDC polypill for secondary CV prevention and treatment over traditional therapies.
• Understanding the impact of a polypill strategy on adherence to CVD treatment.
• Recommendations on how to address major challenges related to effective secondary CV prevention: adherence, risk factor control, access to treatment and health care utilisation and costs related to the aforementioned.
SECURE will be the first trial to address the efficacy of the FDC on CV outcomes in secondary prevention in the elderly population. Measuring and comparing the effect of both strategies on health care resource utilisation and costs will help design more efficient interventions tailored to meet the specific challenges of secondary prevention in different European countries.
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 – pharmaceutical companies, clinicians, policy makers and international organisations – involved in tackling major challenges related to secondary prevention and treatment of chronic diseases in the elderly population. Furthermore, SECURE will provide necessary data to address the critical issue of secondary prevention of CV disease in LMICs (Low and Middle Income Countries), where a FDC polypill strategy could prove useful to address several problems that limit the effectiveness of secondary prevention strategies: inadequate health policies, poor availability, and lack of affordable medication.
The SECURE consortium partners strongly believe that the present study is necessary in order to effectively tackle the CVD epidemic that is taking place worldwide. The demographic changes taking place in Europe will mean that ever increasing numbers of people will live longer and that an increasing proportion of this elderly population will be subject to secondary CV prevention. Currently we have access to very effective pharmacologic and non-pharmacologic interventions for CV prevention in Europe, but their efficacy on the control of the disease growth is limited, mainly due to non-adherence. Moreover, health care costs have continued to rise throughout Europe. The polypill concept is an attractive and imaginative idea that can significantly improve CV prevention and improving patient adherence to treatment, and therefore lowering costs. Importantly, these demographic changes are mirrored in most of the rest of the world and they are coupled with a rapid pace of urbanisation. Most countries have completed, or at least initiated their epidemiologic transition and are faced with an ageing population prone to CV conditions that also afflict Europeans. Hence, the extrapolation of the data and application of the potential benefit of the polypill in LMICs countries could have an impact on sparing millions of lives.

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