FOCUS aims to test the Fixed-Dose-Combination (FDC) concept for secondary cardiovascular disease (CVD) prevention, and for a better understanding of socio-economic factors that influence access and adherence to CVD treatment. The FOCUS FDC pill is a single-day pill containing three active components of well-demonstrated efficacy. It can be produced and administrated at a much lower cost than conventional equivalents and is thus suitable for widespread use in resource-poor countries. The FDC pill will be tested in two complementary controlled clinical studies: a descriptive non-interventional study followed by an interventional randomised trial. The studies will analyse data collected at 40 clinical sites in Europe and 40 sites in three middle-income developing countries. FOCUS is an international collaboration between research institutes, clinicians, pharma Industry, small and medium-sized enterprises (SMEs) and scientific organisations.
As countries experience epidemiological changes, chronic diseases are rapidly becoming more important determinants of national diseases burden. Cardiovascular diseases are the leading cause of death worldwide, and they are responsible for half of all deaths in Europe, causing more than 1.9 million deaths each year in the European Union. The problem is even worse in developing countries.
Our understanding of the causes of cardiovascular disease at the population level has advanced substantially in recent decades. It is now well accepted that conventional or traditional risk factors account for most cases of cardiovascular disease cases.
Large-scale studies undertaken both in developed and emerging countries have demonstrated the existence of large gaps between clinical recommendations and treatment. There are several factors determining inadequate cardiovascular prevention: variability in prescription patterns, poor accessibility, affordability and lack of adherence to treatment. Poor treatment adherence has serious consequences because it translates into increased morbidity and mortality, threatening the effectiveness of any health system.
The principal objective of FOCUS is to develop and test an FDC pill for secondary cardiovascular prevention and to evaluate its potential benefit as a component of a cost-effective, globally available and comprehensive treatment strategy.
The specific objectives of the FOCUS project are:
The main results of FOCUS will be:
The findings and conclusions obtained in FOCUS will allow the drafting of 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 developing countries and beyond.