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Project Overview

The principal objective of  the FOCUS project 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 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.

The specific objectives of the FOCUS project are to:

  1. Demonstrate that better knowledge of factors responsible for an inappropriate use of secondary cardiovascular prevention drugs and of factors related to poor treatment adherence will help to design new strategies for prevention and disease treatment
  2. Prove that an FDC pill therapy is effective in controlling various cardiovascular risk factors
  3. Show that - compared to taking several drugs separately - an FDC pill will result in reductions in inappropriate prescribing, treatment complexity and lack of adherence, and thereby demonstrate that an FDC pill will improve secondary prevention in coronary patients.
Cardiovascular diseases (CVD) are the leading cause of death worldwide, and their incidence is increasing sharply in developing countries. Two insufficiently addressed factors contribute to increased morbidity and mortality, threatening the effectiveness of any health system: poor patient adherence to treatment, and limited access to medication in resource-poor countries and regions. To address these issues, FOCUS aims to test the Fixed-Dose-Combination (FDC) concept for CVD revention and treatment in populations with diverse socio-economic characteristics. The FOCUS FDC pill developed by CNIC and FERRER 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 multi-pill equivalents and is thus especially suitable for widespread use in resource-poor countries. The FOCUS project will perform two seperate, complementary, consecutive studies:
  • Observational Study: descriptive non-interventional study aiming to provide a comprehensive analysis of potential factors precluding adequate secondary prevention, including Health system characteristics, drug affordability and availability, as well as patient characteristics.
  • Randomized Study: interventional, randomized trial with prospective economic evaluation.

The studies will analyze data collected on 40 clinical sites in Europe and 40 sites across Argentina, Brazil and Paraguay. FOCUS is an international collaboration between research institutes, clinicians, pharma industry, SMEs and scientific organisations. It aims to establish a proof of concept of FDC efficacy for secondary CVD prevention, and a better understanding of socio-economic factors that influence access and adherence to CVD treatment. Based on the project results FOCUS will publish recommendations for the use of this medication to improve patient adherence and access to CVD prevention medication in developing countries and beyond.

The FOCUS project will directly contribute to improved use of clinical research findings for treatment of CVD diseases and to creating equitable access to a more efficient CVD prevention medication for patients in developed and resource-poor countries.

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Partners
Centro Nacional de Investigaciones Cardiovasculares (CNIC)
Istituto di Richerche Farmacologiche Mario Negri (IRFMN)
Instituto DAMIC (DAMIC)
Fundació Clínic per a la recerca Biomèdica (FCRB)
ARTTIC (ART)
Federación Argentina de Cardiología (FAC)
World Heart Federation (WHF)
Instituto de Salud Carlos III (ISCIII
GRUPO FERRER (FERRER)