FOCUS

Fixed Dose Combination drugs for Secondary Cardiovascular Prevention

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 Obiettivo del progetto (Objective)

'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 prevention and treatment in populations with diverse socio-economic characteristics. The FOCUS FDC pill developed by the consortium 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 FDC pill will be tested in two complementary controlled clinical studies: a descriptive non-interventional study followed by an interventional randomized trial. The studies will analyze 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, 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. A successful 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.'

Introduzione (Teaser)

Patients with heart conditions are at high risk of suffering from secondary cardiovascular complications. Treatment generally entails a complex cocktail of medications leading to high costs, inappropriate prescription and poor patient compliance.

Descrizione progetto (Article)

Besides being affordable, clinicians believe that a fixed-dose combination (FDC) pill will simplify dosage adjustment for physicians and improve patient follow-up and adherence. This hypothesis was tested under the aegis of the EU-funded FOCUS (Fixed dose combination drugs for secondary cardiovascular prevention) project.

Scientists developed and tested FDC pills containing specific doses of ramipril, simvastatin and acetylsalicylic acid to cost-effectively treat heart conditions.

Researchers carried out a study on post-myocardial infarct patients in two phases, beginning with an observational study followed by a clinical trial. Safety, efficacy and efficiency of FDC pills over multiple pill combinations were assessed at multiple sites in Europe and South America.

Study outcomes revealed that younger age, depression and complex drug combinations lead to poorer medication adherence, whereas good insurance coverage and social support improved patient compliance.

A key finding is the confirmation that FDC pills significantly enhance patient adherence in comparison to patients on a complex drug treatment plan. FDC pills could therefore be more effective at secondary cardiovascular prevention than an optimised multiple-drug regimen.

Project findings were presented at the European Society of Cardiology (ESC) congress and published in the Journal of the American College of Cardiology. FOCUS also published recommendations on FDC pill usage to improve patient medication adherence as well as access to cardiovascular prevention medication.

The industrial partner in the FOCUS project will work on commercialising the FDC pill at an affordable price. Rapid adoption of the FDC concept for secondary cardiovascular prevention and enhanced access to FDC pills in developed and developing countries could potentially save millions of lives. Moreover, substantial cost savings for both patient and national health systems should facilitate widespread application of the FDC pill treatment.

Study outcomes also indicate that this polypill approach could be adopted for the treatment of other chronic diseases like diabetes. This has significant socioeconomic implications.