FOCUS

Fixed Dose Combination drugs for Secondary Cardiovascular Prevention

 Coordinatore FUNDACION CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III 

 Organization address address: C/ MELCHOR FERNANDEZ ALMAGRO 3
city: MADRID
postcode: 28029

contact info
Titolo: Ms.
Nome: Luz
Cognome: álvarez
Email: send email
Telefono: +34 91 453 1300
Fax: +34 91 453 12 45

 Nazionalità Coordinatore Spain [ES]
 Totale costo 4˙812˙682 €
 EC contributo 2˙999˙999 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2009-single-stage
 Funding Scheme CP-FP
 Anno di inizio 2010
 Periodo (anno-mese-giorno) 2010-07-01   -   2014-06-30

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    FUNDACION CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III

 Organization address address: C/ MELCHOR FERNANDEZ ALMAGRO 3
city: MADRID
postcode: 28029

contact info
Titolo: Ms.
Nome: Luz
Cognome: álvarez
Email: send email
Telefono: +34 91 453 1300
Fax: +34 91 453 12 45

ES (MADRID) coordinator 497˙250.00
2    DAMIC SRL

 Organization address address: Avenida Colon 2057
city: CORDOBA
postcode: X5003DCE

contact info
Titolo: Ms.
Nome: Soledad
Cognome: Santirso
Email: send email
Telefono: +54 351 4888231
Fax: +54 351 4888245

AR (CORDOBA) participant 1˙290˙067.00
3    ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

 Organization address address: Via Giuseppe La Masa 19
city: MILANO
postcode: 20156

contact info
Titolo: Ms.
Nome: Maria Grazia
Cognome: Pezzoni
Email: send email
Telefono: 3902390000000
Fax: 390239000000

IT (MILANO) participant 500˙000.00
4    FUNDACIO PRIVADA CLINIC PER A LA RECERCA BIOMEDICA

 Organization address address: CARRER ROSSELLO 149-153
city: BARCELONA
postcode: 8029

contact info
Titolo: Mr.
Nome: Aguado
Cognome: Fernando
Email: send email
Telefono: 34932275707
Fax: 34932279205

ES (BARCELONA) participant 482˙878.00
5    ARTTIC

 Organization address address: Rue du Dessous des Berges 58A
city: PARIS
postcode: 75013

contact info
Titolo: Dr.
Nome: Eric
Cognome: Papon
Email: send email
Telefono: 33153945460
Fax: 33153945470

FR (PARIS) participant 174˙999.00
6    WORLD HEART FEDERATION

 Organization address address: Rue des Battoirs 7
city: GENEVA
postcode: 1211

contact info
Titolo: Ms.
Nome: Sara
Cognome: Ramsey
Email: send email
Telefono: 41228070329
Fax: 41228070339

CH (GENEVA) participant 29˙555.00
7    FEDERACION ARGENTINA DE CARDIOLOGIA

 Organization address address: Bulnes 1004
city: Buenos Aires
postcode: 1176

contact info
Titolo: Dr.
Nome: Luis
Cognome: Guzmán
Email: send email
Telefono: 541149000000

AR (Buenos Aires) participant 20˙250.00
8    INSTITUTO DE SALUD CARLOS III

 Organization address address: CALLE SINESIO DELGADO 4-6
city: MADRID
postcode: 28029

contact info
Titolo: Ms.
Nome: Inmaculada
Cognome: Pastor
Email: send email
Telefono: +34 91 822 27 64

ES (MADRID) participant 5˙000.00
9    FERRER INTERNATIONAL

 Organization address address: AVENIDA DIAGONAL 549
city: BARCELONA
postcode: 8029

contact info
Titolo: Mr.
Nome: Joan
Cognome: Fanes
Email: send email
Telefono: 936003708
Fax: 936003708

ES (BARCELONA) participant 0.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

health    study    followed    fdc    adherence    containing    cardiovascular    socio    published    dose    sites    pill    tested    fixed    interventional    combinations    heart    drug    compliance    prevention    pills    patients    efficacy    combination    diseases    outcomes    cvd    clinical    poor    trial    medication    affordable    recommendations    cardiology    clinicians    resource    treatment    economic    secondary    multiple    patient    countries   

 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.

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