The Fixed-dose Combination Drug for Secondary Cardiovascular Prevention project: Improving equitable access and adherence to secondary cardiovascular prevention with a fixed-dose combination drug. Study design and objectives

In spite of advances in prevention and treatment, the burden of cardiovascular diseases is increasing. A fixed-dose combination (FDC) pill, or “polypill,” composed of evidence-based drugs has been proposed as a means of improving cardiovascular prevention by reducing cost and increasing patient adhe...

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Veröffentlicht in:The American heart journal 2011-11, Vol.162 (5), p.811-817.e1
Hauptverfasser: Sanz, Ginés, MD, PhD, Fuster, Valentin, MD, PhD, Guzmán, Luis, MD, Guglietta, Antonio, MD, PhD, Arnáiz, Joan Albert, MD, PhD, Martínez, Felipe, MD, Sarria, Antonio, MD, PhD, Roncaglioni, Maria Carla, Biol Sci Dr, Taubert, Kathryn, PhD
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container_end_page 817.e1
container_issue 5
container_start_page 811
container_title The American heart journal
container_volume 162
creator Sanz, Ginés, MD, PhD
Fuster, Valentin, MD, PhD
Guzmán, Luis, MD
Guglietta, Antonio, MD, PhD
Arnáiz, Joan Albert, MD, PhD
Martínez, Felipe, MD
Sarria, Antonio, MD, PhD
Roncaglioni, Maria Carla, Biol Sci Dr
Taubert, Kathryn, PhD
description In spite of advances in prevention and treatment, the burden of cardiovascular diseases is increasing. A fixed-dose combination (FDC) pill, or “polypill,” composed of evidence-based drugs has been proposed as a means of improving cardiovascular prevention by reducing cost and increasing patient adherence to treatment. The aim of the FOCUS project, funded by the 7th Framework Programme of the European Commission, is to characterize the factors that underlie inadequate secondary prevention and to test a new FDC. To achieve these goals, a 9-member consortium has been constituted, including institutions from Argentina, France, Italy, Spain, and Switzerland. FOCUS Phase-1 will examine factors potentially related to lack of adequate secondary prevention in 4,000 post–myocardial infarction (MI) patients and analyze the relationship between these factors and patient treatment adherence. Primary end points will be (1) the percentage of patients receiving aspirin, angiotensin-converting enzyme inhibitors, and statins and (2) adherence to treatment measured by the Morisky-Green test. FOCUS Phase-2 is a randomized trial that will compare adherence to treatment in 1,340 post–myocardial infarction patients either receiving an FDC comprising aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and simvastatin (40 mg) or receiving the same 3 drugs separately.
doi_str_mv 10.1016/j.ahj.2011.08.012
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subjects Angiotensin-Converting Enzyme Inhibitors - administration & dosage
Argentina
Aspirin
Aspirin - administration & dosage
Biological and medical sciences
Blood pressure
Cardiology. Vascular system
Cardiovascular
Cardiovascular disease
Cardiovascular Diseases - prevention & control
Disease prevention
Drug Combinations
Drug dosages
Drug therapy
Europe
GDP
Gross Domestic Product
Heart attacks
Heart failure
Hospital costs
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage
Hypotheses
Lung diseases
Medical sciences
Medication Adherence
Mortality
Objectives
Patient Selection
Pharmaceuticals
Platelet Aggregation Inhibitors - administration & dosage
Population
Prescription drugs
Questionnaires
Research Design
Risk factors
Socioeconomic factors
Variables
title The Fixed-dose Combination Drug for Secondary Cardiovascular Prevention project: Improving equitable access and adherence to secondary cardiovascular prevention with a fixed-dose combination drug. Study design and objectives
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