Jordi Blanch Font

Antecedents. La demència representa un repte important per a la salut mundial, amb una prevalença creixent i una càrrega substancial per a les persones, les famílies i els sistemes sanitaris. Conèixer la epidemiologia de la malaltia així com els seus determinants i factors pronòstics a la nostra població resulta fonamental per a la prevenció, l’assistència clínica i la planificació sanitària.
Objectius. Estimar l’evolució de la incidència i la prevalença de la demència en el període 2006-2024 i la seva interacció a grups d’edat i gènere, nivell socioeconòmic, ubicació geogràfica en la població de 50 o més anys. Descriure les característiques basals de les persones diagnosticades de demència, els seus factors de risc i els seus factors pronòstics en la població de 50 o més anys.
Mètodes. Població de l’estudi: Pels objectius d’incidència i factors de risc: pacients registrats al Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària (SIDIAP) de 50 o més anys. Pels objectius de prevalença i factors pronòstics: Població de 50 o més anys amb un diagnòstic de demència.
Es portarà a terme un disseny de cohorts pels estudis d’incidència, identificació dels factors de risc i factors pronòstics i un disseny transversal pels estudis de prevalença i caracterització de la població amb demència.
Resultats esperats, aplicabilitat i rellevància. Esperem observar una disminució en la incidència de demència i un increment en la seva prevalença en la primera meitat del període estudiat i una estabilitat o descens en el segon període. També s’espera descriure els factors relacionats amb la seva aparició i amb el seu pronòstic (edat, sexe, factors socials, estils de vida, factors de risc cardiovasculars, factors sensorials, ús de medicaments, infeccions prèvies i altres comorbiditats). Així com descriure les diferencies observades en funció del determinats geogràfics i socioeconòmics.

Objectius
Objectiu principal.
Analitzar si l’assistència a esdeveniments públics només d’individus als quals se’ls hagi certificat, través d’un passi digital, que presenten o bé un de resultat negatiu del test ràpid d’antígens o bé immunitat enfront el SARS CoV-2 (vacuna confirmada o confirmació de que presenten anticossos), s’associa a un increment de les infeccions detectades per SARS CoV-2 respecte a un grup control de població que no ha assistit a aquest esdeveniment.

Disseny de l’estudi
Estudi d’intervenció no aleatoritzada amb grup control aparellat

Àmbit i període de l’estudi
L’estudi es realitzarà en base als esdeveniments socials i culturals realitzats a la ciutat de Girona en el període entre el 1 d’abril i el 15 de maig de 2021.

En España, la investigación sobre salud en minorías sexuales y de género (MSG) es muy escasa e inexistente en el ámbito cardiovascular (CV). Las MSG norteamericanas tienen estilos de vida menos saludables, mayor prevalencia de factores de riesgo y enfermedad CV y menor uso de estatinas que la población heterosexual. El objetivo es comparar la prevalencia y la incidencia de los estilos de vida, factores de riesgo y enfermedades CV entre el colectivo MSG y la población general. También se comparará el uso de fármacos CV y la utilización de recursos sanitarios en atención primaria. Se combinará un diseño transversal y un longitudinal de cohortes. Los datos se obtendrán de un cuestionario online (sobre orientación sexual y género) y del Sistema de Información para el Desarrollo de la Investigación en Atención Primaria (SIDIAP), una gran base de datos clínicos pseudoanonimizada. El cuestionario se administrará a 768 personas MSG seleccionadas mediante un muestreo dirigido por entrevistados (MDE), con 20 semillas y 6 olas. La cohorte MSG se apareará con una muestra de población general seleccionada al azar (apareada por edad, sexo y estrato socio-económico) obtenida de SIDIAP, que proporcionará los datos clínicos de ambos grupos. Se contará con la participación ciudadana en el diseño del cuestionario, el reclutamiento y la interpretación de los resultados.

Las demencias constituyen un problema mayor de salud pública y su prevención un reto prioritario para el Sistema Nacional de Salud. Objetivos: analizar el efecto del nivel del riesgo cardiovascular (RCV) relativo y la variación temporal del mismo a lo largo del seguimiento, sobre la incidencia de la demencia en población general a partir de 50 años de edad sin antecedentes de enfermedad vascular. Metodología: estudio de cohortes retrospectivas construidas a partir de los datos del Sistema de Información para el Desarrollo de la Investigación en Atención Primaria (SIDIAP), el cual permite disponer de alrededor de 1 millón de personas de al menos 50 años d eedad y más de 63000 casos de demencia y de un periodo de seguimiento de hasta 15 años. Los diagnósticos de demencia en SIDIAP han sido validados en estudios previos. Se evaluará la incidencia de demencia global y se analizarán dos variables de interés: el nivel (reducido/no-reducido) y la variación a lo largo del seguimiento del RCV -estimado según REGICOR y SCORE. Se imputará los valores perdidos y se aplicarán análisis de supervivencia, modelos de riesgo y modelos estructurales. Este proyecto es de bajo coste y de alto impacto para la salud pública ya que responde a una de las prioridades de la sociedad: la calidad de vida en la vejez.

Intrarosa (prasterone) is indicated for the treatment of vulvar and vaginal atrophy (VVA) in post-menopausal women having moderate to severe symptoms. The Intrarosa pessary is administered once daily. The active ingredient prasterone is also known as dehydroepiandrosterone (DHEA). Prasterone is an inactive endogenous steroid that is converted intracellularly in the vaginal cells into active androgens and/or oestrogens which are inactivated locally at their site of synthesis. VVA is a common condition in post-menopausal women and is associated with decreased sex steroid levels in the vaginal tissue, which may be improved using suitable treatment. The effectiveness and safety of Intrarosa in post-menopausal women with moderate to severe VVA symptoms were assessed in the appropriate clinical trials.
In response to the application for market authorization in European Union (EU) countries, a drug utilization study (DUS) to investigate adherence to the SmPC with regards to contraindications in the real life situation was requested by the European Medicines Agency (EMA) which will be performed in 3 EU member states, namely France, Spain and Sweden.

Research question and objectives
The overall aim of the DUS is to describe the baseline characteristics and utilization patterns of EU post-menopausal women initiating treatment with Intrarosa.

Objectives
1. Describe their baseline and historical characteristics of female patients initiating Intrarosa such as age, history and current oestrogen-dependent cancers such as ovarian or breast cancer, endometrial cancer, endometrial hyperplasia, abnormal Pap smear, deep venous thrombosis, pulmonary embolism, thrombophilic disorders, angina and myocardial infarction, acute liver disease, porphyria and indication for use.
2. Estimate the proportion of patients that may have been prescribed Intrarosa outside of the specifications of the product label (‘off-label use’).

Study design
This will be a multi-country cohort study based on secondary data collection using a combination of existing data sources. No longitudinal follow-up of patients will be performed in this study.

Population
This study will be conducted in the outpatient setting of the target countries (France, Spain, Sweden). All patients in the selected countries/databases who initiate Intrarosa in the first 3 years following the product launch will be enrolled. No comparator cohort will be used.

Variables
In order to meet the study objectives, patients’ baseline and historical characteristics (age, indication, co-morbidities) will be described.

Data sources
The following data sources are planned for the DUS Intrarosa
? Electronic Medical Records (EMR) databases: IMS® LPD (France, Spain)
? National registry (Sweden)

Study size
The exact number of prescriptions records available for analysis will depend significantly on the market uptake of Intrarosa in the target countries. The more data will be available, the higher will be the level of confidence for any estimate, i.e. the smaller will be the width of the 95% confidence interval (CI). In case of low numbers, the inclusion of additional target countries (like Germany) or extension of the observational period will be discussed.

Data analysis
The analyses will be descriptive in nature, performed annually for 3 years, and use counts and percentages for categorical variables and means with standard deviations for continuous variables. Analyses will be performed for annual and cumulative study periods separately per database and per country. In case of low patient numbers, analysis may be postponed to the following year to allow for an extended observational period. A detailed description of planned analyses is provided in the statistical analysis plan.

Results and Milestones
Two annual interim study reports and a final report will be submitted to the EMA in Q4 2020, Q4 2021 and Q4 2022. The DUS will include patients who initiate Intrarosa treatment in the first 3 years following the first commercial availability of Intrarosa in the EU. Product launch in the target countries is expected to start in Q4 2018 for Sweden, while for Spain and France, it is expected to start in Q1 2019. Protocol Registration in the EU PAS register is planned in Q4 2018.

Estudio cuantitativo: El objetivo principal es analizar si las aptitudes personales relacionadas con las conductas, están asociados de manera independiente a la incidencia de morbilidad. Estudio con metodología cuantitativa y cualitativa. Proyecto multicéntrico (10 equipos) para la creación de una cohorte de 3083 personas de 35 a 74 años de 9 Comunidades Autónomas. Las variables personales que se avaluaran serán: autoeficacia, activación, alfabetización en salud, resiliencia, locus del control y rasgos de personalidad. Se registraran covariables de tipo sociodemográfico, de capital social y de activos comunitarios en salud. Como objetivo secundario se analizará si las aptitudes personales están asociadas de manera independiente a menor mortalidad por todas las causas, mejor adopción de estilos de vida saludables, mejor calidad de vida y menor utilización de servicios de salud en el seguimiento. Se realizará una exploración física, una analítica y una evaluación cognitiva. Se analizará la incidencia de morbilidad con un modelo de Cox para cada una de las seis variables independientes (objetivo 1); y la mortalidad por todas las causas y de las otras variables dependientes (objetivo 2). Los modelos serán ajustados por las covariables indicadas. La posible heterogeneidad entre CCAA se estimará mediante la introducción de efectos aleatorios en el modelo.
Estudio cualitativo: Profundizar en las opiniones y experiencias de la población sobre la relación entre las aptitudes personales con su percepción de salud, sus estilos de vida y su calidad de vida. Investigación de perspectiva fenomenológica. Se realizaran el número de
grupos de discusión necesarios hasta alcanzar la saturación de discursos. Se hará un análisis de contenido temático interpretativo que se triangulará entre miembros del equipo investigador. Se interpretarán los significados y se creará un marco explicativo con las aportaciones de cada tipo de informantes.

El objetivo del estudio es observar la incidencia de enfermedad renal crónica (ERC) y lesión renal aguda (LRA) asociada con el consumo de inhibidores de la bomba de protones (IBP) en población general. Se trata de un estudio observacional, de cohorte, retrospectivo, que se realizará en el ámbito de la atención primaria del Institut Català de la Salut. Los datos necesarios para realizar el estudio se extraerán del SIDIAP. Se incluirán todos los individuos ? 18 años que al iniciar el estudio no tengan ERC ni LRA. La variable de respuesta será la incidencia de ERC y LRA, y la variable de exposición el consumo de IBP. Se recogerán las siguientes covariables: edad; sexo; consumo de tabaco; IMC; índice Medea; hipertensión arterial; diabetes mellitus; hiperlipidemia; enfermedades cardiovasculares; PAS; creatinina; ácido úrico; antihipertensivos; IECA/ARA II; diuréticos; estatinas ; AINE; antitrombóticos; años de seguimiento y días transcurridos hasta la presentación de ERC o LRA.Se realizarán análisis descriptivos univariante y bivariante de las variables respuesta vs la variable de exposición y una inferencia estadística bivariante. En el análisis multivariante se realizarán análisis de supervivencia.Se espera que las personas que tomen IBP tengan una mayor incidencia de LRA y ERC que los que no tomaron IBP. Debido al elevado consumo de IBPs en la población general su repercusión en la salud pública podría ser importante. Las principales limitaciones del estudio son las de la utilización de grandes bases de datos y la calidad de los registros.

Objetivos: analizar el efecto del nivel del riesgo cardiovascular (RCV) relativo y la variación temporal del mismo a
lo largo del seguimiento sobre la incidencia de la demencia y su severidad, en población general a partir de 35
años de edad sin antecedentes de enfermedad vascular.
Metodología: estudio de cohortes retrospectivas construidas a partir de los datos del Sistema de Información
para el Desarrollo de la Investigación en Atención Primaria (SIDIAP) y del Registro de Demencias de Girona
(ReDeGi). Se analizarán dos variables de interés: el nivel de RCV (adecuado/inadecuado) y la variación a lo largo
del seguimiento del RCV -estimado según REGICOR y SCORE. En los objetivos comunes se evaluará como
variables respuesta la incidencia por subtipos de demencia; en los objetivos específicos se evaluará la incidencia
de demencia global según SIDIAPQ (población catalana), y el grado de severidad de la demencia según ReDeGi.
Se imputará los valores perdidos y se aplicarán análisis de supervivencia, modelos de riesgo y modelos
estructurales. La validez de los diagnósticos de demencia está garantizada según una prueba piloto de este
proyecto que ha estimado una sensibilidad de 85% y un valor predictivo positivo (VPP) del 72% entre SIDIAP y
ReDeGi. Además otro estudio ha estimado un VPP del 86% para los diagnósticos de demencia en SIDIAP en la
región sanitaria de Girona. Aún así se realizará una validación externa mediante la administración online de un
cuestionario a médicos de familia del Instituto Catalán de la Salut en el ámbito catalán.

The ?Real world outcomes across the Alzheimer?s disease spectrum for better care: multi-modal data access platform? (ROADMAP) project provides the foundation for an integrated data environment and framework for real world evidence (RWE in Alzheimer?s disease).

The ROADMAP project aims the development of consensual key outcome measures and data integration tools for dataset characterisation and outcome classification, as well as guidelines on the handling and interpretation of real world evidence data.

Background: Temperature has been associated with hospitalizations and even mortality. However, such association has been reported in both Northern and Southern European countries, suggesting that the absolute temperature cannot solely explain seasonal patterns.
Objective: We aim to evaluate the effect of short-term changes in daily ambient temperature on hospitalisations due to cardiovascular disease and on mortality in Catalan general population.
Methods: This population-based retrospective study includes general population aged 18 years or older inhabiting in Catalonia from 2006-2013. We will obtain demographic and clinical data from SIDIAP, climatic data from the Meteocat and mortality data at a population level from the Instituto Nacional de Estadística. We will use information about temperature from the meteorological station closest to each census track. First, we will describe the hospitalization due to cardiovascular disease and the mortality ratios at a population level. Then we will assess the effect of temperature (and other climatic variables) over cardiovascular hospitalisations or mortality using two approaches: we will fit a Poisson regression at a population level, and a self-controlled case series (SCCS) analysis at individual level.
Limitations: Some potential confounders (i.e. housing conditions, pollution or seasonality of lifestyle factors) are missing. However, fixed confounders will be accounted for in the SCCS analysis.
Relevance and applicability: These findings will improve patients’ lives by means of providing recommendations to reduce cardiovascular and mortality linked to extreme weather, and guidelines to optimize the hospital resources management.

The objective of this study is to describe the population with high cardiovascular (CV) risk and/or familial hypercholesterolemia in Catalonia depending on the LDL-cholesterol concentration and the lipid-lowering treatment. Specifically, the objective is to describe the CV risk factor prevalence, incidence and prevalence of CV disease (CVD) and the treatment strategy in this population.
This will be a cohort study in which the participants will be followed during 3 years (2011-2013). Participants will be selected from the SIDIAP if the following inclusion criteria are met: ?35 years and lipid profile performed within 2006-2011.
The main variables under study will be: previous CVD (myocardial infarct, angina, stroke, peripheral artery disease), presence of familial hypercholesterolemia, CV risk factors (age, sex, hypercholesterolemia, hypertension, diabetes, smoking), lipid-lowering treatment and occurrence of CVD.
We expect that those at higher CV risk (with previous CV disease and more CV risk factors) will follow a more intensive lipid-lowering treatment and will have a higher prevalence and incidence of CVD disease.
The use of the SIDIAP database will allow us to obtain reliable estimates on the proportion of individuals by LDL-cholesterol concentration and lipid-lowering treatment. An important limitation of the present study could be the existence of missing data in the selected variables in the SIDIAP database. To overcome this limitation, multiple imputation will be performed when possible.

Study Background and Rationale: Given the large number of patients with a history of CVD, the substantial risk of further CVD morbidity and mortality, and the present and future availability of effective interventions on potentially key risk factors, it is important to characterize the burden of events (event rates and mortality) as well as the modifiable risk factors for subsequent CVD. The preponderance of existing data informing event rates in patients with existing CVD is derived from clinical trial populations. While such data is informative, clinical trials may underestimate event rates for a variety of reasons including: selection of patients with lower risk due to inclusion or exclusion criteria, disproportionate recruitment from high performing academic centers, or the higher quality of care received by clinical trial participants. Studies of risk factors for CV events have focused mostly on patients without existing CVD (the primary prevention setting) and thus prediction models focus on primary events as opposed to recurrent events. There may be important differences in predictors of primary events in an event-free population, and predictors of subsequent events in a population with existing CVD. Further, the relationship between these risk factors and outcomes may change over time from the primary CVD event, either due to changes in the natural history of disease, or to the use of various interventions. Such research requires population-based data with enough granularity in patient-level information (e.g. risk factors), a sufficient sample size, and a follow-up time long enough for such analyses to be feasible as well as potentially repeat measurements over time. Primary Objective(s): Objective 1: Estimate the rate of ACS (AMI, UA) or IS, plus CV and non-CV mortality, among patients with no history of CVD but who are at an elevated clinical risk due to a diagnosis of diabetes. Objective 2: Estimate the rate of ACS (AMI, UA), IS or HF, plus CV and non-CV mortality, among patients who have had ACS, IS or who have other clinically-evident CVD. Objective 3: Estimate the rate of CV and non-CV mortality among patients with HF secondary to an ACS event or other clinically-evident CVD Secondary Objective(s): Exploratory Objective 1: Evaluate the performance of existing risk equations to predict the rate of CVD-related events among patients with diabetes alone or with a history of ACS, IS or other clinically-evident CVD. Exploratory Objective 2: Estimate the association between LDL-C and risk of AMI, UA, and IS among patients with a history of CVD. Study Design/Type: Retrospective longitudinal descriptive cohort study Study Population or Data Resource: The study population will be derived from the SIDIAP database of electronic medical records in Catalonia and linked databases (e.g. hospital event data, and death records). Summary of Patient Eligibility Criteria: Patients must meet the following criteria: All patients: ? Age ? 30 years ? Continuous enrollment during a ? 2 year baseline period Cohort 1: ? Evidence of diabetes Cohort 2: ? Identified clinically-evident CVD Cohort 3: ? Incident non-fatal ACS or IS event Cohort 4: ? Incident HF subsequent to clinically-evident CVD or ACS or IS event. Outcome Variables: CVD events and CV and non-CV death. Follow-up: Data captured between July 2006 and December 2013 will be eligible for inclusion into this study. The baseline period and start of time at risk are defined differently for each study cohort. All cohorts must have continuous enrollment for ? 2yrs during which they do not experience an ACS or IS event. Sample Size: Minimun estimated sample size was calculated according to the number of expected cardiovascular events in the three cohorts of the study. Minimum sample sizes which will obtained from SIDIAP are the following: 47,000 (cohort 1), 22,500 (cohort 2), 26,000 (cohort 3), 10,000 (cohort 4).These estimated sample sizes will be obtained by far according to previous preliminary analysis in SIDIAP Statistical Considerations: Continuous and nominal variables will be described using number of observations, mean, standard deviation, median, interquartile range, and frequencies. For categorical variables, the number of observations, frequency and percent will be calculated. Incidence rates and 95% CIs will be calculated for ACS and IS and for CVD-related and non-CVD-related mortality The rate of HF will also be calculated for secondary prevention cohorts. Cause-specific hazard rates will be estimated by time-to-event models for each event individually. Other events, including death, will be treated as censored. Royston-Parmar models will be used, which are parametric survival models that use restricted cubic spline functions of time to permit more flexible hazard functions than are possible with Weibull, log-logistic, log-normal, and generalized gamma models.The adjusted hazard function will be based on a model including covariates.

Study Title: Healthcare utilization, costs and treatment patterns associated with cardiovascular events in patients with elevated cardiovascular risk or prior CV events in the SIDIAP database. Indication: Cardiovascular disease Study Background and Rationale: Cardiovascular disease (CVD) is a major cause of premature death worldwide and an important source of disability. Elevated levels of blood lipids represent a major risk factor for the development of CVD. Drug treatment with lipid modifying therapy (LMT) to lower lipids, especially statins, is commonly used but many patients do not attain lipid target levels sufficient to prevent CV events such as myocardial infarction (MI) and stroke. Several studies have examined costs of CV events with a focus on short-term costs and/or first CV event. However, data are limited for long-term costs, especially for patients experiencing a second or third CV event (secondary prevention). The present study will contribute towards filling the gap in available evidence for resource use and costs of CV events by providing data on short-term and long-term costs and for patients with a first and/or second CV event in Catalonia. These data can be used for further health economic analysis to predict the cost-effectiveness of new health technologies that may prevent CV events. Primary Objective(s): The primary objective is to estimate HRU and costs of new CV events in patients with hyperlipidemia or prior CV events within short and long term time periods. Secondary Objective(s): The secondary objectives are to: ? Describe the demographic and clinical characteristics of primary and secondary prevention patients and between those who remain event free and those who develop incident (primary prevention cohort) and recurrent (secondary prevention cohort) events ? Evaluate achieved levels of LDL-C and LDL-C between primary and secondary prevention and those who develop (primary prevention cohort) and recurrent (secondary prevention cohort) ? Describe the treatment patterns (lipid modification medication, medication persistence, titration, switching) for patients with new CV events before and after the event Study Design/Type: Retrospective longitudinal descriptive cohort study Study Population or Data Resource: The study population will be derived from the SIDIAP database of electronic medical records in Catalonia and linked databases (e.g. hospital event data, and death records). Patients will have treatment with a hyperlipidemia drug or a CV event (full description in section 3.2). Summary of Patient Eligibility Criteria: Patients must meet the following criteria: ? Inclusion in the SIDIAP database ? Taking at least two prescriptions for LMT or have at least one CV event. ? Aged 18 years and over at time of prescription for LMT or at the time of a CV event. Outcome Variables: Outcomes are resource use and costs associated with new CV events. Costs are total direct medical costs associated with the resource use. Exposure Variables: Exposure is defined by lipid-modification therapy (ATC codes) or CV event history. Follow-up: Follow-up for the primary objective starts from the date of the prescription for LMT and for those with a history of CV events orat the time of the new CV event among patients with primary prevention and prior CV event patients. Follow-up for the secondary objectives starts from the date of the prescription for LMT and for those with a history of CV events, patients will be followed from the occurrence of that first CV event. Resource use and costs will be captured from the index date through the end of the database records, to patient death or patient lost to practice (no further records available), whichever comes first. Sample Size: Minimun estimated sample size was calculated according to the number of expected cardiovascular events in the three cohorts of the study. Minimum sample sizes which will obtained from SIDIAP are the following: 22,400 (cohort 1), 43,000 (cohort 2), 26,000 (cohort 3).These estimated sample sizes will be obtained by far according to previous preliminary analysis in SIDIAP Statistical Considerations: All study variables, including pre-index and outcomes measures, will be stratified by CVD risk level and analyzed descriptively. The analysis will focus on the first CV event in the follow-up period and that subsequent CV events will be described. Continuous and nominal variables will be described using number of observations, mean, standard deviation, median, interquartile range, and frequencies. For categorical variables, the number of observations, frequency and percent will be calculated. To estimate resource utilization and costs, a statistical transformation (e.g. logarithmic function) will be employed on costs if their distribution is not normal. Bootstrapping methods may also be employed to estimate confidence intervals around cost estimations. Regression analysis will be employed to adjust for potential confounding factors.

Objetivos: Analizar la efectividad, seguridad y relación coste-utilidad de la aspirina en la reducción de enfermedades vasculares, cáncer y mortalidad en pacientes de riesgo elevado en prevención primaria y determinar el efecto del sexo, edad o la diabetes. Diseño: 1) Estudio de cohortes aparejadas por puntuación de propensión. Los datos se obtendrán del Sistema de Información para el Desarrollo de la Investigación en Atención Primaria provenientes los registros de historia clínica electrónica de atención primaria. 2) Un modelo de Markov para el análisis de coste-utilidad con datos de la cohorte y los relativos a los costes obtenidos del Sistema Nacional de Salud. Sujetos: Usuarios de 35 o más años, con riesgo elevado según diferentes criterios y sin enfermedad cardiovascular ni cáncer sin remisión (16500 expuestos y 33000 no expuestos). El período de reclutamiento garantizará de 5-9 años de seguimiento. Variables: Nuevos tratamientos con aspirina (sin facturación tres meses anteriores) y con criterios de cumplimiento (>80%), persistencia (>6 meses). El inicio de aspirina será una variable dependiente del tiempo (fecha de primera facturación). Variable respuesta: enfermedades cardiovasculares, cáncer, efectos secundarios (hemorragias gastro-instestinales o ictus hemorrágicos) o muerte. Variables independientes: variables demográficas factoras de riesgo, otras comorbilidades, datos de exploración, otros tratamientos farmacológicos. Análisis estadístico: Se construirán modelos de regresión de Cox para estimar la incidencia de las variables de interés. A partir de la reducción absoluta de riesgo calculada se calculará también el Número Necesario a Tratar. El análisis de coste-utilidad se realizará en base a la razón de coste-efectividad incremental (ICER).