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BACKGROUND To determine the relationship between short-acting beta-adrenergic agonist (SABA) overuse and healthcare resource use and costs in asthma patients in routine clinical practice. MATERIAL AND METHODS A longitudinal retrospective study in Spanish primary and specialized care using the BIG-PAC® Medical Records Database was conducted. Asthma patients ≥12 years of age who attended ≥ 2 consultations during 2017 and had 1-year follow-up data available were included. Main outcomes were demographics, comorbidities, medication, clinical and healthcare resource use and costs. The relationship between SABA overuseand healthcare costs, and between asthma severity and healthcare costs was determined. RESULTS This SABA use IN Asthma (SABINA) study included 39,555 patients, mean (standard deviation, SD) age 49.8 (20.7) years; 64.2% were female. Charlson comorbidity index was 0.7 (1.0). SABA overuse (≥ 3 canisters/year) was 28.7% (95% CI: 27.7-29.7), with an overall mean number of 3.3 (3.6) canisters/year. Overall, 5.1% of patients were prescribed ≥12 canisters/year. SABA overuse was correlated with healthcare costs (ρ = 0.621; p < 0.001).The adjusted mean annual cost/patient, according to the Global Initiative for Asthma (GINA 2019) classification of asthma severity, was €2,231, €2,345, €2,735, €3,473, and €4,243,for GINA steps 1-5, respectively (p < 0.001). Regardless of asthma severity, SABA overuse yielded a significant increase in healthcare costs per patient and year (€5,702 vs. €1,917, p < 0.001) compared with recommended use (< 2 canisters/year). CONCLUSIONS SABA overuse yields greater costs for the Spanish National Health System. Costs increased according to asthma severity.

Aims To determine the first manifestation of cardiovascular or kidney disease (CVKD) and associated resource use in type 2 diabetes mellitus (T2DM) patients during seven years of follow-up. Methods Observational-retrospective secondary data study using medical records of patients aged ≥18 years with T2DM and without prior CVKD between 2013 and 2019. The index date was 01/01/2013 (fixed date). The manifestation of CVKD was defined by the first diagnosis of heart-failure (HF), chronic-kidney disease (CKD), myocardial-infarction (MI), stroke or peripheral-artery disease (PAD). The main variables were baseline characteristics, manifestation of CVKD, mortality, resource use and costs. Descriptive analyses and Cox model were applied to the data. Results 26,542 patients were selected (mean age: 66.6 years, women: 47.8%, mean duration of T2DM: 17.1 years). 18.7% (N = 4974) developed a first CVKD manifestation during the seven years [distribution: HF (22.4%), CKD (36.6%), MI (14.5%), stroke (15.3%) and PAD (11.3%)]. Overall mortality was 8.3% (N = 2214). The mortality risk of the group that developed HF or CKD as the first manifestation compared to the CVKD-free cohort was higher [HR: 2.5 (95% CI: 1.8–3.4) and 1.8 (95% CI: 1.4–2.3)], respectively. The cumulative costs per patient of HF (€50,942.80) and CKD (€48,979.20) were higher than MI (€47,343.20) and stroke (€47,070.30) and similar to PAD (€51,240.00) vs. €13,098.90 in patients who did not develop CVKD, p Conclusions In T2DM patients, HF and CKD were the first most common manifestations and had higher mortality and re-hospitalisation rates. HF and CKD were associated with the highest resource use and costs for the Spanish National-Health-System.

Resumen Objetivos Describir las caracteristicas clinicas y el manejo terapeutico y determinar los eventos cardiovasculares tras un ano de seguimiento en una poblacion contemporanea con insuficiencia cardiaca (IC) con y sin diabetes tipo 2 en Espana. Tambien se analizo en la poblacion DAPA-HF (pacientes que cumplieron la mayoria de los criterios de inclusion del estudio DAPA-HF) y en los pacientes tratados basalmente con inhibidores SGLT2. Metodos Estudio observacional, retrospectivo, poblacional, empleando la base de datos BIG-PAC. La fecha indice fue 1 de enero de 2019. Se seleccionaron sujetos ≥ 18 anos que recibieron tratamiento por IC en 2019. Se analizaron los eventos durante 2019. Resultados Se identificaron 21.851 pacientes con IC (78 ± 11,3 anos; 53% varones; 50,9% IC con fraccion de eyeccion reducida; 44,5% en clase funcional NYHA II). La prevalencia de IC fue del 1,88% y la incidencia 2,83 por 1.000 pacientes-ano. El 66,1% tomaba inhibidores del sistema renina-angiotensina, el 69,4% betabloqueantes, el 31,2% antialdosteronicos y el 7,5% sacubitrilo/valsartan. Durante el ano de seguimiento, el 29,8% fue hospitalizado por descompensacion de la IC (tiempo medio primer evento 120,9 ± 72,5 dias), un 12,3% murieron, un 8,1% murieron durante la hospitalizacion. Los eventos fueron mas frecuentes en los pacientes con diabetes tipo 2. Las hospitalizaciones por IC fueron mas comunes en la poblacion similar a DAPA-HF. Conclusiones En Espana, la poblacion con IC es anciana y tiene muchas comorbilidades. Aproximadamente la mitad de los pacientes tienen IC con fraccion de eyeccion reducida. Existe margen de mejora en el manejo de la IC, en particular mediante el empleo de aquellos farmacos que reducen tanto la hospitalizacion por IC como la mortalidad, para disminuir la carga de IC.

Resumen Introduccion y objetivos Describir la epidemiologia y el tratamiento administrado recientemente a una amplia cohorte de pacientes con insuficiencia cardiaca (IC). Metodos Estudio observacional retrospectivo de base poblacional, realizado utilizando la base de datos BIG-PAC, que incluye a personas de edad ≥ 18 anos que solicitaron atencion por IC en 2017-2019. Las principales variables fueron: prevalencia/incidencia-anual, comorbilidades, variables clinicas y medicacion administrada. Resultados Se identifico a 19.762 pacientes con IC de un total de 1.189.003 sujetos que requirieron atencion medica en 2017-2019 (en 2019, media de edad, 78,3 anos; el 53,0% varones). De ellos, la distribucion por tipo de fraccion de eyeccion del ventriculo izquierdo (FEVI) fue: el 51,7% con FEVI reducida, el 40,2% con FEVI conservada y el 8,1% con FEVI en rango medio. En el ano 2019, la prevalencia fue del 1,89% (IC95%, 1,70-2,08), con una tasa de incidencia de 2,78 casos nuevos por cada 1.000 sujetos/ano. No se observaron diferencias estadisticamente significativas en prevalencia y/o incidencia durante el periodo 2017-2019. De los pacientes con IC-FEr, solo un 64% tomaba bloqueadores beta; el 80,5%, inhibidores de la enzima de conversion de la angiotensina/antagonistas del receptor de la angiotensina II o sacubitrilo-valsartan, y un 29,8%, un antialdosteronico. Ademas, desde el diagnostico (basal) hasta los 24 meses de seguimiento, se muestra una discreta optimizacion del tratamiento, mas destacada entre los primeros 3-6 meses. Conclusiones Los datos epidemiologicos se mantienen estables, con una prevalencia inferior a la reportada en estudios de base no poblacional. Existe un amplio margen de mejora en la optimizacion del tratamiento medico de la IC-FEr.

Introduction and objectives To describe the epidemiology and treatment of a large contemporary cohort of patients with heart failure (HF). Methods Observational, retrospective, population-based study using the BIG-PAC database, which includes people aged ≥ 18 years seeking care for HF between 2017 and 2019. The main variables were the prevalence/annual incidence rate, comorbidities, clinical variables, and medication administered. Results We identified 19 762 patients with HF from a total of 1 189 003 persons seeking medical attention from 2017 to 2019 (2019: mean age, 78.3 years; 53.0% men). Distribution by type of left ventricular ejection fraction (LVEF) was as follows: 51.7% reduced, 40.2% preserved, and 8.1% mid-range. In 2019, the prevalence was 1.89% (95%CI, 1.70-2.08), with an incidence rate of 2.78 new cases per 1000 persons/y. No statistically significant differences were observed in prevalence and/or incidence from 2017 to 2019. Among patients with HF with reduced ejection fraction (HFrEF), 64% received beta-blockers, 80.5% angiotensin-converting enzyme inhibitor/angiotensin receptor blockers or sacubitril-valsartan, and 29.8% an aldosterone antagonist. In addition, from the diagnosis (baseline) to 24 months of follow-up, there was discreet treatment optimization, which was notable in the first 3 to 6 months. Conclusions Epidemiological data on HF remained stable during the study period, with a lower prevalence than that reported in non–population-based studies. There is wide room for improvement in the optimization of medical treatment of HFrEF.

Depressive Disorders are the most common psychiatric diagnoses in the general population. To estimate the frequency, costs associated with Depressive Disorders in usual clinical practice, and in the whole Spanish population, a longitudinal, retrospective, observational study was carried out using data from the BIG-PAC database®. Study population: all patients aged ≥ 18 years with a diagnosis of a Depressive Disorder in 2015-2017. Prevalence was computed as the proportion of Depressive Disorder cases in the adult general population, and the incidence rate, as the number of new Depressive Disorder cases diagnosed per 1,000 person-years in the population using health services, during 2015-2017. We collected demographic variables, comorbidity, direct health costs, and indirect costs (temporary and permanent disability). Health costs related to Depressive Disorders were estimated according to the annual resource use rate (resource/patient/year). Indirect costs were calculated according to the human capital method. Using the study data and information from the Spanish National Institute of Statistics, we estimated the cost of Depressive Disorders corresponding to the Spanish adult population, including premature mortality. 69,217 Depressive Disorder patients aged ≥ 18 years who met the inclusion/exclusion criteria were studied (mean age: 56.8 years; female: 71.4%). Prevalence of Depressive Disorders in the general population was 4.73% (95% CI: 4.70-4.76%). Annual incidence rates (2015-2017) were 7.12, 7.35 and 8.02 per 1,000 person-years, respectively. Total costs observed in our Depressive Disorder patients were € 223.9 million (corresponding to a mean of € 3,235.3; mean/patient/year), of which, 18.4% were direct health care costs and 81.6%, non-health indirect costs (18% temporary occupational disability, 63.6% permanent disability). Considering also the cost of premature death, the mean cost per patient/year was € 3,402 and the estimated societal costs of Depressive Disorders in Spain were € 6,145 million. The prevalence and incidence of Depressive Disorders are consistent with other series reviewed. Resource use and total costs (especially non-health costs) were high.

Background: The last decade has seen a new era of classifications of asthma pathophysiology which have changed the treatment options available. Objectives: To update the figures of prevalence of T2 asthma, comorbidities, biomarker characterization and costs of severe asthma in patients≥12-years-old adapted to this new situation. Methods: Retroprospective, observational, nationwide study using a top-down approach. Data were obtained from the BIG-PAC®, an electronic medical record database of 1.7 million patients in Spain. Patients≥12-years-old who had received medical care during the period 2016-2017 and diagnosed with asthma at least one year prior to the index date were included and followed for one year. Results: Prevalence of asthma was 5.5%. Of these patients, asthma was severe in 3.031 (7.7%), 81.2% of whom presented T2 asthma. Among severe asthma patients, 64·1% were uncontrolled, 31.2% were Oral corticosteroids-dependent (37% in the uncontrolled severe asthma group) and only 3.8% were on biologics. The most common T2 comorbidities were allergic rhinitis (66·1%), atopic dermatitis (29·1%) and chronic rhinositis with nasal polyps (14.6%). Mortality rates in the total and the uncontrolled severe asthma groups were 4.2% and 5.5% respectively. The total annual costs per patient with severe asthma were 5.890€ (uncontrolled) and 2.841€ (controlled). Conclusions: In the era of biologics, most severe asthma patients present T2 asthma. Despite the availability of new treatments, the rates of uncontrolled and oral corticosteroids-dependent patients with severe asthma remain high, but biologics still underused. The costs of uncontrolled severe asthma are twice as high as those of controlled severe asthma.

Resumen Objetivo Evaluar la persistencia al tratamiento en sujetos con diabetes tipo 2 (DM2) polimedicados que se les administra un nuevo tratamiento con metformina 850 mg de marca vs. generica en situacion de practica clinica habitual. Pacientes y metodos Estudio observacional-retrospectivo, realizado a partir de los registros medicos de pacientes ≥ 50 anos, que iniciaron tratamiento con metformina (marca vs. generico) entre el 01/01/2016 y el 31/12/2017. El seguimiento de los pacientes fue de 2 anos. Principales medidas: persistencia al tratamiento y consecuencias clinicas (control metabolico [HbA1c] e ingresos hospitalarios). Cada paciente del grupo de marca (referencia) se emparejo con otro del grupo generico mediante propensity score matching. Se realizo un modelo de riesgos proporcionales de Cox, p Resultados Se emparejaron 863 pacientes con metformina de marca vs. generica (relacion 1:1). La media de edad fue de 60,8 (DE: 8,8) anos y el 52,6% fueron mujeres. Con metformina de marca, la persistencia a los 24 meses de seguimiento fue un 8,6% superior a la generica (63,2% vs. 58,2%; p = 0,034). El hazard ratio relativo a la marca fue del 0,83 (IC 95%: 0,71-0,96, p = 0,013). Durante el seguimiento hubo una mayor reduccion porcentual de la HbA1c de marca vs. generica (−6,8% vs. −4,1%; p = 0,013). Hubo una reduccion del 19,1% en los ingresos hospitalarios superior con metformina de marca vs. generica (8,9% vs. 11,0%; p = 0,148), aunque sin alcanzar la significacion estadistica. Conclusiones Los pacientes polimedicados que iniciaron un nuevo tratamiento con metformina de marca para la DM2 se asociaron a un mayor grado de persistencia al tratamiento que los que lo iniciaron con metformina generica, repercutiendo en un mejor grado de control metabolico (reduccion porcentual de HbA1c).

Introduction To determine the disease burden and costs in moderate-to-severe chronic osteoarthritis (OA) pain refractory to standard-of-care treatment in the Spanish National Health System (NHS). Methods Ancillary analysis of the OPIOIDS real-world, non-interventional, retrospective, 4-year longitudinal study including patients aged at least 18 years with moderate-to-severe chronic OA pain refractory to standard-of-care with sequential NSAIDs plus opioids. Burden assessment included measurement of analgesia, cognitive functioning, basic activities of daily living, severity and frequency of comorbidities, and all-cause mortality. Costs accounted for healthcare resource utilization and related costs (year 2018). Results Records of 13,317 patients were analyzed; 68.9 (14.7) years old, 71.3% (70.5–72.1%) women, 58.1% refractory to NSAID plus weak opioid and 41.9% to NSAID plus strong opioid, accounting for 10.7% (10.5–10.8%) of patients with chronic OA pain. Mean number of comorbidities was 2.9 (1.8) and its severity was 1.8 (1.7). Pain decreased by 0.9 points (12.2%) and cognitive declined by 2.3 points (9.1%, with 4.3% more patients with cognitive deficit) and dependency worsened by 0.4 points (0.5%, with 2.3% more patients with severe-to-total dependence) over a mean treatment period of 188.6 (185.4–191.8) days on NSAIDs followed by 400.6 (393.7–407.5) days on opioids. The adjusted mortality rate was higher in patients with OA taking NSAID plus strong opioids; hazard ratio 1.44 (1.26–1.65; p

Background Migraine represents a serious burden for national health systems. However, preventive treatment is not optimally applied to reduce the severity and frequency of headache attacks and the related expenses. Our aim was to assess the persistence to traditional migraine prophylaxis available in Spain and its relationship with the healthcare resource use (HRU) and costs. Methods Retrospective observational study with retrospective cohort design of individuals with migraine treated with oral preventive medication for the first time from 01/01/2016 to 30/06/2018. One-year follow-up information was retrieved from the Big-Pac™ database. According to their one-year persistence to oral prophylaxis, two study groups were created and describe regarding HRU and healthcare direct and indirect costs using 95% confidence intervals (CI). The analysis of covariance (ANCOVA) was performed as a sensitivity analysis. Patients were considered persistent if they continued on preventive treatment until the end of the study or switched medications within 60 days or less since the last prescription. Non-persistent were those who permanently discontinued or re-initiated a treatment after 60 days. Results Seven thousand eight hundred sixty-six patients started preventive treatment (mean age (SD) 48.2 (14.8) and 80.4% women), of whom 2,545 (32.4%) were persistent for 6 months and 2,390 (30.4%) for 12 months. Most used first-line preventive treatments were antidepressants (3,642; 46.3%) followed by antiepileptics (1,738; 22.1%) and beta-blockers (1,399; 17.8%). The acute treatments prescribed concomitantly with preventives were NSAIDs (4,530; 57.6%), followed by triptans (2,217; 28.2%). First-time preventive treatment prescribers were mostly primary care physicians (6,044; 76.8%) followed by neurologists (1,221; 15.5%). Non-persistent patients required a higher number of primary care visits (mean difference (95%CI): 3.0 (2.6;3.4)) and days of sick leave (2.7 (0.8;4.5)) than the persistent ones. The mean annual expenditure was €622 (415; 829) higher in patients who not persisted on migraine prophylactic treatment. Conclusions In this study, we observed a high discontinuation rate for migraine prophylaxis which is related to an increase in HRU and costs for non-persistent patients. These results suggest that the treatment adherence implies not only a clinical benefit but also a reduction in HRU and costs.

There is little evidence on the relationship between achieved low-density lipoprotein cholesterol (LDL-C) levels and costs in patients on lipid-lowering therapy (LLT). We described healthcare resource use and costs (direct and indirect) by achieved LDL-C in patients receiving LLT after a recent myocardial infarction (MI) in Spain.This was a retrospective observational study of anonymized electronic medical records from seven regions in Spain (BIG-PACOf 6025 patients (mean age, 69.7 years; 77% male), only 11% achieved LDL-C goals as defined in the 2016 ESC/EAS guidelines ( 70 mg/dL), and just 1% reached the lower target ( 55 mg/dL) in the current 2019 guidelines. Achieving lower LDL-C levels translated to lower healthcare resource use and costs. Mean total (direct and indirect) costs ranged from €5044 for patients with LDL-C 55 mg/dL to €7567 for patients with LDL-C ≥ 130 mg/dL.Very few patients achieved recommended LDL-C goals despite using LLT. Achieving lower LDL-C levels after an MI might be associated with lower healthcare resource use and costs. Use of more intensive LLT, leading to greater reductions in LDL-C, could therefore be beneficial both from a clinical and an economic perspective.

Additional file 3: Figure S3. Multi-state model treatment curves. The graph shows the distribution of the proportions of patients in the different states at any time of the study. Persistence curves for the second and third (or higher) lines of treatment remained similar and stable throughout the study. In contrast, first-line persistence curve decreased and was steeper in the first 6 months (and even more in the first three) as a sign of a higher discontinuation rate in this time window.

Additional file 1: Figure S1. Flow diagram of migraine preventive treatment persistence and discontinuation throughout one year of follow-up. The number of persistent or non-persistent patients as well as the percentage in respect to the total number of patients are indicated in brackets. Persistent patients maintained their medication until the end of the study or change it within 60 days from the last prescription (switching). Non-persistent patients dropped it out permanently or restarted another line of treatment 60 days or more after the last prescription (reinitiation).

Additional file 2: Figure S2. Front-line migraine preventive treatments. N = 7,866 patients.

Economic burden of community-acquired pneumonia (CAP) is recognized. Few studies have documented such burden in adults stratified by age, risk status, and by care setting. Spanish data available is scarce. A retrospective, multicenter study in seven regions of Spain (2017–2019) was conducted. Patients ≥18 years with a primary all-cause CAP episode diagnosis were identified. Episode-level variables included risk-stratum based on presence of an immunocompromising/chronic condition, age, number and length of hospitalized and outpatient episodes, and CAP-related healthcare costs/sick leaves were included. 7,108 episodes [mean age (SD): 59.2 (19.6), 50.42% male, 31.0% hospitalized] were analyzed. Low-risk group accounted for 47.7% of all CAP episodes, 31.5% moderate-risk and 20.8% high-risk. Pneumococcus was identified in 42.2% of cases. Mean CAP episode length was 22.9 days for hospitalized and 13.7 days for outpatient episode. Total healthcare cost for episode was higher in inpatient vs. outpatient: €3,955 vs. €511, p < 0.001, with higher sick leave cost (€3,281 vs. €2,632, p < 0.001), respectively. CAP required hospitalization cost is high regardless of age or comorbidities for the Spanish NHS. Given that almost half of the patients in this study did not have traditional risk factors for CAP, better preventative strategies should seriously be considered.

Background: To determine the incidence of Treatment-Resistant Depression (TRD) in Spain and to estimate its economic burden, using real world data. Methods: A retrospective, observational-study was carried out using data from the BIG-PAC database®. Patients aged ≥18 years with a diagnosis of major depressive-disorder (MDD) who initiated a new antidepressant treatment in 2015-2017 were included. The patients were classified as TRD and non-TRD. Patients were classified as TRD if they had, during the first year of antidepressant treatment: a) failure with ≥2 antidepressants including the prescription of ≥3 antidepressants (N06A) or ≥2 antidepressant and ≥1 antipsychotic (N05A; including lithium) b) antidepressants administered for ≥ 4 weeks each, and c) the time between the end of one treatment and the initiation of the next was ≤ 90 days. Inherent limitations of data collection from databases should also be considered in this analysis (e.g., lack of information about adherence to treatment). Follow-up period: 18 months. The incidence rate was calculated as the number of TRD patients per 1,000 persons-year divided by the population attended. Outcomes: direct healthcare and indirect costs. Two sensitivity analyses were performed varying the index date and the period used to define TRD patients (6 vs.12 months). Results: 21,630 patients with MDD aged ≥ 18 years (mean age: 53.2 years; female: 67.2%) were analyzed, of whom 3,559 met TRD criteria, yielding a 3-year cumulative incidence of 16.5% (95%CI: 16%-17%) among MDD patients. The annual population incidence rate of TRD in 2015-2017, was 0.59, 1.02 and 1.18/1,000 person-years, respectively (mean: 0.93/1,000 person-year). Overall, mean total costs per MDD patient were €4,147.9, being higher for TRD than for non-TRD patients (€6,096 vs. €3,846; p

Background.To determine baseline characteristics, the first manifestation of cardiovascular or kidney disease (CVKD) and associated resource use in type 2 diabetes mellitus (T2DM) patients during 7 years of follow up. Methods.Observational-retrospective secondary data study using medical records of patients aged ≥18 years with T2DM and without prior CVKD during 2013-2019. The index date was 01/01/2013 (fixed date). The manifestation of CVKD was defined by the first diagnosis of heart failure (HF), chronic kidney disease (CKD), myocardial infarction (MI), stroke or peripheral artery disease (PAD). The main variables were baseline characteristics, manifestation of CVKD, mortality, resource use and costs (health, indirect related). Descriptive analyses and Cox model were applied to the data.Results.26,542 patients were selected (mean age: 66.6 years, women: 47.8%, mean duration of T2DM: 17.1 years). 18.7% (N=4974) developed a first CVKD manifestation during the 7 years [distribution: HF (22.4%), CKD (36.6%), MI (14.5%), stroke (15.3%) and PAD (11.3%)]. Overall mortality was 8.3% (N=2,214). The mortality risk of the group that developed HF or CKD as the first manifestation compared to the CVKD-free cohort was higher [HR: 2.5 (CI95%: 1.8-3.4) and 1.8 (95%CI: 1.4-2,3)], respectively. The cumulative costs per patient of HF (€50,942.8) and CKD (€48,979.2) were higher than MI (€47.343.2) and stroke (€47,070.3) and similar to PAD (€51,240,0) vs. €13,098.9 in patients who did not develop CVKD, pConclusions.In T2DM patients, HF and CKD were the first most common manifestations over the 7 years of follow up and had higher mortality and re-hospitalization rates. HF and CKD were associated with the highest resource use and costs for the Spanish National Health System.

Objective This work aims to describe the clinical characteristics and therapeutic management and to determine cardiovascular outcomes after one year of follow-up in a contemporaneous population with heart failure (HF) with and without type 2 diabetes in Spain. These factors were also analyzed in the DAPA-HF-like population (patients who met most inclusion criteria of the DAPA-HF trial) and in patients treated with SGLT2 inhibitors at baseline. Methods This work is an observational, retrospective, population-based study using the BIG-PAC database. The index date was January 1, 2019. People aged ≥ 18 years who received care for HF in 2019 were selected. Events that occurred in 2019 were analyzed. Results We identified 21,851 patients with HF (age 78.0 ± 11.3 years, 53.0% men, 50.9% with HF with reduced left ventricular ejection fraction, 44.5% in NYHA functional class II). HF prevalence was 1.88% and incidence was 2.83 per 1,000 person-years. Regarding HF treatments, 66.1% were taking renin-angiotensin system inhibitors, 69.4% beta blockers, 31.2% aldosterone antagonists, and 7.5% sacubitril/valsartan. During the year of follow-up, 29.8% had HF decompensation which led to hospitalization (mean time to first event of 120.9 ± 72.5 days), 12.3% died, and 8.1% died during hospitalization. Events were more common among patients with type 2 diabetes. Hospitalizations for HF were more common in the DAPA-HF-like population. Conclusions In Spain, the population with HF is elderly and has many comorbidities. Approximately half of patients have HF with reduced left ventricular ejection fraction. There is room for improvement in HF management, particularly through the use of drugs that reduce both HF hospitalization and mortality, in order to reduce the burden of HF.

Introduction: To determine the disease burden and costs in moderate-to-severe chronic osteoarthritis (OA) pain refractory to standard-of-care treatment in the Spanish National Health System (NHS). Methods: Ancillary analysis of the OPIOIDS real-world, non-interventional, retrospective, 4-year longitudinal study including patients aged at least 18 years with moderate-to-severe chronic OA pain refractory to standard-of-care with sequential NSAIDs plus opioids. Burden assessment included measurement of analgesia, cognitive functioning, basic activities of daily living, severity and frequency of comorbidities, and all-cause mortality. Costs accounted for healthcare resource utilization and related costs (year 2018). Results: Records of 13,317 patients were analyzed; 68.9 (14.7) years old, 71.3% (70.5-72.1%) women, 58.1% refractory to NSAID plus weak opioid and 41.9% to NSAID plus strong opioid, accounting for 10.7% (10.5-10.8%) of patients with chronic OA pain. Mean number of comorbidities was 2.9 (1.8) and its severity was 1.8 (1.7). Pain decreased by 0.9 points (12.2%) and cognitive declined by 2.3 points (9.1%, with 4.3% more patients with cognitive deficit) and dependency worsened by 0.4 points (0.5%, with 2.3% more patients with severe-to-total dependence) over a mean treatment period of 188.6 (185.4-191.8) days on NSAIDs followed by 400.6 (393.7-407.5) days on opioids. The adjusted mortality rate was higher in patients with OA taking NSAID plus strong opioids; hazard ratio 1.44 (1.26-1.65; p < 0.001). The 4-year healthcare cost was euro7350/patient (euro7193-7507 or euro1838/year) and was higher in those taking strong versus weak opioids; euro9886 (euro9608-10,164, euro2472/year) vs. euro5519 (euro5349-5689, euro1380/year), p < 0.001. Analgesia cost (16.0% of total cost, 70.2% opioids) was higher with strong versus weak opioids, 19.6% vs. 11.3%, p < 0.001. Conclusions: In routine clinical practice in Spain, patients with moderate-to-severe chronic OA pain refractory to standard analgesic treatment with NSAIDs plus opioids reported modest reductions in pain, while presenting a considerable burden of comorbidities, cognitive impairment, and dependency. Healthcare costs significantly increased for the NHS particularly with NSAIDs plus strong opioids.

To evaluate treatment persistence in patients with polymedicated type 2 diabetes (DM2) receiving new treatment with brand-name vs. generic metformin 850mg in usual clinical practice.Observational, retrospective study based on the medical records of patients aged ≥50 years who initiated metformin treatment (brand-name vs. generic) between 01/01/2016 and 31/12/2017. The follow up was two years.treatment persistence and clinical consequences (metabolic control [HbA1c] and hospital admissions). Each patient in the brand-name group (reference) was paired with a patient from the generic group using propensity score matching. A Cox proportional risk model was constructed (p0.05).863 patients receiving brand-name metformin were matched (ratio 1:1) with patients receiving generic metformin. The median age was 60.8 years (SD: 8.8) years and 52.6% were female. Persistence at 24 months was 8.6% higher for brand-name vs. generic metformin (63.2% vs. 58.2%; p=0.034). The hazard ratio for brand-name metformin was 0.83 (95% CI: 0.71-0.96, p=0.013). During the follow-up there was a greater percentage reduction of HbA1c in the brand-name vs. generic group (-6.8% vs. -4.1%; p=0.013). There was a non-significant 19.1% reduction in hospital admissions in the brand-name vs. generic group (8.9% vs. 11.0%; p=0.148).Polymedicated patients who initiated new brand-name metformin treatment for DM2 had greater treatment persistence than those who initiated it with generic metformin and had better metabolic control (percentage reduction in HbA1c).

Objectives: To determine the prevalence, comorbidities, biomarkers characterization and costs of severe asthma in patients ≥12-year-old in real life. Methods: Retrospective, cross-sectional, nationwide study that used a top-down approach. Data from BIG-PAC® database (Real Life Data) were used, which is an electronic medical record of 1.9 million Spanish patients (pts) aged ≥12 who had demanded medical care during 2017. Severe asthma (SA) was defined as asthma that required GINA step 5 treatment. Uncontrolled pts were defined by GINA 2019 criteria and oral corticosteroid (OCS) dependent pts were defined by prescription of OCS for at least 6 months. Biomarkers such as blood eosinophils, Fractional Exhaled Nitric Oxide (FeNO) and Immunoglobulin E (IgE) were used to phenotype type 2 pts. Results: The prevalence of asthma was 5.5%. Of these, SA was 7.7%, of whom: 64.1% had uncontrolled SA; 81.2% presented type 2 asthma; 31.2% were OCS-dependent (37% in the uncontrolled SA group); The most common type 2 comorbidities were allergic rhinitis (66.1%), atopic dermatitis (29.1%) and CRSwNP (14.6%). Biologics were administered in 3.8% of total SA patients and 4.3% of patients of the uncontrolled group. The mortality rate was 4.2% and 5.5% in the total SA and the uncontrolled SA group respectively. The total annual costs per patient for uncontrolled SA were 6.010€ and 2.791€ in the controlled SA pts. Conclusions: A vast majority of SA pts present with type-2 asthma. SA continues to have high rates of uncontrolled and OCS dependent asthma despite new available treatments. Uncontrolled SA costs twice as much as controlled pts.

Objectives: To determine the percentage of type 2 asthma patients (pts) candidates for the different mAb (anti-IgE, anti-IL5 and anti-IL4/IL13) as well as the percentage of overlapping Methods: Retrospective, cross-sectional, nationwide study. Data from BIG-PAC® database RLD were used. Criteria used to define candidates for different mAb were based on: Omalizumab IgE ≥ 100 IU/ml + positive skin prick test; anti-IL-5, blood eosinophils ≥ 300 cells/µl; Dupilumab, blood eosinophils ≥ 300 cells/µl or FeNO ≥ 50 ppb. The prevalence of uncontrolled severe asthma (uSA) in the overall asthma population was obtained from the BRAVO-1 study (4.9%) Results: The 4.7% of total asthma patients had a type 2 uSA (96% of the uSA). From this, a large overlap between populations eligible for different biologics was observed, with 57.43% pts being possible candidates for all three biologic therapies, 7.8% candidates for both anti-IL5 or dupilumab, 2.47% only candidates for omalizumab, and 0.4% only candidates for dupilumab. According to the criteria stablished, 31.77% of pts did not fulfill criteria for any biologic therapies, although 12.65% of them were oral corticosteroids (OCS) dependent pts Conclusions: Most pts are candidates for more than one biologic treatment. According to the presently stablished criteria, the addition of dupilumab has a negligible impact on the biologic eligible population. Dupilumab covers most of the indications for anti-IL-5 and omalizumab. Moreover, if GINA criteria had been applied, the population between 150-300 blood eosinophils and type 2 OCS dependent pts (also benefiting from dupilumab) would have been included, dupilumab being the only biologic covering all Type 2 pts.