Prevalence, T2 Biomarkers, and Cost of Severe Asthma in the Era of Biologics: The BRAVO-1 Study

Background: The last decade has seen new classifications of the pathophysiology of asthma that have changed the treatment options available. Objectives: To update data on the prevalence of T2 asthma, comorbidities, biomarker characterization, and costs of severe asthma in patients aged ≥12 years, taking into account new classifications and treatment options. Methods: Retrospective, observational, nationwide study using a top-down approach. Data were obtained from BIG-PAC®, an electronic medical record database of 1.7 million patients in Spain. The study population comprised patients aged ≥12 years who had received medical care during the period 2016-2017 and been diagnosed with asthma at least 1 year prior to the index date. Patients were followed for 1 year. Results: The prevalence of asthma was 5.5%. Asthma was severe in 3031 of these patients (7.7%), 81.2% of whom presented T2 asthma. Among patients with severe asthma, 64.1% had uncontrolled disease, 31.2% were oral corticosteroid–dependent (37% in the uncontrolled severe asthma group), and only 3.8% were receiving biologics. The most common T2 comorbidities were allergic rhinitis (66.1%), atopic dermatitis (29.1%), and chronic rhinosinusitis with nasal polyps (14.6%). Mortality rates in the total population and uncontrolled severe asthma groups were 4.2% and 5.5%, respectively. The total annual costs per patient with severe asthma were €5890 (uncontrolled) and €2841 (controlled). Conclusions: In the era of biologics, most severe asthma patients present T2 asthma. Despite the availability of new treatments, rates of oral corticosteroid–dependent patients with uncontrolled severe asthma remain high, although biologics continue to be underused. The costs of uncontrolled severe asthma are twice as high as those of controlled severe asthma. (AU)

Introducción: En la última década se han concadenado una serie de clasificaciones de la fisiopatología del asma que han cambiado las opciones de tratamientos disponibles. Objetivos: Actualizar los datos de prevalencia del asma T2, comorbilidades, caracterización de biomarcadores y costes del asma grave en pacientes ≥12 años en esta nueva situación. Métodos: Estudio retrospectivo, observacional y de ámbito nacional con un enfoque descendente. Los datos se obtuvieron de BIG-PAC®, una base de datos de historias clínicas electrónicas de 1,7 millones de pacientes en España. Se incluyeron pacientes ≥12 años que habían recibido atención médica durante el periodo 2016-2017 y que habían sido diagnosticados de asma al menos un año antes de la fecha índice y fueron seguidos durante un año. Resultados: La prevalencia del asma fue del 5,5%. De estos pacientes, 3.031 presentaban asma grave (7,7%), de los cuales el 81,2% presentaba asma T2. Entre los pacientes con asma grave, el 64,1% no estaban controlados, el 31,2% eran dependientes de corticosteroides orales (37% en el grupo de asma grave no controlada) y solo el 3,8% estaban en tratamiento con biológicos. Las comorbilidades T2 más frecuentes fueron la rinitis alérgica (66,1%), la dermatitis atópica (29,1%) y la rinosinusitis crónica con poliposis nasal (14,6%). Las tasas de mortalidad en los grupos de asma grave total y no controlada fueron del 4,2% y del 5,5%, respectivamente. Los costes totales anuales por paciente con asma grave fueron de 5.890 euros (no controlado) y 2.841 euros (controlado). Conclusiones: En la era de los biológicos, la mayoría de los pacientes con asma grave presentan asma T2. A pesar de la disponibilidad de nuevos tratamientos, las tasas de pacientes con asma grave no controlados y dependientes de corticosteroides orales siguen siendo altas, y los biológicos siguen estando infrautilizados. Los costes del asma grave no controlada duplican los del asma grave controlada. (AU)

Economic Consequences of the Overuse of Short-Acting ß-Adrenergic Agonists in the Treatment of Asthma in Spain.

BACKGROUND AND OBJECTIVE: To determine the relationship between short-acting ß-adrenergic agonist (SABA) overuse and health care resource use and costs in asthma patients in routine clinical practice. METHODS: A longitudinal retrospective study was conducted in Spanish primary and specialized care centers using the BIG-PAC medical records database. The study population comprised asthma patients ≥12 years of age who attended ≥2 consultations during 2017 and had 1-year follow-up data available. The main outcomes were demographics, comorbidities, medication, and clinical and health care resource use and costs. The relationship between SABA overuse and health care costs and between asthma severity and health care costs was determined. RESULTS: The SABA use IN Asthma (SABINA) study included 39 555 patients, with a mean (SD) age of 49.8 (20.7) years (64.2% female). The Charlson comorbidity index was 0.7 (1.0). SABA overuse (≥3 canisters/y) was 28.7% (95%CI, 27.7-29.7), with a mean of 3.3 (3.6) canisters/y. Overall, 5.1% of patients were prescribed ≥12 canisters/y. SABA overuse was correlated with health care costs (ρ=0.621; P<.001). The adjusted mean annual cost/patient according to the Global Initiative for Asthma (GINA 2019) classification of asthma severity was €2231, €2345, €2735, €3473, and €4243 for steps 1-5, respectively (P<.001). Regardless of asthma severity, SABA overuse yielded a significant increase in health care costs per patient and year (€5702 vs €1917, P<.001) compared with recommended use (<2 canisters/y). CONCLUSION: SABA overuse yields high costs for the Spanish National Health System. Costs increased with severity of asthma.

Economic Consequences of the Overuse of Short-Acting ß-Adrenergic Agonists in the Treatment of Asthma in Spain

Objective: To determine the relationship between short-acting ß-adrenergic agonist (SABA) overuse and health care resource use and costs in asthma patients in routine clinical practice. Methods: A longitudinal retrospective study was conducted in Spanish primary and specialized care centers using the BIG-PAC medical records database. The study population comprised asthma patients ≥12 years of age who attended ≥2 consultations during 2017 and had 1-year follow-up data available. The main outcomes were demographics, comorbidities, medication, and clinical and health care resource use and costs. The relationship between SABA overuse and health care costs and between asthma severity and health care costs was determined. Results: The SABA use IN Asthma (SABINA) study included 39 555 patients, with a mean (SD) age of 49.8 (20.7) years (64.2% female). The Charlson comorbidity index was 0.7 (1.0). SABA overuse (≥3 canisters/y) was 28.7% (95%CI, 27.7-29.7), with a mean of 3.3 (3.6) canisters/y. Overall, 5.1% of patients were prescribed ≥12 canisters/y. SABA overuse was correlated with health care costs (ρ=0.621; P<.001). The adjusted mean annual cost/patient according to the Global Initiative for Asthma (GINA 2019) classification of asthma severity was €2231, €2345, €2735, €3473, and €4243 for steps 1-5, respectively (P<.001). Regardless of asthma severity, SABA overuse yielded asignificant increase in health care costs per patient and year (€5702 vs €1917, P<.001) compared with recommended use (<2 canisters/y). Conclusion: SABA overuse yields high costs for the Spanish National Health System. Costs increased with severity of asthma (AU)

Objetivo: Determinar la relación entre la sobreutilización de agonistas beta adrenérgicos de acción corta (SABA) en pacientes con asma y el uso y coste de recursos sanitarios en la práctica clínica rutinaria. Métodos: Se realizó un estudio longitudinal retrospectivo en atención primaria y especializada en España, en el que se utilizó la base de datos de registros médicos BIG-PAC®. Se incluyeron pacientes con asma ≥12 años que asistieron a ≥2 consultas durante 2017 y con datos disponibles del seguimiento durante 1 año. Los principales resultados analizados fueron características demográficas, comorbilidades, medicaciones, y el uso y coste de recursos clínicos y sanitarios. Se determinó la relación de los costes sanitarios tanto con la sobreutilización de SABA como con la severidad del asma. Resultados: Este estudio sobre el uso de SABA en asma (SABINA, del inglés “SABA use IN Asthma”) incluyó a 39.555 pacientes, con una edad media (DE, desviación estándar) de 49,8 años (20,7); 64.2% fueron mujeres. La media del índice de comorbilidad Charlson fue 0,7 (1,0). La sobreutilización de SABA (≥3 envases/año) fue del 28,7% (IC95%: 27,7–29,7), con una media global de 3,3 envases (3,6) /año. En total, el 5,1% de los pacientes fueron prescritos con ≥12 envases/año. La sobreutilización de SABA correlacionó con los costes sanitarios (ρ = 0,621; p < 0,001). El coste medio anual/paciente según la clasificación de severidad del asma de la Global Initiative for Asthma (GINA 2019) fue de 2.231 €, 2.345 €, 2.735 €, 3.473 €, y 4.243 €, para los pasos 1-5, respectivamente (p < 0,001) (AU)

Prevalence, T2-biomarkers and cost of severe asthma in the era of biologics: The BRAVO-1 study.

BACKGROUND AND OBJECTIVES: The last decade has seen a new era of classifications of asthma pathophysiology which have changed the treatment options available. 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.

Características clínicas, manejo y riesgo de complicaciones a un año en pacientes con insuficiencia cardíaca con y sin diabetes tipo 2 en España / Clinical characteristics, management, and one-year risk of complications among patients with heart failure with and without type 2 diabetes in Spain

Objetivos: Describir las características clínicas y el manejo terapéutico y determinar los eventos cardiovasculares tras un año de seguimiento en una población contemporánea con insuficiencia cardíaca (IC) con y sin diabetes tipo 2 en España. También se analizó en la población DAPA-HF (pacientes que cumplieron la mayoría de los criterios de inclusión del estudio DAPA-HF) y en los pacientes tratados basalmente con inhibidores SGLT2.Métodos: Estudio observacional, retrospectivo, poblacional, empleando la base de datos BIG-PAC. La fecha índice fue 1 de enero de 2019. Se seleccionaron sujetos≥18 años que recibieron tratamiento por IC en 2019. Se analizaron los eventos durante 2019.Resultados: Se identificaron 21.851 pacientes con IC (78±11,3 años; 53% varones; 50,9% IC con fracción de eyección 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-año. El 66,1% tomaba inhibidores del sistema renina-angiotensina, el 69,4% betabloqueantes, el 31,2% antialdosterónicos y el 7,5% sacubitrilo/valsartán. Durante el año de seguimiento, el 29,8% fue hospitalizado por descompensación de la IC (tiempo medio primer evento 120,9±72,5 días), un 12,3% murieron, un 8,1% murieron durante la hospitalización. Los eventos fueron más frecuentes en los pacientes con diabetes tipo 2. Las hospitalizaciones por IC fueron más comunes en la población similar a DAPA-HF.Conclusiones: En España, la población con IC es anciana y tiene muchas comorbilidades. Aproximadamente la mitad de los pacientes tienen IC con fracción de eyección reducida. Existe margen de mejora en el manejo de la IC, en particular mediante el empleo de aquellos fármacos que reducen tanto la hospitalización por IC como la mortalidad, para disminuir la carga de IC (AU)

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 (AU)

Clinical characteristics, management, and one-year risk of complications among patients with heart failure with and without type 2 diabetes in Spain.

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.

[Treatment persistence with brand-name vs. generic metformin in monotherapy for type 2 diabetes: real-life retrospective study using the propensity matching score]. / Persistencia al tratamiento con metformina de marca vs. genérica en monoterapia para la diabetes tipo 2: estudio retrospectivo de vida real mediante propensity score matching.

OBJECTIVE: 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. PATIENTS AND METHODS: 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. MAIN MEASURES: 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 (p<0.05). RESULTS: 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). CONCLUSIONS: 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).