Factors Affecting the Success of Step-up Therapy in Patients With Moderate-Severe Asthma: A Real-Life Study.

INTRODUCTION AND OBJECTIVE: Introduction: Clinical practice guidelines recommend regular adjustment of treatment to achieve control of asthma. A step-up approach based on the degree of disease control should be followed. Objective: To perform a real-life analysis of the factors that affect the success or failure of this therapeutic strategy and of the criteria applied by clinicians when applying a step-up approach in a representative sample of patients diagnosed with moderate-severe asthma. MATERIAL AND METHODS: We performed a multicenter retrospective cohort study involving 226 Spanish specialist physicians (98 allergologists, 127 pulmonologists, and 1 family physician). We included 1254 patients (787 women) diagnosed with moderate-severe asthma who underwent step-up therapy during 2016. RESULTS: Step-up was successful in 44% of cases. The factors associated with success were presence of <2 comorbid conditions, lower grade of severity and therapy step before modification, absence of exacerbations during the previous year, fewer daytime/nighttime symptoms, and limitation in activities, as well as type of inhaled corticosteroid/ long-acting ß2-agonist combination after modification, lower body mass index, and higher fractional exhaled nitric oxide. An early increase in the maintenance dose once a lack of control was detected (≤3 months, >3 to ≤6 months, >6 to ≤12 months) was more likely to be successful. CONCLUSION: The factors that determine whether or not this therapeutic strategy manages to control asthma are time since onset of clinical impairment, previous grade of severity, number of comorbid conditions, previous exacerbations, and frequency of symptoms.

Factors Affecting the Success of Step-up Therapy in Patients With Moderate-Severe Asthma: A Real-Life Study

Background: Clinical practice guidelines recommend regular adjustment of treatment to achieve control of asthma. A step-up approachbased on the degree of disease control should be followed.Objective: To perform a real-life analysis of the factors that affect the success or failure of this therapeutic strategy and of the criteriaapplied by clinicians when applying a step-up approach in a representative sample of patients diagnosed with moderate-severe asthma.Material and Methods: We performed a multicenter retrospective cohort study involving 226 Spanish specialist physicians (98 allergologists,127 pulmonologists, and 1 family physician). We included 1254 patients (787 women) diagnosed with moderate-severe asthma whounderwent step-up therapy during 2016.Results: Step-up was successful in 44% of cases. The factors associated with success were presence of <2 comorbid conditions, lower gradeof severity and therapy step before modification, absence of exacerbations during the previous year, fewer daytime/nighttime symptoms,and limitation in activities, as well as type of inhaled corticosteroid/ long-acting β₂-agonist combination after modification, lower bodymass index, and higher fractional exhaled nitric oxide. An early increase in the maintenance dose once a lack of control was detected(≤3 months, >3 to ≤6 months, >6 to ≤12 months) was more likely to be successful.Conclusion: The factors that determine whether or not this therapeutic strategy manages to control asthma are time since onset of clinicalimpairment, previous grade of severity, number of comorbid conditions, previous exacerbations, and frequency of symptoms. (AU)

Antecedentes: Las guías de práctica clínica recomiendan el ajuste del tratamiento hasta alcanzar el control del asma, siguiendo un escaladoprogresivo basado en el grado de control de la enfermedad.Objetivo: Realizar un análisis en vida real de los criterios que utilizan los clínicos para realizar el escalado terapéutico y de los factoresque condicionan el éxito o el fracaso de esta estrategia terapéutica en una muestra representativa de pacientes diagnosticados de asmapersistente moderada y grave.Material y métodos: Estudio multicéntrico retrospectivo de cohorte en el que participaron 226 médicos especialistas españoles (98alergólogos, 127 neumólogos y un médico de atención primaria). Incluimos 1.254 pacientes (787 mujeres) diagnosticados de asmapersistente moderada o grave en los que se realizó un escalado de tratamiento durante 2016.Resultados: El escalado terapéutico fue exitoso en el 44% de los casos. Los factores asociados con el éxito fueron la presencia de <2comorbilidades, menor grado de gravedad y del escalón terapéutico de la terapia antes de la modificación, ausencia de exacerbacionesdurante el año anterior, menos síntomas diurnos/nocturnos y limitación en las actividades ordinarias, así como el tipo de corticosteroideinhalado (ICS) / combinación de β₂-agonista de acción prolongada (LABA) después de la modificación, índice de masa corporal inferiory fracción del óxido nítrico exhalado superior. Un aumento temprano en la dosis de mantenimiento una vez que se detectó una falta decontrol (≤ 3 meses,> 3 a ≤ 6 meses,> 6 a ≤ 12 meses) también se asoció a un aumento de probabilidad de éxito.Conclusión: Los factores que determinan si el escalado terapéutico logra controlar el asma son el tiempo transcurrido desde el inicio deldeterioro clínico, el grado previo de gravedad, el número de afecciones comórbidas, las exacerbaciones previas y la frecuencia de síntomas. (AU)

Factores que condicionan la pérdida de control al reducir escalones terapéuticos en el tratamiento del asma moderada-grave en la práctica clínica habitual: estudio español multicéntrico / Factors that determine the loss of control when reducing therapy by steps in the treatment of moderate-severe asthma in standard clinical practice: a multicentre Spanish study

Introducción: Aunque las guías de práctica clínica recomiendan un ajuste continuado del tratamiento del asma, reduciendo la medicación de mantenimiento cuando se alcanza el control (step-down), existen pocos estudios de práctica clínica habitual orientados a recabar información de los factores que condicionan su fracaso. Objetivo: Determinar los factores que condicionan en la práctica clínica habitual el fracaso del step-down en los pacientes asmáticos moderados-graves controlados con una combinación de glucocorticoides inhalados/agonistas beta-2 adrenérgicos de acción larga. Método: Estudio multicéntrico retrospectivo sobre 374 pacientes con asma moderada-grave controlada con glucocorticoides inhalados/agonistas beta-2 adrenérgicos de acción larga en quienes el facultativo indicó en 2016 un step-down. Resultados: El step-down fracasó en el 41,7%. Los factores relacionados con el fracaso fueron: la mayor edad del paciente (p=0,006), la presencia de 2 o más comorbilidades (p=0,016), el mayor nivel de gravedad (persistente grave vs. persistente moderada) (p<0,001), la mayor edad al diagnóstico (>40 años) (p=0,045), cuanto más alto es el escalón terapéutico previo (p=0,003) y posterior al cambio (p<0,001), cuanto menor sea el tiempo de mejoría/control previo al cambio (p=0,019), el FEV1 más bajo (p=0,001) y un peor Asthma Control Test o Asthma Control Questionnaire antes del step-down (p<0,001). El análisis de regresión logística mostró que existe una mayor probabilidad (odds ratio [IC 95%] de fracaso del step-down en los pacientes más añosos: OR 0,983 [0,969-0,997], con asma grave vs. moderada: OR 0,537 [0,292-0,985] y mayor probabilidad de éxito si llevan más de 6 meses con la enfermedad controlada: OR 2,253 [1,235-4,112]). Conclusión: En condiciones de práctica clínica habitual el step-down fracasa en un porcentaje alto de pacientes y se recomienda indicarlo cuando el paciente lleve más de 6 meses controlado

Background: Although the clinical practice guidelines recommend continuous adjustment of asthma treatment and reducing the maintenance drugs when achieving control (step-down), there are few studies of standard clinical practice aimed at collecting information on the factors that determine step-down failure. Objective: To determine the factors that determine step-down failure in standard clinical practice of patients with moderate-severe asthma controlled by a combination of inhaled glucocorticoids and long-acting beta agonists. Methods: A multicentre retrospective study included 374 patients with moderate-severe asthma controlled with inhaled glucocorticoids and long-acting beta agonists for whom the physician indicated a step-down in 2016. Results: The step-down failed in 41.7% of the patients. The following factors were related to failure: greater patient age (P=.006), presence of at least 2 comorbidities (P=.016), greater severity level (severe persistent vs. moderate persistent) (P<.001), greater age at diagnosis (>40 years) (P=.045), the higher the therapeutic step before (P=.003) and after the change (P<.001), the shorter the time of improvement/control prior to the change (P=.019), lower FEV1 (P=.001) and a poorer Asthma Control Test score or Asthma Control Questionnaire score before the step-down (P<.001). The logistic regression analysis showed a higher probability of step-down failure in the more elderly patients (OR, 0.983; 95% CI 0.969-0.997) and those with severe asthma compared to those with moderate asthma (OR, 0.537; 95% CI 0.292-0.985), as well as an increased probability of success if the patients had the disease controlled for more than 6 months (OR, 2.253; 95% CI 1.235-4.112). Conclusion: In standard clinical practice conditions, step-down fails in a high percentage of patients, and the suggestion is to indicate step-down when the patient has had more than 6 months of disease control

Factors that determine the loss of control when reducing therapy by steps in the treatment of moderate-severe asthma in standard clinical practice: A multicentre Spanish study. / Factores que condicionan la pérdida de control al reducir escalones terapéuticos en el tratamiento del asma moderada-grave en la práctica clínica habitual: estudio español multicéntrico.

BACKGROUND: Although the clinical practice guidelines recommend continuous adjustment of asthma treatment and reducing the maintenance drugs when achieving control (step-down), there are few studies of standard clinical practice aimed at collecting information on the factors that determine step-down failure. OBJECTIVE: To determine the factors that determine step-down failure in standard clinical practice of patients with moderate-severe asthma controlled by a combination of inhaled glucocorticoids and long-acting beta agonists. METHODS: A multicentre retrospective study included 374 patients with moderate-severe asthma controlled with inhaled glucocorticoids and long-acting beta agonists for whom the physician indicated a step-down in 2016. RESULTS: The step-down failed in 41.7% of the patients. The following factors were related to failure: greater patient age (P=.006), presence of at least 2 comorbidities (P=.016), greater severity level (severe persistent vs. moderate persistent) (P<.001), greater age at diagnosis (>40 years) (P=.045), the higher the therapeutic step before (P=.003) and after the change (P<.001), the shorter the time of improvement/control prior to the change (P=.019), lower FEV1 (P=.001) and a poorer Asthma Control Test score or Asthma Control Questionnaire score before the step-down (P<.001). The logistic regression analysis showed a higher probability of step-down failure in the more elderly patients (OR, 0.983; 95% CI 0.969-0.997) and those with severe asthma compared to those with moderate asthma (OR, 0.537; 95% CI 0.292-0.985), as well as an increased probability of success if the patients had the disease controlled for more than 6 months (OR, 2.253; 95% CI 1.235-4.112). CONCLUSION: In standard clinical practice conditions, step-down fails in a high percentage of patients, and the suggestion is to indicate step-down when the patient has had more than 6 months of disease control.

Persistencia al tratamiento y uso de recursos con corticosteroides y agonistas ß-adrenérgicos de larga duración inhalados a dosis fijas para el tratamiento del asma: estudio retrospectivo de base poblacional / Persistence to treatment and resources use with inhaled fixed-dose combinations of corticosteroids and long-acting ß-adrenergic agonists for the treatment of asthma: A population-based retrospective study

Objetivo: Determinar la persistencia, las exacerbaciones y el uso de los recursos en los pacientes que inician tratamiento inhalador con fluticasona propionato/formoterol (PF/Form) con relación a otras combinaciones de corticoide inhalado/agonista ß-adrenérgico de larga duración (CI/LABA) en dosis fijas, para el tratamiento del asma en condiciones de práctica clínica habitual. Material y métodos: Estudio observacional realizado a partir de la revisión de registros médicos. Se incluyeron sujetos ≥18 años que iniciaron tratamiento con CI/LABA y que cumplieran con determinados criterios de inclusión/exclusión. El seguimiento se realizó durante un año. Grupos de estudio: a) PF/Form y b) otras-combinaciones (Otros-CI/LABA). Principales medidas: persistencia, ratio posesión del medicamento (RPM), exacerbaciones y costes (directos/indirectos). El análisis estadístico se elaboró mediante modelos de regresión, con p <0,05. Resultados: Se seleccionó a 3.203 pacientes. Por grupos: a) PF/Form: 7,0% y b) Otros-CI/LABA: 93,0%. La edad media fue de 52,2 años y el 60,8% fueron mujeres. El 44,9% de los pacientes presentaban un asma persistente-moderado. Los pacientes en tratamiento con PF/Form se asociaron a una mayor persistencia (67,6 vs. 61,2%; p=0,043), mayor RPM (80,6 vs. 74,3%; p=0,002) y menores exacerbaciones (16,0 vs. 21,9%; p=0,021), especialmente exacerbaciones severas (4,0 vs. 7,7%; p=0,043). El promedio/unitario del coste total (ANCOVA) fue menor en los pacientes en tratamiento con PF/Form (2.033 vs. 2.486 €; p=0,012), respectivamente. El coste total se asoció a exacerbaciones (ß = 0,618), severidad-asma (ß = 0,214), edad (ß = 0,073) y falta de adherencia (RPM: ß = −0,031), con p <0,01. Conclusiones: Los pacientes en tratamiento con PF/Form se asociaron a una mayor adherencia al tratamiento (persistencia, RPM), circunstancia que repercute en menores exacerbaciones severas y costes totales para el sistema nacional de salud. Estas diferencias podrían ser debidas a las propiedades farmacológicas del fármaco o a otros factores no medidos

Objective: To determine the persistence, exacerbations, and use of resources in patients who use inhaler treatment with fluticasone propionate/formoterol (PF/Form) in relation with other combinations of inhaled corticosteroid/long-acting ß-adrenergic (ICS/LABA) at fixed doses, for the treatment of asthma in real-life practice. Material and methods: Observational study conducted by reviewing medical records. The study included subjects ≥18 years of age who started treatment with ICS/LABA and who met certain inclusion/exclusion criteria. The follow-up was carried out for one year. Study groups: a) PF/Form and b) Other-combinations (Other-ICS/LABA). Main measurements: Persistence, medication possession ratio (MPR), exacerbations, and costs (direct/indirect). The statistical analysis was performed using regression models, with a P<.05. Results: A total of 3,203 patients were included in the study. By groups: a) FP/Form: 7.0% and b) Other-ICS/LABA: 93.0%. The mean age was 52.2 years, and 60.8% were women. A total of 44.9% of patients had persistent-moderate asthma. Patients under treatment with FP/Form were associated with greater persistence (67.6 vs. 61.2%, P=.043), a higher RPM (80.6 vs. 74.3%, P=.002), and less exacerbations (16.0 vs. 21.9%, P=.021), particularly severe-exacerbations (4.0 vs. 7.7%, P=.043). The mean/unit of the total cost (ANCOVA) was lower in patients under treatment with PF/Form (2,033 vs. € 2,486, P=.012), respectively. The total cost was associated with: Exacerbations (ß=0.618), asthma-severity (ß=0.214), age (ß=0.073), and lack-adherence (RPM: ß=−0.031), P<.01. Conclusions: Patients undergoing treatment with PF/Form were associated with greater adherence to treatment (persistence, RPM), a circumstance that leads to less severe exacerbations and total costs for the national health system. These differences could be due to the pharmacological properties of the drug or other factors not measured

[Persistence to treatment and resources use with inhaled fixed-dose combinations of corticosteroids and long-acting ß-adrenergic agonists for the treatment of asthma: A population-based retrospective study]. / Persistencia al tratamiento y uso de recursos con corticosteroides y agonistas ß-adrenérgicos de larga duración inhalados a dosis fijas para el tratamiento del asma: estudio retrospectivo de base poblacional.

OBJECTIVE: To determine the persistence, exacerbations, and use of resources in patients who use inhaler treatment with fluticasone propionate/formoterol (PF/Form) in relation with other combinations of inhaled corticosteroid/long-acting ß-adrenergic (ICS/LABA) at fixed doses, for the treatment of asthma in real-life practice. MATERIAL AND METHODS: Observational study conducted by reviewing medical records. The study included subjects ≥18 years of age who started treatment with ICS/LABA and who met certain inclusion/exclusion criteria. The follow-up was carried out for one year. Study groups: a) PF/Form and b) Other-combinations (Other-ICS/LABA). MAIN MEASUREMENTS: Persistence, medication possession ratio (MPR), exacerbations, and costs (direct/indirect). The statistical analysis was performed using regression models, with a P<.05. RESULTS: A total of 3,203 patients were included in the study. By groups: a) FP/Form: 7.0% and b) Other-ICS/LABA: 93.0%. The mean age was 52.2 years, and 60.8% were women. A total of 44.9% of patients had persistent-moderate asthma. Patients under treatment with FP/Form were associated with greater persistence (67.6 vs. 61.2%, P=.043), a higher RPM (80.6 vs. 74.3%, P=.002), and less exacerbations (16.0 vs. 21.9%, P=.021), particularly severe-exacerbations (4.0 vs. 7.7%, P=.043). The mean/unit of the total cost (ANCOVA) was lower in patients under treatment with PF/Form (2,033 vs. € 2,486, P=.012), respectively. The total cost was associated with: Exacerbations (ß=0.618), asthma-severity (ß=0.214), age (ß=0.073), and lack-adherence (RPM: ß=-0.031), P<.01. CONCLUSIONS: Patients undergoing treatment with PF/Form were associated with greater adherence to treatment (persistence, RPM), a circumstance that leads to less severe exacerbations and total costs for the national health system. These differences could be due to the pharmacological properties of the drug or other factors not measured.