Acceso usuarios
Miguel Villar Martínez, Antonio Luis Aguilar Shea, Marcos Fragiel Saavedra, Beatriz García Fernández Bravo, Irene Serrano García, Manuel Méndez Bailón 
, Elpidio Calvo Manuel
Antecedentes y objetivos La EPOC se caracteriza por exacerbaciones que incrementan la morbimortalidad. El tratamiento farmacológico de mantenimiento se centra en broncodilatadores de acción prolongada. Este estudio evaluó la efectividad de distintas estrategias terapéuticas en condiciones reales.
Materiales y métodos Estudio observacional, longitudinal y retrospectivo con datos de la base española BIFAP (2010-2020) en pacientes con diagnóstico incidente de EPOC. Se estratificó según tratamiento: monoterapia, doble terapia (con/sin glucocorticoides inhalados) y triple terapia. Se aplicaron modelos mixtos de Cox multivariantes ajustados por factores clínicos y comorbilidades para estimar el riesgo de exacerbación moderada-grave.
Resultados Se incluyeron 69.565 pacientes (edad media 63 años; 71% hombres). Edad, sexo femenino y diabetes se asociaron con mayor riesgo de exacerbaciones moderadas-graves; este también aumentó con la escalada terapéutica: monoterapia (HR = 4,14), doble terapia sin glucocorticoides (HR = 2,45), doble terapia con glucocorticoides (HR = 7,11) y triple terapia (HR = 5,31); y con la falta de optimización, por terapia (HR = 3,75) o dispositivos (HR = 1,31). Se observaron diferencias en el riesgo entre principios activos de una misma clase.
Conclusiones En la práctica real, el riesgo de exacerbaciones moderadas-graves está influido por la gravedad basal, particularmente las exacerbaciones previas, y por el patrón terapéutico. LAMA/LABA parece asociarse a un perfil de riesgo más favorable que la doble terapia con glucocorticoides inhalados. La optimización del régimen y simplificación de dispositivos se asocian con menor riesgo y deben priorizarse en el abordaje de la EPOC.
Background and objectives COPD is characterized by exacerbations that increase morbi-mortality. Maintenance pharmacological treatment is based on long-acting bronchodilators. This study assessed the effectiveness of different therapeutic strategies under real-world conditions.
Materials and methods Observational, longitudinal, retrospective cohort study using data from the Spanish BIFAP database (2010-2020) including patients with incident COPD. Patients were stratified by therapy: monotherapy, dual therapy (with/without inhaled glucocorticoids), and triple therapy. Multivariable mixed-effects Cox models adjusted for clinical factors and comorbidities were applied to estimate the risk of moderate-to-severe exacerbations.
Results A total of 69.565 patients were included (mean age 63 years; 71% men). Age, female sex and diabetes were associated with a higher risk of moderate-to-severe exacerbations. Risk increased with treatment escalation: monotherapy (HR = 4.14), dual therapy without inhaled glucocorticoids (HR = 2.45), dual therapy with inhaled glucocorticoids (HR = 7.11), and triple therapy (HR = 5.31), reflecting indication bias. A higher risk was also observed with lack of treatment optimization, either by therapeutic regimen (HR = 3.75) or number of devices (HR = 1.31). Differences in risk were identified among specific active agents within the same therapeutic class.
Conclusions In real-world practice, the risk of moderate-to-severe exacerbations is influenced by baseline disease severity, particularly prior exacerbations, and by the therapeutic pattern. LAMA/LABA appears as the preferred option over dual therapy with inhaled glucocorticoids. Optimizing therapy and simplifying inhaler devices are associated with lower risk and should be prioritized in COPD management.
