Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial.

INTRODUCTION: Treatment with LABA/LAMA is recommended in GOLD B patients. We hypothesized that triple therapy (LABA/LAMA/ICS) will be superior to LABA/LAMA in achieving and maintaining clinical control (CC), a composite outcome that considers both impact and disease stability in a subgroup of GOLD B patients (here termed GOLD B+ patients) characterized by: (1) remaining symptomatic (CAT≥10) despite regular LABA/LAMA therapy; (2) having suffered one moderate exacerbation in the previous year; and (3) having blood eosinophil counts (BEC) ≥150cells/µL. METHODS: The ANTES B+ study is a prospective, multicenter, open label, randomized, pragmatic, controlled trial designed to test this hypothesis. It will randomize 1028 B+ patients to continue with their usual LABA/LAMA combination prescribed by their attending physician or to begin fluticasone furoate (FF) 92µg/umeclidinium (UMEC) 55µg/vilanterol (VI) 22µg in a single inhaler q.d. for 12 months. The primary efficacy outcome will be the level of CC achieved. Secondary outcomes include the clinical important deterioration index (CID), annual rate of exacerbations, and FEV1. Exploratory objectives include the interaction of BEC and smoking status, all-cause mortality and proportion of patients on LABA/LAMA arm that switch therapy arms. Safety analysis include adverse events and incidence of pneumonia. RESULTS: The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026. CONCLUSIONS: The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial.

ANTES: Un año después en la EPOC / ANTES Program: One Year on

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[Translated article] ANTES Program: One Year on / ANTES: Un año después en la EPOC

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Microspirometers in the follow-up of COPD: advantages and disadvantages / El uso de los microespirómetros en el seguimiento de la EPOC: ventajas e inconvenientes

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Prevalencia de anemia asociada a la enfermedad pulmonar obstructiva crónica. Estudio de las variables asociadas / Prevalence of Anaemia Associated With Chronic Obstructive Pulmonary Disease. Study of Associated Variables

Introducción: La anemia es una de las manifestaciones extrapulmonares de la enfermedad pulmonar obstructiva crónica (EPOC). Su prevalencia, su fisiopatología y su repercusión clínica son desconocidas. Los objetivos de nuestro estudio son determinar la prevalencia de la anemia en pacientes con EPOC en fase estable no atribuible a otras causas y establecer la relación de la anemia con variables clínicas, pronósticas y marcadores inflamatorios con un papel relevante en la EPOC. Métodos: Se incluyeron pacientes con EPOC en fase estable sin otras causas conocidas de anemia. Se realizaron pruebas de función respiratoria, determinación de eritropoyetina y marcadores inflamatorios séricos: PCR ultrasensible (PCR), fibrinógeno, interleucina 6 (IL-6), interleucina 8 (IL-8) y factor de necrosis tumoral alfa (TNF-α). Se registró el índice de masa corporal (IMC), el índice de Charlson y el BODE, el número de exacerbaciones en el año previo, la escala de disnea y la calidad de vida. Resultados: Se incluyeron 130 pacientes. La prevalencia de anemia fue del 6,2%. El valor de hemoglobina en los pacientes con anemia fue de 11,9 ± 0,95 g/dl. Los pacientes con anemia tenían un IMC más bajo (p = 0,03), un índice de Charlson mayor (p = 0,002), niveles de eritropoyetina más elevados (p = 0,016), una tendencia a presentar niveles más bajos de FEV1% (p = 0,08) y valores significativamente más bajos de IL-6 (p = 0,003) cuando se comparan con los pacientes no anémicos. Conclusiones: En nuestra serie, la anemia asociada a la EPOC es menos prevalente de lo publicado hasta la actualidad y guarda relación con determinados factores clínicos y marcadores inflamatorios (AU)

Background: Anaemia is one of the extrapulmonary manifestations of chronic obstructive pulmonary disease (COPD). Its real prevalence, physiopathology and clinical repercussion are unknown. The objectives of our study were: to determine the prevalence of anaemia in patients with stable COPD not attributable to other causes and to establish the relationship of anaemia with clinical, prognostic and inflammatory markers with an important role in COPD. Methods: The study included stable COPD patients with no other known causes of anaemia. The following tests were carried out: respiratory function tests; serum determination of erythropoietin and inflammatory markers: high sensitivity C -reactive protein (hs-CRP), fibrinogen, interleukin 6 (IL-6), interleukin 8 (IL-8) and tumour necrosis factor α (TNF-α). Body mass index (BMI), Charlson and BODE indices, the number of exacerbations in the previous year, dyspnoea and quality of life were also calculated. Results: One hundred and thirty patients were included. Anaemia prevalence was 6.2%. Mean haemoglobin value in anaemic patients was 11.9 ± 0.95 g/dL. Patients with anaemia had a lower BMI (P=0.03), higher Charlson index (P=0.002), more elevated erythropoietin levels (P=.016), a tendency to present a lower FEV1% value (P=.08) and significantly lower IL-6 values when compared to non-anaemic patients (P=0.003). Conclusions: In our series, the anaemia associated with COPD was less prevalent than that published in the literature to date, and was related to certain clinical and inflammatory markers (AU)