www.medigraphic.org.mx RESUMEN. Introducción: La enfermedad pulmonar obstructiva crónica (EPOC) es una de las principales causas de muerte en México y en el mundo. Pese a que en los últimos años se ha alcanzado un gran progreso en su manejo y tratamiento, esto también ha conllevado una mayor complejidad. En México, es fundamental el desarrollo de guías de práctica clínica (GPC) que estén basadas en estándares internacionales para establecer recomendaciones a todos los niveles de atención. Objetivos: El objetivo fue desarrollar una GPC con recomendaciones clínicas desarrolladas de forma sistematizada para asistir a la toma de decisiones, tanto de médicos de todos los niveles de atención, como de pacientes, cuidadores de pacientes y todos los elaboradores de políticas públicas involucrados en el manejo de pacientes con enfermedad pulmonar obstructiva crónica. Material y métodos: Este documento fue desarrollado por parte de la Sociedad Mexicana de Neumología y Cirugía de Tórax en cumplimiento con los estándares internacionales como los descritos por el Instituto de Medicina de los Estados Unidos (IOM, por sus siglas en inglés). Se integró un Grupo de Desarrollo de la Guía (GDG) de manera interdisciplinaria, considerando la participación de neumólogos y metodólogos con experiencia en revisiones sistemáticas de la literatura y el desarrollo de GPC. De forma sistematizada, se consensuaron los alcances, las preguntas clínicas y se evaluaron otras Guías Internacionales sobre el tema. Se evaluó críticamente la calidad metodológica de esas GPC. A través del abordaje ADAPTE, se transculturizó la GPC a nuestro país y, finalmente, utilizando metodología de consenso formal de expertos, se desarrollaron las recomendaciones clínicas. Resultados: Se consensuaron 40 preguntas estructuradas clínicamente relevantes para el diagnóstico y tratamiento, así como las recomendaciones clínicas pertinentes y su texto de soporte. Las recomendaciones abarcan preguntas sobre diagnóstico y tratamiento. Conclusión: Esta GPC pretende proveer recomendaciones clínicas para el diagnóstico y manejo terapéutico de los distintos estadios de la EPOC basadas en evidencia científica, que asisten en el proceso de toma de decisiones compartidas y que esperamos contribuyan a mejorar la calidad de la atención clínica en las pacientes con EPOC. Palabras clave: Guías de Práctica Clínica, medicina basada en evidencia, enfermedad pulmonar obstructiva crónica. ABSTRACT. Introduction: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of the death in Mexico and worldwide. In recent years, great progress has been achieved in its management and treatment, which also entails greater complexity. In Mexico, the development of clinical practice guidelines (CPG) under international standards is essential to stablish recommendations at all levels of care. Objectives: This Clinical Practice Guideline provides systematically developed clinical recommendations to assist clinical decision makers involved in the management of patients with COPD. Material ...
<b>Rationale and objectives:</b> Patients with chronic obstructive pulmonary disease (COPD), usually diagnosed after the 6th decade, frequently suffer from comorbidities. Whether COPD patients 50 years or younger (Young COPD) have similar comorbidities with the same frequency and mortality impact as aged-matched controls or older COPD patients is unknown. <b>Methods:</b> We compared comorbidity number, prevalence and type in 3 groups of individuals with ≥ 10 pack-years of smoking: A Young (≤ 50 years) COPD group (n = 160), an age-balanced control group without airflow obstruction (n = 125), and Old (> 50 years) COPD group (n = 1860). We also compared survival between the young COPD and control subjects. Using Cox proportional model, we determined the comorbidities associated with mortality risk and generated Comorbidomes for the «Young» and «Old» COPD groups. <b>Results:</b> The severity distribution by GOLD spirometric stages and BODE quartiles were similar between Young and Old COPD groups. After adjusting for age, sex, and pack-years, the prevalence of subjects with at least one comorbidity was 31% for controls, 77% for the Young, and 86% for older COPD patients. Compared to controls, «Young» COPDs’ had a nine-fold increased mortality risk (p < 0.0001). «Comorbidomes» differed between Young and Old COPD groups, with tuberculosis, substance use, and bipolar disorders being distinct comorbidities associated with increased mortality risk in the Young COPD group. <b>Conclusion:</b> Young COPD patients carry a higher comorbidity prevalence and mortality risk compared to non-obstructed control subjects. Young COPD differed from older COPD patients by the behavioral-related comorbidities that increase their risk of premature death.
<b>Background:</b> In the Phase III KRONOS study, triple therapy with budesonide/glycopyrronium/formoterol fumarate metered dose inhaler (BGF MDI) was shown to reduce exacerbations and improve lung function versus glycopyrronium/formoterol fumarate dihydrate (GFF) MDI in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). However, whether the benefits related to the ICS component of BGF are driven by patients with high blood eosinophil counts (EOS) and/or airway reversibility has not been previously studied. <b>Methods:</b> KRONOS was a Phase III, double-blind, parallel-group, multicenter, randomized, controlled study of patients with moderate-to-very-severe COPD. Patients were randomized 2:2:1:1 to receive BGF 320/14.4/10 μg, GFF 14.4/10 μg, budesonide/formoterol fumarate dihydrate (BFF) MDI 320/10 μg via a single Aerosphere inhaler, or open-label budesonide/formoterol fumarate dihydrate dry powder inhaler 400/12 μg (BUD/FORM DPI; Symbicort Turbuhaler) twice-daily for 24 weeks. Efficacy outcomes included in this post-hoc analysis were change from baseline in morning pre-dose trough FEV1 over weeks 12–24 and the rate of moderate-to-severe and severe COPD exacerbations. Adverse events in the non-reversible subgroup are also reported. <b>Results:</b> Of 1896 patients analyzed, 948 (50%) were non-reversible and had EOS <300 cells/mm<sup>3</sup>. In this group, BGF significantly improved morning pre-dose trough FEV<sub>1</sub> versus BFF and BUD/FORM (least squares mean treatment difference, 95% confidence interval [CI] 69 mL [39, 99], unadjusted <i>p</i> < 0.0001 and 51 mL [20, 81], unadjusted <i>p</i> = 0.0011, respectively) and was comparable to GFF. BGF also significantly reduced annual moderate-to-severe exacerbation rates versus GFF (rate ratio [95% CI] 0.53 [0.37, 0.76], unadjusted <i>p</i> = 0.0005), with numerical reductions observed versus BFF and BUD/FORM. These results were similar for the overall study population. Safety findings were generally similar between non-reversible patients with EOS <300 cells/mm<sup>3</sup> and the overall population. <b>Conclusions:</b> In patients with moderate-to-very-severe COPD without airway reversibility and EOS <300 cells/mm<sup>3</sup>, BGF significantly improved morning pre-dose trough FEV1 versus BFF and BUD/FORM and significantly reduced the rate of moderate-to-severe exacerbations versus GFF. These findings demonstrate that BGF can provide benefits for a broad range of patients with COPD, and that the overall findings of the KRONOS primary analysis were not driven by patients with reversible airflow obstruction or high eosinophil counts. <b>Trial registration:</b> ClinicalTrials.gov, NCT02497001. Registered 14 July 2015, https://clinicaltrials.gov/ct2/show/NCT02497001
<b><i>Background:</i></b> The 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends regular bronchodilator therapy in all group A patients with chronic obstructive pulmonary disease (COPD). <b><i>Objective:</i></b> The aim of this study was to evaluate whether regular inhaled treatment in group A patients with COPD improves their health outcomes, including exacerbations and symptoms. <b><i>Methods:</i></b> We recruited patients from 2 Korean prospective cohorts. Eligible COPD patients had a modified Medical Research Council (mMRC) dyspnea score of <2, a St. George's Respiratory Questionnaire for COPD (SGRQ-C) total score of <25, and had no more than 1 exacerbation and no hospitalizations during the previous year. Incidence rates of exacerbations and changes in symptom scores were analyzed. <b><i>Results:</i></b> After propensity score matching, there were 107 patient pairs, with and without regular inhaled treatment, who were followed up for mean times of 2.6 and 3.1 years, respectively. The incidence rates of exacerbations in those with and without regular treatment were not significantly different (incidence rate ratio 1.24 [95% CI 0.68 to 2.25]). Significant differences in favor of regular treatment were observed at 6 and 12 months for the SGRQ-C total scores (mean between-group difference -4.7 [95% CI -7.9 to -1.6] and -4.8 [95% CI -7.9 to -1.7], respectively). Regular treatment with a long-acting bronchodilator was also associated with significantly better scores on the SGRQ-C (mean between-group difference -5.0 [95% CI -8.6 to -1.4]) compared to no regular treatment at 12 months of follow-up. <b><i>Conclusions:</i></b> Regular inhaled treatment in group A patients with COPD was associated with a symptomatic benefit but not with a reduction of exacerbation rates.
<b><i>Background:</i></b> Many studies have described asthma-COPD overlap (ACO) among patients diagnosed with asthma or chronic obstructive pulmonary disease (COPD), but less so in broad populations of patients with chronic airway obstruction. <b><i>Objective:</i></b> This study aimed to (i) examine the prevalence of ACO, asthma, and COPD phenotypes among subjects referred for pulmonary function testing (PFT), who had airway obstruction in spirometry (forced expiratory volume in 1 s [FEV<sub>1</sub>]/forced vital capacity [FVC] < 0.7); and (ii) delineate the therapeutic approach of each group. <b><i>Methods:</i></b> Cross-sectional study of patients who were referred for PFT at the Rokach Institute, in Jerusalem. Working definitions were as follows: (a) COPD: post-bronchodilator (BD) FEV<sub>1</sub>/FVC < 0.70; (b) asthma: physician-diagnosed asthma before age 40 and/or minimum post-BD increase in FEV<sub>1</sub> or FVC of 12% and 200 mL; and (c) ACO: the combination of the 2. Demographics, smoking habits, episodes of exacerbation, health-related quality of life (HRQL), and respiratory medication utilization were analysed. <b><i>Results:</i></b> Of 3,669 referrals from January 1 to April 30, 2017, 1,220 had airway obstruction of which 215 were included. Of these, 82 (38.1%) had ACO, 49 (22.8%) asthma, and 84 (39.1%) COPD. ACO subjects tended to (a) be predominantly female; (b) be older than asthmatics, (c) be smokers; (d) have worse HRQL in the activity domain; and (d) have more exacerbations. Treatment of ACO and COPD patients differed from that of asthmatics, but not from each other, in the proportion of subjects on maintenance treatment, use of LABA, LAMA, and ICS, alone or in combination, and in the number of inhaler devices used by patients. Conclusion: ACO represented > 1/3 of patients referred for PFT. Despite a clearly identifiable phenotype, ACO patients received treatment similar to COPD patients, suggesting poor ACO identification. Our data emphasize the need to raise the awareness of ACO among clinicians, in order to guide better recognition and appropriate treatment in individual patients.
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