Chronic obstructive pulmonary disease (COPD) in Spain and the different aspects of its social impact: a multidisciplinary opinion document.

Chronic obstructive pulmonary disease (COPD) is one of the most prevalent diseases in the World, and one of the most important causes of mortality and morbidity. In adults 40 years and older, it affects more than 10% of the population and has enormous personal, family and social burden. Tobacco smoking is its main cause, but not the only one, and there is probably a genetic predisposition that increases the risk in some patients. The paradigm of this disease is changing in Spain, with an increase of women that has occurred in recent years. Many of the physio pathological mechanisms of this condition are well known, but the psychological alterations to which it leads, the impact of COPD on relatives and caregivers, the limitation of daily life observed in these patients, and the economic and societal burden that they represent for the health system, are not so well-known. A major problem is the high under-diagnosis, mainly due to difficulties for obtaining, in a systematic way, spirometries in hospitals and health-care centers. For this reason, the Fundación de Ciencias de la Salud and the Spanish National Network Center for Research in Respiratory Diseases (CIBERES) have brought together experts in COPD, patients and their organizations, clinical psychologists, experts in health economics, nurses and journalists to obtain their opinion about COPD in Spain. They also discussed the scientific bibliometrics on COPD that is being carried out from the CIBERES and speculated on the future of this condition. The format of the meeting consisted in the discussion of a series of questions that were addressed by different speakers and discussed until a consensus conclusion was reached.

Geographic distribution of chronic obstructive pulmonary disease prevalence in Africa, Asia and Australasia.

OBJECTIVE: To visualise spatial data on chronic obstructive pulmonary disease (COPD) prevalence in Africa, Asia and Australasia using a Geographic Information System (GIS) inverse distance weighted (IDW) interpolation technique.DESIGN: Prevalence rates from population surveys on individuals aged ≥40, with spirometry-confirmed COPD, were searched systematically. The prevalence observed in 59 selected surveys and the geographic coordinates of the places where they were conducted informed a GIS computer programme. The prevalence was represented by an ascending chromatic scale (blue-green-yellow-orange-brown-red) in the GIS maps.RESULTS: IDW-interpolation GIS maps were obtained of all the geographic areas investigated, and even from regions lacking data. Areas of high/very high prevalence were found in: Southern Africa and in most of the Central and Eastern Africa regions; in practically all of Central Asia; in the western regions of Southern Asia; in the southern regions of the East European Plain and the West Siberian Plain of Northern Asia; and in the Malay Archipelago. Intermediate prevalence predominated in Oceania and in most of the other regions of Africa and Asia.CONCLUSION: Despite some biases inherent to the interpolation method used in the present study, our approach provided an understandable visual perspective of the COPD prevalence distribution in these geographic regions.

Correction to: Cost-effectiveness analysis of umeclidinium bromide/vilanterol 62.5/25 mcg versus tiotropium/olodaterol 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease: a Spanish National Healthcare System perspective.

Following publication of the original article [1], we have been notified of the below corrections to the 5th paragraph in the Discussion section.

Cost-effectiveness analysis of umeclidinium bromide/vilanterol 62.5/25 mcg versus tiotropium/olodaterol 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease: a Spanish National Healthcare System perspective.

BACKGROUND: A head-to-head study demonstrated the superiority of once-daily umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 mcg on trough forced expiratory volume in 1 s (FEV1) versus once-daily tiotropium/olodaterol (TIO/OLO) 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease (COPD). This analysis evaluated the cost effectiveness of UMEC/VI versus TIO/OLO from a Spanish National Healthcare System perspective, using data from this study and Spanish literature. METHODS: This analysis was conducted from the perspective of the Spanish National Healthcare System with a 3-year horizon as base case. A disease progression model using a linked risk equation approach was used to estimate disease progression and associated healthcare costs, and quality-adjusted life years (QALYs). The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study was used to develop the statistical risk equations for clinical endpoints, and costs were calculated using a health state approach (by dyspnea severity). Utilities for QALY calculation were estimated using patient baseline characteristics within a regression fit to Spanish observational data. Treatment effect, expressed as change from baseline in FEV1 was obtained from the head-to-head study and used in the model (UMEC/VI minus TIO/OLO difference: + 52 mL [95% confidence interval: 28, 77]). Baseline patient characteristics were sourced from Spanish literature or the head-to-head study if unavailable. A scenario analysis using only the intent-to-treat (ITT) population from the head-to-head study, and sensitivity analyses (including probabilistic sensitivity analyses), were conducted. Direct healthcare costs (2017 Euro) were obtained from Spanish sources and costs and benefits were discounted at 3% per annum. RESULTS: UMEC/VI was associated with small improvements in QALYs (+ 0.029) over a 3-year time horizon, compared with TIO/OLO, alongside cost savings of €393/patient. The ITT scenario analysis and sensitivity analyses had similar results. All probabilistic simulations resulted in UMEC/VI being less costly and more effective than TIO/OLO. CONCLUSION: UMEC/VI dominated TIO/OLO (more effective and less expensive). These results may aid payers and decision-makers in Spain when making judgements on which long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) treatments can be considered cost effective in Spain.

Diagnosis of alpha1-antitrypsin deficiency not just in severe COPD.

Alpha1-antitrypsin deficiency (AATD) is a well known genetic risk factor for pulmonary disease and is the most frequent hereditary disease diagnosed in adults. Despite being one of the most common hereditary diseases, AATD remains under-diagnosed because of its variable clinical presentation and the poor knowledge of this disease by physicians. With the aim of identifying clinical differences that could influence early diagnosis, we compared two groups of six AATD Pi*ZZ patients with different lung function severity and clinical expression at diagnosis. On comparing the two groups, we observed a younger mean age at diagnosis and more exacerbations in the severe group, but the percentage of smokers did not statistically differ between the two groups. Our results suggest that AATD continues being a disease suspected on younger patients with a worse lung function. In addition these findings confirm the clinical variability of the disease and that there are still unknown factors that contribute to its development. Therefore, early diagnosis may modify the prognosis of this disease.

Combining case-finding methods for COPD in primary care: a large, two-stage design study.

BACKGROUND: Underdiagnosis of chronic obstructive pulmonary disease (COPD) is common. We aimed to assess the effectiveness of using the Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS) questionnaire with pre-bronchodilator (BD) peak expiratory flow (PEF) measurements as a case-finding strategy for COPD in primary care. METHODS: This was a two-stage, cross-sectional study comprising a population survey in a primary care population aged 35 years without previous COPD, followed by a validation study using COPD-PS 4 or PEF 2.2 l/s·m2, and confirmed by spirometry (post-BD forced expiratory volume in 1 s/forced vital capacity [FEV1/FVC] <0.70). The predictive capacity of the strategy was assessed in a case-control sub-study. RESULTS: Of a total of 10 071 individuals, 6969 (69.2%) participants were included. Both tests were positive in 4.3% subjects, PEF only in 2.1% and COPD-PS only in 5.1%. Of the 802 with positive screening results, COPD was confirmed using spirometry in 130, accounting for 1.9% of all participants and 16.2% of those who tested positive on COPD-PS or PEF. Among the 130 true-positives, the mean score for the COPD-PS questionnaire was 5.1 l/s·m2 (± standard deviation [SD] 1.7) and 1.9 l/s·m2 (±SD 0.8) for pre-BD PEF, both significantly worse than in the 672 false-positives. The combined use of both screening tests had a sensitivity of 67.5%, a specificity of 71.3% and a diagnostic accuracy of 69.6%. CONCLUSION: Case finding for COPD using COPD-PS + PEF led to a 90% reduction in the number of spirometry tests performed.

Medicina basada en la no-evidencia: el ejemplo del uso de los corticosteroides sistémicos en la agudización de la EPOC / Non-evidence based medicine: example of the use of systemic corticosteroids in exacerbation of COPD

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Prevention of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline

This document provides clinical recommendations for the prevention of chronic obstructive pulmonary disease (COPD) exacerbations. It represents a collaborative effort between the European Respiratory Society and the American Thoracic Society.Comprehensive evidence syntheses were performed to summarise all available evidence relevant to the Task Force's questions. The evidence was appraised using the Grading of Recommendations, Assessment, Development and Evaluation approach and the results were summarised in evidence profiles. The evidence syntheses were discussed and recommendations formulated by a multidisciplinary Task Force of COPD experts.After considering the balance of desirable (benefits) and undesirable consequences (burden in the form of adverse effects and cost), quality of evidence, feasibility, and acceptability of various interventions, the Task Force made recommendations for mucolytic, long-acting muscarinic antagonist, phosphodiesterase-4 inhibitor (roflumilast) and macrolide therapy, as well as a conditional recommendation against fluoroquinolone therapy. All of the recommendations were conditional, except for a strong recommendation for the use of a long-acting antimuscarinic agent versus a long-acting ß2-adrenergic, indicating that there was uncertainty about the balance of desirable and undesirable consequences of the intervention, and that well-informed patients may make different choices regarding whether to have or not have the specific intervention.The guideline summarises the evidence and provides recommendations for pharmacological therapy for the prevention of COPD exacerbations

Fiabilidad del registro del diagnóstico de la enfermedad pulmonar obstructiva crónica en Atención Primaria / Reliability of a chronic obstructive pulmonary disease diagnosis register in Primary Care

Introducción/objetivo. Una de las principales limitaciones en los estudios sobre la EPOC en bases de datos sanitarias podría ser la baja calidad de la información contenida en ellas. Nuestro principal objetivo fue evaluar la fiabilidad del diagnóstico de EPOC en Atención Primaria. En segundo término, describir las características de los pacientes en función de la conformidad del diagnóstico. Material y métodos. Estudio transversal usando bases de datos sanitarias de Cantabria. De una muestra preseleccionada se obtuvieron 1.457 pacientes etiquetados con EPOC en la historia clínica. Se verificó el diagnóstico en las mismas bases de datos y se crearon 3 grupos: EPOC-confirmada, EPOC no confirmada-no descartada y error-diagnóstico. Fueron recogidas variables descriptivas, clínicas, comorbilidades y tratamientos. Resultados. El diagnóstico de EPOC fue confirmado en 766 pacientes: 52,6% (IC 95%: 50,0-55,2). La frecuencia del error-diagnóstico fue del 7,2% (IC 95%: 5,8-8,6). El porcentaje de este sobrediagnóstico fue mayor en mujeres. La edad, el hábito tabáquico, la severidad en función del FEV1 y la frecuencia y gravedad de las agudizaciones fueron mayores en el grupo de EPOC-confirmada (p<0,001). En los errores-diagnósticos se registraron una media de 1,95 episodios en los últimos 4 años. Los corticoides inhalados estaban prescritos en el 76,9% de los pacientes con EPOC-confirmada y en el 41,9% de los errores-diagnósticos. Conclusiones. La fiabilidad del registro del diagnóstico de EPOC fue deficiente, con solo un 52,6% de certeza diagnóstica. En todos los grupos constó la prescripción de tratamientos para la EPOC de forma estable, destacando el uso de corticoides inhalados (AU)

Introduction/objective. One of main limitations in studies of COPD in health databases could be the low quality of the information. Our first aim was evaluate reliability of the registry of COPD diagnosis register in Primary Care. A description and comparison is also presented of the characteristics of the patients according to the diagnostic confirmation. Material and methods. A cross-sectional study using healthcare databases of Cantabria. A pre-selected sample of 1,457 patients was obtained in which COPD diagnosis was specifically registered. COPD confirmation was classified into confirmed COPD, not confirmed-not rejected COPD, and diagnostic error (over-diagnosis). Descriptive and clinical characteristics, comorbidities, and treatments were collected in each group. Results. COPD was confirmed in 766 patients: 52.6% (95%CI: 49.9-55.2). Prevalence of over-diagnosis was 7.2% (95%CI: 5.9-8.6). There were statistically significant gender differences. In the COPD confirmed group age, tobacco consumption and severity according to FEV1 was higher. An average of 1.95 bronchial exacerbations during the last 4years was observed among diagnostic errors. Inhaled corticosteroids were prescribed in 74.9% of COPD confirmed patients, and in 41.9% of over-diagnosed patients. Conclusions. The reliability of the COPD register was deficient, with only 52.6% with a confirmed diagnosis. Stable treatment for COPD was prescribed in all groups, highlighting the use of inhaled corticosteroids (AU)

Guía española de la enfermedad pulmonar obstructiva crónica (GesEPOC) 2017: tratamiento farmacológico en fase estable / Spanish guidelines for management of chronic obstructive pulmonary disease (GesEPOC) 2017: pharmacological treatment of stable phase

La enfermedad pulmonar obstructiva crónica (EPOC) presenta una gran heterogeneidad clínica, por lo que su tratamiento se debe individualizar según el nivel de riesgo y el fenotipo. La Guía española de la EPOC (GesEPOC) estableció por primera vez en 2012 unas pautas de tratamiento farmacológico basadas en fenotipos clínicos. Estas pautas han sido adoptadas posteriormente por otras normativas nacionales, y han sido respaldadas por nuevas evidencias publicadas desde entonces. En esta actualización 2017 se ha sustituido la clasificación de gravedad inicial por una clasificación de riesgo mucho más sencilla (bajo o alto riesgo), basándose en la función pulmonar, el grado de disnea y la historia de agudizaciones, y se recomienda la determinación del fenotipo clínico únicamente en pacientes de alto riesgo. Se mantienen los mismos fenotipos clínicos: no agudizador, EPOC-asma (ACO), agudizador con enfisema y agudizador con bronquitis crónica. La base del tratamiento farmacológico de la EPOC es la broncodilatación, y también es el único tratamiento recomendado en pacientes de bajo riesgo. En los pacientes con alto riesgo se añadirán diversos fármacos a los broncodilatadores según el fenotipo clínico. GesEPOC supone una aproximación al tratamiento de la EPOC más individualizado según las características clínicas de los pacientes y su nivel de riesgo o de complejidad.(AU)

The clinical presentation of chronic obstructive pulmonary disease (COPD) varies widely, so treatment must be tailored according to the level of risk and phenotype. In 2012, the Spanish COPD Guidelines (GesEPOC) first established pharmacological treatment regimens based on clinical phenotypes. These regimens were subsequently adopted by other national guidelines, and since then, have been backed up by new evidence. In this 2017 update, the original severity classification has been replaced by a much simpler risk classification (low or high risk), on the basis of lung function, dyspnea grade, and history of exacerbations, while determination of clinical phenotype is recommended only in high-risk patients. The same clinical phenotypes have been maintained: non-exacerbator, asthma-COPD overlap (ACO), exacerbator with emphysema, and exacerbator with bronchitis. Pharmacological treatment of COPD is based on bronchodilators, the only treatment recommended in low-risk patients. High-risk patients will receive different drugs in addition to bronchodilators, depending on their clinical phenotype. GesEPOC reflects a more individualized approach to COPD treatment, according to patient clinical characteristics and level of risk or complexity.(AU)

Is aclidinium alone or combined with a LABA a rational choice for symptomatic COPD patients?

BACKGROUND: As emphasized by international recommendations and largely confirmed by clinical experience, long-acting bronchodilators play a central role in the maintenance treatment of chronic obstructive pulmonary disease (COPD) due to their proven efficacy in reducing airflow obstruction and improving symptoms. MAIN BODY: There are some important aspects to define with regard to inhalation therapy for COPD, particularly those concerning the selection criteria and the optimal use of long-acting bronchodilators. First of all, it needs to be determined in which patients and clinical situations monotherapy with one bronchodilator, such as a long-acting muscarinic antagonist (LAMA), should be considered adequate, and in which cases the use of combination therapies, such as the "double bronchodilation" with a LAMA and a long-acting ß2-agonist (LABA), should be preferred. Another critical issue concerns the effect of the frequency of daily administration of inhaled agents on the control of symptoms during the 24 h. COPD symptoms are known to exhibit considerable circadian variability with worsening in the early morning, and a significant proportion of patients have disease-related sleep disorders which can adversely affect their quality of life. The worsening of symptoms in the early morning may be due, at least in part, to a reduction in airway caliber caused by an increased "cholinergic tone" at night. As such, the coverage of nighttime and early morning symptoms is a reasonable therapeutic goal, which can be achieved by many patients using LAMAs such as aclidinium bromide twice daily (BID). Therapeutic adherence is known to be a multifactorial phenomenon that is frequently affected by other aspects than dosing frequency, including the technical features and ease of use of the inhalers. To this end, it should be mentioned that certain new-generation inhalers such as Genuair® have been associated in clinical trials with higher patient preference. CONCLUSION: In this work, in addition to presenting an overview of the main evidence on the efficacy of COPD treatment with the LAMA aclidinium bromide BID, we suggest some selection criteria for the monotherapy with one long-acting bronchodilator or the combination therapy with LAMA and LABA in COPD patients, with particular reference to specific clinical scenarios.

[Reliability of a chronic obstructive pulmonary disease diagnosis register in Primary Care]. / Fiabilidad del registro del diagnóstico de la enfermedad pulmonar obstructiva crónica en Atención Primaria.

INTRODUCTION/OBJECTIVE: One of main limitations in studies of COPD in health databases could be the low quality of the information. Our first aim was evaluate reliability of the registry of COPD diagnosis register in Primary Care. A description and comparison is also presented of the characteristics of the patients according to the diagnostic confirmation. MATERIAL AND METHODS: A cross-sectional study using healthcare databases of Cantabria. A pre-selected sample of 1,457 patients was obtained in which COPD diagnosis was specifically registered. COPD confirmation was classified into confirmed COPD, not confirmed-not rejected COPD, and diagnostic error (over-diagnosis). Descriptive and clinical characteristics, comorbidities, and treatments were collected in each group. RESULTS: COPD was confirmed in 766 patients: 52.6% (95%CI: 49.9-55.2). Prevalence of over-diagnosis was 7.2% (95%CI: 5.9-8.6). There were statistically significant gender differences. In the COPD confirmed group age, tobacco consumption and severity according to FEV1 was higher. An average of 1.95 bronchial exacerbations during the last 4years was observed among diagnostic errors. Inhaled corticosteroids were prescribed in 74.9% of COPD confirmed patients, and in 41.9% of over-diagnosed patients. CONCLUSIONS: The reliability of the COPD register was deficient, with only 52.6% with a confirmed diagnosis. Stable treatment for COPD was prescribed in all groups, highlighting the use of inhaled corticosteroids.

Características de los casos incluidos en el Registro Español de Pacientes con déficit de alfa-1 antitripsina / Profiles of cases included in the Spanish registry of patients with alpha-1 antitrypsin deficiency

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