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Marc Miravitlles,1 Miguel Roman-Rodríguez,2,3 Xavier Ribera,4 John Ritz,5 José Luis Izquierdo6,7 On behalf of OPTI investigator’s group1Pneumology Department, Hospital Universitari Vall d´Hebron/Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain; 2Centro de Salud Dra. Teresa Pique, Mallorca, Spain; 3Instituto de Investigación Sanitaria de las Islas Baleares (IdISBa), Mallorca, Spain; 4Boehringer Ingelheim España, Sant Cugat del Vallés, Barcelona, Spain; 5Syneos Health - Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA; 6Department of Medicine and Medical Specialties, Universidad de Alcalá, Madrid, Spain; 7Pneumology Department, Hospital Universitario de Guadalajara, Guadalajara, SpainCorrespondence: Marc Miravitlles,Pneumology Department, Hospital Universitari Vall d’Hebron, P. Vall d’Hebron 119-129, Barcelona, ES– 08035, Spain, Email marcm@separ.esPurpose: Inhaled corticosteroids (ICS) are frequently used to treat chronic obstructive pulmonary disease (COPD) outside the current recommendations. Our aim was to describe ICS use in COPD patients and to identify factors associated with ICS use among COPD patients treated within primary care in Spain.Patients and Methods: This was a cross-sectional, non-interventional and multicenter study of patients with COPD treated in primary care. Patient characteristics and exacerbations were described in terms of ICS use among the overall cohort, and among those with spirometry confirmed COPD (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] ratio < 70%). Multivariable logistic regression was used to identify factors associated with ICS use.Results: A total of 901 patients were included, of which 47.9% (n = 432) were treated with ICS. A total of 240 patients (26.6%) experienced moderate/severe exacerbations in the prior year, while 309 (34.3%) during the previous two years. History of asthma totaled 11.6% (n = 105). The most frequent phenotype was non-exacerbator (51.6%), and the proportion of patient with moderate or severe exacerbations was significantly higher among ICS treated patients compared to non-treated: 37.5% versus 16.6% during the previous year (p < 0.001), and 46.8% versus 22.8% during the previous 2-years (p < 0.001), respectively. Patient characteristics were similar among spirometry confirmed patients and the overall population. Factors significantly associated with ICS use were a history of asthma (OR = 4.39, 95% CI: 2.67– 7.26), the presence of moderate or severe exacerbations in the last year (OR = 2.52, 95% CI: 1.81– 3.49), followed by higher mMRC and higher CAT score.Conclusion: Nearly half of patients in primary care in Spain are treated with ICS, despite most of them being non-exacerbators. History of asthma, exacerbations, and worse dyspnea and CAT scores are associated with ICS use.Keywords: chronic obstructive pulmonary disease, primary care, inhaled corticosteroids, exacerbations

Additional file 2: Table A1. Search strategy in MEDLINE (through PubMed), CENTRAL and EMBASE.

Additional file 1: Fig A1. Bias risk assessment.

Additional file 1: Supplementary material.

The Spanish COPD Guidelines (GesEPOC) were first published in 2012, and since then have undergone a series of updates incorporating new evidence on the diagnosis and treatment of COPD. GesEPOC was drawn up in partnership with scientific societies involved in the treatment of COPD and the Spanish Patients' Forum. Their recommendations are based on an evaluation of the evidence using GRADE methodology, and a narrative description of the evidence in areas in which GRADE cannot be applied. In this article, we summarize the recommendations on the pharmacological treatment of stable COPD based on 9 PICO questions. COPD treatment is a 4-step process: 1) diagnosis, 2) determination of the risk level, 3) initial and subsequent inhaled therapy, and 4) identification and management of treatable traits. For the selection of inhaled therapy, high-risk patients are divided into 3 phenotypes: non-exacerbator, eosinophilic exacerbator, and non-eosinophilic exacerbator. Some treatable traits are general and should be investigated in all patients, such as smoking or inhalation technique, while others affect severe patients in particular, such as chronic hypoxemia and chronic bronchial infection. COPD treatment is based on long-acting bronchodilators with single agents or in combination, depending on the patient's risk level. Eosinophilic exacerbators must receive inhaled corticosteroids, while non-eosinophilic exacerbators require a more detailed evaluation to choose the best therapeutic option. The new GesEPOC also includes recommendations on the withdrawal of inhaled corticosteroids and on indications for alpha-1 antitrypsin treatment. GesEPOC offers a more individualized approach to COPD treatment tailored according to the clinical characteristics of patients and their level of complexity.

We aimed to describe the effectiveness and safety of inhaled antibiotics in chronic obstructive pulmonary disease (COPD) patients, as well as the patient profile in which they are usually prescribed and the patient groups that can most benefit from this treatment.

Screening of liver disease in alpha-1 antitrypsin deficiency (AATD) is usually carried out with liver enzymes, with low sensitivity. We conducted a multicenter cross-sectional study aiming to describe the utility of transient elastography for the identification of liver disease in patients with AATD. A total of 148 AATD patients were included. Among these, 54.7% were Pi*ZZ and 45.3% were heterozygous for the Z allele. Between 4.9% and 16.5% of patients had abnormal liver enzymes, without differences among genotypes. Liver stiffness measurement (LSM) was significantly higher in Pi*ZZ individuals than in heterozygous Z (5.6 vs. 4.6 kPa, p = 0.001). In total, in 8 (5%) individuals LSM was &gt, 7.5 kPa, considered significant liver fibrosis, and ≥10 kPa in 3 (1.9%) all being Pi*ZZ. Elevated liver enzymes were more frequently observed in patients with LSM &gt, 7.5 kPa, but in 5 out of 8 of these patients all liver enzymes were within normal range. In patients with AATD, the presence of abnormal liver enzymes is frequent, however, most of these patients do not present significant liver fibrosis. Transient elastography can help to identify patients with liver fibrosis even with normal liver enzymes and should be performed in all Z-allele carriers to screen for liver disease.

Additional file 1: Figure S1. Kaplan–Meier plot of time to leaving the database. Figure S2. Time to first exacerbation in those with 0 or 1 exacerbation and 2+ exacerbations during the baseline year. Figure S3. Time to first exacerbation in those with mild or moderate COPD and those with severe or very severe COPD, based on GOLD categories. Figure S4. Time to first exacerbation in those with a diagnosis of asthma prior to the baseline year and to those who have never received an asthma diagnosis. Figure S5. Time to first exacerbation in those with a baseline blood eosinophil level

Additional file 1: Supplementary Table 1. Patients with FEV1 decline or SGRQ increase 6, 12, 18, 24, 30, 36, 42, and 48 months after the first confirmed FEV1 decline or SGRQ increase by GOLD 2, GOLD 3, and GOLD 4. Supplementary Table 2. Patients with FEV1 decline or SGRQ deterioration in the total UPLIFT population 6, 12, 18, 24, 30, 36, 42, and 48 months after the initial unconfirmed FEV1 decline or SGRQ deterioration. Supplementary Table 3. Risk of exacerbation or death by unconfirmed clinically important deterioration status at Months 6 and 12. Supplementary Table 4. Risk of exacerbation or death by confirmed clinically important deterioration status at Month 6 in the tiotropium and placebo arms, and at Month 12 in the tiotropium and placebo arms and total population. Supplementary Table 5. Risk of exacerbation or death by confirmed clinically important deterioration status calculated using clinically important deterioration event as a time-varying covariate. Supplementary Table 6. Patients with FEV1 decline or SGRQ deterioration in the total UPLIFT population 6, 12, 18, 24, 30, 36, and 42 months after the initial confirmed FEV1 decline or SGRQ deterioration: Tiotropium and placebo. Supplementary Table 7. Timing of FEV1 decline and SGRQ deterioration relative to each other in the tiotropium and placebo arms. Supplementary Figure 1. Time to first event for (A) trough FEV1 decline ≥100 mL, (B) SGRQ increase ≥4 units and (C) moderate/severe exacerbation.

Currently, chronic obstructive pulmonary disease (COPD) patients and their physicians face a number of significant clinical challenges, one of which is the high degree of uncertainty related to chronic bronchial infection (CBI). By reviewing the current literature, several challenges can be identified, which should be considered as goals for research. One of these is to establish the bases for identifying the biological and clinical implications of the presence of potentially pathogenic microorganisms in the airways that should be more clearly elucidated according to the COPD phenotype. Another urgent area of research is the role of long-term preventive antibiotics. Clinical trials need to be carried out with inhaled antibiotic therapy to help clarify the profile of those antibiotics. The role of inhaled corticosteroids in patients with COPD and CBI needs to be studied to instruct the clinical management of these patients. Finally, it should be explored and confirmed whether a suitable antimicrobial treatment during exacerbations may contribute to breaking the vicious circle of CBI in COPD. The present review addresses the current state of the art in these areas to provide evidence which will enable us to progressively plan better healthcare for these patients. Yes

Additional file 1. Tiotropium in chronic obstructive pulmonary disease – a review of clinical development. An infographic that provides a summary of the clinical trial results of tiotropium in chronic obstructive pulmonary disease

Observational studies indicate that overutilization of inhaled corticosteroids (ICS) is common in patients with chronic obstructive pulmonary disease (COPD). Overprescription and the high risk of serious ICS-related adverse events make withdrawal of this treatment necessary in patients for whom the treatment-related risks outweigh the expected benefits. Elaboration of an optimal, universal, user-friendly algorithm for withdrawal of ICS therapy has been identified as an important clinical need. This article reviews the available evidence on the efficacy, risks, and indications of ICS in COPD, as well as the benefits of ICS treatment withdrawal in patients for whom its use is not recommended by current guidelines. After discussing proposed approaches to ICS withdrawal published by professional associations and individual authors, we present a new algorithm developed by consensus of an international group of experts in the field of COPD. This relatively simple algorithm is based on consideration and integrated assessment of the most relevant factors (markers) influencing decision-making, such a history of exacerbations, peripheral blood eosinophil count, presence of infection, and risk of community-acquired pneumonia.

This epidemiological study aimed to describe and compare the characteristics and outcomes of COPD patients starting treatment with a long-acting anti-muscarinic (LAMA) or a combination of a long-acting beta-2 agonist (LABA)/LAMA in primary care in Catalonia (Spain) over a one-year period. Data were obtained from the Information System for the Development in Research in Primary Care (SIDIAP), a population database containing information of 5.8 million inhabitants (80% of the population of Catalonia). Patients initiating treatment with a LAMA or LABA/LAMA in 2015 were identified, and information about demographic and clinical characteristics was collected. Then, patients were matched 1:1 for age, sex, FEV1%, history of exacerbations, history of asthma and duration of treatment, and the outcomes between the two groups were compared. During 2015, 5729 individuals with COPD started treatment with a LAMA (69.8%) or LAMA/LABA (30.2%). There were no remarkable differences between groups except for a lower FEV1 and more previous hospital admissions in individuals on LABA/LAMA. The number of tests and referrals was low and decreased in both groups during follow-up. For the same severity status, the evolution was similar with a reduction in exacerbations in both groups. Treatment was changed during follow-up in up to 34.2% of patients in the LABA/LAMA and 26.3% in the LAMA group, but adherence was equally good for both. Our results suggest that initial therapy with LAMA in monotherapy may be adequate in a significant group of mild to moderate patients with COPD and a low risk of exacerbations managed in primary care., Chronic lung disease: Simple and effective treatment A single rather than combined long-acting inhaler therapy may be adequate for most patients when treating mild to moderate chronic lung disease. Marc Miravitlles at the Hospital Universitari Vall d’Hebron, Barcelona, Spain, and co-workers have shown that, in the initial stages of chronic obstructive pulmonary disease (COPD), treatment with an inhaled drug called a long-acting anti-muscarinic agent (LAMA) is as effective as an alternative inhaler that combines LAMA with another drug (LABA). The researchers identified 5729 COPD patients from Catalonia starting on inhaled treatment in 2015 and followed up on their progress after 1 year. Patients starting on LAMA monotherapy were matched closely in terms of demographics and previous medical history to those starting on LAMA/LABA treatment. The team found no remarkable differences in clinical characteristics between the groups over the year.

Ignacio Blanco,1 Isidro Diego,2 Patricia Bueno,3 Eloy Fernández,4 Francisco Casas-Maldonado,5 Cristina Esquinas,6 Joan B Soriano,7 Marc Miravitlles6 1Alpha1-Antitrypsin Deficiency Spanish Registry, Lung Foundation Breathe, Spanish Society of Pneumology, Barcelona, 2Materials and Energy Department, School of Mining Engineering, Oviedo University, 3Internal Medicine Department, County Hospital of Jarrio, 4Clinical Analysis Laboratory, University Hospital of Cabueñes, Principality of Asturias, 5Pneumology Department, University Hospital San Cecilio, Granada, 6Pneumology Department, Hospital Universitari Vall d’Hebron, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, 7Instituto de Investigación Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, Spain Abstract: Existing data on COPD prevalence are limited or totally lacking in many regions of Europe. The geographic information system inverse distance weighted (IDW) interpolation technique has proved to be an effective tool in spatial distribution estimation of epidemiological variables, when real data are few and widely separated. Therefore, in order to represent cartographically the prevalence of COPD in Europe, an IDW interpolation mapping was performed. The point prevalence data provided by 62 studies from 19 countries (21 from 5 Northern European countries, 11 from 3 Western European countries, 14 from 5 Central European countries, and 16 from 6 Southern European countries) were identified using validated spirometric criteria. Despite the lack of data in many areas (including all regions of the eastern part of the continent), the IDW mapping predicted the COPD prevalence in the whole territory, even in extensive areas lacking real data. Although the quality of the data obtained from some studies may have some limitations related to different confounding factors, this methodology may be a suitable tool for obtaining epidemiological estimates that can enable us to better address this major public health problem. Keywords: epidemiology, geographic information system, GIS, Geographic Resources Analysis Support System

The Appendix. (DOCX 90 kb)

Prescribing patterns in chronic obstructive pulmonary disease (COPD) are often inconsistent with published guidelines. This retrospective, observational study utilised data from the Optimum Patient Care Research Database to examine the changes in COPD prescribing patterns over time and to identify predictors of physician treatment choice for patients newly diagnosed with COPD. Initial therapy was defined as the treatment(s) prescribed at or within 1 year before COPD diagnosis. Changes over time were assessed in three cohorts based on the date of diagnosis: (1) 1997-2001; (2) 2002-2006; and (3) 2007-2010. Factors affecting the odds of being prescribed any initial therapy or any initial maintenance therapy were identified by univariable and multivariable logistic regression. The analysis included 20,154 patients, 45% of whom were prescribed an initial regimen containing an inhaled corticosteroid (ICS), whereas 28% received no initial pharmacological treatment. Prescribing of ICS monotherapy decreased over time, as did the proportion of patients receiving no therapy at or within 1 year before diagnosis. Comorbid asthma, a high exacerbation rate, increased symptoms and poor lung function each increased the likelihood of being prescribed any initial therapy or initial maintenance therapy; comorbid asthma and an annual rate of ⩾3 exacerbations were the strongest predictors. In conclusion, our analyses revealed major differences between actual prescribing behaviour and guideline recommendations for patients with newly diagnosed COPD, with many patients receiving no treatment and large numbers of patients receiving ICS-containing regimens. Predictors of initial therapy were identified.

Detailed search strategy. (DOCX 14 kb)

Characteristics of the included studies. (DOCX 121 kb)

Detailed search strategy. (DOCX 14 kb)

This document provides clinical recommendations for treatment of chronic obstructive pulmonary disease (COPD) exacerbations. Comprehensive evidence syntheses, including meta-analyses, 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 and undesirable consequences, quality of evidence, feasibility, and acceptability of various interventions, the Task Force made: 1) a strong recommendation for noninvasive mechanical ventilation of patients with acute or acute-on-chronic respiratory failure; 2) conditional recommendations for oral corticosteroids in outpatients, oral rather than intravenous corticosteroids in hospitalised patients, antibiotic therapy, home-based management, and the initiation of pulmonary rehabilitation within 3 weeks after hospital discharge; and 3) a conditional recommendation against the initiation of pulmonary rehabilitation during hospitalisation. The Task Force provided recommendations related to corticosteroid therapy, antibiotic therapy, noninvasive mechanical ventilation, home-based management, and early pulmonary rehabilitation in patients having a COPD exacerbation. These recommendations should be reconsidered as new evidence becomes available.

Pere Almagro,1 Sergi Yun,1 Ana Sangil,1 Mónica Rodríguez-Carballeira,1 Meritxell Marine,1 Pedro Landete,2 Juan José Soler-Cataluña,3 Joan B Soriano,4 Marc Miravitlles5 1Multimorbidity Patients Unit, Internal Medicine Department, Hospital Universitario Mutua de Terrassa, Universidad de Barcelona, Terrassa, Barcelona, 2Department of Pneumology, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, 3Department of Pneumology, Hospital Arnau de Vilanova-Lliria, Valencia, 4Instituto de Investigación Hospital Universitario de la Princesa (IISP), Universidad Autónoma de Madrid, Madrid, 5Department of Pneumology, Vall d’Hebron University Hospital, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain Abstract: Current recommendations to consider initiation of palliative care (PC) in COPD patients are often based on an expected poor prognosis. However, this approach is not evidence-based, and which and when COPD patients should start PC is controversial. We aimed to assess whether current suggested recommendations for initiating PC were sufficiently reliable. We identified prognostic variables proposed in the literature for initiating PC; then, we ascertained their relationship with 1-year mortality, and finally, we validated their utility in our cohort of 697 patients hospitalized for COPD exacerbation. From 24 articles of 499 screened, we selected 20 variables and retrieved 48 original articles in which we were able to calculate the relationship between each of them and 1-year mortality. The number of studies where 1-year mortality was detailed for these variables ranged from 9 for previous hospitalizations or FEV1 ≤30% to none for albumin ≤25mg/dL. The percentage of 1-year mortality in the literature for these variables ranged from 5% to 60%. In the validation cohort study, the prevalence of these proposed variables ranged from 8% to 64%; only 10 of the 18 variables analyzed in our cohort reached statistical significance with Cox regression analysis, and none overcame an area under the curve ≥0.7. We conclude that none of the suggested criteria for initiating PC based on an expected poor vital prognosis in COPD patients in the short or medium term offers sufficient reliability, and consequently, they should be avoided as exclusive criteria for considering PC or at least critically appraised. Keywords: COPD, palliative care, prognosis, mortality, survival, end of life

Characteristics of the included studies. (DOCX 121 kb)

Miriam Barrecheguren,1,2 Mónica Monteagudo,3 Pere Simonet,3–5 Carl Llor,6 Esther Rodriguez,1,7 Jaume Ferrer,1,2,7 Cristina Esquinas,1 Marc Miravitlles1,2,7 1Department of Pneumology, Vall d´Hebron University Hospital, 2Medicine Department, Autonomous University of Barcelona (UAB), 3IDIAP Jordi Gol, 4Departament Ciències Clíniques, Universitat de Barcelona, Barcelona, 5Primary Care Centre Viladecans-2, Viladecans, 6Primary Care Centre Via Roma, Barcelona, 7CIBER of Respiratory Diseases (CIBERES), Spain Introduction: Alpha-1 antitrypsin deficiency (AATD) remains an underdiagnosed condition despite initiatives developed to increase awareness. The objective was to describe the current situation of the diagnosis of AATD in primary care (PC) in Catalonia, Spain.Methods: We performed a population-based study with data from the Information System for Development in Research in Primary Care, a population database that contains information of 5.8 million inhabitants (80% of the population of Catalonia). We collected the number of alpha-1 antitrypsin (AAT) determinations performed in the PC in two periods (2007–2008 and 2010–2011) and described the characteristics of the individuals tested.Results: A total of 12,409 AAT determinations were performed (5,559 in 2007–2008 and 6,850 in 2010–2011), with 10.7% of them in children. As a possible indication for AAT determination, 28.9% adults and 29.4% children had a previous diagnosis of a disease related to AATD; transaminase levels were above normal in 17.7% of children and 47.1% of adults. In total, 663 (5.3%) individuals had intermediate AATD (50–100mg/dL), 24 (0.2%) individuals had a severe deficiency (

Supplementary material. Table S1. Comparison of guidelines and recommendations definitions of exacerbations of COPD. Table S2. Comparison of guidelines and recommendations assessment of exacerbation risk. (DOCX 30Â kb)

Carlos Roncero,1 Ana Isabel Campuzano,2 Jose Antonio Quintano,3 Jesús Molina,4 Joselín Pérez,2 Marc Miravitlles51Addiction and Dual Diagnosis Unit, Psychiatry Department, Vall d’Hebron Hospital-ASPB. Ciber de Salud Mental (CIBERSAM) and Department of Psychiatry and Legal Medicine, Universidad Autónoma de Barcelona, Barcelona, Spain; 2Medical Department, Grupo Ferrer, Barcelona,Spain; 3Primary Care Center Lucena I, Lucena, Cordoba, Spain; 4Primary Care Center Francia, Dirección Asistencial Oeste, Madrid, Spain; 5Department of Pneumology, Hospital Universitari Vall d’Hebron. Ciber de Enfermedades Respiratorias (CIBERES), Barcelona, SpainPurpose: We investigated the association between cognitive impairment and chronic obstructive pulmonary disease (COPD), taking into account demographic and clinical variables evaluated during routine practice.Patients and methods: We performed a post hoc analysis of a cross-sectional study that included subjects with stable COPD. Sociodemographic and clinical information was recorded using the Body mass index, airflow Obstruction, Dyspnea and Exacerbations index and the Charlson comorbidity index. Cognitive performance was studied by the mini-mental state examination, with a score less than 27 indicating clinical impairment. Depressive symptoms, physical activity, and quality of life (EuroQoL-5 dimensions and COPD Assessment Test) were also evaluated.Results: The analysis included 940 subjects. The prevalence of cognitive impairment was 39.4%. Multivariate logistic regression models revealed that cognitive impairment was associated with educational level (odds ratio [OR] =0.096, 95% confidence interval [CI] =0.011–0.447) and poorer quality of life measured by the EuroQoL-5 dimensions social tariff (OR =0.967, 95% CI=0.950–0.983). When questionnaires were not included in the analysis, cognitive impairment was associated with educational level (OR =0.063, 95% CI =0.010–0.934), number of exacerbations (OR =11.070, 95% CI =1.450–84.534), Body mass index, airflow Obstruction, Dyspnea and Exacerbations index score (OR =1.261, 95% CI =1.049–1.515), and the Charlson comorbidity index (OR =1.412, 95% CI =1.118–1.783).Conclusion: Cognitive impairment is common in COPD and is associated with low educational level, higher disease severity, and increased comorbidity. This could have therapeutic implications for this population.Keywords: chronic obstructive pulmonary disease, cognitive function, mini-mental state examination, depression, quality of life, comorbidity

RATIONALE AND OBJECTIVES: Alpha-1 antitrypsin deficiency (AATD) is a genetic condition that leads to an increased risk of emphysema and liver disease. Despite extensive investigation, there remain unanswered questions concerning the natural history, pathophysiology, genetics and the prognosis of the lung disease in association with AATD. The European Alpha-1 Clinical Research Collaboration (EARCO) is designed to bring together researchers from European countries and to create a standardised database for the follow-up of patients with AATD. STUDY DESIGN AND POPULATION: The EARCO Registry is a non-interventional, multicentre, pan-European, longitudinal observational cohort study enrolling patients with AATD. Data will be collected prospectively without interference/modification of patient's management by the study team. The major inclusion criterion is diagnosed severe AATD, defined by an AAT serum level

An algorithm to identify patients with ACO rather than asthma or COPD alone http://ow.ly/Viyy308Ehdk