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Melanie Schroeder,1 Nicole Benjamin,2 Laura Atienza,3 Chandroday Biswas,4 Alan Martin,5 John D Whalen,6 José Luis Izquierdo Alonso,7 Juan Antonio Riesco Miranda,8 Juan José Soler-Cataluña,9 Alicia Huerta,3 Afisi S Ismaila10,11 1Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK; 2Global Health Economics, ICON plc., Boston, MA, USA; 3Market Access, GlaxoSmithKline SA, Madrid, Spain; 4Global Health Economics, ICON plc., Bengaluru, Karnataka, India; 5Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, UK; 6Global Health Economics, ICON plc., Abingdon, UK; 7Pneumology, Hospital Universitario de Guadalajara, Guadalajara, Spain; 8Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, Spain; 9Pneumology Department, Hospital Arnau de Vilanova-Lliria (Valencia), Valencia, Spain; 10Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA; 11Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaGlaxoSmithKline Plc., 1250 South Collegeville Road, Collegeville, PA 19426-0989, USATel +1 (919) 315 8229Email afisi.s.ismaila@gsk.comPurpose: To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective.Patients and Methods: The validated GALAXY-COPD model was used to simulate disease progression and predict healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 3-year time horizon for a Spanish population. Patient characteristics from published literature were supplemented by data from FULFIL (NCT02345161), which compared FF/UMEC/VI vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations. Treatment effects, extrapolated to 3 years, were based on Week 24 results in the FULFIL intent-to-treat population, including change in forced expiratory volume in 1 second, St. George’s Respiratory Questionnaire score, and exacerbation rates. Treatment, exacerbations, and COPD management costs (2019€) were informed by Spanish public sources and published literature. A 3% discount rate for costs and benefits was applied. One-way sensitivity and scenario analyses, and probabilistic sensitivity analysis (PSA), were performed.Results: FF/UMEC/VI treatment led to fewer moderate and severe exacerbations (2.126 and 0.306, respectively) vs BUD/FOR (2.608 and 0.515, respectively), with a mean incremental cost of € 69 and gain of 0.107 QALYs, which resulted in an ICER of € 642 per QALY gained. In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs. Overall, 95% of 1000 PSA simulations resulted in an ICER less than € 11,000 per QALY gained for FF/UMEC/VI vs BUD/FOR, confirming robustness of the results. The probability of FF/UMEC/VI being cost-effective vs BUD/FOR was 100% at a willingness-to-pay threshold of € 30,000 per QALY gained.Conclusion: At the accepted Spanish ICER threshold of € 30,000, FF/UMEC/VI represents a cost-effective treatment option vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations.Keywords: cost-utility analysis, health-related quality of life, incremental cost-effectiveness ratio, fluticasone furoate, vilanterol, umeclidinium

José Luis López-Campos,1,2 Bernardino Alcázar Navarrete,3 Juan Antonio Riesco Miranda,2,4 Borja G Cosío,2,5 Juan P de-Torres,6 Bartolomé Celli,7 Carlos A Jiménez-Ruiz,8 Ciro Casanova Macario9 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Sevilla, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; 3Hospital de Loja, Loja, Granada, Spain; 4Hospital Universitario de Cáceres, Cáceres, Spain; 5Hospital Universitario Son Espases-IdISBa, Palma de Mallorca, Spain; 6Respirology Division, Queen’s University, Kingston, ON, Canada; 7Brigham and Women’s Hospital, Harvard Medical School Boston, Boston, MA, USA; 8Unidad Especializada en Tabaquismo, Hospital Clínico San Carlos, Madrid, Spain; 9Servicio de Neumología-Unidad de Investigación, Hospital Universitario La Candelaria, Universidad de La Laguna, La Laguna, SpainCorrespondence: José Luis López-CamposHospital Universitario Virgen del Rocio, Avda. Manuel Siurot, S/N, Sevilla 41013, SpainTel +34955013166Email lcampos@separ.esIntroduction: Despite the evidence provided by clinical trials, there are some uncertainties and controversies regarding the use of triple inhaled therapy. With the aim of evaluating clinical practice in specialized respiratory units, a Delphi consensus document was implemented on the use of single-inhaler fixed-dose triple therapies after 1 year of use in Spain.Methods: A scientific committee of COPD experts defined a thematic index, guided a systematic literature review and helped design the Delphi questionnaire. This was sent to the other 45 COPD experts between April and June 2019. Agreement/disagreement on 58 statements was tested in two rounds using a Likert scale. Replies were classified as a consensus when ≥ 80% of the panelists agreed; a majority when a degree of agreement of ≥ 66% was reached; and divergence if agreement was < 66%.Results: After two rounds, 44.44% of the statements reached consensus, 14.81% reached majority and 40.74% were divergent. Panelists agreed that escalating from double bronchodilation should be phenotype-based and aim to prevent exacerbations but not for improving symptoms. The addition of an antimuscarinic to inhaled corticosteroids combinations achieves improvement in lung function, symptoms and exacerbation prevention. Main safety concerns included the increased risk of pneumonia as compared to bronchodilator therapies, with similar cardiovascular effects. There was no consensus agreement on patient type response based on blood eosinophil counts or obstruction severity.Conclusion: The low degree of consensus among panelists may reflect the complexity of severe COPD management. The information provided here may be useful to clinicians implementing personalized medicine for COPD patients.Keywords: chronic obstructive pulmonary disease, LABA/LAMA, LABA/ICS, bronchodilator agents, inhaled corticosteroids, triple therapy, statements, Delphi consensus

Juan-Antonio Riesco-Miranda,1,2 Segismundo Solano-Reina,3 Carlos Rábade-Castedo,4 José-Ignacio de Granda-Orive,5 Esther Pastor-Esplá,6 Marcos García-Rueda,7 Francisco-Javier Callejas-Gonzalez,8 Ángel Azpeitia-Anadón,9 Silvia Mas,10 Carlos-Andrés Jiménez-Ruiz11 1Servicio de Neumología, Hospital Universitario de Cáceres, Cáceres, Spain; 2CIBERES, Madrid, Spain; 3Servicio de Neumología, Hospital General Universitario Gregorio Marañón, Madrid, Spain; 4Servicio de Neumología, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; 5Servicio de Neumología, Hospital Universitario Doce de Octubre, Universidad Complutense de Madrid, Madrid, Spain; 6Servicio de Neumología, Hospital Universitario San Juan de Alicante, Alicante, Spain; 7Servicio de Neumología, Hospital Universitario Carlos Haya, Málaga, Spain; 8Servicio de Neumología, Complejo Hospitalario Universitario de Albacete, Albacete, Spain; 9Departamento Médico Labs, Esteve S.A, Barcelona, Spain; 10Universidad Pompeu Fabra, Barcelona, Spain; 11Unidad Especializada de Tabaquismo, Hospital Clínico Universitario, Madrid, SpainCorrespondence: Silvia MasUniversitat Pompeu Fabra, Campus Poble Nou, Roc Boronat 138, Barcelona, 08018, SpainEmail silviamas.md@gmail.comPurpose: Smokers attending smoking cessation units (SCUs) may offer a unique opportunity for early recognition of undiagnosed chronic obstructive pulmonary disease (COPD). We aimed at assessing the impact of SCUs on the early diagnosis of COPD and describing the clinical and smoking profile of newly-diagnosed COPD cases at SCUs certified by the Spanish Society of Respiratory Diseases and Thoracic Surgery (SEPAR).Patients and Methods: A multicenter cross-sectional observational cohort study (DIPREPOQ study) was performed in eight SEPAR-certified SCUs in Spain. Adult current smokers with no previously diagnosed respiratory disease and having one o more respiratory symptoms were included. Lung functional tests were performed and previously undiagnosed COPD cases were identified and characterized based on national guidelines.Results: Out of 401 individuals newly attending the SCUs, 252 participants were included and 73 (28.9%) met the definition of previously undiagnosed COPD. A characterization of patients with COPD being newly recognized in SCUs showed: age (mean±SD) 61± 9 years; men 59%; active work status 53.1%; functional class I/II dyspnea 82.8%, GOLD state mild/moderate/severe 57%/31%/12%; non-exacerbators 90%, CAT 14± 4; emphysema in X-rays 40%. Most common co-morbidities were cardiovascular and psychiatric (anxiety and depression) ones. Usual smoking history included a lengthy smoking history (41± 9 years) and a current consumption of 24± 9 cigarettes/day.Conclusions and Implications: Consistently certified SCUs can have a substantial contribution to early diagnosis of COPD. A typical profile of newly detected cases is reported, with most patients being men at their early sixties, with mild symptoms and with high and lengthy smoking history. Our study reports a high usefulness of lung functional tests to detect undiagnosed COPD in appropriately selected participants attending SCUs at a large national scale, using a standardized methodology. This is likely to be facilitated by the certification of SCUs using well-defined requirements by national scientific societies.Keywords: health consequences, smoking, chronic obstructive pulmonary disease, smoking cessation unit

Carlos A Jiménez-Ruiz,1 Segismundo Solano-Reina,2 Jaime Signes-Costa,3 Eva de Higes-Martinez,4 José I Granda-Orive,5 José J Lorza-Blasco,6 Juan A Riesco-Miranda,7 Neus Altet-Gomez,8 Miguel Barrueco,9 Itziar Oyagüez,10 Javier Rejas11 On behalf of the SEPAR’s Integrated Tobacco Research Program 1Specialised Tobacco Unit, Community of Madrid, 2Tobacco Unit, Department of Pulmonary Medicine, Hospital General Universitario Gregorio Marañón, Madrid, 3Department of Pulmonary Medicine, Hospital Universitario San Juan, Alicante, 4Department of Pulmonary Medicine, Hospital Universitario Fundación Alcorcón, 5Department of Pulmonary Medicine, Hospital Universitario 12 de Octubre, Madrid, 6Department of Pulmonary Medicine, Complejo Hospitalario de Navarra, Pamplona, Navarre, 7Department of Pulmonary Medicine, Hospital de San Pedro Alcántara, Cáceres, 8Drassanes Tobacco Unit, Hospital Universitari Vall-d’Hebron-Drassanes, The Jordi Gol University Institute for Research Primary Healthcare, Barcelona, 9Department of Pulmonary Medicine, Hospital Universitario de Salamanca, Biomedical Research Institute, Salamanca, 10Pharmacoeconomics & Outcomes Research Iberia, 11Department of Pharmacoeconomics and Health Outcomes Research, Pfizer, Sociedad Limitada Unificada, Alcobendas, Madrid, Spain Abstract: The aim of the study was to assess the budgetary impact of funding smoking-cessation drugs in COPD patients in Spain. A hybrid model (cohort and Markov) was developed for a 5-year time horizon. Only approved cessation drugs (varenicline, bupropion, and nicotine replacement therapy) were considered. Irrespective of the drug, the model allowed for an initial cessation attempt, and up to three additional attempts in case of failure or smoking relapse during a 5-year period. Drug effectiveness was based on controlled clinical trials. National Health System perspective was applied; therefore, only medical resources were included. The pharmaceutical costs for smoking-cessation drugs, extra medical follow-up as a consequence of public reimbursement, and annual savings for health costs avoided due to stopping smoking were considered. The model estimated that 17,756 COPD patients would stop smoking if public funding was available, compared with 1,303 without reimbursement. In the reimbursement scenario, the savings accounted for a total of €48.0 million, compensating for expenditures on drugs and medical visits (€40.4 million). Accumulated total additional savings in 5 years (€4.3 million) compared with the scenario without reimbursement was shown. Sensitivity analyses supported the results robustness. Funding smoking-cessation drugs in COPD patients seems to be an efficient option and a National Health System drug reimbursement scheme would represent a cost-saving policy in Spain. Keywords: pharmacotherapy, COPD, smoking cessation, budgetary impact, health service

Introduction: We have carried out a systematic review of the literature (SRL) and a meta-analysis (MA) to answer: 1. Validity of the nicotine metabolite ratio (NMR) in improving the effectiveness of pharmacological treatments (PT) for smoking cessation (SC). 2. Validity of the NMR to improve the safety of the use of these PT? and 3. Validity of NMR in improving adherence to these PT?, Method: We carried out an SRL (six databases) and an MA for responding to the questions., Results: PT for SC (any treatment) is more effective in smoking subjects with slow NMR compared with fast NMR. Varenicline (VR) is equally effective in fast and slow NMR (RR 1.04 [CI 95% 0.75, 1.44]). When we compared those smokers who were treated to quit smoking with VR or nicotine replacement therapy (NRT) in fast metabolizers, we found that abstinence was in favor of those who were treated with VR (RR 1.40 [CI 95% 1.02, 1.91]). Those who were treated to quit smoking with NRT presented better results in slow Metabolizers (RR 0.70 [CI 95% 0.58, 0.83]). NMR increases the safety and adherence of treatments., Conclusions: We suggest that NMR is a good biomarker in the personalization of smoking cessation.

Introduction: There are multiple systematic reviews and meta-analyses on the efficacy and safety of pharmacological treatments against nicotine dependence. However, there are few guidelines to answer frequent questions asked by a clinician treating a smoker. Therefore, the aim of this paper is to facilitate the treatment of tobacco addiction., Material and Methods: 12 PICO questions are formulated from a GLOBAL PICO question: "Efficacy and safety of pharmacological treatment of tobacco dependence". A systematic review was carried out to answer each of the questions and recommendations were made. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system was used to grade the certainty of the estimated effects and the strength of the recommendations., Results: Varenicline, nicotine replacement therapy (NRT), bupropion and cytisine are more effective than placebo. Varenicline and combined nicotine therapy are superior to the other therapies. In smokers with high dependence, a combination of drugs is recommended, being more effective those associations containing varenicline. Other optimization strategies with lower efficacy consist of increasing the doses, the duration, or retreat with varenicline. In specific populations varenicline or NRT is recommended. In hospitalized, the treatment of choice is NRT. In pregnancy it is indicated to prioritize behavioral treatment. The financing of smoking cessation treatments increases the number of smokers who quit smoking. There is no scientific evidence of the efficacy of pharmacological treatment of smoking cessation in adolescents., Conclusions: The answers to the 12 questions allow us to extract recommendations and algorithms for the pharmacological treatment of tobacco dependence., (Copyright © 2023 The Author(s). Published by Elsevier España, S.L.U. All rights reserved.)

Introduction: The professional dedicated to respiratory health has an exemplary role in tobacco control, promoting smoking cessation in their patients. However, multiple circumstances cause a low implementation. Therefore, the objective of the study is to identify the consumption, knowledge and perception of tobacco and its emerging products in a representative sample of professionals involved in the treatment of respiratory patients integrated into the Spanish Society of Pneumology and Thoracic Surgery (SEPAR)., Methods: Descriptive analysis of a structured online interview addressed to 5340 SEPAR members., Results: In a sample of 802 respondents, more than 33% have smoked at some time and 6.6% continue to smoke. More than 66% consider smoking as a chronic disease. More than 90% consider their role model important and advise their patients to quit smoking, but less than half carry out a smoking intervention. Only 35% of them believe that the ban on smoking in health centers is always complied. More than 75% do not consider nicotine delivery devices an option for smoking cessation or harm reduction. 22% are unaware of water pipes and 29% of heated tobacco., Conclusions: Professionals specialized in respiratory diseases are highly sensitized to smoking. Despite this, there are still weak points such as the insufficient implementation of smoking cessation interventions or the scant training in smoking and in new emerging products., (© 2023 Sociedad Española de Neumología y Cirugía Torácica (SEPAR). Published by Elsevier España, S.L.U.)

The prevalence of active smoking in adults with asthma is similar in the total population. Smoking is associated with worse clinical control of the disease, a rapid reduction of lung function and a variable response to corticoids. Tobacco consumption negatively affects the quality of life of asthmatic patients as well as increasing the number of medical visits and hospital admissions due to exacerbations. Moreover, smoking entails a higher risk of developing lung cancer, cardiovascular comorbidities and death in asthmatic patients. Nevertheless, current asthma guidelines do not include specific recommendations on the management of smoking asthmatic patients and the treatment of the smoking habit in this subpopulation. For this reason, a narrative review of the literature was carried out for consensus using a nominal group methodology developed throughout 2019 to extract practical recommendations that would allow the diagnosis and treatment of asthma in smokers, as well as the treatment of smoking in asthmatics, to be improved. The conclusions and recommendations were validated at the SEPAR national congress of the same year. Among the most relevant, the need to address smoking in people with asthma through health advice, pharmacological treatment and behavioral therapy was emphasized, as this is a factor that negatively impacts the symptoms, prognosis and response to asthma treatment. In smokers with suspected asthma, the presence of emphysema and the differential diagnosis of other diseases should be evaluated and the impact of smoking on the result of diagnostic tests should be considered. It is also concluded that smoking reduces the response to treatment with inhaled corticosteroids, which is why combined therapy with bronchodilators is recommended.

In the last decade, the appearance of electronic cigarettes and new tobacco products (heated tobacco or smokeless tobacco) has generated a growing interest in harm reduction methods that are defined as mechanisms that seek to reduce the harmful consequences of tobacco without give up the pleasant effects of it by replacing it with these new electronic devices. However, these products are addictive and not safe as they contain nicotine. Harm reduction is a false solution as it represents a commercial strategy of the tobacco industry to increase its sales, making it difficult to control smoking, since it keeps smokers from consuming tobacco and prevents them from making serious attempts to quit. In addition, these products are a gateway to adolescents in tobacco., (© 2022 Sociedad Española de Neumología y Cirugía Torácica (SEPAR). Published by Elsevier España, S.L.U.)

Introduction: The Smoking and the Diffuse Interstitial Lung Diseases (ILD) groups of ALAT and SEPAR collaborated in the preparation of this document., Materials and Methods: This document uses PICO methodology to answer various questions on the relationship between tobacco use and diffuse ILD., Results and Conclusions: The main recommendations are: a) moderate level of evidence and strong recommendation to consider smoking as a risk factor for the development and/or modification of the progression of diffuse ILD; b) moderate level of evidence to identify an increase in mortality in diffuse ILD, irrespective of histologic pattern. Low evidence for ascribing it to smoking and strong recommendation for the early identification of patients with diffuse ILD. Further studies are needed to evaluate the effect of smoking cessation in patients with diffuse ILD; c) low level of evidence and weak recommendation for defining the impact of passive smoking in diffuse ILD; d) low level of evidence to demonstrate that smoking cessation improves the outcomes of patients diagnosed with diffuse ILD and strong recommendation to advise smoking cessation in smokers with diffuse ILD, and e) low level of evidence to support the clinical or epidemiological usefulness of active case finding for diffuse ILD in smoking cessation programs, and strong recommendation justifying the performance of spirometry in active case finding, based not on current smoking status, but on previous accumulated consumption, even in asymptomatic cases., (Copyright © 2019 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Smoking at the time of surgery is associated with postoperative complications. Quitting smoking before surgery is linked to fewer complications during the hospital stay. This work analysed whether a smoking cessation intervention before surgery is economically worthwhile when funded by the National Health System (NHS) in Spain., Methods: The economic analysis considered costs and benefits of the intervention to the NHS for the year 2016. The population who would benefit comprised adult smokers who were ready to quit and for whom surgery requiring admission to hospital was planned. The intervention, a combination of medical counselling and use of a smoking cessation drug which should occur 12 weeks before surgery, considered one attempt only to quit smoking. Benefits were costs avoided by averting postoperative complications if cessation was successful. The analysis compared the net economic outcome (benefit minus cost of intervention) and the return on investment, for intervention funded by the NHS versus the current situation without funding., Results: Smoking cessation increased by 21·7 per cent with funding; the rate was 32·5 per cent when funded versus 10·7 per cent without funding, producing 9611 extra quitters. The cost per averted smoker was €1753 with a benefit of €503, achieving a net economic benefit of €4·8 million per year. Given the annual cost of the intervention (€17·4 million, of which €5·6 million (32·5 per cent) represents drugs), the return on investment was 28·7 per cent annually, equivalent to €1·29 per €1 of investment., Conclusion: From the perspective of the Spanish NHS, the benefit of funding smoking cessation before surgery, in terms of healthcare cost savings, appears to greatly outweigh the costs., (© 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.)

The socio-cultural setting influences youth smoking and its prevalence presumibly has decreased., Objectives: To assess smoking prevalence in high school students, as well as the environmental influence on its onset in the Osona Disrtict of Barcelona (ODB), and to determine whether it has decreased., Material and Methods: A cross-sectional study was conducted on high school students in the ODB. In the anonymous questionnaire it was sked asked about smoking and the influence of the social and cultural setting on its onset., Results: A total of 842 students participated, with 714 questionnaires completed, of which 705 were included as valid. A total of 203 (93.5%) students lived in an urban setting. There were 159 smoker students and 62% were women. The smokers were 70 (44%) christians, 3 (1.9%) muslims, 14 (8.%) students with other religions, and 72 (45.3%) non-denominational students. It was detected that 529 (76.3%) of the students consumed alcohol consumers, and 308 (46.5%) consumed other substances. There were 40 (61%) students that suffered a disease, and also 334 students who had ill relatives. There were 207 (29.4%) fathers and 152 (22%) mothers who smoked and 214 (59%) students declared family smoking. Finally 582 (82.6%) had smoker friends. Among fathers, 212 (30.1%), had high level studies, 331 (48.7%) had mid- level studies, and 137 (20.1%) fathers had primary studies. Among mothers, it was 279 (39.6%), 294 (41.7%), and 116 (16.5%). respectively. Being a smoker was associated with alcohol (P=.000) and other substances consumption (P=.000), being non-denominational (P=.000), did not to suffer any disease (P=.043), with having mother (P=.001), father (P=.005), brother or sister (P=.006), and family members (P=.016) who smoked, and smoker friends (P=.000)., Conclusions: smoking prevalence in high school students in the ODB is high, but has decreased. Smoking was associated with alcohol and consumption of other substances, being non-denominational, and with friends, parents, and relatives who smoked. It is necessary to establish prevention programs addressed to teenagers, parents and teachers., (Publicado por Elsevier España, S.L.U.)

Background: Smoking is considered an epidemic, indeed, one of the most important public health problems worldwide. It is also the most significant preventable cause of death, of a high number of premature deaths, and avoidable chronic diseases. It is considered an enormous economic burden for the world., Objective: To provide an overview of smoking-cessation treatments, including pharmacological and psychological options, and to gather current scientific evidence available on them., Methods: Research included reviewing publications from 2007-2018 in four databases using algorithms related to bupropion, varenicline, nicotine replacement therapy, smoking cessation, psychological treatment, motivational interview, cognitive-behavioral therapy and clinical guidelines for smoking treatment. Meta-analyses or systematic reviews and randomized or quasi-randomized trials were selected. We also included clinical guidelines for smoking treatment from Mexico and other countries., Results: After refining the search, 37 articles met the criteria and were included in the review. The results were grouped by type of intervention., Conclusions: It is necessary to conduct research on combinations of both kinds of treatment with an integral, multidisciplinary vision. Current standard for smoking cessation is a combined psychological and pharmacological treatment., (Copyright: © 2019 SecretarÍa de Salud.)

A large number of COPD patients are smokers. The particular characteristics of this group as well as their need to quit usually require psychological counselling and pharmacological treatment to achieve abstinence and, often, intensively. Little information is available about this issue.  The main objective of the study was to evaluate the effectiveness of varenicline after 24 weeks of treatment, with continuous abstinence between weeks 9 and 24.  This study was a post-authorization, open label, observational study of prospective follow-up. Patients included were smokers with severe or very severe COPD criteria who were treated with varenicline for 24 weeks, i.e. with a 12-week extension over the usual treatment.  The outcomes in the population of subjects completing 24 weeks of follow-up were at week 24: continuous abstinence 36.8%, 7 days point prevalence abstinence 65.7%, and continuous smoking 31.5%.The outcomes in the intention-to-treat population included at baseline were: continuous abstinence 17.7% of patients, 7 days point prevalence abstinence 31.6%, continuous smoking 15.1% and not valid/unknown 51.8%.  The mean CAT score at week 24 was 15 and reduction from the baseline was 3.77 (paired T test, p<0.01). The most common adverse events reported were nausea, vivid dreams, stomach ache, insomnia, headache and vomiting.  Patients included in VALUE were active smokers despite all of them had a severe COPD which suggests a very high degree of dependence. Although the study do not allow to infer the results to the global population of smokers with severe COPD, the outcomes have shown that, at 24 weeks follow up 36.8% of the patients were successful in quitting but from 79 patients enrolled initially only 17.7% quit.

The ALAT and SEPAR Treatment and Control of Smoking Groups have collaborated in the preparation of this document which attempts to answer, by way of PICO methodology, different questions on health interventions for helping COPD patients to stop smoking. The main recommendations are: (i)moderate-quality evidence and strong recommendation for performing spirometry in COPD patients and in smokers with a high risk of developing the disease, as a motivational tool (particularly for showing evidence of lung age), a diagnostic tool, and for active case-finding; (ii)high-quality evidence and strong recommendation for using intensive dedicated behavioral counselling and drug treatment for helping COPD patients to stop smoking; (iii)high-quality evidence and strong recommendation for initiating interventions for helping COPD patients to stop smoking during hospitalization with improvement when the intervention is prolonged after discharge, and (iv)high-quality evidence and strong recommendation for funding treatment of smoking in COPD patients, in view of the impact on health and health economics., (Copyright © 2017 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: To describe the evidence- and experience-based expert consensus on the use of single-agent bronchodilators in patients with stable mild-moderate chronic obstructive pulmonary disease (COPD)., Methods: Using Delphi methodology, a panel of 7 respiratory medicine experts was established, who, in the first nominal group meeting defined the scope, users, and document sections. The panel drew up 14 questions on the use of single-agent bronchodilators in patients with mild-moderate stable COPD to be answered with a systematic review of the literature. The results of the review were discussed in a second nominal group meeting and 17 statements were generated. Agreement/disagreement with the statements was tested among16 different experts including respiratory medicine experts and primary care physicians. Statements were scored from1 (total disagreement) to10 (total agreement). Agreement was considered if at least 70% voted ≥7. The level of evidence and grade of recommendation of the systematic literature review was assessed using the Oxford Centre for Evidence-based Medicine levels., Results: A total of 12 of the 17 statements were selected. Specific statements were generated on different profiles of patients with stable mild-moderate COPD in whom single-agent bronchodilators could be prescribed., Conclusions: These statements on the use of single-agent bronchodilators might improve the outcomes and prognosis of patients with stable mild-moderate COPD., (Copyright © 2017 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.)

Marijuana is the most widely usedillegal drug in the world, with a prevalence of 2.5%-5%, and the second most commonly smoked substance after tobacco. The components of smoke from combustion of marijuana are similar to those produced by the combustion of tobacco, but they differ in terms of psychoactive components and use. Inhalation of cannabis smoke affects the respiratory tract, so the available evidence must be updated in order to provide pulmonologists with the latest scientific information. In this article, we review the impact of cannabis consumption on the lungs, taking into account that the respiratory route is the most popular route of cannabis consumption., (Copyright © 2017 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.)

Between 15 and 27% of patients admitted to Spanish hospitals are smokers. Hospitalization is an ideal time for a smoker to decide to quit. We performed a MEDLINE search of controlled, randomized or observational studies associated with helping hospitalized patients quit smoking, published between January 1, 2002 and September 30, 2015. On the basis of the results of those studies, we have issued some recommendations for the treatment of smoking in hospitalized patients. The recommendations were drawn up according to the GRADE system. Offering the smoker psychological counselling and prolonging follow-up for at least 4 weeks after discharge is the most effective recommendation for helping hospitalized patients to quit., (Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: To determine the prevalence of smoking and analyze associated factors in a cohort of patients diagnosed with tuberculosis (TB) in Spain between 2006 and 2013., Methods: Multicenter, cross-sectional, descriptive, observational study using a national database of TB patients, using logistic regression to calculate odds ratios (OR) and confidence intervals (CI)., Results: We analyzed 5,846 cases (62 % men, mean age 39 years, 33 % foreigners). 23.4 % were alcohol abuser, 1.3 % were injected drug users (IDU), 4.6 % were co-infected with HIV, and 7.5 % had a history of TB treatment. 6.6 % and 0.8 % showed resistance to one and multiple drugs, respectively. The predominant clinical presentation was pulmonary (71 %) with a cavitary radiological pattern in 32.8 % of cases. 82 % of cases were confirmed microbiologically, and 54 % were smear-positive microscopy. 2,300 (39.3 %) patients were smokers. The following factors were associated with smoking: male sex (OR = 2.26;CI:1.97;2.60), Spanish origin (OR = 2.79;CI:2.40-3.24), alcoholism (OR = 2.85;CI:2.46;3.31), IDU (OR = 2.78;CI:1.48;5.52), homelessness (OR = 1.99;CI:1.14-3.57), pulmonary TB (OR = 1.61;CI:1.16;2.24), cavitary radiological pattern (OR = 1.99;CI:1.43;2.79) and a smear-positive microscopy at the time of diagnosis (OR = 1.39;CI:1.14;1.17)., Conclusions: The prevalence of smoking among TB patients is high. Smokers with TB have a distinct sociodemographic, clinical, radiological and microbiological profile to non-smokers.

Streptococcus pneumoniae is responsible for several clinical syndromes, such as community-acquired pneumonia, sinusitis, otitis media, and others. The most severe clinical entity caused by this bacteria is undoubtedly invasive pneumococcal disease. Certain factors are known to increase the risk of presenting invasive pneumococcal disease, the most important being smoking habit and underlying concomitant diseases. This article comprises a consensus document on antipneumococcal vaccination in smokers, drawn up by a Smoking Expert Group from the Spanish Society of Pulmonology and Thoracic Surgery and the Latin American Chest Association., (Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.)

Background: The MPOWER strategy encourages suitable monitoring of the tobacco epidemic among health professionals in all countries., Objective: To analyse the prevalence of and attitudes towards tobacco use among Spanish health professionals., Methods: A study was conducted based on an online survey. The study population consisted of health professionals (primary care physicians, specialist physicians and nurses). The questionnaire used included questions about tobacco consumption, knowledge of and attitudes towards smoking. The sample size was calculated according to a database with 9,500 e-mail addresses and listings of health centres and hospitals all over Spain. Statistical analysis was done using the SPSS software programme., Results: The study group comprised a total of 612 health professionals: 322 were women (52.6%), 196 were nurses and 416 were physicians. 11.7% of health professionals were smokers (9.6% regular smokers and 2.1% occasional smokers) and 41.3% were ex-smokers. Within the group of daily smokers, differences were observed between the nurses and the physicians: 11.2 versus 8.9% (p = 0.009). Smoking was recognized as a chronic disorder by 58.2% of health professionals, and 54.6% knew that the most effective intervention to help quit is a combination of psychological and pharmacological treatment. 56% of health professionals always asked their patients about their tobacco consumption., Conclusions: 11.7% of Spanish health professionals are smokers. We found that they have low knowledge about strategies to quit smoking and that there is a low level of therapeutic intervention on smokers., (© 2015 S. Karger AG, Basel.)

The electronic cigarette (EC) is a device formed by three basic elements: battery, atomizer and cartridge. When assembled, it looks like a cigarette. The cartridge contains different substances: propylene glycol, glycerine and, sometimes, nicotine. When the user "vapes", the battery is activated, the atomizer is heated and the liquid is drawn in and vaporized. The smoker inhales the mist produced. Various substances have been detected in this mist: formaldehyde, acetaldehyde and acrolein and some heavy metals. Although these are found in lower concentrations than in cigarettes, they may still be harmful for the human body. Several surveys show that 3-10% of smokers regularly use e-cigarettes. A randomized study has shown that the efficacy of e-cigarettes for helping smokers to quit is similar to nicotine patches. Nevertheless, the study has relevant methodological limitations and reliable conclusions cannot be deduced. This report sets down the Position Statement of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) on the efficacy and safety of e-cigarettes. This statement declares that e-cigarettes should be regulated as medicinal products., (Copyright © 2013 SEPAR. Published by Elsevier Espana. All rights reserved.)

Background: In 2005, the Spanish government approved Law 28/2005 on health measures against smoking; this was amended in 2010 by Law 42/2010., Objective: The purpose of this study was to assess the impact of these laws on passive smoking., Methods: Three epidemiological studies were conducted on a representative sample of the population via telephone surveys. The first was conducted prior to the first law coming into force, the second a year after its approval and the third a year after the approval of the second., Results: Six thousand eight hundred people were surveyed in 2005, 3,289 in 2007 and 3,298 in 2011. The first survey showed that 49.5% of nonsmokers were exposed to second-hand smoke (SHS) while by 2007, following the introduction of Law 28/2005, this exposure had been reduced to 37.9% (results previously published in 2008). The 2011 survey, conducted following the introduction of Law 42/2010, showed that just 21% of people were exposed. These data indicate that overall exposure to SHS was reduced by 22% between 2005 and 2007 and by a further 16.9% between 2007 and 2011. The overall impact of Law 42/2010 is estimated to be around 44% and Law 28/2005 around 22%., Conclusion: Legislation introduced in Spain has markedly reduced the exposure of nonsmokers to SHS., (© 2013 S. Karger AG, Basel.)

While Spain's national tobacco control legislation prohibits smoking in many indoor public places, the law provides for an exception to the prohibition of smoking by allowing separate seating sections and ventilation options in certain public places such as bars and restaurants, hotels and airports. Accordingly, Spain's law is not aligned with Article 8 Guidelines of the World Health Organization's Framework Convention on Tobacco Control, which requires parties to ensure universal protection against secondhand smoke exposure in all enclosed public places, workplaces and on all means of public transport. Spain's law is currently being promoted by the tobacco companies in other countries as a model for smoke-free legislation. In order to prevent weakening of smoke-free laws in other countries through industry-supported exceptions, we investigated the tactics used by the tobacco companies before the implementation of the new law and assessed the consequences of these actions in the hospitality sector. Internal tobacco industry documents made public through US litigation settlements dating back to the 1980s were searched in 2008-9. Documents show that tobacco companies sought to protect hospitality venues from smoking restrictions by promoting separate seating for smokers and ineffective ventilation technologies, supporting an unenforceable voluntary agreement between the Madrid local government and the hospitality industry, influencing ventilation standards setting and manipulating Spanish media. The Spanish National Assembly should adopt comprehensive smoke-free legislation that does not accommodate the interests of the tobacco industry. In doing so, Spain's smoke-free public places law would be better aligned with the Framework Convention on Tobacco Control.

Smoking is the primary avoidable cause of premature death and morbidity in our country. According to data from the WHO, tobacco costs more than 5 million lives per year, a figure that is assumed to continue increasing and will be 10 million by the year 2030. As health professionals we are obliged to be actively involved in this serious health problem, by correctly identifying, diagnosing and treating all smokers to help them in the process of giving up and help them achieve total abstinence. There is scientific evidence that smoking is the direct cause and reason for the worsening of many respiratory diseases, which due to their nature are basically the responsibility of the pneumologist, who officially, according to the Health Service Administration, is the specialist and expert in this area. The Smoking and Health Area of SEPAR was started in 1995. Its primary objectives were to increase the awareness of the smoking problem among the members of our Scientific Society, improve their scientific knowledge of this diseases, to help in diagnostic and treatment interventions in smokers, and lastly, to promote interventions for the prevention and treatment of smoking by the health and political Administrations. Nowadays it is one of the most dynamic areas of SEPAR and has more than 400 members. There are many unresolved challenges in our area, but the fundamental one which continues to occupy a particular place for the Administration, for our patients, for other health professionals of other specialties and scientific societies, and for all SEPAR professionals, is a key aspect of which there is no doubt: to defend the health and well-being of our population against the main cause of avoidable disease and death, tobacco.

Objective: The prevalence and associated health cost of asthma have been increasing in developed countries, and 70% of the overall disease cost is due to exacerbations. The primary objective of this study was to determine the hospital cost of an asthma exacerbation in Spain. The secondary objective was to determine what maintenance treatments patients were using to control asthma before the exacerbation and how the exacerbation was treated. The study formed part of a broader study (COAX II), with the same objectives in each of the 8 participating European countries., Patients and Methods: Prospective observational study that enrolled 126 patients with an asthma exacerbation treated in the usual way in 6 Spanish hospitals over a 3-month period (from January 1 to March 31, 2000)., Results: According to the criteria of the Global Initiative for Asthma, 33.3% of the exacerbations were mild, 38.9% moderate, 26.2% severe, and 1.6% were associated with risk of imminent respiratory arrest. Use of corticosteroids was widespread among patients with moderate and severe asthma, but only 68% of the patients with severe asthma used long-acting beta2 agonists. The mean cost was 1555.70 Euros (95% confidence interval [CI], 1237.60 Euros-1907.00 Euros), of which 93.8% (1460.60 Euros; 95% CI, 1152.50 Euros-1779.40 Euros) was due to direct costs, and 6.2% (95.10 Euros; 95% CI, 35.50 Euros-177.00 Euros) to indirect costs. Cost rose with increasing severity of the exacerbation--292.60 Euros for a mild exacerbation, 1230.50 Euros for a moderate exacerbation, and 3543.10 Euros for a severe exacerbation., Conclusions: The mean cost was 1555.70 Euros. The costs of moderate and severe exacerbations were 4 and 12 times that of a mild exacerbation, respectively. Long-acting beta2 agonists were less widely used than recommended by the guidelines for treatment of moderate and severe persistent asthma leading to asthma exacerbations.

Background and Objective: The objective of the study was to evaluate the effectiveness of the pharmacological treatment of tobacco dependence according to the criteria established by SEPAR., Patients and Method: Longitudinal, prospective and multicentre study. We included smokers aged more than 18 years who attended 5 smokers clinics and received nicotine replacement therapy (NRT), bupropion or both. The punctual and continuous abstinence was studied at the 15, 30, 60, 90 and 180 days with each one of the proposed treatments. Effective results were defined as the intention to treat., Results: There were 904 smokers, 476 males and 428 females, mean age 42.51 (10.09). Of the 904 individuals who started the treatment, 820, 776, 687, 719 and 679 were present at the follow-up sessions at 15, 30, 60, 90 and 180 days, respectively. The punctual global abstinence at 15 and 180 days was 65.6% and 43.1%, while the continuous one was 57.4% and 38.8% at two and six months, respectively. Significant differences were not observed with regard to the punctual or continuous abstinence among patients treated with NRT, bupropion or both., Conclusions: The pharmacological treatment of tobacco dependence used individually according to the recommendations of the clinical guidelines allows to obtain good results with regard to the momentous and continuous abstinence. The effectiveness of the different first line treatments is similar in all the phases of the therapeutic process.

Introduction and Objectives: Many studies of lung cancer survival are carried out in patients selected for certain features that usually influence prognosis favorably. The objective of this study was to assess the overall survival of unselected patients with a diagnosis of lung cancer in our practice., Patients and Methods: We studied 610 patients for whom survival information was available, a population comprising 88% of the 694 with lung cancer diagnosed in our hospital from 1991 through 1998. The variables analyzed for their correlation with survival were age, sex, histology, tumor-node-metastasis (TNM) stage, treatment, and time of diagnosis (with patients grouped by 2-year periods)., Results: The cases of 596 men and 14 women with a mean age of approximately 67 years were studied. Small cell tumors were found in 141, non-small cell tumors in 447, and other tissue types in 22. Surgical excision was carried out on 118 (19.3%), and treatment was confined to control of symptoms for 6.4% of the patients with small cell tumors and 40.5% of those with non-small cell cancer. Symptomatic treatment alone was more common for patients older than 70 years (52.5%) and less common during the last 2 years of the study period (1997-1998: 19%). Overall 5-year survival was 7.9% (2.8% in small cell cancer and 9.4% in non-small cell cancer). Survival rates were lower in patients over 70 years of age. Significant differences in survival were seen for successive TNM stages, with the exception of IIIA and IIIB. The 1997-1998 period saw better survival rates, at 40.8% after 1 year and 11.2% after 5 years., Conclusions: The survival rates in lung cancer patients in our hospital practice are low because the rate of surgical resections is low owing to the high percentage of cases found in advanced stages. Our observations are similar to those reported from other European countries.

Introduction: Respiratory effort-related arousals (RERA) are secondary to subtle obstructions of the upper airway during sleep and can appear in the absence of a predominance of apneas and hypopneas, causing excessive daytime sleepiness. Analyzing the possible consequences of these new respiratory events is of increasing interest. Habitually sleepy drivers are at high risk of having traffic accidents related to sleep disorders (apneas, hypopneas and RERA)., Objective: The aim of this study was to determine whether excess RERA alone is an independent risk factor among sleepy drivers., Method: We studied 40 habitually sleepy drivers and 23 age- and sex-matched controls selected from a sample of 4,002 automobile drivers. We surveyed sleep habits, daytime sleepiness and traffic accidents. Sleep studies of esophageal pressure were performed., Results: The sleepy drivers with apneas (apnea/hypopnea index > 10) had a higher 5-year accident rate (0.33 0.50) than did control drivers (0.004 0.21; p < 0.05). However, a high RERA index, but not sleep apnea, was an independent risk factor among the habitually sleepy drivers. The adjusted odds ratio (OR) for a RERA index > or = 10 was 7.6 (confidence interval [CI], 1.2 to 48); for a RERA index > or = 15, the OR was 17 (CI 1.5 to 91)., Conclusions: The high risk of traffic accidents among sleepy drivers is mainly determined by the presence of RERA rather than the presence of apneas and hypopneas. These findings verify the importance of identifying RERA in routine sleep laboratory studies.

Objectives: Our main objective was to determine the incidence of bronchopulmonary cancer in Extremadura (Spain). We also studied the presence of risk factors such as smoking and exposure to other carcinogens., Material and Methods: This prospective study used a protocol followed by all hospitals in Extremadura; enrolled were patients with a diagnosis of bronchopulmonary carcinoma in 1998 who lived habitually in the region. Cyto-histological confirmation of the diagnosis was sought or, when such confirmation was unavailable, diagnostic agreement among researchers was based on clinical, radiological and/or endoscopic data., Results: The incidences adjusted to world population were 53.4, 2.16 and 25.3 per 100,000 inhabitants for men, women and the entire population sample, respectively. Patterns in the provinces of Cáceres and Badajoz were very similar. Of 433 cases recorded, 95% were men and 78% were aged 60 years or older. Cyto-histological confirmation of diagnosis was available for 92.2%. Most tumors were epidermoid (41.1%). The time between the start of smoking and diagnosis was significantly shorter in heavier smokers.