Clinical Practice Guideline of Spanish Society of Pneumology and Thoracic Surgery (SEPAR) on Pharmacological Treatment of Tobacco Dependence 2023

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. (AU)

Clinical Practice Guideline of Spanish Society of Pneumology and Thoracic Surgery (SEPAR) on Pharmacological Treatment of Tobacco Dependence 2023.

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.

Prevalence, Knowledge and Perceptions of Smoking and Tobacco Products and Vape Among SEPAR Members.

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.

Introducción: El profesional dedicado a la salud respiratoria tiene un papel ejemplar en el control del tabaquismo, promoviendo el abandono del hábito tabáquico en sus pacientes. Sin embargo, múltiples circunstancias provocan una baja implementación. Por tanto, el objetivo del estudio es identificar el consumo, el conocimiento y la percepción sobre el tabaco y sus productos emergentes en una muestra representativa de profesionales implicados en el tratamiento de pacientes respiratorios integrados en la Sociedad Española de Neumología y Cirugía Torácica (SEPAR). Métodos: Análisis descriptivo de una entrevista estructurada en línea dirigida a 5.340 miembros de la SEPAR. Resultados: En una muestra de 802 encuestados, más del 33% ha fumado alguna vez y el 6.6% sigue fumando. Más del 66% considera el tabaquismo como una enfermedad crónica. Más del 90% considera importante su modelo a seguir y aconseja a sus pacientes que dejen de fumar, pero menos de la mitad realiza una intervención para dejar de fumar. Solo el 35% de ellos cree que la prohibición de fumar en los centros de salud se cumple siempre. Más del 75% no considera que los dispositivos de suministro de nicotina sean una opción para dejar de fumar o reducir los daños. El 22% desconoce las pipas de agua y el 29% el tabaco calentado. Conclusiones: Los profesionales especialistas en enfermedades respiratorias están altamente sensibilizados al tabaquismo. A pesar de ello, aún existen puntos débiles como la insuficiente implantación de intervenciones para dejar de fumar o la escasa formación en tabaquismo y en nuevos productos emergentes.

Consensus document on asthma and smoking of the Regional Asthma Forum of SEPAR. / Documento de consenso sobre asma y tabaquismo del Foro Autonómico de Asma de la SEPAR.

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.

La prevalencia de tabaquismo activo en adultos con asma es similar a la de la población general. El tabaquismo se asocia con un peor control clínico de la enfermedad, una disminución acelerada de la función pulmonar y una respuesta irregular a la terapia con glucocorticoides. El consumo de tabaco impacta negativamente en la calidad de vida de los pacientes asmáticos y provoca un incremento en el número de visitas y de hospitalizaciones por exacerbaciones. Además, el tabaquismo aumenta el riesgo de cáncer de pulmón, comorbilidades cardiovasculares y muerte en pacientes asmáticos. A pesar de todo ello, las guías actuales del manejo del asma no incluyen recomendaciones específicas para el manejo de los pacientes asmáticos fumadores. Por este motivo, se procedió a una revisión narrativa de la literatura para un consenso mediante metodología de grupo nominal desarrollada a lo largo del año 2019 para extraer recomendaciones prácticas que permitieran mejorar el diagnóstico y el tratamiento del asma en fumadores, así como el tratamiento del tabaquismo en asmáticos. Las conclusiones y recomendaciones fueron validadas en el congreso nacional de la SEPAR del mismo año. Entre las más relevantes, se incidió en la necesidad de abordar el tabaquismo en las personas con asma mediante consejo sanitario, tratamiento farmacológico y terapia conductual, al ser un factor que impacta negativamente en la sintomatología, el pronóstico y la respuesta al tratamiento del asma. En el fumador con sospecha de asma, se debe evaluar la presencia de enfisema y el diagnóstico diferencial de otras enfermedades y considerar el impacto del tabaquismo en el resultado de las pruebas diagnósticas. También se concluye que el hábito tabáquico reduce la respuesta al tratamiento con corticoides inhalados, por lo que se recomienda terapia combinada con broncodilatadores.

[Positioning Document of Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) on Tobacco Harm Reduction Strategies]. / Documento de posicionamiento de la Sociedad Española de Neumología y Cirugía Torácica (SEPAR) ante las estrategias de reducción del daño del tabaco.

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.

Certified Smoking Cessation Units in Spain: High Potential for Detection of Undiagnosed Chronic Obstructive Pulmonary Disease and Profile of Newly Diagnosed Cases.

PURPOSE: 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.

A Delphi Consensus Document on the Use of Single-Inhaler Fixed-Dose Triple Therapies in COPD Patients.

Introduction: 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.

Cost-Effectiveness Analysis of a Once-Daily Single-Inhaler Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease (COPD) Using the FULFIL Trial: A Spanish Perspective.

Purpose: 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.

Preguntas y respuestas relacionadas con tabaquismo en pacientes con EPID. Aplicación de metodología con formato PICO / Questions and Answers on Smoking in Patients With Diffuse ILD. Use of PICO Methodology

INTRODUCCIÓN: Los grupos de Tabaquismo y de Enfermedades Pulmonares Intersticiales Difusas (EPID) de ALAT y SEPAR han colaborado para la realización de este documento. MATERIAL Y MÉTODOS: En el mismo se da respuesta, siguiendo metodología PICO, a diferentes interrogantes sobre la relación entre el consumo de tabaco y las EPID. RESULTADOS Y CONCLUSIONES: Sus principales recomendaciones son: a) evidencia moderada y recomendación fuerte para considerar el tabaquismo como un factor de riesgo para el desarrollo y/o modificador de la progresión de EPID; b) evidencia moderada para identificar que existe un incremento de la mortalidad en la EPID independientemente de su patrón histológico. Evidencia baja para adjudicarlo al tabaquismo y recomendación fuerte para identificar a los pacientes con EPID precozmente. Se hacen necesarios nuevos estudios que evalúen el efecto de la cesación tabáquica en los pacientes con EPID; c) evidencia baja y recomendación débil para definir el impacto del tabaquismo de segunda mano en la EPID; d) evidencia baja para demostrar que la cesación tabáquica mejora los resultados de los pacientes diagnosticados de EPID y recomendación fuerte para aconsejar la cesación tabáquica en casos de EPID en fumadores, y e) evidencia baja que demuestre la utilidad clínica o epidemiológica de la búsqueda activa de los casos de EPID en los programas de cesación tabáquica y recomendación fuerte para justificar la realización de espirometría durante esta búsqueda independientemente del estatus actual de tabaquismo pero con la dosis acumulada previamente, aun en casos asintomáticos

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

Questions and Answers on Smoking in Patients With Diffuse ILD. Use of PICO Methodology. / Preguntas y respuestas relacionadas con tabaquismo en pacientes con EPID. Aplicación de metodología con formato PICO.

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.

SMOKING CESSATION TREATMENTS: CURRENT PSYCHOLOGICAL AND PHARMACOLOGICAL OPTIONS.

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.

Smoking cessation treatments: current psychological and pharmacological options

Abstract 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.