A new approach to grading and treating COPD based on clinical phenotypes: summary of the Spanish COPD guidelines (GesEPOC).

After the development of the COPD Strategy of the National Health Service in Spain, all scientific societies, patient organisations, and central and regional governments formed a partnership to enhance care and research in COPD. At the same time, the Spanish Society of Pneumology and Thoracic Surgery (SEPAR) took the initiative to convene the various scientific societies involved in the National COPD Strategy and invited them to participate in the development of the new Spanish guidelines for COPD (Guía Española de la EPOC; GesEPOC). Probably the more innovative approach of GesEPOC is to base treatment of stable COPD on clinical phenotypes, a term which has become increasingly used in recent years to refer to the different clinical forms of COPD with different prognostic implications. The proposed phenotypes are: (A) infrequent exacerbators with either chronic bronchitis or emphysema; (B) overlap COPD-asthma; (C) frequent exacerbators with emphysema predominant; and (D) frequent exacerbators with chronic bronchitis predominant. The assessment of severity has also been updated with the incorporation of multidimensional indices. The severity of the obstruction, as measured by forced expiratory volume in 1 second, is essential but not sufficient. Multidimensional indices such as the BODE index have shown excellent prognostic value. If the 6-minute walking test is not performed routinely, its substitution by the frequency of exacerbations (BODEx index) provides similar prognostic properties. This proposal aims to achieve a more personalised management of COPD according to the clinical characteristics and multidimensional assessment of severity.

Frequency and characteristics of asthma in smokers attending smoking cessation units in Spain.

INTRODUCTION: The interaction between smoking and asthma impairs lung function and increases airflow obstruction severity. The identification of smoking patterns in smokers with and without asthma is crucial to provide the best care strategies. The aims of this study are to estimate asthma frequency, describe asthma features, and characterize smoking in smokers attending smoking cessation units. MATERIAL AND METHODS: We carried out a cross-sectional study in five smoking cessation units with different geographical distribution to estimate asthma frequency in smokers, characterize asthma features in smokers, as well as smoking in asthmatic smokers. RESULTS: Asthma frequency among smokers was 18.6%. Asthmatic smokers presented high passive exposure, low smoking self-efficacy and will to quit smoking, as well as a high exacerbation frequency, severe symptoms, and frequent use of long-acting beta agonists, inhaled steroids, and short-acting beta agonists. DISCUSSION: Smokers with asthma constitute a high-risk group with worsened evolution of pulmonary involvement. All smokers should be regularly screened for asthma. Effective smoking cessation strategies should be proposed to smokers with asthma in order to reverse the harmful effects of smoking on the airway, together with a comprehensive and integral approach.

[Spanish COPD Guidelines (GesEPOC): Pharmacological treatment of stable COPD]. / Guía Española de la EPOC (GesEPOC). Tratamiento farmacológico de la EPOC estable.

Recognizing the clinical heterogeneity of COPD suggests a specific therapeutic approach directed by the so-called clinical phenotypes of the disease. The Spanish COPD Guidelines (GesEPOC) is an initiative of SEPAR, which, together with the scientific societies involved in COPD patient care, and the Spanish Patient Forum, has developed these new clinical practice guidelines. This present article describes the severity classification and the pharmacological treatment of stable COPD. GesEPOC identifies four clinical phenotypes with differential treatment: non-exacerbator, mixed COPD-asthma, exacerbator with emphysema and exacerbator with chronic bronchitis. Pharmacological treatment of COPD is based on bronchodilation in addition to other drugs depending on the clinical phenotype and severity. Severity is established by the BODE/BODEx multidimensional scales. Severity can also be approximated by assessing airflow obstruction, dyspnea, level of physical activity and history of exacerbations. GesEPOC is a new, more individualized approach to COPD treatment according to the clinical characteristics of the patients.

Cost-Effectiveness of Once-Daily Single-Inhaler COPD Triple Therapy in Spain: IMPACT Trial.

Purpose: Given between-country differences in healthcare systems, treatment costs, and disease management guidelines, country-specific cost-effectiveness analyses are important. This study evaluated the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI among patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations from a Spanish healthcare system perspective. Patients and Methods: Baseline data and treatment effects from the IMPACT trial were populated into the validated GALAXY COPD progression model. Utilities were estimated using Spanish observational data. Direct healthcare costs (2019 €) were informed by Spanish public sources. A 3% discount rate for costs and benefits was applied. The time horizon and treatment duration were 3 years (base case). One-way sensitivity, scenario, and probabilistic sensitivity analyses were performed. Results: FF/UMEC/VI treatment resulted in fewer exacerbations over 3 years (4.130 vs 3.648) versus FF/VI, with a mean (95% confidence interval [CI]) incremental cost of €444 (€149, €713) per patient and benefit of 0.064 (0.053, 0.076) quality-adjusted life years (QALYs), resulting in an incremental cost-effectiveness ratio (ICER) of €6887 per QALY gained. FF/UMEC/VI was a dominant treatment strategy versus UMEC/VI, resulting in fewer exacerbations (4.130 vs 3.360), with a mean (95% CI) incremental cost of -€450 (-€844, -€149) and benefit of 0.054 (0.043, 0.064) QALYs. FF/UMEC/VI was cost-effective versus FF/VI and UMEC/VI across all analyses. Conclusion: FF/UMEC/VI was predicted to be a cost-effective treatment option versus FF/VI or UMEC/VI in symptomatic COPD patients at risk of exacerbations in Spain, across all scenarios and sensitivity analyses.

Spanish COPD Guidelines (GesEPOC) 2021: Updated Pharmacological treatment of stable COPD. / Actualización 2021 de la Guía Española de la EPOC (GesEPOC). Tratamiento farmacológico de la EPOC estable.

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.

Spanish COPD Guidelines (GesEPOC) 2021 Update Diagnosis and Treatment of COPD Exacerbation Syndrome. / Actualización 2021 de la guía española de la EPOC (GesEPOC). Diagnóstico y tratamiento del síndrome de agudización de la EPOC.

This article details the GesEPOC 2021 recommendations on the diagnosis and treatment of COPD exacerbation syndrome (CES). The guidelines propose a definition-based syndromic approach, a new classification of severity, and the recognition of different treatable traits (TT), representing a new step toward personalized medicine. The evidence is evaluated using GRADE methodology, with the incorporation of 6 new PICO questions. The diagnostic process comprises four stages: 1) establish a diagnosis of CES, 2) assess the severity of the episode, 3) identify the trigger, and 4) address TTs. This diagnostic process differentiates an outpatient approach, that recommends the inclusion of a basic battery of tests, from a more comprehensive hospital approach, that includes the study of different biomarkers and imaging tests. Bronchodilator treatment for immediate relief of symptoms is considered essential for all patients, while the use of antibiotics, systemic corticosteroids, oxygen therapy, and assisted ventilation and the treatment of comorbidities will vary depending on severity and possible TTs. The use of antibiotics will be indicated particularly if sputum color changes, when ventilatory assistance is required, in cases involving pneumonia, and in patients with elevated C-reactive protein (≥ 20 mg/L). Systemic corticosteroids are recommended in CES that requires admission and are suggested in moderate CES. These drugs are more effective in patients with blood eosinophil counts ≥ 300 cells/mm3. Acute-phase non-invasive mechanical ventilation is specified primarily for patients with CES who develop respiratory acidosis despite initial treatment.

[Translated article] Spanish COPD Guidelines (GesEPOC) 2021 Update. Diagnosis and Treatment of COPD Exacerbation Syndrome.

This article details the GesEPOC 2021 recommendations on the diagnosis and treatment of COPD exacerbation syndrome (CES). The guidelines propose a definition-based syndromic approach, a new classification of severity, and the recognition of different treatable traits (TT), representing a new step toward personalized medicine. The evidence is evaluated using GRADE methodology, with the incorporation of 6 new PICO questions. The diagnostic process comprises four stages: 1) establish a diagnosis of CES, 2) assess the severity of the episode, 3) identify the trigger, and 4) address TTs. This diagnostic process differentiates an outpatient approach, that recommends the inclusion of a basic battery of tests, from a more comprehensive hospital approach, that includes the study of different biomarkers and imaging tests. Bronchodilator treatment for immediate relief of symptoms is considered essential for all patients, while the use of antibiotics, systemic corticosteroids, oxygen therapy, and assisted ventilation and the treatment of comorbidities will vary depending on severity and possible TTs. The use of antibiotics will be indicated particularly if sputum color changes, when ventilatory assistance is required, in cases involving pneumonia, and in patients with elevated C-reactive protein (≥ 20 mg/L). Systemic corticosteroids are recommended in CES that requires admission and are suggested in moderate CES. These drugs are more effective in patients with blood eosinophil counts ≥ 300 cells/mm3. Acute-phase non-invasive mechanical ventilation is specified primarily for patients with CES who develop respiratory acidosis despite initial treatment.

Effectiveness of a Gamification Strategy to Prevent Childhood Obesity in Schools: A Cluster Controlled Trial.

OBJECTIVE: The aim of this study was to examine the effectiveness of a school-based gamification strategy to prevent childhood obesity. METHODS: Schools were randomized in Santiago, Chile, between March and May 2018 to control or to receive a nutrition and physical activity intervention using a gamification strategy (i.e., the use of points, levels, and rewards) to achieve healthy challenges. The intervention was delivered for 7 months and participants were assessed at 4 and 7 months. Primary outcomes were mean difference in BMI z score and waist circumference (WC) between trial arms at 7 months. Secondary outcomes were mean difference in BMI and systolic and diastolic blood pressure between trial arms at 7 months.  RESULTS: A total of 24 schools (5 controls) and 2,197 students (653 controls) were analyzed. Mean BMI z score was lower in the intervention arm compared with control (adjusted mean difference -0.133, 95% CI: -0.25 to -0.01), whereas no evidence of reduction in WC was found. Mean BMI and systolic blood pressure were lower in the intervention arm compared with control. No evidence of reduction in diastolic blood pressure was found. CONCLUSIONS: The multicomponent intervention was effective in preventing obesity but not in reducing WC. Gamification is a potentially powerful tool to increase the effectiveness of school-based interventions to prevent obesity.

Profile of Cardiovascular Disease Patients Who are Diagnosed with COPD in a Smoking-Cessation Unit.

INTRODUCTION: Cardiovascular diseases (CVDs) and chronic obstructive pulmonary disease (COPD) have similar prevalence rates and risk factors, and both frequently occur in the same patient. The primary objective of the study was to evaluate the rate of COPD patients among subjects with some form of CVD referring to a smoking cessation unit. The secondary objective was to analyze the demographic and clinical profile of these subjects and to identify independent factors potentially associated with COPD. METHODS: Observational, prospective study involving 132 patients with smoking habits, and some form of CVD, referring to the smoking cessation unit at the Pulmonology Department of the University Hospital of Cáceres, Spain, between October 2015 and March 2017. RESULTS: A total of 58 patients (43.9%) were diagnosed with COPD. Main CVDs were: ischemic heart disease (76.5%), chronic heart failure (24.8%), peripheral arterial disease (18.5%), and atrial fibrillation (7.6%). Independent factors were: pack-years (> 30 versus < 30; odds ratio, OR 5.3; 95% CI 1.3-21.4); forced expiratory volume in the first second (OR 0.9; 95% CI 0.9-1.0); chronic heart failure (yes versus no; OR 4.7; 95% CI 1.3-16.4); and modified Medical Research Council (mMRC) dyspnea (2-3 versus 0; OR 18.7; 95% CI 1.9-182.0). CONCLUSIONS: Four of ten patients with some form of CVD also experience COPD. Dyspnea, airflow limitation, smoking habits, and chronic heart failure were significant factors associated with COPD in patients with CVD. Smoking cessation units are useful to improve the diagnosis of COPD in these patients. Further prospective studies with a greater cohort of patients are required to corroborate the present results and to enhance the knowledge of the clinical profile of these patients.

Relationship Between Clinical Control, Respiratory Symptoms and Quality of Life for Patients with COPD.

Background: The concept of clinical control has been proposed as an instrument for evaluating patients with COPD. However, the possible association between clinical control, reduced symptom severity and HRQoL has yet to be confirmed. Methods: This multicentre, prospective and observational study was carried out in 15 pulmonology clinics in Spain. The patients were followed up for six months, with a baseline visit (V0), followed by visits at three months (V1) and six months (V2). Clinical control was determined at V1, with the application of both clinical criteria and the COPD assessment test (CAT). All patients reported their symptoms by a validated symptom diary (E-RS) using a portable device, and their HRQoL was assessed using the EQ5D questionnaire. The relationship between clinical control and E-RS and HRQoL during follow-up was assessed with t-test. Results: A total of 126 patients were screened. After application of the inclusion/exclusion criteria, 93 were finally included (mean age 66 ± 8 years, 84.9% male), with a mean FEV1 predicted of 49.8% ± 16.5%. Of these patients, 44 (47.3%) achieved clinical control at V1, according to CAT criteria, and 50 (53.8%), according to clinical criteria. The E-RS scores differed between controlled and uncontrolled patients at all time points, both according to CAT (mean differences of -4.6, -5.6 and -6.2 units at V0, V1 and V2, respectively, p<0.005 for all comparisons) and to clinical criteria (mean differences of -3.3, -5-6 and -4.99 units, respectively, p<0.005 for all comparisons). The controlled patients also presented a significantly better HRQoL, measured by the EQ5D questionnaire (mean difference 0.13 and 0.10 at V2 by CAT or clinical criteria, respectively, p<0.05). Conclusion: Clinical control in patients with COPD, whether measured by CAT or by clinical criteria, is associated with a lower symptom load and a better HRQoL.

Clinical Features Of Women With COPD: Sex Differences In A Cross-Sectional Study In Spain ("The ESPIRAL-ES Study").

Aim: This cross-sectional multicenter study was performed aimed at describing the clinical characteristics of women with COPD attended in routine daily practice in Spain. Methods and results: Of a total of 1610 consecutive patients diagnosed with COPD recruited in primary care centers and pneumology services throughout Spain over a 90-day period, 17.9% (n=286) were women, with a median age of 62 years. Differences in COPD phenotypes by sex were statistically significant (P = 0.002). Males as compared with females showed a higher prevalence of non-exacerbator (47.9% vs 42.2%) and exacerbator with chronic bronchitis (22.9% vs 18.8%) phenotypes, whereas the ACOS phenotype was more common among females (21.7% vs 12.9%). The mean (SD) CAT score was similar in men than in women (20.8 [9.0] vs 21.2 [8.7], P = 0.481), as well as the impact of the disease on the quality of life according to CAT scores of <5 (no impact), 5-9 (low), 10-20 (medium), >20 (high), and >30 (very high). Sex-related differences according to smoking status were statistically significant (P < 0.001), with a higher percentage of men as compared with women in the groups of current smokers and ex-smokers; never-smokers were higher in women (9.1%) than in men (0.6%). The mean number of comorbidities was 2.01 (1.43) (95% CI 1.93-2.09) in males and 1.99 (1.42) (95% CI 1.83-2.16) (P = 0.930) in females, but cardiovascular diseases (hypertension, ischemic heart disease, chronic heart failure) were more frequent in men, whereas metabolic disorders (osteoporosis) were more frequent in women. Conclusion: This study highlights the impact of COPD in women and the importance of continuing sex-based research in tobacco-related respiratory diseases.

Geographic variations of the prevalence and distribution of COPD phenotypes in Spain: "the ESPIRAL-ES study".

PURPOSE: The purpose of this study was to assess the prevalence of COPD phenotypes at a national level and to determine their geographic distribution among different autonomous communities in Spain. PATIENTS AND METHODS: A total of 1,610 patients (82% men, median age 67 years) recruited in primary care centers and pneumology services participated in an observational, cross-sectional, and multicenter study. Phenotypes evaluated were the non-exacerbator phenotype, the asthma-COPD overlap syndrome (ACOS), the exacerbator phenotype with emphysema, and the exacerbator phenotype with chronic bronchitis. RESULTS: The non-exacerbator phenotype was the most common (46.7%) followed by exacerbator with chronic bronchitis (22.4%) and exacerbator with emphysema (16.4%). The ACOS phenotype accounted for the lowest rate (14.5%). For each phenotype, the highest prevalence rates were concentrated in two or three autonomous communities, with relatively similar rates for the remaining regions. Overall prevalence rates were higher for the non-exacerbator and the exacerbator with chronic bronchitis phenotypes than for ACOS and the exacerbator with chronic bronchitis phenotypes. Differences in the distribution of COPD phenotypes according to gender, age, physician specialty, smoking habit, number of comorbidities, quality of life assessed with the COPD Assessment Test, and BODEx index (body mass index, airflow obstruction, dyspnea, and exacerbations) were all statistically significant. CONCLUSION: Differences in the prevalence rates of COPD phenotypes among the Spanish autonomous communities have been documented. Mapping the distribution of COPD phenotypes is useful to highlight regional differences as starting point for comparisons across time. This geographic analysis provides health-care planners a valuable platform to assess changes in COPD burden at nationwide and regional levels.

Active smoking and COPD phenotype: distribution and impact on prognostic factors.

PURPOSE: Smoking can affect both the phenotypic expression of COPD and factors such as disease severity, quality of life, and comorbidities. Our objective was to evaluate if the impact of active smoking on these factors varies according to the disease phenotype. PATIENTS AND METHODS: This was a Spanish, observational, cross-sectional, multicenter study of patients with a diagnosis of COPD. Smoking rates were described among four different phenotypes (non-exacerbators, asthma-COPD overlap syndrome [ACOS], exacerbators with emphysema, and exacerbators with chronic bronchitis), and correlated with disease severity (body mass index, obstruction, dyspnea and exacerbations [BODEx] index and dyspnea grade), quality of life according to the COPD assessment test (CAT), and presence of comorbidities, according to phenotypic expression. RESULTS: In total, 1,610 patients were recruited, of whom 46.70% were classified as non-exacerbators, 14.53% as ACOS, 16.37% as exacerbators with emphysema, and 22.40% as exacerbators with chronic bronchitis. Smokers were predominant in the latter 2 groups (58.91% and 57.67%, respectively, P=0.03). Active smoking was significantly associated with better quality of life and a higher dyspnea grade, although differences were observed depending on clinical phenotype. CONCLUSION: Active smoking is more common among exacerbator phenotypes and appears to affect quality of life and dyspnea grade differently, depending on the clinical expression of the disease.

Spanish Guidelines for Management of Chronic Obstructive Pulmonary Disease (GesEPOC) 2017. Pharmacological Treatment of Stable Phase. / Guía española de la enfermedad pulmonar obstructiva crónica (GesEPOC) 2017. Tratamiento farmacológico en fase estable.

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

Actualización 2021 de la Guía Española de la EPOC (GesEPOC). Tratamiento farmacológico de la EPOC estable / Spanish COPD Guidelines (GesEPOC) 2021: Updated Pharmacological treatment of stable COPD

La Guía Española de la Enfermedad Pulmonar Obstructiva Crónica (GesEPOC) se publicó por primera vez en 2012 y desde entonces ha experimentado una serie de actualizaciones que incorporan las nuevas evidencias sobre el diagnóstico y tratamiento de la EPOC. GesEPOC es una guía de práctica clínica elaborada con la colaboración de las sociedades científicas implicadas en el tratamiento de la EPOC y del Foro Español de Pacientes. Sus recomendaciones se basan en una evaluación de la evidencia mediante la metodología GRADE y en una descripción narrativa de la evidencia en aquellas cuestiones en que la aplicación de GRADE no es posible. En este artículo se resumen las recomendaciones sobre el tratamiento farmacológico de la EPOC estable basadas en la elaboración de nueve preguntas PICO. El proceso de tratamiento de la EPOC comprende cuatro etapas: 1) diagnóstico, 2) determinación del nivel de riesgo, 3) tratamiento inhalado inicial y de continuación e 4) identificación y abordaje de los rasgos tratables. Para la elección del tratamiento inhalado los pacientes de alto riesgo se dividirán en tres fenotipos: no agudizador, agudizador eosinofílico y agudizador no eosinofílico. Los rasgos tratables comprenden unos de tipo general, que deben investigarse en todos los pacientes, como el tabaquismo o la técnica inhalatoria y otros más específicos, que afectan sobre todo a los pacientes graves, como la hipoxemia crónica o la infección bronquial crónica. La base del tratamiento de la EPOC la constituyen los broncodilatadores de larga duración en monoterapia o en combinación según el nivel de riesgo del paciente. Los pacientes agudizadores eosinofílicos deben recibir corticosteroides inhalados y los no eosinofílicos requieren una evaluación más detallada para elegir la mejor opción terapéutica. La nueva GesEPOC también incluye recomendaciones sobre la retirada de corticosteroides inhalados y sobre la indicación de tratamiento con alfa-1 antitripsina. GesEPOC supone una aproximación al tratamiento de la EPOC más individualizada según las características clínicas de los pacientes y su nivel de riesgo o de complejidad. Palabras clave: EPOC Normativa Tratamiento Fenotipos Control

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. Keywords: COPD Guidelines Treatment Phenotypes Control

"Correct use of inhaled corticosteroids in chronic obstructive pulmonary disease": a consensus document.

INTRODUCTION: Indications for inhaled corticosteroids (IC) in combination with long-acting bronchodilators (LABD) are well defined in clinical practice guidelines. However, there are some doubts about their efficacy and safety. The aim of this document is to establish an expert consensus to clarify these issues. METHOD: A coordinator group was formed, which systematically reviewed the scientific evidence with the aim of identifying areas of uncertainty about the efficacy of ICs, the adverse effects associated with their use and criteria for withdrawal. Their proposals were submitted to a panel of experts and the Delphi technique was used to test the level of consensus. RESULTS: Twenty-five experts participated in the panel, and consensus was reached on the use of IC in the mixed chronic obstructive pulmonary disease (COPD)-asthma phenotype and in frequent exacerbators, and on not using IC in association with LABD for improving lung function in COPD. There was no general consensus on restricting the use of IC to prevent adverse effects. The panel did agree that IC withdrawal is feasible but should be undertaken gradually, and patients who have discontinued must be evaluated in the short term. CONCLUSIONS: Consensus was reached regarding the indication of IC in mixed COPD-asthma and frequent exacerbator phenotypes. The potential for adverse effects must be taken into consideration, but there is no consensus on whether limiting use is justified. The withdrawal of ICs was uniformly agreed to be feasible.

Spanish COPD Guidelines (GesEPOC): pharmacological treatment of stable COPD. Spanish Society of Pulmonology and Thoracic Surgery.

Recognizing the clinical heterogeneity of COPD suggests a specific therapeutic approach directed by the so-called clinical phenotypes of the disease. The Spanish COPD Guidelines (GesEPOC) is an initiative of SEPAR, which, together with the scientific societies involved in COPD patient care, and the Spanish Patient Forum, has developed these new clinical practice guidelines. This present article describes the severity classification and the pharmacological treatment of stable COPD. GesEPOC identifies four clinical phenotypes with differential treatment: non-exacerbator, mixed COPD-asthma, exacerbator with emphysema and exacerbator with chronic bronchitis. Pharmacological treatment of COPD is based on bronchodilation in addition to other drugs depending on the clinical phenotype and severity. Severity is established by the BODE/BODEx multidimensional scales. Severity can also be approximated by assessing airflow obstruction, dyspnea, level of physical activity and history of exacerbations. GesEPOC is a new, more individualized approach to COPD treatment according to the clinical characteristics of the patients.

Guía española de la enfermedad pulmonar obstructiva crónica (GesEPOC) 2017. Tratamiento farmacológico en fase estable / Spanish Guidelines for Management of Chronic Obstructive Pulmonary Disease (GesEPOC) 2017. Pharmacological Treatment of Stable Phase

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

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

A cost-effectiveness model of smoking cessation based on a randomised controlled trial of varenicline versus placebo in patients with chronic obstructive pulmonary disease.

OBJECTIVES: Smoking is an important risk factor in chronic obstructive pulmonary disease (COPD). A recent clinical trial demonstrated the efficacy of varenicline versus placebo as an aid to smoking cessation in patients with COPD. This study examines the cost-effectiveness of varenicline from the perspective of the healthcare systems of Spain (base case), the UK, France, Germany, Greece and Italy. METHODS: A Markov model was developed to determine the cost-effectiveness of varenicline as an aid to smoking cessation, compared to a placebo, in a COPD population. Cost-effectiveness was determined by the incremental cost per quality-adjusted life year (QALY) gained. RESULTS: In the Spanish base case varenicline had an incremental cost of €1021/person for an average of 0.24 life years (0.17 QALYs), gained over the lifetime of a cohort of COPD patients, resulting in an incremental cost-effectiveness ratio (ICER) of €5,566. In the other European countries, the ICER varied between €4,519 (UK) and €10,167 (Italy). Probabilistic sensitivity analysis suggested varenicline had a high probability (>95%) of being cost-effective at a threshold of €30,000/QALY. CONCLUSIONS: Varenicline is expected to be a cost-effective aid to smoking cessation in COPD patients in all of the countries studied.