Juan Antonio Riesco-Miranda

Purpose: To develop a consensus document on how to follow-up patients with COPD in clinical practice in Spain. Methods: A qualitative, three-round Delphi survey was conducted in the framework of Spanish pneumologists attending COPD patients in routine daily practice. Participants completed a 35-item questionnaire on how to follow-up COPD patients, according to four sections: 1) assessment of the patient’s clinical conditions, 2) therapeutical interventions, 3) frequency of follow-up visits, and 4) healthcare pathways. Consensus was defined if more than 70% of participants agree. Results: A total of 155 specialists in respiratory medicine (53% men; mean age 47 years) participated in the study (69% with more than 10 years of professional practice). More than 80% of participants agreed on the use of clinical practice guidelines but 81.9% considered that recommendations on follow-up should be more explicit. Assessment of lung function (FEV1), dyspnea, and exacerbations were the clinical variables that reached a higher level of consensus. Dyspnea values were reported as the main indicator to assess increased bronchodilation, and exacerbations were the most important to assess the use of inhaled corticosteroids. Follow-up of low-risk patients should be performed in the primary care setting, and patients should be visited every 12 months, whereas high‑risk patients should be monitored by pneumologists and including nursing visits. Conclusion: The participants agree that the guidelines should include more specific indications to define the follow-up of the COPD patient, and there is lack of evidence in many aspects. There is consensus on the importance of care to coordinate with nursing and primary care, but the protocols to follow and the working tasks for each healthcare setting remain unclear.

Background: Cytisinicline has proven to be an effective, efficient, and safe molecule in smoking cessation. However, the established 25-day regimen could be insufficient in a high percentage of smokers, so it is necessary to study maintained therapies of this drug. Objective: This study aims to compare the efficacy of the cytisinicline regimen used in routine clinical practice versus 2 maintained regimens of 50 and 75 days, respectively. In addition, the safety and economic impact of each regime will be determined. Methods: A prospective, multicenter, open-label, controlled, parallel, phase IV clinical trial of 402 smoker patients prepared to quit smoking. The study was conducted in 10 hospitals in Spain. A control group is compared to 2 intervention groups in which the duration of the drug is increased without increasing its dose, administering half and all, respectively, of an additional marketed container that includes 100 tablets. Thus, participants will be randomized to three groups in a 1:1:1 ratio to receive cytisinicline: (1) a control group treated with cytisinicline according to the usual clinical guidelines and product information (25 days); (2) a group with a 50-day cytisinicline regimen (an additional 25 days at a dose of 1.5 mg every 12 hours), seeking to increase its efficacy while minimally impacting adherence; and (3) a group with a 75-day regimen (an additional 50 days at a dose of 1.5 mg every 12 hours), attempting to increase its efficacy, although the longer duration of the drug may threaten adherence. Efficacy in the 3 arms will be analyzed through sustained abstinence at 6 and 12 months, point abstinence rate assessed every 7 days, and abstinence rate from Day 25 to Day 50 and from Day 25 to Day 75 in the 3 study arms. (1) The variation in withdrawal and craving symptoms in the 3 groups, (2) safety through the percentage of adverse events in the 3 treatment arms, and (3) economic impact by evaluating the cost-effectiveness and cost-utility ratios of the 2 prolonged regimens versus the usual clinical cytisinicline regimen. To calculate the differences between the 3 groups for each outcome variable, a univariate analysis will be performed. Statistically significant variables will be included in a multivariate model. Results: Recruitment for the trial and patient enrollment were completed in November 2026. Follow-up of all participants will extend to December 2027. Conclusions: In conclusion, this study evaluates the optimization of cytisinicline in daily clinical practice, increasing the benefits of its pharmaceutical properties without affecting patient safety. All of this will improve the effectiveness of smoking cessation by reducing the number of smokers, which implies lower morbidity and mortality and lower costs associated with smoking. Trial Registration: European Clinical Trials Register 2024-518936-36-00; https://euclinicaltrials.eu/ctis-public/view/2024-518936-36-00 International Registered Report Identifier (IRRID): PRR1-10.2196/76815

Introduction: We hypothesize that the predictors of smoking cessation in the mediumterm are not the same as in the long-term of follow-up. The aim of this study was to identify predictors for smoking cessation (continuous abstinence) and determine if these are maintained over time. Methods:...

BACKGROUND Cytisinicline has proven to be an effective, efficient, and safe molecule in smoking cessation. However, the established 25-day regimen could be insufficient in a high percentage of smokers, so it is necessary to study maintained therapies of this drug. OBJECTIVE This study aims to compare the efficacy of the cytisinicline regimen used in routine clinical practice versus 2 maintained regimens of 50 and 75 days, respectively. In addition, the safety and economic impact of each regime will be determined. METHODS A prospective, multicenter, open-label, controlled, parallel, phase IV clinical trial of 402 smoker patients prepared to quit smoking. The study was conducted in 10 hospitals in Spain. A control group is compared to 2 intervention groups in which the duration of the drug is increased without increasing its dose, administering half and all, respectively, of an additional marketed container that includes 100 tablets. Thus, participants will be randomized to three groups in a 1:1:1 ratio to receive cytisinicline: (1) a control group treated with cytisinicline according to the usual clinical guidelines and product information (25 days); (2) a group with a 50-day cytisinicline regimen (an additional 25 days at a dose of 1.5 mg every 12 hours), seeking to increase its efficacy while minimally impacting adherence; and (3) a group with a 75-day regimen (an additional 50 days at a dose of 1.5 mg every 12 hours), attempting to increase its efficacy, although the longer duration of the drug may threaten adherence. Efficacy in the 3 arms will be analyzed through sustained abstinence at 6 and 12 months, point abstinence rate assessed every 7 days, and abstinence rate from Day 25 to Day 50 and from Day 25 to Day 75 in the 3 study arms. (1) The variation in withdrawal and craving symptoms in the 3 groups, (2) safety through the percentage of adverse events in the 3 treatment arms, and (3) economic impact by evaluating the cost-effectiveness and cost-utility ratios of the 2 prolonged regimens versus the usual clinical cytisinicline regimen. To calculate the differences between the 3 groups for each outcome variable, a univariate analysis will be performed. Statistically significant variables will be included in a multivariate model. RESULTS Recruitment for the trial and patient enrollment were completed in November 2026. Follow-up of all participants will extend to December 2027. CONCLUSIONS In conclusion, this study evaluates the optimization of cytisinicline in daily clinical practice, increasing the benefits of its pharmaceutical properties without affecting patient safety. All of this will improve the effectiveness of smoking cessation by reducing the number of smokers, which implies lower morbidity and mortality and lower costs associated with smoking. CLINICALTRIAL European Clinical Trials Register 2024-518936-36-00; https://euclinicaltrials.eu/ctis-public/view/2024-518936-36-00 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/76815

Chronic obstructive pulmonary disease (COPD) represents one of the most frequent causes of hospital readmissions and in-hospital mortality. One in five patients requires readmission within 30 days of discharge following an admission for exacerbation. These ‘early readmissions’ increase morbidity and mortality, as patients often do not recover their baseline lung function. The identification of factors associated with increased risk has been a major focus of research in recent years. Studies describe patient-related predictors, although some studies also suggest that better-resourced centres provide superior care. Objective: To describe resources, performance, and care provided in pneumology units in Spain, assessing their association with 30-day readmission for COPD and in-hospital mortality. Methods: This survey was conducted in 116 hospitals responsible for the COPD pathway in pneumology units/departments from November 2022 to March 2023. Results: Of the 116 participating hospitals, 56% had a pneumology department while 25.9% had a pneumology section. The vast majority were public and university hospitals. The number of beds allocated to pneumology/100,000 inhabitants was 6.6 (3.1–9.2) and pulmonologist staffing was 3.3 (2.6–4.1) per 100,000 inhabitants. There was an intermediate respiratory care unit (IMCU) dependent on the pneumology department in 31.9% of units and a respiratory team for 24 h emergency care in 30% of units, while only 9.5% had interventional pneumology units for bronchoscopic procedures. COPD rehabilitation programmes were offered in 58.6% of pneumology units. The average rate of patients on ventilatory support in acute failure was 13.8 (9.2–25) per 100 discharges, with a 30-day COPD readmission rate of 14.9%, with significant differences according to the level of complexity (p = 0.041), with a mean length of stay of 8.72 (1.26) days. The overall in-hospital mortality in pneumology units was 4.10 (1.18) per 100 admissions. In the adjusted model, having a discharge support programme and interventions performed during admission (number of patients with ventilatory support) were predictors of a favourable outcome. Hospital stay was also maintained as a predictor of an unfavourable outcome. Conclusions: There is significant variability in resources and the organisation of care in pneumology units in Spain. The availability of a discharge support programme and greater use of ventilatory support at discharge are factors associated with a lower 30-day COPD readmission rate in the pneumology unit. This information is relevant to improve the care of patients with COPD and as a future line of research.

Objective: To describe resources, performance and care provided in pulmonology units in Spain, assessing their association with 30-day readmission for Chronic obstructive pul-monary disease (COPD) and in-hospital mortality. Methods: This survey was conducted on 116 responsible for the COPD pathway in Pneumology Units/Services from November 2022 to March 2023. Results: Of the 116 participating hospitals, 56% had a pulmonology service and 25.9% had pneumology section. The great majority were public and university hospitals. The number of beds allocated to pulmonology/100,000 inhabitants was 6.6 (3.1-9.2) and pulmonologist staffing was 3.3 (2.6-4.1) per-100,000 inhabitants. In 31.9% of pulmonology unit, there was Intermediate Care Unit dependiente (IMCU) and respiratory team for 24-hour emergency care in 30%, while only 9.5% had interventional pulmonology units. COPD rehabilitation programmes were offered in 58.6% of pulmonology units. The average rate of patients on ventilatory support in acute failure was 13.8 (9.2-25) per-100 discharges, with a 30-day COPD readmission rate of 14.9% with significant differences according to the level of complexity (p=0.041), with a mean length of stay of 8.72 (1.26) days. The overall in-hospital mortality in pulmonology units was 4.10 (1.18) per-100 admissions. In the adjusted model having a discharge support programme and interventions performed during admission (number of patients with ventilatory support) were predictors of a favourable outcome. Hospital stay was also maintained as a predictor of an unfavourable outcome. Conclusions: Knowledge of resources and outcomes in the COPD process will allow appropriate planning to improve the quality of care.

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? We carried out an SRL (six databases) and an MA for responding to the questions. 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. We suggest that NMR is a good biomarker in the personalization of smoking cessation.

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.