Recommendations for the Implementation of the Self-Administration of Alpha-1 Antitrypsin.

Purpose: Administration of exogenous alpha-1 antitrypsin (AAT) is the only specific therapy for the management of pulmonary morbidity in patients with AAT deficiency. It requires weekly or biweekly intravenous infusions, which may impact patient independence and quality of life. Self-administration of AAT therapy is an alternative to reduce the burden for patients who require AAT therapy. We presented herein experts' recommendations for the implementation of a program for the self-administration of AAT. Methods: This project was conducted using a modified nominal group technique and was undertaken in two online meetings involving the participation of 25 experts: specialists in pulmonology (n=17), nurses (n=5) and hospital pharmacists (n=3). Results: The following issues were discussed, and several recommendations were agreed upon on the following topics: a) patient profile and clinical evaluation, establishing selection criteria that should include clinical as well as social criteria; b) role of health care professionals, suggested roles for specialists in pulmonology, nurses, and hospital pharmacists; c) training by the nurse, including recommendations before initiating the training and the content of the training sessions; and d) logistic issues and follow-up, adherence, and patient support. Conclusion: We expect this proposal to increase awareness of this therapeutic alternative and facilitate the implementation of self-administration programs, thus contributing to optimizing the patient experience with AAT therapy. Further research on the outcomes of these programs, especially from the patient perspective, will also help to improve their design and implementation.

Severe COVID-19 Illness and α1-Antitrypsin Deficiency: COVID-AATD Study.

BACKGROUND: Epidemiologic studies have reported that the geographical distribution of the prevalence of allelic variants of serine protein inhibitor-A1 (SERPINA1) and severe cases of COVID-19 were similar. METHODS: A multicenter, cross-sectional, observational study to evaluate the frequency of alpha-1 antitrypsin deficiency (AATD) in patients with COVID-19 and whether it was associated with having suffered severe COVID-19. RESULTS: 2022 patients who had laboratory-confirmed SARS-CoV-2 infection. Mutations associated with AATD were more frequent in severe COVID versus non-severe (23% vs. 18.8%, p = 0.022). The frequency of Pi*Z was 37.8/1000 in severe COVID versus 17.5/1000 in non-severe, p = 0.001. Having an A1AT level below 116 was more frequent in severe COVID versus non-severe (29.5% vs. 23.1, p = 0.003). Factors associated with a higher likelihood of severe COVID-19 were being male, older, smoking, age-associated comorbidities, and having an A1AT level below 116 mg/dL [OR 1.398, p = 0.003], and a variant of the SERPINA1 gene that could affect A1AT protein [OR 1.294, p = 0.022]. CONCLUSIONS: These observations suggest that patients with AATD should be considered at a higher risk of developing severe COVID-19. Further studies are needed on the role of A1AT in the prognosis of SARS-CoV-2 infection and its possible therapeutic role.

Is the motivation to quit smoking a predictor of abstinence maintenance?

INTRODUCTION: The aim of this study was to explore the utility of measuring motivation to quit smoking as a predictor of abstinence maintenance among smokers who wanted to quit and who were included in a multicenter study conducted in daily clinical practice. METHODS: This observational, longitudinal (prospective cohort), multicenter study was conducted in smoking clinics in Spain and the Argentine Republic in daily clinical practice. Motivation was assessed using three quantitative motivation tests and a Visual Analogue Scale. Statistical analysis included descriptive, association measures and logistic regression models. RESULTS: Of a total of 404 subjects, 273 were ultimately included for analysis (147 women; 53.8%), mean age 51±11 years). In one year, 53.5% (36.13% by intention to treat) of subjects (146) were successful in quitting smoking [men: 45.2% (66) and women: 54.8% (80)], with no differences between sexes. None of the scales utilized was associated, in an unquestionable or direct way, with long-term abstinence, although three of them, in a very complex model, with additional variables and added interactions, were associated with the 'result' variable, when other variables intervened in certain circumstances. CONCLUSIONS: None of the analyzed motivational scales alone demonstrated an association with success or failure in quitting smoking; thus, their use in isolation is of no value. Some of the scales analyzed might be related to the maintenance of abstinence but in complex models where other variables intervene, which makes interpretation considerably difficult. Therefore, the predictive capacity of the tests analyzed, based on the models, was low.

Fagerström Test and Heaviness Smoking Index. Are they Interchangeable as a Dependence Test for Nicotine?

Objective: The purpose of this study was to evaluate the degree of agreement between the Fagerström Test for Cigarette Dependence (FTCD) and the Heaviness of Smoking Index (HSI) in daily smokers admitted to smoking cessation clinics from National Healthcare System in Spain and Argentine Republic. Material and methods: An observational, longitudinal, multicenter study (prospective cohort) conducted in smoking clinics in daily clinical practice. The patients were consecutively included as they attended the consultations. The statistical analysis was descriptive, and correlation and concordance tests as well as analysis and regression models were used. Results: In total, 308 subjects were included [161 women (52.3%)], with a mean age of 51.4 (10.8) years. We found an absence of agreement and the existence of a proportional difference between both tests [Regression coefficient for global series: 0.55 (0.52-0.59) p < .001]. This difference increased as the value of the FTCD score increased; that is, the higher the value of the FTCD score was, the greater the difference in relation to the value of the HSI score. Likewise, Cohen's kappa concordance coefficient, according to various combinations of categorization of both tests, showed that the agreement between these variables was only good. Approximately 20% of the subjects were not classified with the same degree of dependence by the two tests. Thus, a classification mismatch existed. Conclusions: We found an absence of agreement between both tests. These data imply that we should not substitute one test for the other when we analyze nicotine dependence in a population of smokers.

Is There an Association Between the Degree of Nicotine Dependence and the Motivation to Stop Smoking? / ¿Existe asociación entre el grado de dependencia por la nicotina y la motivación para dejar de fumar?

OBJECTIVE: To evaluate the association between degrees of nicotine dependence measured by the Fagerström test (FTCD) and different tests of motivation to stop smoking. MATERIAL AND METHODS: Observational study, multicenter conducted in smoking clinics in daily clinical practice. Demographics, smoking status, FTCD scores, and motivation test results were collected: Richmond test (TR), Henri Mondor Paris motivation test (HMP), Khimji-Watts test (KW), and the visual analog scale of motivation to stop smoking. The statistical analysis was descriptive, and correlation and analysis tests and regression models were used. RESULTS: A total of 314 subjects were included [162 women (51.59%)]. Males smoked an average of 3.3 cigarettes/day more than women (95% CI: 0.9-5.6 cigarettes/day, p=0.006) and their cumulative consumption was 7.8 pack-years higher than in women (95% CI: 2.1 to 13.5 pack-years). We found no association between FTCD and the motivation tests to stop smoking used in this study. CONCLUSIONS: We found no association between the degree of dependence and the motivation to quit smoking measured by the aforementioned instruments.

Varenicline in smokers with severe or very severe COPD after 24 weeks of treatment. A descriptive analysis: VALUE study.

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.