Cytisine as a smoking cessation aid: Preliminary observations with a modified therapeutic scheme in real life.

INTRODUCTION: Cigarette smoke accounts for over 90,000 deaths each year in Italy. Tobacco dependence treatment guidelines suggest adopting an integrated pharmacological-behavioral model of intervention. Cytisine is a partial agonist of nicotinic receptors. Trials conducted to date have demonstrated its good efficacy in promoting smoking cessation. The cytisine scheme of treatment consists of 25 days of treatment. A 40-day regimen, with an escalating dose and an extended duration of the treatment, has been in use in many anti-smoking centers in Italy for several years, but to date there are no reports on the use of cytisine with this scheme. METHODS: A retrospective, real-life, observational study was conducted between January 2016 and September 2022. The 300 patients who had received at least one dose of study medication were selected. Continuous variables were compared by the Wilcoxon-Mann-Whitney test. Univariate and multivariate logistic regression models were implemented for self-reported seven-day point prevalence for abstinence at three, six and 12 months. RESULTS: The median age of the patients was 59 years, 57% were women. The median smoking exposure was 33.8 pack-years. Self-reported smoking abstinence at three, six and 12 months was 68.7%, 56.3% and 47.3% respectively. 84% completed the cytisine treatment, 31.3% reported adverse events and in 8.3% these led to dropping out of the treatment. CONCLUSION: Cytisine, administered with a novel therapeutic scheme in the real-life setting of a specialized anti-smoking center, significantly promotes smoking abstinence. However, more studies are needed to assess the tolerability and efficacy of this new regimen.

Cytisine Therapy Improved Smoking Cessation in the Randomized Screening and Multiple Intervention on Lung Epidemics Lung Cancer Screening Trial.

INTRODUCTION: Cytisine, a partial agonist-binding nicotine acetylcholine receptor, is a promising cessation intervention. We conducted a single-center, randomized, controlled trial (RCT) in Italy to assess the efficacy and tolerability of cytisine as a smoking cessation therapy among lung cancer screening participants. METHODS: From July 2019 to March 2020, the Screening and Multiple Intervention on Lung Epidemics RCT enrolled 869 current heavy tobacco users in a low-dose computed tomography screening program, with a randomized comparison of pharmacologic intervention with cytisine plus counseling (N = 470) versus counseling alone (N = 399). The primary outcome was continuous smoking abstinence at 12 months, biochemically verified through carbon monoxide measurement. RESULTS: At the 12-month follow-up, the quit rate was 32.1% (151 participants) in the intervention arm and 7.3% (29 participants) in the control arm. The adjusted OR of continuous abstinence was 7.2 (95% confidence interval: 4.6-11.2). Self-reported adverse events occurred more frequently in the intervention arm (399 events among 196 participants) than in the control arm (230 events among 133 participants, p < 0.01). The most common adverse events were gastrointestinal symptoms, comprising abdominal swelling, gastritis, and constipation. CONCLUSIONS: The efficacy and safety observed in the Screening and Multiple Intervention on Lung Epidemics RCT indicate that cytisine, a very low-cost medication, is a useful treatment option for smoking cessation and a feasible strategy to improve low-dose computed tomography screening outcomes with a potential benefit for all-cause mortality.

Factors associated with a change in smoking habit during the first COVID-19 lockdown: an Italian cross-sectional study among ever-smokers.

BACKGROUND: The COVID-19 pandemic and the lockdown period lasted from March to May 2020, resulted in a highly stressful situation yielding different negative health consequences, including the worsening of smoking habit. METHODS: A web-based cross-sectional study on a convenient sample of 1013 Italian ever smokers aged 18 years or more was conducted. Data were derived from surveys compiled by three different groups of people: subjects belonging to Smoking Cessation Services, Healthcare Providers and Nursing Sciences' students. All institutions were from Northern Italy. The primary outcome self-reported worsening (relapse or increase) or improvement (quit or reduce) of smoking habit during lockdown period. Multiple unconditional (for worsening) and multinomial (for improving) logistic regressions were carried out. RESULTS: Among 962 participants, 56.0% were ex-smokers. Overall, 13.2% of ex-smokers before lockdown reported relapsing and 32.7% of current smokers increasing cigarette intake. Among current smokers before lockdown, 10.1% quit smoking and 13.5% decreased cigarette intake. Out of 7 selected stressors related to COVID-19, four were significantly related to relapse (OR for the highest vs. the lowest tertile ranging between 2.24 and 3.62): fear of being infected and getting sick; fear of dying due to the virus; anxiety in listening to news of the epidemic; sense of powerlessness in protecting oneself from contagion. In addition to these stressors, even the other 3 stressors were related with increasing cigarette intensity (OR ranging between 1.90 and 4.18): sense of powerlessness in protecting loved ones from contagion; fear of losing loved ones due to virus; fear of infecting other. CONCLUSION: The lockdown during the COVID-19 pandemic was associated with both self-reported relapse or increase smoking habit and also quitting or reduction of it.

Covid-19 and ex-smokers: an underestimated prognostic factor?

Dear Editor, The recent and explosive worldwide outbreak of Covid-19 leads many scientists and clinicians to identify the most responsible triggering risk factors in individuals without comorbidities, as well as potential prognostic factors. A notable field of research has been conducted on the role of smoking, which has been initially hypothesized as being a protective factor for Covid-19....

A pilot study with early adolescents: dealing with diet, tobacco and air pollution using practical experiences and biological markers.

BACKGROUND: Tobacco use and the Western diet are two of the most important and investigated topics in relation to adolescents' health. In addition, air pollution is a crucial subject for future generations. School is a key social environment that should promote healthy behaviors in children and adolescents. In this field many different programs have been conducted, with mixed results and effectiveness. Research data suggest that comprehensive and multicomponent approaches may have a greater effect on tobacco use and diet, especially when integrated into a community-wide approach. METHODS: The present work describes a multi-area pilot study called "La Scuola della Salute" (the School of Health) with a focus on the methodological aspects of the intervention. In our study we assessed different web-based and practical experiences related to adolescents' smoking and dietary behaviors and awareness of smoke-related air pollution. Furthermore, to make adolescents more conscious of smoking and dietary behaviors, we conducted experiential workshops that addressed smoking and environmental pollution, food education, and lifestyle. Teachers and school administrators were involved in the project. RESULTS: At baseline we investigated dietary habits, tobacco use, and individual and social characteristics by means of lifestyle questionnaires. In addition, we collected anthropometric parameters and performance indicators such as exhaled carbon monoxide and urinary fructose to assess smoking and nutrition habits. At the end of the intervention lifestyle questionnaire and biological markers were collected again: knowledge about these topics was significantly improved, and the urinary fructose was able to estimate the levels of obesity in the classes. CONCLUSIONS: The integrated approach, combined with the use of biological markers, could be an innovative approach to the promotion of healthy lifestyles among adolescents, but further research is needed.

Hospital doctors' smoking behavior and attitude towards smoking cessation interventions for patients: a survey in an Italian Comprehensive Cancer Centre.

PURPOSE: Tobacco control guidelines recommend all healthcare professionals to ask patients about their smoking status and to offer them at least minimal cessation advice. However, few data are available about the daily practice of hospital clinicians who work with smoking cancer patients. This study assesses, in a comprehensive cancer center, the physicians' smoking habit, their clinical practice in offering a smoking cessation intervention to patients who smoke, and the training they received in this field. METHODS: A Web-based survey was sent to 285 physicians. RESULTS: The survey response rate was 75%. Sixty-two percent, 24%, and 14% of responders were never, former, and current smokers, respectively. Six percent of all responding physicians have already participated in smoking cessation training and 43% of them declared their willingness to be trained. Eighty-six percent of all responding physicians asked about the patients' smoking status, 50% routinely advised patients to quit smoking, and 32% assessed their motivation to do so. Smoking cessation guidelines were not followed mostly for lack of time, fear to increase patients' stress, and lack of smoking cessation training. Ninety-four percent of responding physicians knew the smoking cessation service for outpatients and 65% referred at least one patient, 66% of responding physicians knew the service for inpatients, and 36% of them asked for at least one intervention in the ward. CONCLUSIONS: This study pointed out partial adherence of the physicians working in a leading cancer center to the smoking cessation guidelines. The clinicians' smoking habits did not influence the training and the clinical practice in offering patients smoking cessation interventions.

Stopping Smoking Reduces Mortality in Low-Dose Computed Tomography Screening Participants.

INTRODUCTION: The National Lung Screening Trial has achieved a 7% reduction in total mortality with low-dose computed tomography (LDCT) screening as compared with in the chest radiography arm. Other randomized trials are under way, comparing LDCT screening with no intervention. None of these studies was designed to investigate the impact of smoking habits on screening outcome. In the present study, we tested the effect of stopping smoking on the overall mortality of participants undergoing repeated LDCT screening for many years. METHODS: Between 2000 and 2010, 3381 smokers aged 50 years or older were enrolled in two LDCT screening programs. On the basis of the last follow-up information, subjects were divided into two groups: current smokers throughout the screening period and former smokers. RESULTS: With a median follow-up time of 9.7 years and a total of 32,857 person-years (PYs) of follow-up, a total of 151 deaths were observed in the group of 1797 current smokers (17,846 PYs) versus 109 among 1584 former smokers (15,011 PYs), corresponding to mortality rates of 8.46 and 7.26 for every 1000 PYs, respectively. Compared with current smokers, former smokers had an adjusted mortality hazard ratio of 0.61 (95% confidence interval: 0.44-0.83), with a 39% reduction in mortality. A similar reduction in mortality was observed in the subset of 712 late quitters, with a hazard ratio of 0.65 (95% confidence interval: 0.44-0.96). CONCLUSIONS: Stopping smoking significantly reduces the overall mortality of smokers enrolled in LDCT screening programs. The beneficial effect of stopping smoking on total mortality appears to be threefold to fivefold greater than the one achieved by earlier detection in the National Lung Screening Trial.

Extended varenicline treatment in a severe cardiopathic cigarette smoker: a case report.

INTRODUCTION: Tobacco smoking is the leading cause of cardiovascular morbidity and mortality and quitting tobacco use should be fundamental for cardiovascular patients. Varenicline is a smoking cessation pharmacological therapy able to improve the possibilities to successfully achieve this result. In 2011 the US Food and Drug Administration issued a safety announcement that varenicline may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. Following studies found no significant increase in cardiovascular serious adverse events associated with varenicline. For the first time in the literature, we describe the case of a cardiopathic hard smoker who received varenicline for 9 months without any side effect. By describing this case we want to underline the safety of varenicline, to illustrate the setting and the method that we used to support him and to underline the importance of promoting smoking cessation in heart patients. CASE PRESENTATION: Varenicline was used to promote smoking cessation in a 52-year-old Caucasian man who smoked 40 cigarettes per day, despite two ischemic cardiovascular events. He asked for a consultation in a pharmacy's smoking cessation service and after the assessment phase varenicline was prescribed. Due to his difficulty to quit smoking and given his good tolerance of the drug, we extended the treatment with varenicline to 9 months in order to achieve and maintain a complete smoking abstinence; intensive behavioural counselling was combined with the pharmacological therapy. By using exhaled carbon monoxide measurement we assessed smoking abstinence up to 2 years. CONCLUSIONS: The use of varenicline for a period longer than 6 months has not been described in the literature, particularly in heart patients. The extended varenicline therapy was clinically monitored and allowed the patient to consolidate his abstinence; the intensive behavioural counselling helped him to overcome his strong psychological dependence. Promoting smoking cessation in people who have cardiovascular disease is crucial. Currently available medications, such as varenicline, increase the chances of success and the risk of possible side effects is outweighed by the lifetime benefits and we hope that clinicians use them more frequently and confidently.

A combined smoking cessation intervention within a lung cancer screening trial: a pilot observational study.

AIMS AND BACKGROUND: The time of lung cancer screening may provide the ideal setting to discuss and initiate a smoking cessation plan that includes pharmacologic aids. No studies to date have fully investigated the potential effectiveness of such combined approach. METHODS: We prospectively evaluated the biochemically verified 1-year continuous abstinence rate from smoking of 187 persistent smokers enrolled within the Multicentric Italian Lung Detection Trial (MILD), who received a pharmacologic aid to quit smoking with varenicline along with behavioral counseling. The propensity of study subjects to succeed in smoking cessation was also monitored. RESULTS: At 12 months, the continuous abstinence rate from smoking was achieved in 37 out of 187 patients (19.8%), with a propensity to succeed in smoking cessation for the assisted attempt equal to 1.43, as compared to an unassisted MILD patient. At the end of the third month of therapy, 48.7% of subjects showed a continuous abstinence rate, while only 33.7% of patients were abstinent from smoking at 6 months. At baseline, the subgroup of MILD participants who were originally allocated to lung tomography showed higher smoking intensity than those allocated to no screening. CONCLUSIONS: A combined smoking cessation intervention can be implemented with satisfactory results within a lung cancer screening program; this preliminary observation needs to be replicated in a prospective investigation. Clinicians should consider that lung cancer screening may be falsely reassuring for persistent smokers; therefore it should always be coupled with a smoking cessation program.

Particulate matters from diesel heavy duty trucks exhaust versus cigarettes emissions: a new educational antismoking instrument.

BACKGROUND: Indoor smoking in public places and workplaces is forbidden in Italy since 2003, but some health concerns are arising from outdoor secondhand smoke (SHS) exposure for non-smokers. One of the biggest Italian Steel Manufacturer, with several factories in Italy and abroad, the Marcegaglia Group, recently introduced the outdoor smoking ban within the perimeter of all their factories. In order to encourage their smoker employees to quit, the Marcegaglia management decided to set up an educational framework by measuring the PM1, PM2.5 and PM10 emissions from heavy duty trucks and to compare them with the emissions of cigarettes in an indoor controlled environment under the same conditions. METHODS: The exhaust pipe of two trucks powered by a diesel engine of about 13.000/14.000 cc(3) were connected with a flexible hose to a hole in the window of a container of 36 m(3) volume used as field office. The trucks operated idling for 8 min and then, after adequate office ventilation, a smoker smoked a cigarette. Particulate matter emission was thereafter analyzed. RESULTS: Cigarette pollution was much higher than the heavy duty truck one. Mean of the two tests was: PM1 truck 125.0(47.0), cigarettes 231.7(90.9) p = 0.002; PM2.5 truck 250.8(98.7), cigarettes 591.8(306.1) p = 0.006; PM10 truck 255.8(52.4), cigarettes 624.0(321.6) p = 0.002. CONCLUSIONS: Our findings may be important for policies that aim reducing outdoor SHS exposure. They may also help smokers to quit tobacco dependence by giving them an educational perspective that rebuts the common alibi that traffic pollution is more dangerous than cigarettes pollution.

Comparison between particulate matter and ultrafine particle emission by electronic and normal cigarettes in real-life conditions.

AIMS: Electronic cigarettes may be safer than conventional cigarettes as they generate less indoor pollution in terms of particulate matter (PM); however, recent findings in experimental conditions demonstrated that secondhand exposure to PM may be expected from e-cigarette smoking. The aim of the present study was to investigate the emission of PM generated by e-cigarettes and normal cigarettes under real-life conditions. METHODS: Real-time measurement and comparison of PM and ultrafine particles (UFP) generated by electronic cigarettes with and without nicotine and by normal cigarettes in a 50 m3 office of an Italian comprehensive cancer center was performed. PM mass as PM1, PM2.5, PM7, PM10, total suspended particles (TSP) in µg/m³ and UFP in number of particles per cubic centimeter from 10 to 1,000 nanometers were measured. Outdoor concentrations were measured contemporaneously to compensate for urban background changes. RESULTS: Regardless of their nicotine content, e-cigarettes generated lower PM levels than conventional cigarettes. Notably, nicotine-enriched e-cigarettes produced lower PM levels than their nicotine-free counterparts. CONCLUSION: E-cigarettes appear to generate less indoor pollution than normal cigarettes and may therefore be safer. Further studies are required to investigate the long-term health-related effects of secondhand e-cigarette exposure.

Antismoking centers in Milan's communal pharmacies: analysis of the 2010-2011 campaign.

AIMS AND BACKGROUND: According to recent assessments from the Italian Istituto Superiore della Sanità, information and assistance to smokers are still far from satisfactory. We evaluated the impact of a new smoking cessation service located in pharmacies. Smokers' individual characteristics were also considered. MATERIAL AND METHODS: A 1-year pilot study was carried out from October 2010 to September 2011. Five pharmacies in Milan were selected. A psychologist with experience in smoking cessation was present in each pharmacy one afternoon per week, and pharmacists were trained by a team from the Antismoking Center of the Fondazione IRCCS Istituto Nazionale dei Tumori. Each pharmacy was equipped with informative material, carbon monoxide analyzers, and motivational and nicotine dependence questionnaires, in addition to a clinical briefcase. Counseling sessions were also arranged upon request. RESULTS: In the first 12 months of activity, 216 persons asked for a consultation. The sample, aged 15-79 years, reported the following median values: 30 pack/years, 14 ppm CO, and a Fagerström Test of Nicotine Dependence score of 5. More than one-third of the sample (40.3%) had one pathology and 25% had more than one. In some cases (15.7%), people just wanted information about what the service offered. For those who tried to quit, smoking cessation rates were 33.3% at 3 months, 28% at 6 months, and 24.6% at 1 year. Three kinds of pharmacologic therapies were suggested to smokers: nicotine replacement therapy (75.5%), varenicline (17.5%), and bupropion (7%). CONCLUSIONS: The results show that an accessible and free smoking cessation service is considered useful by smokers as demonstrated by the large number of requests compared with other smoking centers in Italy. Increased involvement of pharmacists in supporting smoking cessation makes this a promising initiative for the near future.

The electronic cigarette: potential health benefit or mere business?

Electronic cigarettes (e-cigarettes) have attracted considerable attention as a possible alternative to tobacco cigarettes, but uncertainties about their impact on health and indoor air quality as well as their commercial success without a clear regulatory framework are arousing concern. We have therefore tried to summarize the health-related implications of the use of e-cigarettes in order to help physicians and health professionals provide accurate information on this device. Given the lack of unequivocal scientific data on their toxicity and safety, we conclude that at the moment there is no reason to approve e-cigarettes as a safe alternative to tobacco smoke.

Breast change perception in women after smoking cessation. A pilot study.

AIMS AND BACKGROUND: There are several barriers to smoking cessation that are unique to women. Compared to men, women report lower levels of motivation to quit and greater perceived difficulty with cessation. However, recent studies might favor commitment by women to quit through higher risk perception related e.g. to the development of premature facial wrinkling or the decrease in mammographic density due to cigarette smoking. METHODS: A pilot study to evaluate the perception of breast change after cessation and its possible motivational effect on maintenance was carried out. We interviewed 25 premenopausal women who had quit ≥1 year before. We obtained information from the women and discussed changes in breast size and fullness. The two groups of women with and without breast change were statistically compared using the nonparametric Mann-Whitney test (continuous variables) and the Fisher test (categorical variables). RESULTS: Median age was 41 years (range, 30-49 years). Median carbon monoxide (CO) before quitting was 18 ppm and median pack years (PY) was 22.5; both parameters characterize a category of mild smokers. Sixteen women (64%) reported breast changes 6 months after quitting smoking. This outcome was paralleled by only moderate effects on weight or body mass index (BMI) increase after quitting. Notably, of the 16 women with breast change, only 3 (19%) with a normal baseline BMI showed a BMI increase to >25. CONCLUSIONS: Within the limitations of the small size of a pilot study, these results indicate that premenopausal women experience subjective perception of change in breast size after smoking cessation, which may not be totally explained by weight gain. Further studies are needed to understand the effect, if any, of such perception on the motivation to quit smoking.

Efficacy of pins and diplomas as a reward for long-term smoking cessation.

AIMS AND BACKGROUND: Since 2004, the Antismoking Center of the National Cancer Institute of Milan has rewarded those who have been ex-smokers for longer than a year with a "former smoker" pin and a diploma. We investigated firstly whether these rewards contributed to maintain smoking withdrawal, secondly, which one of these was more appreciated and why, and thirdly, how they may have influenced the ex-smokers' perception of smoking and how this was reflected on those surrounding them (i.e., ex-smokers' personal and/or interpersonal areas). METHODS: A multiple-choice questionnaire was developed to investigate how much the rewards were appreciated and their effectiveness in maintaining smoking cessation. Moreover, smokers and non-smokers were asked about the impact of the pin. The questionnaire was completed on the phone by the last 100 ex-smokers who entered the pin and diploma program. RESULTS: All subjects appreciated the rewards, but only a few of them considered them as an aid to maintain long-term smoking cessation. Those who preferred the diploma stated that it represented a contribution to their self-esteem, an official recognition of being an ex-smoker, besides being something to show with pride to others. Those who preferred the pin principally stated it allowed them to be an example to other smokers. Most of the subjects reported that they wore the pin in several circumstances, raising interest and admiration. CONCLUSIONS: Rewarding ex-smokers one year after smoking cessation with a small prize may be a useful practice to improve the doctor-patient relationship, which is vital to maintain smoking cessation, and to boost the awareness of the availability of aids to reach this objective.