Summary Background Substantial concerns have been raised about the neuropsychiatric safety of the smoking cessation medications varenicline and bupropion. Their efficacy relative to nicotine patch ...largely relies on indirect comparisons, and there is limited information on safety and efficacy in smokers with psychiatric disorders. We compared the relative neuropsychiatric safety risk and efficacy of varenicline and bupropion with nicotine patch and placebo in smokers with and without psychiatric disorders. Methods We did a randomised, double-blind, triple-dummy, placebo-controlled and active-controlled (nicotine patch; 21 mg per day with taper) trial of varenicline (1 mg twice a day) and bupropion (150 mg twice a day) for 12 weeks with 12-week non-treatment follow-up done at 140 centres (clinical trial centres, academic centres, and outpatient clinics) in 16 countries between Nov 30, 2011, and Jan 13, 2015. Participants were motivated-to-quit smokers with and without psychiatric disorders who received brief cessation counselling at each visit. Randomisation was computer generated (1:1:1:1 ratio). Participants, investigators, and research personnel were masked to treatment assignments. The primary endpoint was the incidence of a composite measure of moderate and severe neuropsychiatric adverse events. The main efficacy endpoint was biochemically confirmed continuous abstinence for weeks 9–12. All participants randomly assigned were included in the efficacy analysis and those who received treatment were included in the safety analysis. The trial is registered at ClinicalTrials.gov (number NCT01456936 ) and is now closed. Findings 8144 participants were randomly assigned, 4116 to the psychiatric cohort (4074 included in the safety analysis) and 4028 to the non-psychiatric cohort (3984 included in the safety analysis). In the non-psychiatric cohort, 13 (1·3%) of 990 participants reported moderate and severe neuropsychiatric adverse events in the varenicline group, 22 (2·2%) of 989 in the bupropion group, 25 (2·5%) of 1006 in the nicotine patch group, and 24 (2·4%) of 999 in the placebo group. The varenicline–placebo and bupropion–placebo risk differences (RDs) for moderate and severe neuropsychiatric adverse events were −1·28 (95% CI −2·40 to −0·15) and −0·08 (−1·37 to 1·21), respectively; the RDs for comparisons with nicotine patch were −1·07 (−2·21 to 0·08) and 0·13 (−1·19 to 1·45), respectively. In the psychiatric cohort, moderate and severe neuropsychiatric adverse events were reported in 67 (6·5%) of 1026 participants in the varenicline group, 68 (6·7%) of 1017 in the bupropion group, 53 (5·2%) of 1016 in the nicotine patch group, and 50 (4·9%) of 1015 in the placebo group. The varenicline–placebo and bupropion–placebo RDs were 1·59 (95% CI −0·42 to 3·59) and 1·78 (−0·24 to 3·81), respectively; the RDs versus nicotine patch were 1·22 (−0·81 to 3·25) and 1·42 (−0·63 to 3·46), respectively. Varenicline-treated participants achieved higher abstinence rates than those on placebo (odds ratio OR 3·61, 95% CI 3·07 to 4·24), nicotine patch (1·68, 1·46 to 1·93), and bupropion (1·75, 1·52 to 2·01). Those on bupropion and nicotine patch achieved higher abstinence rates than those on placebo (OR 2·07 1·75 to 2·45 and 2·15 1·82 to 2·54, respectively). Across cohorts, the most frequent adverse events by treatment group were nausea (varenicline, 25% 511 of 2016 participants), insomnia (bupropion, 12% 245 of 2006 participants), abnormal dreams (nicotine patch, 12% 251 of 2022 participants), and headache (placebo, 10% 199 of 2014 participants). Efficacy treatment comparison did not differ by cohort. Interpretation The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo. Varenicline was more effective than placebo, nicotine patch, and bupropion in helping smokers achieve abstinence, whereas bupropion and nicotine patch were more effective than placebo. Funding Pfizer and GlaxoSmithKline.
Background
Nicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the ...transition from cigarette smoking to complete abstinence.
Objectives
To determine the effectiveness and safety of nicotine replacement therapy (NRT), including gum, transdermal patch, intranasal spray and inhaled and oral preparations, for achieving long‐term smoking cessation, compared to placebo or 'no NRT' interventions.
Search methods
We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of nicotine replacement therapy in the title, or keywords. Date of most recent search is July 2017.
Selection criteria
Randomized trials in people motivated to quit which compared NRT to placebo or to no treatment. We excluded trials that did not report cessation rates, and those with follow‐up of less than six months. We recorded adverse events from included and excluded studies that compared NRT with placebo. Studies comparing different types, durations, and doses of NRT, and studies comparing NRT to other pharmacotherapies, are covered in separate reviews.
Data collection and analysis
Screening, data extraction and 'Risk of bias' assessment followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow‐up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta‐analysis using a Mantel‐Haenszel fixed‐effect model.
Main results
We identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non‐NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for nicotine nasal spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare.
Authors' conclusions
There is high‐quality evidence that all of the licensed forms of NRT (gum, transdermal patch, nasal spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non‐ischaemic chest pain and palpitations.
Young adults receive health screenings at lower rates than other age groups, and it may be difficult to detect diseases in the early stages for this group. We examined differences in health status ...relative to smoking in a young age group using the results of health screenings conducted in engaged and newly married couples in a cross-sectional database.
The participants in this study were 808 young adults who visited a municipal hospital health screening center from July 2017 to March 2019. They completed a self-administered questionnaire, and physical measurements and a blood test were taken. They were classified into non-cigarette smokers, past cigarette smokers, and current cigarette smokers according to smoking behavior. In this study, we compared metabolic syndrome, the main components of which include obesity, high blood pressure, high blood triglycerides, low levels of HDL cholesterol and insulin resistance, with smoking behavior.
The mean age of the participants was 30.9±3.3 years (males 32.0±3.2, females 29.8±3.1), and 13.9% were current cigarette smokers (males 22.8%, females 5.1%). The proportion of men in their 30s was 76.6% for male group and 50.0% for female group, indicating that the male group had a relatively higher proportion of older and current smokers. Significant differences were found in age, sex, blood pressure, metabolic abnormalities, and drinking status according to smoking status. Cigarette smokers had a 2.4-fold greater risk of metabolic syndrome (95% confidence interval CI, 1.43-3.96) than non-cigarette smokers; in particular, they had a 2.6-fold (95% CI, 1.44-4.55) greater risk of hypertriglyceridemia and a three-fold (95% CI, 1.45-6.35) greater risk of low HDL cholesterol.
In comparison with non-single, young and generally healthy city dwellers, the risk of metabolic syndrome was significantly higher in smokers than in non-smokers, and in particular, it was confirmed that the risk of hypertriglyceridemia and low HDL cholesterolemia was higher. Smoking cessation is necessary, even for the young, because smoking may cause changes in blood lipids even if the smoking duration is short.
Background and objectives: Despite reductions in prevalence in recent years, tobacco smoking remains one of the main preventable causes of ill-health and premature death worldwide. This paper reviews ...the extent and nature of harms caused by smoking, the benefits of stopping, patterns of smoking, psychological, pharmacological and social factors that contribute to uptake and maintenance of smoking, the effectiveness of population and individual level interventions aimed at combatting tobacco smoking, and the effectiveness of methods used to reduce the harm caused by continued use of tobacco or nicotine in some form.
Results and conclusions: Smoking behaviour is maintained primarily by the positive and negative reinforcing properties of nicotine delivered rapidly in a way that is affordable and palatable, with the negative health consequences mostly being sufficiently uncertain and distant in time not to create sufficient immediate concern to deter the behaviour. Raising immediate concerns about smoking by tax increases, social marketing and brief advice from health professionals can increase the rate at which smokers try to stop. Providing behavioural and pharmacological support can improve the rate at which those quit attempts succeed. Implementing national programmes containing these components are effective in reducing tobacco smoking prevalence and reducing smoking-related death and disease.
•Youth are using JUUL as a discreet way to use nicotine in and around school.•JUUL does not appear to be thought of by its users as a cessation device.•Data from social media can serve as an early ...warning system to inform public health.
As vaping rapidly becomes more prevalent, social media data can be harnessed to capture individuals’ discussions of e-cigarette products quickly. The JUUL vaporizer is the latest advancement in e-cigarette technology, which delivers nicotine to the user from a device that is the size and shape of a thumb drive. Despite JUUL’s growing popularity, little research has been conducted on JUUL. Here we utilized Twitter data to determine the public’s early experiences with JUUL describing topics of posts.
Twitter posts containing the term “JUUL” were obtained for 1 April 2107 to 14 December 2017. Text classifiers were used to identify topics in posts (n = 81,689).
The most prevalent topic wasPerson Tagging (use of @username to tag someone in a post) at 20.48% followed by Pods (mentions of JUUL’s refill cartridge) at 14.72% and Buying (mentions of purchases) at 10.49%. The topic School (posts indicative of using JUUL or seeing someone use JUUL while at elementary, middle, or high school) comprised 3.66% of posts. The topic of Quit Smoking was rare at 0.29%.
Data from social media may be used to extend the surveillance of newly introduced vaping products. Findings suggest Twitter users are bonding around, and inquiring about, JUUL on social media. JUUL’s discreetness may facilitate its use in places where vaping is prohibited. Educators may be in need of training on how to identify JUUL in the classroom. Despite JUUL’s branding as a smoking alternative, very few Twitter users mentioned smoking cessation with JUUL.
More smokers report using e-cigarettes to help them quit than FDA-approved pharmacotherapy.
To assess the association of e-cigarettes with future abstinence from cigarette and tobacco use.
Cohort ...study of US sample, with annual follow-up.
US adult (ages 18+) daily cigarette smokers identified at Wave 1 (W1; 2013-14) of the PATH Study, who reported a quit attempt before W2 and completed W3 (n = 2443).
Use of e-cigarettes, pharmacotherapy (including nicotine replacement therapy), or no product for last quit attempt (LQA), and current daily e-cigarette use at W2.
Propensity score matching (PSM) of groups using different methods to quit.
12+ months abstinence at W3 from cigarettes and from all tobacco (including e-cigarettes). 30+ days abstinence at W3 was a secondary outcome.
Among daily smokers with an LQA, 23.5% used e-cigarettes, 19.3% used pharmacotherapy only (including NRT) and 57.2% used no product. Cigarette abstinence for 12+ months at W3 was ~10% in each group. Half of the cigarette abstainers in the e-cigarette group were using e-cigarettes at W3. Different methods to help quitting had statistically comparable 12+ month cigarette abstinence at W3 (e-cigarettes vs no product: Risk Difference (RD) = 0.01, 95% CI: -0.04 to 0.06; e-cigarettes vs pharmacotherapy: RD = 0.02, 95% CI:-0.04 to 0.09). Likewise, daily e-cigarette users at W2 did not show a cessation benefit over comparable no-e-cigarette users and this finding was robust to sensitivity analyses. Abstinence for 30+ days at W3 was also similar across products.
The frequency of e-cigarette use during the LQA was not assessed, nor was it possible to assess continuous abstinence from the LQA.
Among US daily smokers who quit cigarettes in 2014-15, use of e-cigarettes in that attempt compared to approved cessation aids or no products showed similar abstinence rates 1-2 years later.
Objective To evaluate the impact of telling patients their estimated spirometric lung age as an incentive to quit smoking.Design Randomised controlled trial.Setting Five general practices in ...Hertfordshire, England.Participants 561 current smokers aged over 35.Intervention All participants were offered spirometric assessment of lung function. Participants in intervention group received their results in terms of “lung age” (the age of the average healthy individual who would perform similar to them on spirometry). Those in the control group received a raw figure for forced expiratory volume at one second (FEV1). Both groups were advised to quit and offered referral to local NHS smoking cessation services.Main outcome measures The primary outcome measure was verified cessation of smoking by salivary cotinine testing 12 months after recruitment. Secondary outcomes were reported changes in daily consumption of cigarettes and identification of new diagnoses of chronic obstructive lung disease.Results Follow-up was 89%. Independently verified quit rates at 12 months in the intervention and control groups, respectively, were 13.6% and 6.4% (difference 7.2%, P=0.005, 95% confidence interval 2.2% to 12.1%; number needed to treat 14). People with worse spirometric lung age were no more likely to have quit than those with normal lung age in either group. Cost per successful quitter was estimated at £280 (€366, $556). A new diagnosis of obstructive lung disease was made in 17% in the intervention group and 14% in the control group; a total of 16% (89/561) of participants.Conclusion Telling smokers their lung age significantly improves the likelihood of them quitting smoking, but the mechanism by which this intervention achieves its effect is unclear.Trial registration National Research Register N0096173751.
PDF
