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The New England Journal of Medicine Feb 2019E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.
METHODS
We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.
RESULTS
A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.
CONCLUSIONS
E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608 .).
Topics: Adult; Electronic Nicotine Delivery Systems; Female; Humans; Male; Middle Aged; Nicotine; Smoking Cessation; Tobacco Use Cessation Devices; Tobacco Use Disorder; Treatment Outcome; Vaping
PubMed: 30699054
DOI: 10.1056/NEJMoa1808779 -
The Cochrane Database of Systematic... May 2018Nicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus... (Meta-Analysis)
Meta-Analysis Review
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, abstract 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, except for those in pregnancy (where less than six months, these were excluded from the main analysis). 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. A subset of six trials conducted in pregnant women found a statistically significant benefit of NRT on abstinence close to the time of delivery (RR 1.32, 95% CI 1.04 to 1.69; 2129 participants); in the four trials that followed up participants post-partum the result was no longer statistically significant (RR 1.29, 95% CI 0.90 to 1.86; 1675 participants). 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.
Topics: Administration, Cutaneous; Administration, Inhalation; Chewing Gum; Female; Humans; Male; Nicotine; Nicotinic Agonists; Randomized Controlled Trials as Topic; Smoking Cessation; Smoking Prevention; Tablets; Time Factors; Tobacco Use Cessation Devices
PubMed: 29852054
DOI: 10.1002/14651858.CD000146.pub5 -
High Blood Pressure & Cardiovascular... Oct 2020Tobacco use is one of the major public health concerns and it is the most preventable cause of morbidity and mortality worldwide. Smoking cessation reduces subsequent... (Review)
Review
Tobacco use is one of the major public health concerns and it is the most preventable cause of morbidity and mortality worldwide. Smoking cessation reduces subsequent cardiovascular events and mortality. Smoking is a real chronic disorder characterized by the development of an addiction status mainly due to nicotine. This condition makes the smokers generally unable to quit smoking without help. Different strategies are available to treat smoking dependence that include both non-pharmacological (behavioral counselling) and pharmacological therapies. Currently, it is well accepted that smoking cessation drugs are effective and safe in real-world settings. Nicotine replacement therapy (NRT), varenicline, bupropion and cytisine are the main pharmacological strategies available for smoking cessation. Their efficacy and safety have been proved even in patients with chronic cardiovascular disease. Each of these drugs has peculiar characteristics and the clinician should customize the smoking cessation strategy based on currently available scientific evidence and patient's preference, paying particular attention to those patients having specific cardiovascular and psychiatric comorbidities. The present document aims to summarize the current viable pharmacological strategies for smoking cessation, also discussing the controversial issue regarding the use of alternative tobacco products, in order to provide useful practical indications to all physicians, mainly to those involved in cardiovascular prevention.
Topics: Alkaloids; Azocines; Bupropion; Clinical Decision-Making; Electronic Nicotine Delivery Systems; Humans; Quinolizines; Recurrence; Risk Factors; Smoking; Smoking Cessation; Smoking Cessation Agents; Tobacco Use Cessation Devices; Tobacco Use Disorder; Treatment Outcome; Varenicline
PubMed: 32578165
DOI: 10.1007/s40292-020-00396-9 -
International Journal of Environmental... Mar 2020The aim of this review of reviews was to collate the latest evidence from systematic reviews about the maternal and child health outcomes of being exposed to tobacco and... (Review)
Review
Exposure to Tobacco, Environmental Tobacco Smoke and Nicotine in Pregnancy: A Pragmatic Overview of Reviews of Maternal and Child Outcomes, Effectiveness of Interventions and Barriers and Facilitators to Quitting.
The aim of this review of reviews was to collate the latest evidence from systematic reviews about the maternal and child health outcomes of being exposed to tobacco and nicotine during pregnancy; the effectiveness of interventions designed to reduce these exposures, and barriers to and facilitators of smoking cessation during pregnancy. Two databases were searched to obtain systematic reviews published from 2010 to 2019. Pertinent data from 76 articles were summarized using a narrative synthesis (PROSPERO reference: CRD42018085896). Exposure to smoke or tobacco in other forms during pregnancy is associated with an increased risk of obstetric complications and adverse health outcomes for children exposed in-utero. Counselling interventions are modestly effective, while incentive-based interventions appear to substantially increase smoking cessation. Nicotine replacement therapy is effective during pregnancy but the evidence is not conclusive. Predictors and barriers to smoking cessation in pregnancy are also discussed. Smoking during pregnancy poses substantial risk to mother's and child's health. Psychosocial interventions and nicotine replacement therapy (NRT) appear to be effective in helping pregnant women quit smoking. Barriers to smoking cessation must be identified and steps taken to eradicate them in order to reduce smoking among pregnant women. More research is needed on smoking cessation medications and e-cigarettes.
Topics: Child; Electronic Nicotine Delivery Systems; Female; Humans; Nicotine; Pregnancy; Smoking Cessation; Nicotiana; Tobacco Smoke Pollution; Tobacco Use Cessation Devices
PubMed: 32204415
DOI: 10.3390/ijerph17062034 -
European Heart Journal Supplements :... Jun 2020Despite significant efforts during the last decades, cigarette smoking still remains prevalent. Discouraging the use of all tobacco products, it is certainly the most...
Despite significant efforts during the last decades, cigarette smoking still remains prevalent. Discouraging the use of all tobacco products, it is certainly the most effective mean to enhance public health, but complete prohibition is unlikely to succeed. The greatest challenge is the approach to chronic smokers, particularly those affected with cardiovascular conditions. To better support these patients during the difficult process leading to complete smoke cessation, it is important to characterize each patient from a clinical and psychological perspective, introducing the most reliable approaches to incentivize and support abstinence, such as varenicline and nicotine replacement therapy, thus providing a personalized recommendation. The recent introduction of electronic systems for nicotine release or tobacco heating (electronic cigarettes), offers an important challenge. These devices are reasonably considered as tools, thus providing a useful alternative which unable the patient a smoother transition toward smoking cessation, also presenting an array of choices among which a personalized selection could be made. This technology, though, should not be overemphasized, considering also its potential harmful effects, and certainly its use should be strongly discouraged in non-smokers, particularly at young age. This approach, cautious and pragmatic, aside from demonization or over-enthusiastic appraisal, could provide favourable results in the constant struggle against cigarette smoking.
PubMed: 32523433
DOI: 10.1093/eurheartj/suaa053 -
Federal Practitioner : For the Health... Jan 2022Myocardial perfusion imaging (MPI) is commonly used to assess the presence and severity of coronary artery disease (CAD). A radiopharmaceutical is used before and after... (Review)
Review
BACKGROUND
Myocardial perfusion imaging (MPI) is commonly used to assess the presence and severity of coronary artery disease (CAD). A radiopharmaceutical is used before and after patients undergo either exercise-induced stress via a treadmill or medication-induced stress. While certain therapies that are known to influence the accuracy of results are avoided prior to conducting MPI, it is currently unknown whether nicotine and nicotine replacement therapy (NRT) should be avoided, even though they may have significant effects on coronary circulation.
OBSERVATIONS
Nicotine has been demonstrated to have both vasoconstrictive and vasodilatory properties. However, in patients with underlying CAD, vasoconstrictive properties appear to predominate and can allow the disease to appear more severe than it is during MPI. Similarly, NRT products may cause vasoconstriction but to a lesser degree given the lower concentration of nicotine present. Due to the lack of robust studies, the clinical impact of these findings on clinician diagnosis and patient management remains unclear.
CONCLUSIONS
Based on the available data, nicotine and NRT should ideally be avoided prior to MPI. The specific time frame in which they would be stopped before conducting MPI differs based on the pharmacokinetics of each product. More studies are needed to analyze the impact of nicotine and NRT on the accuracy of MPI using medication.
PubMed: 35185316
DOI: 10.12788/fp.0217 -
Australian Prescriber Feb 2022The most effective intervention for stopping smoking is a combination of professional counselling and pharmacotherapy. Medicines are recommended for all smokers who are... (Review)
Review
The most effective intervention for stopping smoking is a combination of professional counselling and pharmacotherapy. Medicines are recommended for all smokers who are motivated to quit and are nicotine dependent. Combination nicotine replacement therapy with a patch and an oral product is more effective than the patch alone. An adequate dose of nicotine must be used for an adequate duration. Varenicline is the most effective oral drug. It is safe in people with stable mental illness. Vaping nicotine is a second-line treatment which can be considered for smokers who are unable to quit with other methods.
PubMed: 35233133
DOI: 10.18773/austprescr.2022.001 -
Health Technology Assessment... Oct 2021Cigarette smoking is one of the leading causes of early death. Varenicline [Champix (UK), Pfizer Europe MA EEIG, Brussels, Belgium; or Chantix (USA), Pfizer Inc.,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cigarette smoking is one of the leading causes of early death. Varenicline [Champix (UK), Pfizer Europe MA EEIG, Brussels, Belgium; or Chantix (USA), Pfizer Inc., Mission, KS, USA], bupropion (Zyban; GlaxoSmithKline, Brentford, UK) and nicotine replacement therapy are licensed aids for quitting smoking in the UK. Although not licensed, e-cigarettes may also be used in English smoking cessation services. Concerns have been raised about the safety of these medicines and e-cigarettes.
OBJECTIVES
To determine the clinical effectiveness, safety and cost-effectiveness of smoking cessation medicines and e-cigarettes.
DESIGN
Systematic reviews, network meta-analyses and cost-effectiveness analysis informed by the network meta-analysis results.
SETTING
Primary care practices, hospitals, clinics, universities, workplaces, nursing or residential homes.
PARTICIPANTS
Smokers aged ≥ 18 years of all ethnicities using UK-licensed smoking cessation therapies and/or e-cigarettes.
INTERVENTIONS
Varenicline, bupropion and nicotine replacement therapy as monotherapies and in combination treatments at standard, low or high dose, combination nicotine replacement therapy and e-cigarette monotherapies.
MAIN OUTCOME MEASURES
Effectiveness - continuous or sustained abstinence. Safety - serious adverse events, major adverse cardiovascular events and major adverse neuropsychiatric events.
DATA SOURCES
Ten databases, reference lists of relevant research articles and previous reviews. Searches were performed from inception until 16 March 2017 and updated on 19 February 2019.
REVIEW METHODS
Three reviewers screened the search results. Data were extracted and risk of bias was assessed by one reviewer and checked by the other reviewers. Network meta-analyses were conducted for effectiveness and safety outcomes. Cost-effectiveness was evaluated using an amended version of the Benefits of Smoking Cessation on Outcomes model.
RESULTS
Most monotherapies and combination treatments were more effective than placebo at achieving sustained abstinence. Varenicline standard plus nicotine replacement therapy standard (odds ratio 5.75, 95% credible interval 2.27 to 14.90) was ranked first for sustained abstinence, followed by e-cigarette low (odds ratio 3.22, 95% credible interval 0.97 to 12.60), although these estimates have high uncertainty. We found effect modification for counselling and dependence, with a higher proportion of smokers who received counselling achieving sustained abstinence than those who did not receive counselling, and higher odds of sustained abstinence among participants with higher average dependence scores. We found that bupropion standard increased odds of serious adverse events compared with placebo (odds ratio 1.27, 95% credible interval 1.04 to 1.58). There were no differences between interventions in terms of major adverse cardiovascular events. There was evidence of increased odds of major adverse neuropsychiatric events for smokers randomised to varenicline standard compared with those randomised to bupropion standard (odds ratio 1.43, 95% credible interval 1.02 to 2.09). There was a high level of uncertainty about the most cost-effective intervention, although all were cost-effective compared with nicotine replacement therapy low at the £20,000 per quality-adjusted life-year threshold. E-cigarette low appeared to be most cost-effective in the base case, followed by varenicline standard plus nicotine replacement therapy standard. When the impact of major adverse neuropsychiatric events was excluded, varenicline standard plus nicotine replacement therapy standard was most cost-effective, followed by varenicline low plus nicotine replacement therapy standard. When limited to licensed interventions in the UK, nicotine replacement therapy standard was most cost-effective, followed by varenicline standard.
LIMITATIONS
Comparisons between active interventions were informed almost exclusively by indirect evidence. Findings were imprecise because of the small numbers of adverse events identified.
CONCLUSIONS
Combined therapies of medicines are among the most clinically effective, safe and cost-effective treatment options for smokers. Although the combined therapy of nicotine replacement therapy and varenicline at standard doses was the most effective treatment, this is currently unlicensed for use in the UK.
FUTURE WORK
Researchers should examine the use of these treatments alongside counselling and continue investigating the long-term effectiveness and safety of e-cigarettes for smoking cessation compared with active interventions such as nicotine replacement therapy.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42016041302.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 59. See the NIHR Journals Library website for further project information.
Topics: Cost-Benefit Analysis; Electronic Nicotine Delivery Systems; Humans; Network Meta-Analysis; Smoking Cessation; Tobacco Use Cessation Devices; Varenicline
PubMed: 34668482
DOI: 10.3310/hta25590 -
International Journal of Health Sciences Jul 2016Today tobacco use is the single greatest preventable cause of death in the world. Tobacco use is often incorrectly perceived to be solely a personal choice. This is... (Review)
Review
Today tobacco use is the single greatest preventable cause of death in the world. Tobacco use is often incorrectly perceived to be solely a personal choice. This is contradicted by the fact that when fully aware of the health impact, most tobacco users want to quit but find it difficult to stop due to the addictiveness of nicotine. Henceforth, Nicotine replacement therapy (NRT) came into existence which temporarily replaces much of the nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence. Various alternative nicotine sources (gum, transdermal patch, nasal spray, inhaler and sublingual tablets/lozenges) have been incorporated into tobacco cessation programs. Recent research is more focusing on rapid delivery of nicotine (Nicotine preloading, true pulmonary inhaler) and immunological approaches (nicotine vaccine) to tackle nicotine dependence. These NRTs are in general well tolerated and have minimal adverse effects. The review aims to summarize literature on various modes of nicotine replacement therapy methods currently used to treat nicotine dependence, and to give an overview about future possible approaches to treat tobacco use disorder.
PubMed: 27610066
DOI: No ID Found