Safety Of Nicotine Replacement Therapy Research Articles

Smoking cessation strategies: An in-depth analysis of nicotine replacement therapy and alternatives

Introduction and purpose: The primary objective of this literature review is to thoroughly investigate the topic of nicotine replacement therapy, considering the latest discoveries and detailing various forms of available nicotine substitution. Materials and methods: Literature review of PubMed and Google Scholar databases. State of Knowledge: Tobacco smoking remains one of the leading causes of premature death worldwide, accounting for millions of deaths each year. Nicotine, the addictive component of tobacco, is responsible for sustaining cigarette smoking patterns and making smoking cessation particularly challenging. Nicotine replacement therapy (NRT) is now considered one of the primary methods to help individuals quit smoking by reducing withdrawal symptoms and cravings associated with cessation. Conclusions: Over the years, extensive research has confirmed the effectiveness and safety of NRT, resulting in the development of different forms of nicotine substitution. The outcomes of using these various forms are similar and premature discontinuation by patients remains a primary reason for NRT failure. Therefore, it is crucial for each patient to select the form of NRT that meets their individual preferences. The best results are obtained by combining multiple forms of substitution simultaneously, as well as integrating them with other therapeutic methods.

Safety of Nicotine Replacement Therapy during Pregnancy: A Narrative Review.

Smoking during pregnancy is a public health problem worldwide and the leading preventable cause of fetal morbidity and mortality and obstetric disease. Although the risk of tobacco-related harm can be substantially reduced if mothers stop smoking in the first trimester, the proportion of women who do so remains modest; therefore, the treatment of smoking in pregnant women will be the first therapeutic measure that health professionals should adopt when providing care to pregnant women. The recommendation of nicotine replacement therapy during pregnancy remains controversial due to the potential effects on the health of the fetus. The aim of this review was to provide an overview of human studies about the use of nicotine replacement therapy during pregnancy, evaluating the efficacy and safety of the different formulations. The electronic databases PubMed and EMBASE were searched from May 2012 to May 2022. A total of 95 articles were identified through database searching using a combination of keywords. Out of 79 screened articles and after the removal of duplicates, 28 full-text articles were assessed for eligibility and 12 articles were finally included for review. Although demonstrated to be effective in adult smokers, evidence in support of NRT in pregnant women is limited. The results of the apparent safety of the use of NRT during pregnancy contradict the FDA classification of the different NRT formulations. Faster-acting formulations seem to be the safest and even most beneficial forms for the offspring. NRT is not completely harmless for the fetus or for the mother; however, if an adequate assessment of the risk-benefit binomial is made, its use during pregnancy to aid in quitting smoking does seem appropriate. It is necessary to establish individual recommendations on the formulation and dose to be used during pregnancy based on individual nicotinic needs.

Management of Psychiatric Disorders during the Perinatal Period.

Management of Psychiatric Disorders during the Perinatal Period.

Barriers and Facilitators to Staying Smoke-Free after Having a Baby, a Qualitative Study: Women's Views on Support Needed to Prevent Returning to Smoking Postpartum.

Background: Postpartum return to smoking (PPRS) is a common and important public health problem. Interventions to prevent PPRS have not been shown to be effective. We aimed to qualitatively explore the barriers and facilitators to staying smoke-free after having a baby, and women’s views on the support needed to avoid PPRS to inform future intervention development. Methods: We conducted semi-structured telephone interviews (n = 26) with pregnant women who quit smoking (n = 9), and postpartum women who were abstinent at delivery and returned to smoking (n = 7) or stayed smoke-free (n = 10). Inductive thematic analysis was used. Results: Five overarching themes were identified: (i) smoking intentions; (ii) facilitators to staying smoke-free; (iii) barriers to staying smoke-free; (iv) support to avoid relapse; and (v) e-cigarettes, nicotine replacement therapy, and varenicline. Facilitators to staying smoke-free were the health benefits to their baby, whilst barriers included stress, cravings, and being in environments where they would previously have smoked. Women wanted continuous offers of support to stay smoke-free throughout the extended postpartum period, with a particular interest in support for partners to quit smoking and self-help support. Women expressed safety concerns for e-cigarettes, nicotine replacement therapy, and varenicline. Conclusions: Offers of support to stay smoke-free should continue throughout the postpartum and engage with partners or other household members who smoke. Reassuring women about the relative safety of nicotine replacement therapy and e-cigarettes by a health professional, particularly for those who are breastfeeding, could be beneficial.

Fetal safety of nicotine replacement therapy in pregnancy: systematic review and meta-analysis.

Smoking in pregnancy causes substantial avoidable harm to mothers and offspring; nicotine replacement therapy (NRT) may prevent this, and is used to help women to quit. A recently updated Cochrane Review of randomized controlled trials (RCTs) investigating impacts of NRT in pregnancy focuses primarily on efficacy data, but also reports adverse impacts from NRT. Here we identify and summarize NRT impacts on adverse pregnancy outcomes reported in non-randomized controlled trials (non-RCTs). Systematic reviews and meta-analyses of RCTs and non-RCT studies of NRT in pregnancy, with design-specific risk of bias assessment and grading of recommendations, assessment, development and evaluations (GRADE) criteria applied to selected outcomes. Relevant Cochrane Review findings are reported alongside those from this new review. Seven RCTs were included; n=2340. Nine meta-analyses were performed; non-statistically significant estimates indicated potentially reduced risk from NRT compared with smoking for mean birth weight, low birth weight, preterm birth, intensive care admissions, neonatal death, congenital anomalies and caesarean section and potentially increased risks for miscarriage and stillbirth. GRADE assessment for mean birth weight and miscarriage outcomes indicated 'low' confidence in findings. Twenty-three non-RCTs were included; n=931 163. Eleven large studies from five routine health-care cohorts reported clinical outcomes; 12 small studies investigated mainly physiological outcomes within in-patient women given NRT. Findings from meta-analyses for congenital anomalies, stillbirth and preterm birth were underpowered and not in a consistent direction; GRADE assessment of confidence in findings was 'very low'. Routine health-care studies were of higher quality, but implications of reported findings were unclear as there was inadequate measurement and reporting of women's smoking. Available evidence from randomized controlled trials and non-randomized comparative studies does not currently provide clear evidence as to whether maternal use of nicotine replacement therapy during pregnancy is harmful to the fetus.

Factors influencing the uptake and use of nicotine replacement therapy and e-cigarettes in pregnant women who smoke: a qualitative evidence synthesis.

Nicotine replacement therapy (NRT) delivers nicotine without the toxic chemicals present in tobacco smoke. It is an effective smoking cessation aid in non-pregnant smokers, but there is less evidence of effectiveness in pregnancy. Systematic review evidence suggests that pregnant women do not adhere to NRT as prescribed, which might undermine effectiveness. Electronic cigarettes (e-cigarettes) have grown in popularity, but effectiveness and safety in pregnancy are not yet established. The determinants of uptake and use of NRT and e-cigarettes in pregnancy are unknown. To explore factors affecting uptake and use of NRT and e-cigarettes in pregnancy. We searched MEDLINE(R), CINAHL and PsycINFO on 1 February 2019. We manually searched OpenGrey database and screened references of included studies and relevant reviews. We also conducted forward citation searches of included studies. We selected studies that used qualitative methods of data collection and analysis, included women who had smoked in pregnancy, and elicited participants' views about using NRT/e-cigarettes for smoking cessation or harm reduction (i.e. to smoke fewer cigarettes) during pregnancy. We identified determinants of uptake and use of NRT/e-cigarettes in pregnancy using a thematic synthesis approach. Two review authors assessed the quality of included studies with the Wallace tool. Two review authors used the CERQual approach to assess confidence in review findings. The contexts of studies from this review and the relevant Cochrane effectiveness review were not similar enough to fully integrate findings; however, we created a matrix to juxtapose findings from this review with the descriptions of behavioural support from trials in the effectiveness review. We included 21 studies: 15 focused on NRT, 3 on e-cigarettes, and 3 on both. Studies took place in five high-income countries. Most studies contributed few relevant data; substantially fewer data were available on determinants of e-cigarettes. Many studies focused predominantly on issues relating to smoking cessation, and determinants of NRT/e-cigarette use was often presented as one of the themes. We identified six descriptive themes and 18 findings within those themes; from these we developed three overarching analytical themes representing key determinants of uptake and adherence to NRT and/or e-cigarettes in pregnancy. The analytical themes show that women's desire to protect their unborn babies from harm is one of the main reasons they use these products. Furthermore, women consider advice from health professionals when deciding whether to use NRT or e-cigarettes; when health professionals tell women that NRT or e-cigarettes are safer than smoking and that it is okay for them to use these in pregnancy, women report feeling more confident about using them. Conversely, women who are told that NRT or e-cigarettes are as dangerous or more dangerous than smoking and that they should not use them during pregnancy feel less confident about using them. Women's past experiences with NRT can also affect their willingness to use NRT in pregnancy; women who feel that NRT had worked for them (or someone they know) in the past were more confident about using it again. However, women who had negative experiences were more reluctant to use NRT. No trials on e-cigarette use in pregnancy were included in the Cochrane effectiveness review, so we considered only NRT findings when integrating results from this review and the effectiveness review. No qualitative studies were conducted alongside trials, making full integration of the findings challenging. Women enrolled in trials would have agreed to being allocated to NRT or control group and would have received standardised information on NRT at the start of the trial. Overall, the findings of this synthesis are less relevant to women's decisions about starting NRT in trials and more likely to help explain trial participants' adherence to NRT after starting it. We considered most findings to be of moderate certainty; we assessed findings on NRT use as being of higher certainty than those on e-cigarette use. This was mainly due to the limited data from fewer studies (only in the UK and USA) that contributed to e-cigarette findings. Overall, we judged studies to be of acceptable quality with only minor methodological issues. Consistent messages from health professionals, based on high-quality evidence and clearly explaining the safety of NRT and e-cigarettes compared to smoking in pregnancy, could help women use NRT and e-cigarettes more consistently/as recommended. This may improve their attitudes towards NRT or e-cigarettes, increase their willingness to use these in their attempt to quit, and subsequently encourage them to stay smoke-free.

Smoking-cessation pharmacotherapy for patients with stroke and TIA: Systematic review

Data regarding the efficacy and safety of smoking-cessation pharmacotherapy after stroke are lacking. We systematically reviewed data on this topic by searching Medline, Cochrane, and Clinicaltrials.gov to identify randomized clinical trials (RCT) and observational studies that assessed the efficacy and safety of nicotine replacement therapy (NRT), varenicline, and bupropion in patients with stroke and TIA. We included studies that reported rates of smoking cessation, worsening or recurrent cerebrovascular disease, seizures, or neuropsychiatric events. We identified 2 RCTs and 6 observational studies; 3 included ischemic stroke and TIA, 2 subarachnoid hemorrhage (SAH), and 3 did not specify. Four studies assessed efficacy; cessation rates ranged from 33% to 66% with pharmacological therapy combined with behavioral interventions versus 15% to 46% without, but no individual study demonstrated a statistically significant benefit. Safety data for varenicline and buopropion in ischemic stroke were scarce. Patients with SAH who received NRT had more seizures (9% vs 2%; P = 0.024) and delirium (19% vs 7%; P = 0.006) in one study, but less frequent vasospasm in 3 studies. In conclusion, combined with behavioral interventions, smoking-cessation therapies resulted in numerically higher cessation rates. Limited safety data may prompt caution regarding seizures and delirium in patients with subarachnoid hemorrhage.

The role of dentists in nicotine replacement therapy.

Dear Editor, We read the article titled “Nicotine replacement therapy: A friend or foe” with great interest.[1] As authors pointed out smoking is one of the greatest causes of premature death and preventable illness in both developed and developing countries. Health-care professionals, especially dentists, can play an important role in assisting their patients with tobacco cessation.[2] We would like to share few more literature regarding the role of dentists in nicotine replacement therapy (NRT). Though most of the dental curriculums around the world don't have structured modules to train dentists in specific smoking cessation strategies, multiple studies exploring knowledge, attitude, and practice regarding tobacco cessation methods among dental practitioners have provided encouraging insights. Rajput et al. explored the attitudes, practices, and perceived barriers in Tobacco cessation counseling (TCC) among dental practitioners in India and found that seventy-three percent of the dentists agreed that TCC is their responsibility.[3] Moreover, Madhu et al. studied the attitude and practice of the dental students toward tobacco cessation methods using a cross-sectional design and found that almost 50% preferred to recommend nicotine replacement therapies (NRT) as a tobacco cessation advises to the patients.[4] Existing literature supports the fact that dental practitioners have the motivation and knowledge base to support tobacco cessation in their patients. It is the need of the hour for establishing tobacco cessation clinics in dental clinics especially in rural areas where a dentist does the behavioral counseling during which patients are advised to stop the tobacco use, with structured counseling methods.[5] There are no standardized tobacco intervention model for dental care settings. However, the American Dental Hygienists Association recommends a three-steP “AAR” brief tobacco intervention model for dental care settings: Ask every patient about tobacco use, Advise all tobacco users to quit, and Refer tobacco users to nationally available tobacco quitlines via fax or electronic referral.[6] Moreover, dentists can also assess the severity of tobacco addiction using Fagerstrom scale, i.e., the patient is asked a series of 6 questions and scores are given based on the patient's responses and based on the scoring, the patient can be prescribed pharmacotherapy in the form of nicotine replacement therapy (NRT).[5] There are multiple ways in which a dentist can assist their patient with NRT. One potential model for incorporating the provision of NRT in dental practices is NRT sampling (NRTS), in which a short starter course (e.g., 2 weeks) of NRT is given to all medically eligible smokers irrespective of their motivations to quit or seek treatment. Another specific area were dentists can contribute is in modifications NRT practices such as nicotine replacement therapy with tooth-whitening agents. Availability of NRT with stain removal or tooth-whitening activity would provide an opportunity for dentists to illustrate some early measurable benefits of smoking cessation, reinforce smokers’ commitment to quit, and support them on the path to a stable state of not smoking. Dentists can also play a key role in maximizing the benefits of NRT by educating the public regarding the relative safety of NRT when compared to smoking, as most of the studies from around the world indicate that the public incorrectly believes that nicotine is responsible for most of the cancer caused by smoking. Considering the need of the hour and the multiple role a dentist can play in tobacco cessation, the dental councils should consider including tobacco cessation training modules in the curriculum at the BDS level.[5] Furthermore, conferences, workshops, and CDEs regarding tobacco cessation services also should be promoted among dentists to educate and motivate them to start or continue their tobacco cessation services to their patients.[4] Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

Impact of Nicotine Replacement and Electronic Nicotine Delivery Systems on Fetal Brain Development.

Maternal tobacco smoking during pregnancy remains a major public health issue. The neurotoxic properties of nicotine are associated with fetal neurodevelopmental disorders and perinatal morbimortality. Recent research has demonstrated the effects of nicotine toxicity on genetic and epigenetic alterations. Smoking cessation strategies including nicotine replacement therapy (NRT) and electronic nicotine delivery systems (ENDS) show lack of clear evidence of effectiveness and safety in pregnant women. Limited trials using randomized controls concluded that the intermittent use formulation of NRT (gum, sprays, inhaler) in pregnant women is safe because the total dose of nicotine delivered to the fetus is less than continuous-use formulations (transdermal patch). Electronic nicotine delivery systems (ENDS) were hyped as a safer alternative during pregnancy. However, refill liquids of ENDS are suspected to be cytotoxic for the fetus. Animal studies revealed the impact of ENDS on neural stem cells, showing a similar risk of pre- and postnatal neurobiological and neurobehavioral disorders to that associated with the exposure to traditional tobacco smoking during early life. There is currently no clear evidence of impact on fetal brain development, but recent research suggests that the current guidelines should be reconsidered. The safety of NRT and ENDS is increasingly being called into question. In this review, we discuss the special features (pharmacodynamics, pharmacokinetics, and metabolism) of nicotine, NRT, and ENDS during pregnancy and postnatal environmental exposure. Further, we assess their impact on pre- and postnatal neurodevelopment.

Overcoming Challenges to Treating Tobacco use During Pregnancy - A Qualitative study of Australian General Practitioners Barriers

BackgroundGeneral practitioners can play an important role in addressing smoking among pregnant women but studies suggest they rarely do so. The aim of this study was to explore general practitioners perceptions about the management of smoking in pregnancy, and what would enable them to provide better care.MethodsQualitative semi-structured interviews were conducted (Feb-July 2017), with 19 Australian general practitioners recruited from a sample that participated in a national survey on managing smoking during pregnancy; and through a national conference. The interview guide was structured using the theoretical domains framework, exploring previously reported barriers and two specific components of smoking cessation care - nicotine replacement therapy prescription and Quitline referral.ResultsParticipants reported high confidence and knowledge to provide pregnant patients adequate support for quitting. Nonetheless, participants reported lacking communication skills, focusing on providing information on smoking harm, accepting cutting down cigarettes as adequate, while following the ‘Stages of Change’ model and only providing treatment options to motivated patients. Lack of time, nicotine replacement therapy cost and safety concerns, and being unfamiliar with the Quitline (particularly for Aboriginal and Torres Strait Islander pregnant smokers) were perceived as challenges. Participants reported needing better communication skills, clear detailed nicotine replacement therapy guidelines for special populations, and visual resources they could use to discuss treatment options with patients.ConclusionsDifficulty communicating with pregnant patients about smoking, using the ‘Stages of Change’ model to guide support provision and concerns regarding nicotine replacement therapy safety are barriers to providing cessation support to pregnant patients for general practitioners. Training on specific effective behaviour change techniques, clear guidance for nicotine replacement therapy use, and practical visual patient education tools may facilitate smoking cessation care provision to pregnant women.

Short-Term Safety of Nicotine Replacement in Smokers Hospitalized With Coronary Heart Disease.

BackgroundLittle is known about the safety of nicotine replacement therapy (NRT) in smokers hospitalized with coronary heart disease.Methods and ResultsWe examined the short‐term safety of NRT use among smokers hospitalized for coronary heart disease in a geographically and structurally diverse sample of US hospitals in the year 2014. We compared smokers who started NRT in the first 2 days of hospitalization with smokers without any exposure to NRT and adjusted for baseline differences through propensity score matching. Outcomes included inpatient mortality, hospital length of stay, and 1‐month readmission. From 270 hospitals, we included 27 459 smokers (mean age, 58 years; 69% men; 56.9% in intensive care unit), of whom 4885 (17.8%) received NRT (97.2% used the nicotine patch, at a median dose of 21 mg/d for 3 days). After propensity matching, covariates were well balanced within each patient group. Among patients with myocardial infarction, compared with patients who did not receive NRT, those who received NRT showed no difference in mortality (2.1% versus 2.3%; P=0.98), mean length of stay (4.4±3.5 versus 4.3±3.3 days; P=0.60), or 1‐month readmission (15.8% versus 14.6%; P=0.31). Results were similar for patients undergoing percutaneous coronary intervention or coronary artery bypass surgery.ConclusionsAmong smokers hospitalized for treatment of coronary heart disease, use of NRT was not associated with any differences in short‐term outcomes. Given the known beneficial effects of NRT in treating nicotine withdrawal, reducing cravings, and promoting smoking cessation after discharge, our findings suggest that NRT is a safe and reasonable treatment option.

Nicotine replacement therapy versus control for smoking cessation.

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. 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. 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. 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. 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. 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. 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.

Postnatal Cardiovascular Consequences in the Offspring of Pregnant Rats Exposed to Smoking and Smoking Cessation Pharmacotherapies.

Approximately 20% of pregnant women smoke despite intentions to quit. Smoking cessation drugs, such as nicotine replacement therapy (NRT) and bupropion, are recommended treatments. Adverse cardiovascular outcomes in offspring have raised concerns about NRT's safety during pregnancy. However, the effect of bupropion is unknown. Using a rat model, we determined whether NRT and bupropion interventions during pregnancy are safer than continued smoking on offspring's cardiovascular function. Male offspring of controls and dams exposed to cigarette smoke (1.6 packs/day, inhalation), nicotine (2 mg/kg/d subcutaneously), and bupropion (13 mg/kg twice daily orally) were assessed for fetoplacental weight, cardiac function, blood pressure, and vascular reactivity. Fetoplacental weights were decreased and spontaneous beating and intracellular calcium in neonatal cardiomyocytes were increased in smoking, nicotine, and bupropion offspring; however, these effects were more accentuated in smoking followed by nicotine and bupropion offspring. Increased heart rate and decreased cardiac output, stroke volume, and left ventricular percent posterior wall thickening were observed in smoking, nicotine, and bupropion offspring. The left ventricular mass was reduced in smoking and nicotine but not in bupropion offspring. Blood pressure was higher with decreased endothelium-dependent relaxation and exaggerated vascular contraction to angiotensin II in smoking and nicotine offspring, with more pronounced dysfunctions in smoking than nicotine offspring. Maternal bupropion did not impact offspring's blood pressure, endothelium-dependent relaxation, and vascular contraction. In conclusion, maternal nicotine intervention adversely affects offspring's cardiovascular outcomes, albeit less severely than continued smoking. However, bupropion causes cardiac derangement in offspring but does not adversely affect blood pressure and vascular function.

Safety of nicotine replacement therapy in critically ill smokers: a retrospective cohort study.

Nicotine replacement therapy (NRT) is a common first-line treatment to prevent nicotine withdrawal in smokers. However, available literature reports conflicting results regarding its efficacy and safety in critically ill patients. The objective of this study was to evaluate the relationship between NRT in smokers in the intensive care unit (ICU) and outcomes. This case-control study was conducted in a university-affiliated tertiary hospital ICU. Over a period of five years, 126 active smokers who received transdermal NRT were matched to 126 active smokers who did not receive NRT. The groups were case-matched for sex, age and Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The primary outcome was administration of antipsychotic medication. Secondary outcomes included use of physical restraints, 30-day mortality, and ventilation requirements. Antipsychotic medication was prescribed in 43 (34.1%) patients who received NRT compared to 14 (11.1%) in controls (P <0.01). Physical restraints were used in 37 (29.4%) patients who received NRT, compared to 12 (9.5%) of controls (P <0.01). The 30-day mortality and number of patients intubated was not statistically different between groups. Average length of intubation time was greater in the NRT group (2.56 days; standard deviation 4.16) compared to the control group (1.44 days; standard deviation 2.68) (P=0.012). The use of NRT to prevent nicotine withdrawal in ICU patients is associated with increased use of antipsychotic medication and physical restraint, and with prolonged mechanical ventilation.

Understanding Pregnant Smokers' Adherence to Nicotine Replacement Therapy During a Quit Attempt: A Qualitative Study.

Pregnant smokers may be offered nicotine replacement therapy (NRT) alongside behavioral support to assist with a quit attempt. Yet trials of NRT have found adherence to be low among pregnant women, and this has made it difficult to determine the efficacy of NRT. The aim of this study is to understand the experience of pregnant women who use NRT but discontinue this early or do not use the medication as recommended. Semi-structured telephone interviews were conducted with 14 pregnant smokers who had recently been prescribed NRT, but self-reported poor NRT adherence or discontinuing treatment prematurely. Data were transcribed and analyzed using inductive thematic analysis There were four main themes identified; expectations of NRT, experience of using NRT, safety concerns and experience of using e-cigarettes. Some women intentionally used NRT to substitute a proportion of their cigarette intake and smoked alongside. Most women smoked while using NRT. Women who underutilized NRT did so as they experienced side effects, or were concerned that using NRT instead of smoking could actually increase their nicotine exposure and potential for increased nicotine dependence or fetal harm. Most women spoke about the use of e-cigarettes as a smoking cessation method but only a few had actually experienced using them during pregnancy. Many women underused NRT but simultaneously smoked. Challenging negative perceptions about NRT and educating women further about the risks of smoking may encourage them to use NRT products as recommended. These findings add to the research surrounding the efficacy of NRT during pregnancy by providing insight into how pregnant women use NRT during a quit attempt and how this may influence adherence. It may assist health professionals to support pregnant smokers by increasing their understanding about the differing ways in which women use NRT and help them address concerns women may have about the safety of NRT.

Is it okay to use the nicotine patch during pregnancy?

Evidence-Based Answer Evidence is conflicting on the efficacy and safety of nicotine replacement therapy (NRT) in pregnancy. Guidelines recommend against NRT until more evidence is available (SOR: C, expert opinion).

Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy.

Nicotine replacement therapy (NRT) aids smoking reduction and cessation. Although NRT is effective and safe, some smokers may achieve high nicotine levels. The purpose of this study was to determine the incidence and severity of nicotine-related adverse events in subjects with levels of cotinine, a metabolite of nicotine, that increased by >50% compared with baseline smoking in controlled clinical trials of NRT. Data from participants in randomized, double-blind, controlled trials of various formulations of NRT (Nicorette®), including patch, gum, oral inhaler, sublingual tablet, nasal spray, mouth spray, and combinations, were extracted from a clinical database. Eligible studies were performed between 1989 and 2010. In addition to baseline, at least 1 subsequent plasma or salivary cotinine concentration was measured, and adverse events were recorded simultaneously. Of 28 eligible studies, 24 were smoking cessation studies and 4 were smoking reduction studies. Cotinine levels that increased by >50% above baseline were recorded during treatment in 746 of 7,120 subjects (10.5%). Nausea was reported in 16 subjects (0.2% of the total, upper 99% confidence limit [CL] 0.4%), vomiting in 2 subjects (0.0%, upper 99% CL 0.1%), palpitations in 5 subjects (0.1%, upper 99% CL 0.2%), dizziness in 11 subjects (0.2%; upper 99% CL 0.3%), and headache in 35 subjects (0.5%, upper 99% CL 0.7%). Typical symptoms indicating nicotine overdose together with high cotinine levels were rare during treatment with NRT. These findings support the safety of NRT for smoking cessation or reduction.

Effectiveness and safety of nicotine replacement therapy: A systematic review

Abstract Nicotine replacement therapy (NRT) is the use of various forms of nicotine delivery methods intended to replace the nicotine obtained from smoking or other tobacco usage. This reduces the withdrawal symptoms associated with smoking cessation and helps resist the urge to smoke cigarettes. The aim of this review is to determine the effectiveness of the different forms of NRT (chewing gum, transdermal patches, nasal spray, inhalers, and tablets) in achieving asceticism from cigarettes. As a method of delivering nicotine into the bloodstream, NRT is thought to be a comparatively less-dangerous method than tobacco smoking.

Postnatal Metabolic and Reproductive Consequences of Fetal and Neonatal Exposure to the Smoking Cessation Drug Bupropion

In all, 10% to 20% of all pregnant women smoke despite intentions to quit. Smoking cessation drugs such as nicotine replacement therapy (NRT) and bupropion are recommended for pregnant women. Our observation that developmental exposure to nicotine adversely affects metabolic and reproductive outcomes in rats has raised concerns about NRT's safety during pregnancy. Conversely, the effect of bupropion has not been reported. The goal of this study was to examine the effect of fetal and neonatal exposure to bupropion on postnatal metabolic and reproductive outcomes. Dams (N = 5/group) were exposed to saline or bupropion (5 or 10 mg/kg per d) for 2 weeks prior to mating until weaning. We assessed weight, adiposity, and glucose homeostasis in all offspring until 26 weeks of age. Onset of puberty, fertility, and pregnancy outcomes in the female offspring were also assessed. Fetal and neonatal exposure to bupropion did not cause metabolic derangement in the offspring despite a significant decrease in birth weight in the offspring of dams treated with 10/mg/kg per d bupropion (5.9 ± 0.2 g vs control 6.7 ± 0.2 g; P = .02). Moreover, with the exception of accelerated pubertal onset in F1 and F2 offspring, bupropion administration to pregnant dams had no impact on fertility or pregnancy outcomes for either the dam or the female offspring. Fetal and neonatal exposure to the smoking cessation drug bupropion, unlike NRT, does not appear to adversely affect metabolic outcomes or the fertility of the female offspring. However, bupropion does appear to alter pubertal onset through an as yet unknown mechanism.

Short-term efficacy of nicotine replacement therapy for smoking cessation in adolescents: A randomized controlled trial

The aim of this randomized, double-blind placebo-controlled clinical trial is to test the efficacy and safety of nicotine replacement therapy (NRT) in promoting end-of-treatment abstinence among adolescents and whether this relation is moderated by medication compliance. Participants (N=257, age: 16.7±1.13years) attended an information meeting followed by a 6- or 9-week treatment. Self-reported smoking cessation, compliance, and side effects were measured by means of online questionnaires. Intent-to-treat analyses showed that independent of compliance, NRT is effective in promoting abstinence rates after 2weeks (OR=2.02, 95% CI=1.11–3.69), but not end-of-treatment abstinence. However, end-of-treatment abstinence rates significantly increased in high-compliant (OR=1.09, 95% CI=1.01–1.17) and not in low-compliant participants. No serious adverse events were found. Future research is warranted to disentangle the process involving the decrease in abstinence rates and compliance rates from the third week after the quit date onwards.