Publications by authors named "Ivan Berlin"

112 Publications

Smoking and diabetes interplay: A comprehensive review and joint statement.

Diabetes Metab 2022 Jun 29;48(6):101370. Epub 2022 Jun 29.

Outpatient Addiction Center, Georges Pompidou European Hospital, AP-HP, Sorbonne Paris Cité, Paris, France.

Evidence shows that smoking increases the risk of pre-diabetes and diabetes in the general population. Among persons with diabetes, smoking has been found to increase the risk of all-cause mortality and aggravate chronic diabetic complications and glycemic control. The current paper, which is a joint position statement by the French-Speaking Society on Tobacco (Société Francophone de Tabacologie) and the French-Speaking Society of Diabetes (Société Francophone du Diabète), summarizes the data available on the association between smoking and diabetes and on the impact of smoking and smoking cessation among individuals with type 1, type 2, and gestational diabetes mellitus. It also provides evidence-based information about the pharmacological and behavioral strategies for smoking cessation in these patients.
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http://dx.doi.org/10.1016/j.diabet.2022.101370DOI Listing
June 2022

Formative Provider Testing of a New Encounter Decision Aid for Smoking Cessation: Questionnaire Study.

JMIR Form Res 2022 Apr 20;6(4):e32960. Epub 2022 Apr 20.

Center for Primary Care and Public Health (Unisanté), Lausanne, Switzerland.

Background: Smoking cessation is an essential part of preventing and reducing the risk of smoking-associated morbidity and mortality. However, there is often little time to discuss smoking cessation in primary care. Decision aids (DAs) designed for clinic visits (encounter DAs) need to be clear, short, and concise to optimize therapeutic education, increase interaction, and improve the therapeutic alliance. Such a DA for smoking cessation could potentially improve counseling and increase the use of pharmacological treatments.

Objective: We aimed to collect feedback on an electronic encounter DA that facilitates physician-patient interaction and shared decision-making for smoking cessation in primary care.

Methods: We developed an electronic, encounter DA (howtoquit.ch) from a paper version created by our team in 2017 following user-centered design principles. The DA is a 1-page interactive website presenting and comparing medications for tobacco cessation and electronic cigarettes. Each smoking cessation medication has a drop down menu that presents additional information, a video demonstration, and prescribing information for physicians. To test the DA, we submitted a questionnaire to approximately 20 general practitioner residents of an academic general medicine department, 5 general practitioners, and 6 experts in the field of smoking cessation. The questionnaire consisted of 4 multiple-choice and 2 free-text questions assessing the usability or acceptability of the DA, the acquisition of new knowledge for practitioners, the perceived utility in supporting shared decision-making, perceived strengths and weaknesses, and whether the participants would recommend the tool to other clinicians.

Results: In all, 6 residents, 3 general practitioners in private practice, and 2 tobacco cessation experts completed the questionnaire (N=11), with 4 additional experts providing open-text feedback. On the 11 questionnaires, the DA was rated as practical and intuitive (mean 4.6/5), and providers felt it supported shared decision-making (mean 4.4/5), as comparisons were readily possible. Inclusion of explanatory videos was seen as a bonus. Several changes were suggested, like grouping together similar medications and adding a landing page to briefly explain the site. Changes were implemented according to end-user comments.

Conclusions: The overall assessment of the encounter DA by a group of physicians and experts was positive. The ultimate objective is to have the tool deployed and easily accessible for all to use.
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http://dx.doi.org/10.2196/32960DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9069282PMC
April 2022

Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial.

BMJ 2021 12 1;375:e065217. Epub 2021 Dec 1.

EDHEC Business School, Roubaix, France.

Objective: To evaluate the efficacy of financial incentives dependent on continuous smoking abstinence on smoking cessation and birth outcomes among pregnant smokers.

Design: Single blind, randomised controlled trial.

Setting: Financial Incentive for Smoking Cessation in Pregnancy (FISCP) trial in 18 maternity wards in France.

Participants: 460 pregnant smokers aged at least 18 years who smoked ≤5 cigarettes/day or ≤3 roll-your-own cigarettes/day and had a pregnancy gestation of <18 weeks were randomised to a financial incentives group (n=231) or a control group (n=229).

Interventions: Participants in the financial incentives group received a voucher equivalent to €20 (£17; $23), and further progressively increasing vouchers at each study visit if they remained abstinent. Participants in the control group received no financial incentive for abstinence. All participants received a €20 show-up fee at each of six visits.

Main Outcome Measures: The main outcome measure was continuous smoking abstinence from the first post-quit date visit to visit 6, before delivery. Secondary outcomes in the mothers were point prevalence abstinence, time to smoking relapse, withdrawal symptoms, blood pressure, and alcohol and cannabis use in past 30 days. Secondary outcomes in the babies were gestational age at birth, birth characteristics (birth weight, length, head circumference, Apgar score), and a poor neonatal outcome-a composite measure of transfer to the neonatal unit, congenital malformation, convulsions, or perinatal death.

Results: Mean age was 29 years. In the financial incentives and control groups, respectively, 137 (59%) and 148 (65%) were employed, 163 (71%) and 171 (75%) were in a relationship, and 41 (18%) and 31 (13%) were married. The participants had smoked a median of 60 cigarettes in the past seven days. The continuous abstinence rate was significantly higher in the financial incentives group (16%, 38/231) than control group (7%, 17/229): odds ratio 2.45 (95% confidence interval 1.34 to 4.49), P=0.004). The point prevalence abstinence rate was higher (4.61, 1.41 to 15.01, P=0.011), the median time to relapse was longer (visit 5 (interquartile range 3-6) and visit 4 (3-6), P<0.001)), and craving for tobacco was lower (β=-1.81, 95% confidence interval -3.55 to -0.08, P=0.04) in the financial incentives group than control group. Financial incentives were associated with a 7% reduction in the risk of a poor neonatal outcome: 4 babies (2%) in the financial incentives group and 18 babies (9%) in the control group: mean difference 14 (95% confidence interval 5 to 23), P=0.003. Post hoc analyses suggested that more babies in the financial incentives group had birth weights ≥2500 g than in the control group: unadjusted odds ratio 1.95 (95% confidence interval 0.99 to 3.85), P=0.055; sex adjusted odds ratio 2.05 (1.03 to 4.10), P=0.041; and sex and prematurity adjusted odds ratio 2.06 (0.90 to 4.71), P=0.086. As these are post hoc analyses, the results should be interpreted with caution.

Conclusions: Financial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.

Trial Registration: ClinicalTrials.gov NCT02606227.
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http://dx.doi.org/10.1136/bmj-2021-065217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8634365PMC
December 2021

[Three approaches to doctor-patient communication and prevention : Which model for which situation ?]

Rev Med Suisse 2021 Nov;17(758):1934-1938

Département formation, recherche et innovation, Unisanté, 1010 Lausanne.

Doctors learn different communication approaches for use during prevention consultations to promote healthy habits, so as to set up a partnership and to promote patient autonomy. Three of these approaches are shared decision making, when there is more than one reasonable choice, motivational interviewing, principally for behaviour change and therapeutic education, a pedagogical approach helping patients develop skills so that they may have a better management of their chronic illness. This article presents an overview of the commonalities and the differences between these approaches, often considered separately, nevertheless they are complementary and in practice, using elements of all three during a consultation could improve preventative care.
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November 2021

International expert consensus on electronic nicotine delivery systems and heated tobacco products: a Delphi survey.

BMJ Open 2021 09 7;11(9):e045724. Epub 2021 Sep 7.

Centre universitaire de médecine générale et santé publique UNISANTE, Université de Lausanne, Faculte de biologie et médecine, Lausanne, Switzerland.

Objectives: To provide a consensus from a panel of international experts about electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP).

Design: Cross-sectional survey.

Methods: A Delphi survey was conducted among international experts in tobacco control and smoking cessation. The first part addressed statements or recommendations about ENDS, the second about HTP, both divided into four categories: regulation, sale, use and general issues.

Setting: Experts from 15 countries.

Participants: Individuals with clinical, public health or research expertise in tobacco control and/or smoking cessation.

Results: 268 experts were contacted, 92 (34%) completed the first, 55/92 (60%) the second round. Consensus for ENDS: components of e-liquids, an upper limit of nicotine concentration should be defined; a warning on the lack of evidence in long-term safety and addiction potential should be stated; ENDS should not be regulated as consumer products but either as a new category of nicotine delivery or tobacco products; ENDS should not be sold in general stores but in specialised shops, shops selling tobacco or in pharmacies with restriction on sale to minors; administration of illegal drugs is likely with ENDS. Consensus for HTP: HTP have the same addictive potential as cigarettes; they should be regulated as a tobacco product with similar warning messages as cigarettes; their advertisement should not be allowed. ENDS and HTP use should not be allowed in indoor public places; a specific tax should be implemented for ENDS, taxes on HTP should not be lower than those for cigarettes; use of cigarettes is more likely with both ENDS and HTP (dual use) than quitting smoking.

Conclusions: Experts in tobacco control and/or smoking cessation recommend differential regulation for ENDS and HTP. The results of this survey may be useful for health authorities, decision makers and researchers of the tobacco use and cessation field.
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http://dx.doi.org/10.1136/bmjopen-2020-045724DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451280PMC
September 2021

Special Issue on the Effects of Prenatal Smoking/Nicotine Exposure on the Child's Health.

Int J Environ Res Public Health 2021 05 20;18(10). Epub 2021 May 20.

Department of Pharmacology, Assistance Publique-Hôpitaux de Paris, Sorbonne University, 75013 Paris, France.

Smoking increases the risk of negative pregnancy and perinatal outcomes and may have negative effects on a child's short and long-term health [...].
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http://dx.doi.org/10.3390/ijerph18105465DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161150PMC
May 2021

Nicotine Replacement Therapy during Pregnancy and Child Health Outcomes: A Systematic Review.

Int J Environ Res Public Health 2021 04 11;18(8). Epub 2021 Apr 11.

Department of Obstetrics and Gynecology, North Hospital, APHM, Chemin des Bourrely, 13015 Marseille, France.

Tobacco smoking in pregnancy is a worldwide public health problem. A majority of pregnant smokers need assistance to stop smoking. Most scientific societies recommend nicotine replacement therapy (NRT) during pregnancy but this recommendation remains controversial because of the known fetal toxicity of nicotine. The objective of this systematic review was to provide an overview of human studies about child health outcomes associated with NRT use during pregnancy. The electronic databases MEDLINE, the Cochrane Database, Web of Science, and ClinicalTrials.gov were searched from the inception of each database until 26 December 2020. A total of 103 articles were identified through database searching using combination of keywords. Out of 75 screened articles and after removal of duplicates, ten full-text articles were assessed for eligibility and five were included in the qualitative synthesis. NRT prescription seems to be associated with higher risk of infantile colic at 6 months as in case of smoking during pregnancy, and with risk of attention-deficit/hyperactivity disorder. No association between NRT during pregnancy and other infant health disorders or major congenital anomalies has been reported. Well-designed controlled clinical trials with sufficient follows-up are needed to provide more information on the use of NRT or other pharmacotherapies for smoking cessation during pregnancy on post-natal child health outcomes.
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http://dx.doi.org/10.3390/ijerph18084004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8070414PMC
April 2021

Changes in smoking and alcohol consumption during COVID-19-related lockdown: a cross-sectional study in France.

Eur J Public Health 2021 10;31(5):1076-1083

Department of Prevention and Health Promotion, Santé publique France, the National Public Health Agency, Saint-Maurice, France.

Background: In many countries, lockdown measures were implemented to curb the COVID-19 pandemic. This situation may have an impact on mental health, tobacco smoking and alcohol consumption. The aim of this research report is therefore to describe changes in tobacco and alcohol consumption in the general French population during the first 2 weeks of lockdown and identify any associated factors.

Methods: Self-reported changes in smoking and alcohol consumption following the lockdown implemented in France on 17 March 2020 were collected from 2003 respondents aged 18 years and older in an online cross-sectional survey carried out from 30 March to 1 April 2020. Anxiety and depression levels were assessed using the Hospital Anxiety and Depression Scale.

Results: Among current smokers, 26.7% reported an increase in their tobacco consumption since lockdown and 18.6% reported a decrease, while it remained stable for 54.7%. The increase in tobacco consumption was associated with an age of 18-34 years, a high level of education, and anxiety. Among alcohol drinkers, 10.7% reported an increase in their alcohol consumption since lockdown and 24.4% reported a decrease, while it remained stable for 64.8%. The increase in alcohol consumption was associated with an age of 18-49 years, living in cities of more than 100 000 inhabitants, a high socio-professional category, and a depressive mood.

Conclusions: The national lockdown implemented in France during the COVID-19 pandemic influenced tobacco and alcohol consumption in different ways according to sociodemographic group and mental health.
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http://dx.doi.org/10.1093/eurpub/ckab054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8083514PMC
October 2021

Association of smoking reduction and mortality: protocol for a systematic review and meta-analysis of longitudinal observational studies.

BMJ Open 2021 01 20;11(1):e039483. Epub 2021 Jan 20.

Pharmacology, Hopital Pitie-Salpetriere, Paris, Île-de-France, France.

Introduction: Strong evidence shows that smoking cessation decreases mortality. Much less is known regarding the association between reduction in cigarettes per day (CPD) and mortality. The primary aim of this systematic review is to compare the mortality risk between smokers achieving a sustained reduction of CPD and smokers maintaining their smoking rate. The secondary aims are to compare the mortality risk between smokers achieving complete, sustained smoking cessation and (1) smokers maintaining their smoking rate and (2) smokers who achieved a sustained reduction in smoking rate.

Methods And Analysis: MEDLINE, Web of Sciences and Embase will be searched using a prespecified search strategy, up to 23 November 2020, and will be limited to studies published in English and in French. Longitudinal observational studies using individual data including smokers with at least two distant CPD assessments and a follow-up period of systematic mortality data recording will be included. The main outcome will be the all-cause mortality. The secondary outcome will be specific mortality. The Newcastle-Ottawa Scale will be used to assess the risk of bias of individual studies. Outcomes will be analysed using HRs. All other outcomes' effect size reported in included studies will be converted in HRs using validated methods.

Ethics And Dissemination: We intend to publish the results of our review in a peer-reviewed journal and to present the findings at national and international meetings and conferences.

Prospero Registration Number: CRD42019138354.
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http://dx.doi.org/10.1136/bmjopen-2020-039483DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818821PMC
January 2021

Does Smoking Protect against Being Hospitalized for COVID-19?

Int J Environ Res Public Health 2020 12 21;17(24). Epub 2020 Dec 21.

Institut de Cardiologie, Hôpital Pitié-Salpêtrière-Assistance Publique-Hôpitaux de Paris, 75013 Paris, France.

Gonzalez-Rubio et al [...].
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http://dx.doi.org/10.3390/ijerph17249559DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767126PMC
December 2020

Using Trial Sequential Analysis for estimating the sample sizes of further trials: example using smoking cessation intervention.

BMC Med Res Methodol 2020 11 30;20(1):284. Epub 2020 Nov 30.

Division of Epidemiology and Public Health, University of Nottingham, Nottingham, NG5 1PB, UK.

Background: Assessing benefits and harms of health interventions is resource-intensive and often requires feasibility and pilot trials followed by adequately powered randomised clinical trials. Data from feasibility and pilot trials are used to inform the design and sample size of the adequately powered randomised clinical trials. When a randomised clinical trial is conducted, results from feasibility and pilot trials may be disregarded in terms of benefits and harms.

Methods: We describe using feasibility and pilot trial data in the Trial Sequential Analysis software to estimate the required sample size for one or more trials investigating a behavioural smoking cessation intervention. We show how data from a new, planned trial can be combined with data from the earlier trials using trial sequential analysis methods to assess the intervention's effects.

Results: We provide a worked example to illustrate how we successfully used the Trial Sequential Analysis software to arrive at a sensible sample size for a new randomised clinical trial and use it in the argumentation for research funds for the trial.

Conclusions: Trial Sequential Analysis can utilise data from feasibility and pilot trials as well as other trials, to estimate a sample size for one or more, similarly designed, future randomised clinical trials. As this method uses available data, estimated sample sizes may be smaller than they would have been using conventional sample size estimation methods.
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http://dx.doi.org/10.1186/s12874-020-01169-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7702700PMC
November 2020

Risk of COVID-19 and smoking.

Authors:
Ivan Berlin

Heart 2020 Nov 4. Epub 2020 Nov 4.

Department of Pharmacology, Hôpital Pitié-Salpêtrière-Sorbonne Université, Paris, France

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http://dx.doi.org/10.1136/heartjnl-2020-318311DOI Listing
November 2020

Tobacco and COVID-19: a crisis within a crisis?

Can J Public Health 2020 12 14;111(6):995-999. Epub 2020 Oct 14.

Santé Publique France, The National Public Health Agency, Saint-Maurice, France.

During the pandemic, the world's media have publicized preliminary findings suggesting that tobacco use is protective against COVID-19. An ad hoc multidisciplinary group was created to address the major public health implications of this messaging. Key messages of this commentary are as follows: 1) The COVID-19 crisis may increase tobacco consumption and decrease access to healthcare. As a result, smoking-related morbidity and mortality could increase in the coming months and years; 2) Smoking and tobacco-related diseases are prognostic factors for severe COVID-19; and 3) In theory, smokers may be at lower risk of COVID-19 infection because of having fewer social contacts. In conclusion, tobacco control is a greater challenge than ever in the context of the COVID-19 pandemic. Public decision-makers must be vigilant in ensuring that public health practices are consistent and compliant with the principles of the WHO Framework Convention on Tobacco Control. In addition, researchers and the media have a responsibility to be cautious in communicating preliminary results that may promote non-evidence-based research, self-destructive individual behaviours, and commercial agendas.
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http://dx.doi.org/10.17269/s41997-020-00427-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7556572PMC
December 2020

Tobacco and Nicotine Cessation During Pregnancy.

Obstet Gynecol 2020 08;136(2):428-429

Département de Pharmacologie, Hôpital Pitié-Salpêtrière, Paris, France; and Centre Universitaire de Médecine Générale et Santé Publique, UNISANTE, Université de Lausanne, Switzerland.

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http://dx.doi.org/10.1097/AOG.0000000000004033DOI Listing
August 2020

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

Addiction 2021 02 1;116(2):239-277. Epub 2020 Oct 1.

Division of Primary Care, Faculty of Medicine and Health Sciences, University of Nottingham, UK.

Background And Aims: 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).

Methods: 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.

Findings: 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.

Conclusions: 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.
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http://dx.doi.org/10.1111/add.15185DOI Listing
February 2021

COVID-19 and Smoking.

Nicotine Tob Res 2020 08;22(9):1650-1652

Centre Universitaire de Médecine Générale et Santé Publique, UNISANTE, Université de Lausanne, Lausanne, Switzerland.

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http://dx.doi.org/10.1093/ntr/ntaa059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7184428PMC
August 2020

Pharmacological interventions for promoting smoking cessation during pregnancy.

Cochrane Database Syst Rev 2020 03 4;3:CD010078. Epub 2020 Mar 4.

University of Nottingham, Division of Primary Care, Room 1502, Tower Building, University Park, Nottingham, Nottinghamshire, UK, NG7 2RD.

Background: Tobacco smoking in pregnancy causes serious health problems for the developing fetus and mother. When used by non-pregnant smokers, pharmacotherapies (nicotine replacement therapy (NRT), bupropion, and varenicline) are effective for increasing smoking cessation, however their efficacy and safety in pregnancy remains unknown. Electronic cigarettes (ECs) are becoming widely used, but their efficacy and safety when used for smoking cessation in pregnancy are also unknown.

Objectives: To determine the efficacy and safety of smoking cessation pharmacotherapies and ECs used during pregnancy for smoking cessation in later pregnancy and after childbirth, and to determine adherence to smoking cessation pharmacotherapies and ECs for smoking cessation during pregnancy.

Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (20 May 2019), trial registers, and grey literature, and checked references of retrieved studies.

Selection Criteria: Randomised controlled trials (RCTs) conducted in pregnant women, comparing smoking cessation pharmacotherapy or EC use with either placebo or no pharmacotherapy/EC control. We excluded quasi-randomised, cross-over, and within-participant designs, and RCTs with additional intervention components not matched between trial arms.

Data Collection And Analysis: We followed standard Cochrane methods. The primary efficacy outcome was smoking cessation in later pregnancy; safety was assessed by 11 outcomes (principally birth outcomes) that indicated neonatal and infant well-being. We also collated data on adherence to trial treatments. We calculated the risk ratio (RR) or mean difference (MD) and the 95% confidence intervals (CI) for each outcome for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate.

Main Results: We included 11 trials that enrolled a total of 2412 pregnant women who smoked at enrolment, nine trials of NRT and two trials of bupropion as adjuncts to behavioural support, with comparable behavioural support provided in the control arms. No trials investigated varenicline or ECs. We assessed four trials as at low risk of bias overall. The overall certainty of the evidence was low across outcomes and comparisons as assessed using GRADE, with reductions in confidence due to risk of bias, imprecision, and inconsistency. Compared to placebo and non-placebo (behavioural support only) controls, there was low-certainty evidence that NRT increased the likelihood of smoking abstinence in later pregnancy (RR 1.37, 95% CI 1.08 to 1.74; I² = 34%, 9 studies, 2336 women). However, in subgroup analysis by comparator type, there was a subgroup difference between placebo-controlled and non-placebo controlled RCTs (test for subgroup differences P = 0.008). There was unclear evidence of an effect in placebo-controlled RCTs (RR 1.21, 95% CI 0.95 to 1.55; I² = 0%, 6 studies, 2063 women), whereas non-placebo-controlled trials showed clearer evidence of a benefit (RR 8.55, 95% CI 2.05 to 35.71; I² = 0%, 3 studies, 273 women). An additional subgroup analysis in which studies were grouped by the type of NRT used found no difference in the effectiveness of NRT in those using patches or fast-acting NRT (test for subgroup differences P = 0.08). There was no evidence of a difference between NRT and control groups in rates of miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care, caesarean section, congenital abnormalities, or neonatal death. In one study infants born to women who had been randomised to NRT had higher rates of 'survival without developmental impairment' at two years of age compared to the placebo group. Non-serious adverse effects observed with NRT included headache, nausea, and local reactions (e.g. skin irritation from patches or foul taste from gum), but data could not be pooled. Adherence to NRT treatment regimens was generally low. We identified low-certainty evidence that there was no difference in smoking abstinence rates observed in later pregnancy in women using bupropion when compared to placebo control (RR 0.74, 95% CI 0.21 to 2.64; I² = 0%, 2 studies, 76 women). Evidence investigating the safety outcomes of bupropion use was sparse, but the existing evidence showed no difference between the bupropion and control group.

Authors' Conclusions: NRT used for smoking cessation in pregnancy may increase smoking cessation rates in late pregnancy. However, this evidence is of low certainty, as the effect was not evident when potentially biased, non-placebo-controlled RCTs were excluded from the analysis. Future studies may therefore change this conclusion. We found no evidence that NRT has either positive or negative impacts on birth outcomes; however, the evidence for some of these outcomes was also judged to be of low certainty due to imprecision and inconsistency. We found no evidence that bupropion may be an effective aid for smoking cessation during pregnancy, and there was little evidence evaluating its safety in this population. Further research evidence on the efficacy and safety of pharmacotherapy and EC use for smoking cessation in pregnancy is needed, ideally from placebo-controlled RCTs that achieve higher adherence rates and that monitor infants' outcomes into childhood. Future RCTs of NRT should investigate higher doses than those tested in the studies included in this review.
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http://dx.doi.org/10.1002/14651858.CD010078.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059898PMC
March 2020

Varenicline: mode of action, efficacy, safety and accumulated experience salient for clinical populations.

Curr Med Res Opin 2020 05 14;36(5):713-730. Epub 2020 Mar 14.

Pfizer Inc, New York, NY, USA.

Varenicline, a selective partial agonist of the α4β2 nicotinic acetylcholine receptor, is a smoking cessation pharmacotherapy that more than doubles the chance of quitting smoking at 6 months compared with placebo. This article reviews salient knowledge of the discovery, pharmacological characteristics, and the efficacy and safety of varenicline in general and in specific populations of smokers and provides recommendations to support use in clinical practice.: Literature searches for varenicline were conducted using PubMed, with date limitations of 2000-2018 inclusive, using search terms covering the discovery, mechanism of action, pharmacokinetics, efficacy and safety in different populations of smokers, alternative quit approaches and combination therapy. Selection of safety and efficacy data was limited to clinical trials, meta-analyses and observational studies. Standard administration of varenicline is efficacious in helping smokers to quit, including smokers with cardiovascular disease and chronic obstructive pulmonary disease. Furthermore, varenicline efficacy may be improved with pre-loading, a gradual quitting approach for smokers unwilling or unable to quit abruptly, and extended treatment in smokers who have recently quit to help maintain abstinence. Initial concerns regarding the association of varenicline with increased risk of neuropsychiatric and cardiovascular adverse events have been disproven after extensive clinical evaluations, and the benefit-risk profile of varenicline is considered favorable. Varenicline is efficacious and safe for all adult smokers with a range of clinical characteristics. Evidence suggests that approaches offering greater flexibility in timing and duration of treatment may further extend treatment efficacy and clinical reach.
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http://dx.doi.org/10.1080/03007995.2020.1729708DOI Listing
May 2020

Comparison of e-cigarette use characteristics between exclusive e-cigarette users and dual e-cigarette and conventional cigarette users: an on-line survey in France.

Addiction 2019 12 1;114(12):2247-2251. Epub 2019 Sep 1.

Service d'Addictologie, Centre Hospitalier Universitaire Caremeau, Nîmes, France.

Background And Aims: Completely substituting e-cigarettes (EC) for combustible tobacco cigarettes reduces exposure to toxicants and carcinogens. However, a large proportion of EC users (dual users) continue to smoke conventional cigarettes. This study aimed to compare estimated nicotine intake and e-cigarette use characteristics between exclusive EC users and dual users.

Design: Web-based anonymous cross-sectional survey.

Setting: France.

Participants: A total of 3189 adults, current users of electronic cigarettes (EC). Data collection between 4 October 2014 and 11 November 2014.

Measurements: Primary outcome: estimated nicotine intake per day (mg) from participants' reports.

Secondary Outcomes: duration, frequency of EC use and nicotine content of e-liquids used/day. Dual use was defined as using at least one cigarette per day while also using EC.

Findings: A total of 2836 respondents reported exclusive EC use and 353 reported being dual users. Backward stepwise logistic regression showed that dual users had higher estimated combined daily nicotine intake from e-liquids and cigarettes [estimate: 2.14, standard error (SE) = 0.26, adjusted odds ratio (aOR) = 8.48, 95% confidence interval (CI) = 5.11-14.09, P < 0.001], but lower daily nicotine intake from EC (estimate: -2.14, SE = 0.26, aOR = 0.12, CI = 0.07-0.196, P < 0.001) and reported fewer months of EC use (estimate: -0.31, SE = 0.14, aOR = 0.73, CI = 0.56-0.95, P = 0.022) compared with exclusive EC users.

Conclusion: Dual e-cigarette users in France may have higher nicotine intake overall than exclusive e-cigarette users, but they may take in less nicotine from their e-cigarettes.
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http://dx.doi.org/10.1111/add.14780DOI Listing
December 2019

RE: "ASSOCIATION BETWEEN REDUCTIONS OF NUMBER OF CIGARETTES SMOKED PER DAY AND MORTALITY AMONG OLDER ADULTS IN THE UNITED STATES".

Am J Epidemiol 2019 09;188(9):1756-1757

Département de pharmacologie, Hôpital Pitié-Salpêtrière-Sorbonne Université, Paris, France.

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http://dx.doi.org/10.1093/aje/kwz154DOI Listing
September 2019

It's Time to Bury the "Smoker's Paradox".

Nicotine Tob Res 2019 08;21(9):1149-1150

Department of Preventive Cardiology, Oslo University Hospital, Oslo, Norway.

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http://dx.doi.org/10.1093/ntr/ntz106DOI Listing
August 2019

Exploring the Association of Sex Differences and Exposure to Maternal Smoking With Low Fetal Growth.

JAMA Psychiatry 2019 07;76(7):766

Department of General Practice, Turku University Hospital, University of Turku, Turku, Finland.

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http://dx.doi.org/10.1001/jamapsychiatry.2019.1130DOI Listing
July 2019

Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol.

BMJ Open 2019 05 24;9(5):e028832. Epub 2019 May 24.

Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), INSERM, AP-HP, Hôpital Pitié-Salpêtrière, Paris, France.

Introduction: Electronic cigarettes (EC) mainly with nicotine content are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy and safety as an aid for smoking cessation are lacking. METHODS AND ANALYSIS: randomised, placebo and reference treatment-controlled, multicentre, double-blind, double-dummy, parallel-group trial. smokers smoking at least 10 cigarettes/day in the past year and motivated to quit, aged 18-70 years. : (A) EC without nicotine (ECwoN) plus placebo tablets of varenicline administered by oral route: , (B) EC with nicotine (ECwN) plus placebo tablets of varenicline: Voltage regulated EC will be used with liquid containing 12 mg/mL of nicotine for ad libitum use. : blond tobacco. (C) : ECwoN plus 0.5 mg varenicline tablets: Varenicline administered according to the marketing authorisationauthorisation. : 1 week+3 months. continuous smoking abstinence rate (CAR) (abstinence from conventional/combustible cigarettes) during the last 4 weeks (weeks 9-12) of the treatment period defined as self-report of no smoking during the previous 2 weeks and expired air carbon monoxide ≤8 at visit 4 at week 10 after target quit date (TQD), that is, 11 weeks after treatment initiation AND at visit 5, week 12 after TQD, that is, 13 weeks after treatment initiation. : safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms with respect of baseline.

Ethics And Dissemination: The ethics committee approval was obtained on 17 April 2018. All data collected about the study participants will be anonymised. Investigators will communicate trial results to participants, health authorities, healthcare professionals, the public and other relevant groups without any publication restrictions.

Trial Registration Number: NCT03630614; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-028832DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6538086PMC
May 2019

Saliva cotinine concentrations in pregnant women who smoke and use nicotine patches.

Addiction 2019 09 30;114(9):1651-1658. Epub 2019 Jun 30.

Département de pharmacologie, Hôpital Pitié-Salpêtrière, Paris, France.

Background And Aims: Due to concerns about increased exposure to nicotine, pregnant women using nicotine replacement therapy (NRT) to stop smoking are usually advised to stop using NRT if they relapse to smoking. This study investigated whether this is justified. We compared changes in saliva cotinine from baseline to 2 weeks post-target quit date pregnant smokers who relapsed to smoking and continued to use their patches having been assigned to use nicotine patches or placebo.

Design And Setting: Controlled pre-post design stratified by intervention condition from the 'Study of Nicotine Patch in Pregnancy', a randomized, placebo-controlled trial.

Participants: A sample of 268 pregnant women, assigned placebo (n = 122) or nicotine (n = 146) patches, who returned for further supplies of patches and who reported any smoking in the week prior to a visit at 2 weeks after their target quit date.

Measurements: Saliva cotinine concentrations were measured at baseline and 2 weeks after participants' target quit dates. Any smoking in the previous week was assessed by self-report, validated by expired air carbon monoxide (CO).

Findings: There was no change in saliva cotinine concentrations between baseline and 2 weeks post-target quit date in saliva cotinine concentration in the nicotine patch group [ratio of geometric means = 0.94, 95% confidence interval (CI) = 0.83 to 1.07; P = 0.37, Bayes factor = 0.15]. However, there was a reduction in reported number of cigarettes smoked/day (mean difference -6, 95% CIs -7 to -5, P < 0.001) and in CO concentrations (mean difference -3.0 parts per million, 95% CIs -4.2 to -1.9, P < 0.001). These changes were not significantly different from changes in the placebo group except for cigarette consumption, which reduced more in the nicotine group (P = 0.046).

Conclusions: In women trying to stop smoking with the aid of a nicotine patch but having smoked at 2 weeks post-target quit, their nicotine concentration did not change from baseline, but they reported smoking fewer cigarettes and had lower carbon monoxide concentrations.
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http://dx.doi.org/10.1111/add.14662DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771792PMC
September 2019

Comparison of nicotine exposure during pregnancy when smoking and abstinent with nicotine replacement therapy: systematic review and meta-analysis.

Addiction 2019 03 11;114(3):406-424. Epub 2018 Dec 11.

Division of Primary Care, University of Nottingham, Nottingham, UK.

Background And Aims: Smoking during pregnancy is strongly associated with negative pregnancy and perinatal outcomes. Some guidelines recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy, but adherence with NRT is generally poor and could be partially explained by nicotine-related safety concerns. We compared pregnant women's cotinine and nicotine exposures from smoking with those when they were abstinent from smoking and using NRT.

Design: Systematic review with meta-analysis and narrative reporting. Twelve studies were included: in most, only one type of NRT was used. Seven were quality-assessed and judge of variable quality.

Setting: Studies from any setting that reported nicotine or cotinine levels when smoking and later when abstinent and using NRT.

Participants: Pregnant women who smoked and became abstinent but used NRT either in a cessation study or in a study investigating other impacts of NRT.

Measurements: We quality-assessed longitudinal cohort studies using a modified version of the Newcastle-Ottawa scale. For meta-analysis, we used mean within-person differences in cotinine or nicotine levels when smoking and at later follow-up when abstinent and using NRT. Where such data were not available, we calculated differences in group mean levels and reported these narratively, indicating where data were not completely longitudinal.

Findings: Of the 12 included studies, four cotinine-measuring studies (n = 83) were combined in a random effects meta-analysis; the pooled estimate for the mean difference (95% confidence intervals) in cotinine levels between when women were smoking and abstinent but using NRT was 75.3 (57.1 to 93.4) ng/ml (I  = 42.1%, P = 0.11). Of eight narratively-described studies, six reported lower cotinine and/or nicotine levels when abstinent and using NRT; two had mixed findings, with higher levels when abstinent but using NRT reported from at least one assay time-point.

Conclusions: Pregnant women who use nicotine replacement therapy instead of smoking reduce their nicotine exposure.
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http://dx.doi.org/10.1111/add.14473DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6590470PMC
March 2019

Incidence of Lung Cancer among Young Women.

Authors:
Ivan Berlin

N Engl J Med 2018 09;379(10):988

Hôpital Pitié–Salpêtrière, Paris, France

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http://dx.doi.org/10.1056/NEJMc1808250DOI Listing
September 2018

Incidence of Lung Cancer among Young Women.

Authors:
Ivan Berlin

N Engl J Med 2018 09;379(10):988

Hôpital Pitié–Salpêtrière, Paris, France

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http://dx.doi.org/10.1056/NEJMc1808250DOI Listing
September 2018

Maternal Smoking During Pregnancy and Negative Health Outcomes in the Offspring.

Nicotine Tob Res 2018 05;20(6):663-664

University of Connecticut School of Medicineà, Farmington, CT.

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http://dx.doi.org/10.1093/ntr/nty035DOI Listing
May 2018

Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized Controlled Trial (STAMP).

Nicotine Tob Res 2019 01;21(2):163-172

Santé publique France, the National Public Health Agency, Saint Maurice Cedex, France.

Introduction: The Internet offers an interesting alternative to face-to-face and telephone-based support for smoking cessation. This study was designed to assess the effectiveness of a personalized and automated Internet-based program.

Methods: French current adult smokers willing to quit within 2 weeks were recruited for a randomized controlled trial. The intervention consisted of an automated program of 45 e-mails ("e-coaching") sent over a 3-month period. The control group received a PDF version of a booklet on smoking cessation. Self-reported 7-day point prevalence smoking abstinence was measured at 6 months (primary outcome), at 3 and 12 months of follow-up (secondary outcomes).

Results: 2478 smokers were randomized (1242 for e-coaching, 1236 for the booklet). Cessation rate in the intention-to-treat population was not significantly different between the two groups at 6 and 12 months, but was higher in the e-coaching group at 3 months than in the control group (27.5% vs. 23.5%, p = .02, odds ratio [OR] = 1.24, confidence interval [CI] = [1.03-1.49]). After adjustment for baseline conditions, the effect of the intervention in the per-protocol (PP) sample was significant at 3 months (adjusted odds ratio [aOR] = 1.72 [1.31-2.28], p < .001, N = 1042) and at 6 months (aOR = 1.27 [1.00-1.60], p = .05, N = 1082). GLM repeated measure analyses showed significant group by time interaction in the intent-to-treat and a significant group effect in the PP population.

Conclusions: Analyzed intention-to-treat, e-coaching was superior to a booklet at 3 months (end of intervention) but no more superior at 6 and 12 months follow-up. Among those who actually followed the program, the effectiveness is also observed 3 months after the intervention is stopped.

Implications: Analyzed intention-to-treat, our French tailored and personalized Internet-based cessation program was superior to a smoking cessation booklet at 3 months (end of intervention) but no more superior at 6 months follow-up. Among those who actually followed the program (PP population), the effectiveness is observed in the short-term but also 3 months after the intervention is stopped.
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http://dx.doi.org/10.1093/ntr/nty016DOI Listing
January 2019

Nicotine Intake in Pregnant Smokers and a General Population of Smokers.

J Stud Alcohol Drugs 2018 01;79(1):126-131

National Institutes of Health, National Institute on Drug Abuse, Intramural Research Program, Baltimore, Maryland.

Objective: The purpose of this study was to assess whether pregnant smokers have the same nicotine intake from cigarettes as a general population of smokers and whether the known lower daily cigarette consumption among pregnant smokers is associated with higher nicotine intake among pregnant smokers.

Method: The study was a cross-sectional comparison of pregnant smokers and a general population of smokers in smoking cessation clinics. Participants were treatment-seeking pregnant (n = 476), nonpregnant female (n = 116), and male (n = 195) smokers who participated in two independent smoking cessation trials. Nicotine intake was measured as saliva cotinine/ cigarette/kg body weight ratio.

Results: The mean saliva cotinine (μg/L)/ cigarette/kg body weight (0.21, SD = 0.15) of pregnant smokers was similar to that of nonpregnant female smokers (0.24, SD = 0.14) and higher than that of male smokers (0.18, SD = 0.12, p = .002) despite a substantially lower number of cigarettes per day (pregnant smokers: 12, SD = 6; nonpregnant female smokers: 26.6, SD = 11.7; male smokers: 23.5, SD = 9.5, p < .001). Among pregnant smokers, saliva cotinine, as expected, increased in parallel with the number of cigarettes per day, but nicotine intake (cotinine/cigarette/kg body weight) was inversely associated with daily cigarette consumption (p < .001). No association between cigarettes per day and nicotine intake was observed in male and nonpregnant female smokers (p = .43).

Conclusions: This secondary analysis showed that pregnant smokers' nicotine intake was similar to that of a general population of smokers despite a lower cigarette consumption rate. Among pregnant smokers, lower daily cigarette consumption was associated with higher nicotine intake from cigarettes, suggesting compensatory smoking.
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January 2018
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