Dataset Information

Safety of varenicline as an aid to smoking cessation in professional drivers and its impact on driving behaviors: An observational cohort study of taxi drivers in Beijing.

ABSTRACT: INTRODUCTION:Varenicline is an effective smoking cessation medicine. However, the possible adverse neuropsychiatric events reported by Food and Drug Administration for varenicline may cause safety problems for professional drivers. We aimed to investigate its safety and impacts on driving behaviors among taxi drivers in Beijing, China. METHODS:An observational cohort study was conducted in a smoking cessation clinic in Beijing, China, between September 2017 and April 2018. Smokers with varenicline for smoking cessation were included and categorized into taxi-driver smokers (n=103) and non-taxi-driver smokers (n=119). All participants received varenicline up to 12 weeks and five standardized counseling sessions. Treatment-related adverse events (AEs) were collected in all participants and their impacts on driving behaviors were assessed in taxi-driver smokers. Multiple logistic regression analysis was used to examine potential risk factors for vareniclinerelated somnolence/fatigue. RESULTS:The incidence of most treatment-related AEs was similar between taxi-driver smokers and non-taxi-driver smokers, but treatment-related somnolence/ fatigue was more frequently reported in taxi-driver smokers (18.4% vs 6.7%; p=0.008). Most taxi-driver smokers (87.4%) reported that treatment-related AEs did not affect their driving behaviors, and no traffic accident was reported during treatment. CONCLUSIONS:Varenicline appears to be a well-tolerated smoking cessation aid for Beijing taxi drivers and has less impact on driving behaviors. However, taxi-driver smokers were more likely to report somnolence/fatigue during varenicline treatment and physicians should pay more attention to this occupational population.

SUBMITTER: Chu S

PROVIDER: S-EPMC7263361 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Safety of varenicline as an aid to smoking cessation in professional drivers and its impact on driving behaviors: An observational cohort study of taxi drivers in Beijing.

Chu Shuilian S Liang Lirong L Jing Hang H Zhang Di D Tong Zhaohui Z

Tobacco induced diseases 20200527

<h4>Introduction</h4>Varenicline is an effective smoking cessation medicine. However, the possible adverse neuropsychiatric events reported by Food and Drug Administration for varenicline may cause safety problems for professional drivers. We aimed to investigate its safety and impacts on driving behaviors among taxi drivers in Beijing, China.<h4>Methods</h4>An observational cohort study was conducted in a smoking cessation clinic in Beijing, China, between September 2017 and April 2018. Smokers ...[more]

PMID: 32494237

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Project description:Background and aimsVarenicline effectiveness may be related to the level of adherence, which might be reduced by adverse effects such as nausea. The aim of the study was to test a possible effect of nausea on smoking cessation outcomes mediated by adherence.DesignMediation path analysis.SettingMultiple sites within Canada and the United States.ParticipantsTreatment-seeking smokers receiving varenicline from two smoking cessation clinical trials: Quit2Live (NCT01836276; n = 449) and Pharmacogenetics of Nicotine Addiction Treatment (PNAT) (NCT01314001; n = 421).MeasurementsNausea severity was collected through self-report and adherence was biologically assessed using varenicline concentrations (Quit2Live, plasma sample at week 4; PNAT, saliva sample at week 2). In Quit2Live, the end-points were cotinine-verified abstinence at weeks 4, 12 and 26. In PNAT, the end-points were carbon monoxide-verified abstinence at weeks 2, 12 and 26.FindingsEarly nausea was not directly associated with abstinence [odds ratio (OR) ranging from 0.73-1.28; P ? 0.26]. However early nausea was indirectly associated with lower cessation rates at multiple timepoints (ORs ranging from 0.92-0.94; 95% CI between 0.83-0.99) in a relationship mediated by reduced varenicline adherence (assessed by plasma varenicline concentrations) in the primary trial (Quit2Live). This relationship between nausea, adherence and cessation was similar in direction but weaker in effect size (ORs ranging from 0.98-0.99; 95% CI between 0.90-1.03) in a secondary trial (PNAT), where adherence was assessed using salivary varenicline concentrations.ConclusionsThese data suggest that early nausea during varenicline treatment may be indirectly associated with lower likelihood of smoking cessation through reducing varenicline adherence. Differences in robustness between the trials may be due to the different biological matrices (plasma vs. saliva) and/or timing used to assess varenicline adherence. The results of the first study suggest that improved management of early nausea during varenicline treatment may positively impact smoking cessation success through increasing varenicline adherence.

Project description:ImportanceSome cigarette smokers may not be ready to quit immediately but may be willing to reduce cigarette consumption with the goal of quitting.ObjectiveTo determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction.Design, setting, and participantsRandomized, double-blind, placebo-controlled, multinational clinical trial with a 24-week treatment period and 28-week follow-up conducted between July 2011 and July 2013 at 61 centers in 10 countries. The 1510 participants were cigarette smokers who were not willing or able to quit smoking within the next month but willing to reduce smoking and make a quit attempt within the next 3 months. Participants were recruited through advertising.InterventionsTwenty-four weeks of varenicline titrated to 1 mg twice daily or placebo with a reduction target of 50% or more in number of cigarettes smoked by 4 weeks, 75% or more by 8 weeks, and a quit attempt by 12 weeks.Main outcomes and measuresPrimary efficacy end point was carbon monoxide-confirmed self-reported abstinence during weeks 15 through 24. Secondary outcomes were carbon monoxide-confirmed self-reported abstinence for weeks 21 through 24 and weeks 21 through 52.ResultsThe varenicline group (n = 760) had significantly higher continuous abstinence rates during weeks 15 through 24 vs the placebo group (n = 750) (32.1% for the varenicline group vs 6.9% for the placebo group; risk difference (RD), 25.2% [95% CI, 21.4%-29.0%]; relative risk (RR), 4.6 [95% CI, 3.5-6.1]). The varenicline group had significantly higher continuous abstinence rates vs the placebo group during weeks 21 through 24 (37.8% for the varenicline group vs 12.5% for the placebo group; RD, 25.2% [95% CI, 21.1%-29.4%]; RR, 3.0 [95% CI, 2.4-3.7]) and weeks 21 through 52 (27.0% for the varenicline group vs 9.9% for the placebo group; RD, 17.1% [95% CI, 13.3%-20.9%]; RR, 2.7 [95% CI, 2.1-3.5]). Serious adverse events occurred in 3.7% of the varenicline group and 2.2% of the placebo group (P = .07).Conclusions and relevanceAmong cigarette smokers not willing or able to quit within the next month but willing to reduce cigarette consumption and make a quit attempt at 3 months, use of varenicline for 24 weeks compared with placebo significantly increased smoking cessation rates at the end of treatment, and also at 1 year. Varenicline offers a treatment option for smokers whose needs are not addressed by clinical guidelines recommending abrupt smoking cessation.Trial registrationclinicaltrials.gov Identifier: NCT01370356.

Project description:IntroductionWomen have lower rates of quitting than men with both bupropion and nicotine replacement. It is unknown whether varenicline demonstrates differential efficacy for men and women. The purpose of this study was to conduct the first comprehensive meta-analysis of clinical trial data examining sex differences in the efficacy of varenicline for smoking cessation.MethodsSearching MEDLINE, EMBASE, and PsychINFO, 17 of 43 clinical trials of varenicline for smoking cessation published through December 31, 2014 were low-bias randomized double-blind placebo-controlled trials. Data (n = 6710 smokers, 34% female, n = 16 studies, 96% of available data) was analyzed with Metafor program in R. Outcome endpoints were 7-day point-prevalence (PP) and continuous-abstinence (CA) at week 12 (end of treatment), week 24 (6-month follow-up), and week 52 (12-month follow-up).ResultsUsing placebo, women were less likely than men to quit (PP-12, CA-24; P < .05 for sex). Using varenicline, similar rates of abstinence for men and women were demonstrated for all six outcomes (eg, PP-12 abstinence rates were 53% in both women and men). Varenicline versus placebo outcomes demonstrated that varenicline was more effective for women for short and intermediate outcomes (PP-12, CA-12, CA-24; P < .05 sex × medication interaction). For end-of-treatment PP, varenicline was 46% more effective for women. For continuous abstinence, varenicline was 34% (CA-12) and 31% (CA-24) more effective for women.ConclusionsUnlike other smoking cessation medications, varenicline demonstrated greater efficacy among women smokers for short and immediate-term outcomes and equal efficacy for 1-year outcomes. Varenicline may be particularly useful for reducing the sex disparity typically seen in rates of smoking cessation.ImplicationsVarenicline is currently the most effective FDA-approved smoking cessation medication and this is the first demonstration that women compared with men have a preferred therapeutic response for a smoking cessation medication when considering short-term outcomes. Importantly, this is also the first demonstration that women have similar rates of quitting to men when considering longer-term, 1-year outcomes.

Dataset Information

Safety of varenicline as an aid to smoking cessation in professional drivers and its impact on driving behaviors: An observational cohort study of taxi drivers in Beijing.

Publications

Safety of varenicline as an aid to smoking cessation in professional drivers and its impact on driving behaviors: An observational cohort study of taxi drivers in Beijing.

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