A comparison of neuropsychiatric adverse events during early treatment with varenicline or a nicotine patch

Cunningham, Francesca; Hur, Kwan; Dong, Diane; Miller, Donald R.; Zhang, Rongping; Wei, Xiangming; McCarren, Madeline; Mosholder, Andrew D.; Aspinall, Sherrie L.; Good, Chester B.

doi:10.1111/add.13329

Cited by 19 publications

(16 citation statements)

References 65 publications

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“…With regard to neuropsychiatric events, a recent trial in 8144 smokers with and without psychiatric disorders found no signiﬁcant increase in neuropsychiatric adverse events attributable to varenicline relative to nicotine patch or placebo 6. Previous observational studies also found no association between varenicline use and neuropsychiatric risks 11 21 22 28 29…”

Section: Discussionmentioning

confidence: 99%

Cardiovascular and neuropsychiatric risks of varenicline and bupropion in smokers with chronic obstructive pulmonary disease

Kotz

Viechtbauer

Simpson

et al. 2017

Thorax

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Section: Discussionmentioning

confidence: 99%

Cardiovascular and neuropsychiatric risks of varenicline and bupropion in smokers with chronic obstructive pulmonary disease

Kotz

Viechtbauer

Simpson

et al. 2017

Thorax

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“…Furthermore, the model does not include possible costs or effects of adverse events of varenicline. However, recent studies have not shown an adverse safety profile for varenicline 57, 58, 59, 60, 61, 62. Close collaboration with stakeholders and experts in the field of smoking cessation both nationally and internationally allowed us to evaluate interventions for which no effectiveness data could be identified for Germany.…”

Section: Discussionmentioning

confidence: 99%

Cost‐effectiveness of increasing the reach of smoking cessation interventions in Germany: results from the EQUIPTMOD

Huber¹,

Präger²,

Coyle

et al. 2017

Addiction

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AimsTo evaluate costs, effects and cost‐effectiveness of increased reach of specific smoking cessation interventions in Germany.DesignA Markov‐based state transition return on investment model (EQUIPTMOD) was used to evaluate current smoking cessation interventions as well as two prospective investment scenarios. A health‐care perspective (extended to include out‐of‐pocket payments) with life‐time horizon was considered. A probabilistic analysis was used to assess uncertainty concerning predicted estimates.SettingGermany.ParticipantsCohort of current smoking population (18+ years) in Germany.InterventionsInterventions included group‐based behavioural support, financial incentive programmes and varenicline. For prospective scenario 1 the reach of group‐based behavioral support, financial incentive programme and varenicline was increased by 1% of yearly quit attempts (= 57 915 quit attempts), while prospective scenario 2 represented a higher reach, mirroring the levels observed in England.MeasurementsEQUIPTMOD considered reach, intervention cost, number of quitters, quality‐of‐life years (QALYs) gained, cost‐effectiveness and return on investment.FindingsThe highest returns through reduction in smoking‐related health‐care costs were seen for the financial incentive programme (€2.71 per €1 invested), followed by that of group‐based behavioural support (€1.63 per €1 invested), compared with no interventions. Varenicline had lower returns (€1.02 per €1 invested) than the other two interventions. At the population level, prospective scenario 1 led to 15 034 QALYs gained and €27 million cost‐savings, compared with current investment. Intervention effects and reach contributed most to the uncertainty around the return‐on‐investment estimates. At a hypothetical willingness‐to‐pay threshold of only €5000, the probability of being cost‐effective is approximately 75% for prospective scenario 1.ConclusionsIncreasing the reach of group‐based behavioural support, financial incentives and varenicline for smoking cessation by just 1% of current annual quit attempts provides a strategy to German policymakers that improves the population's health outcomes and that may be considered cost‐effective.

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“…Observational studies. Several large retrospective observational cohort studies, looking at a variety of endpoint measures, have investigated whether varenicline is associated with an increased risk of neuropsychiatric AEs, using NRT or bupropion as a comparator 88,[96][97][98][99][100][101][102] (Supplementary Table 3). Four of these studies [98][99][100][101] are included in varenicline prescribing information.…”

Section: Current Medical Research and Opinionmentioning

confidence: 99%

“…One study analyzed data in the QResearch database to look at the incidence of fatal and non-fatal selfharm and depression within 6 months of treatment with varenicline or NRT and found no increased risk for these events versus NRT 88 . Another study compared inpatient discharge diagnosis for seven separate psychiatric conditions within 30 days of treatment initiation in smokers using varenicline (N ¼ 11,774) versus NRT (N ¼ 23,548) and reported no between-treatment differences 96 . A secondary endpoint looking at outpatient visits for these same disorders found no differences except for schizophrenia.…”

Section: Current Medical Research and Opinionmentioning

confidence: 99%

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

Tonstad

Arons

Rollema³

et al. 2020

Current Medical Research and Opinion

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Objective: Varenicline, a selective partial agonist of the a4b2 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. Methods: 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. Results: 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. Conclusions: 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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A comparison of neuropsychiatric adverse events during early treatment with varenicline or a nicotine patch

Cited by 19 publications

References 65 publications

Cardiovascular and neuropsychiatric risks of varenicline and bupropion in smokers with chronic obstructive pulmonary disease

Cardiovascular and neuropsychiatric risks of varenicline and bupropion in smokers with chronic obstructive pulmonary disease

Cost‐effectiveness of increasing the reach of smoking cessation interventions in Germany: results from the EQUIPTMOD

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

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