Safety of Varenicline for Smoking Cessation in Psychiatric and Addicts Patients

Raich, Antònia; Ballbè, Montse; Nieva, Gemma; Cano, Margarita González; Fernández, Teresa; Bruguera, Eugeni; Fernández, Esteve

doi:10.3109/10826084.2015.1133646

Cited by 9 publications

(19 citation statements)

References 21 publications

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“…The adverse events observed in the psychiatric disorder group in our sample were: dry mouth, flatulence, abnormal dreams, and nausea. According to diagnostic groups, the patients using methadone presented more adverse events than the alcohol group, but we did not observe other significant differences across diagnostic groups 22 . In our previous study, we reported that reducing the dose to 1 mg/day improved treatment adherence in patients who experienced adverse events and we also found that varenicline did not induce any significant exacerbations of psychiatric symptoms 22 .…”

Section: Resultscontrasting

confidence: 83%

“…Our team assessed the safety of varenicline in a previous study 22 . In the present study, we again evaluated safety, finding that varenicline was safe in this sample.…”

Section: Resultsmentioning

confidence: 99%

“…Modifications in pharmacological treatment for psychiatric pathologies and adherence to pharmacological treatment to quit smoking were monitored and recorded. The results regarding safety have been previously reported in detail 22 .…”

Section: Methodsmentioning

confidence: 90%

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Multimodal treatment for smoking cessation with varenicline in alcoholic, methadone-maintained, and psychotic patients: A one-year follow-up

et al. 2018

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INTRODUCTION Numerous studies have evaluated the efficacy and safety of varenicline for smoking cessation in smokers in the general population and, to a lesser extent, among the psychiatric population. However, few studies have evaluated varenicline in patients with other addictions. The present study was conducted to assess outcomes of a multimodal treatment for smoking cessation intervention with varenicline in a sample of alcohol and substance use disorders and patients with psychotic disorders. METHODS This was a prospective, multicenter study. The patient sample comprised alcoholics in remission, methadone-maintained patients, and patients with psychotic disorders, all of whom wanted to stop smoking. All participants received multimodal treatment for smoking cessation therapy (psychological therapy plus varenicline). Smoking abstinence and changes in the psychopathological state of patients were assessed at predefined time points during a 12-month follow-up. The probability of tobacco abstinence after one year of treatment was computed using Kaplan-Meier life tables. RESULTS The probability of abstinence at one year was 0.225 (95% CI: 0.1430-0.319). By group, the probabilities were as follows: patients with psychotic disorders 0.254 (95% CI: 0.118-0.415); alcoholics 0.237 (95% CI: 0.098-0.409); and methadone-maintained patients 0.177 (95% CI: 0.065-0.335). Patients with previous quit attempts had a higher probability of achieving abstinence at one year (p<0.01). CONCLUSIONS The results of this study support the use of multimodal treatment with varenicline in patients with alcohol addiction in remission, patients on methadone maintenance, and patients with stable psychotic disorders. Previous smoking cessation attempts were predictive of smoking cessation success in these patients.

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Section: Resultscontrasting

confidence: 83%

“…Our team assessed the safety of varenicline in a previous study 22 . In the present study, we again evaluated safety, finding that varenicline was safe in this sample.…”

Section: Resultsmentioning

confidence: 99%

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Multimodal treatment for smoking cessation with varenicline in alcoholic, methadone-maintained, and psychotic patients: A one-year follow-up

et al. 2018

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“…10 49 In a prospective longitudinal study among psychiatric patients, there was no exacerbation of psychiatric symptoms detected except gastrointestinal adverse events. 50 However, although it is not within the scope of this study, what need to be mentioned is that an increased rate of outpatient visits for schizophrenia was previously reported to be present only in patients with a pre-existing mental health disorder. 32 This may be explained by mediation through individual genetic liability.…”

Section: Main Findings and Interpretationmentioning

confidence: 79%

Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting

et al. 2021

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ObjectivesTo evaluate the real-world association between varenicline and neuropsychiatric adverse events (NPAEs) in general and chronic obstructive pulmonary disease (COPD) population with and without psychiatric disorders compared with nicotine replacement therapy (NRT) to strengthen the knowledge of varenicline safety.DesignA retrospective cohort study.SettingPrescription database IADB.nl, the Netherlands.ParticipantsNew users of varenicline or NRT among general (≥18 years) and COPD (≥40 years) population. Psychiatric subcohort was defined as people prescribed psychotropic medications (≥2) within 6 months before the index date.Outcome measuresThe incidence of NPAEs including depression, anxiety and insomnia, defined by new or naive prescriptions of related medications in IADB.nl within 24 weeks after the first treatment initiation of varenicline or NRT.ResultsFor the general population in non-psychiatric cohort, the incidence of total NPAEs in varenicline (4480) and NRT (1970) groups was 10.5% and 12.6%, respectively (adjusted OR (aOR) 0.85, 95% CI 0.72 to 1.00). For the general population in psychiatric cohort, the incidence of total NPAEs was much higher, 75.3% and 78.5% for varenicline (1427) and NRT (1200) groups, respectively (aOR 0.82, 95% CI 0.68 to 0.99). For the COPD population (1598), there were no differences in the incidence of NPAEs between comparison groups in both the psychiatric cohort (aOR 0.97, 95% CI 0.66 to 1.44) and non-psychiatric cohort (aOR 0.81, 95% CI 0.54 to 1.20). Results from subgroup or sensitivity analyses also did not reveal increased risks of NPAEs but showed decreased risk of some subgroup NPAEs associated with varenicline.ConclusionsIn contrast to the concerns of a possible increased risk of NPAEs among varenicline users, we found a relative decreased risk of total NPAEs in varenicline users of the general population in psychiatric or non-psychiatric cohorts compared with NRT and no difference for NPAEs between varenicline and NRT users in smaller population with COPD.

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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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Safety of Varenicline for Smoking Cessation in Psychiatric and Addicts Patients

Abstract: Gastrointestinal adverse events are the most incident in this sample of psychiatric patients and no exacerbation of psychiatric symptoms was detected, thus indicating a good safety record for varenicline use for smoking cessation in psychiatric patients.

Cited by 9 publications

References 21 publications

Multimodal treatment for smoking cessation with varenicline in alcoholic, methadone-maintained, and psychotic patients: A one-year follow-up

Multimodal treatment for smoking cessation with varenicline in alcoholic, methadone-maintained, and psychotic patients: A one-year follow-up

Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting

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

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