Safety and efficacy of first-line smoking cessation pharmacotherapies in bipolar disorders: subgroup analysis of a randomized clinical trial
Open accessAbstract
Objectives Post hoc analyses of EAGLES data to examine safety and efficacy of first-line smoking cessation pharmacotherapies in smokers with bipolar disorders (BD).Methods Smokers with BD I/II (n = 285; 81.4% with BD I) and a comparison nonpsychiatric cohort (NPC; n = 2794) were randomly assigned to varenicline, bupropion, nicotine replacement therapy (NRT), or placebo for 12 weeks, plus weekly counseling. Primary outcomes were occurrence of moderate to severe neuropsychiatric adverse events (NPSAEs) and Weeks 9-12 biochemically-confirmed continuous abstinence (CA) rates.Results For BD smokers, NPSAE risk differences versus placebo were: varenicline, 6.17 (95% CI: -7.84 to 20.18); bupropion, 4.09 (-8.82 to 16.99); NRT, -0.56 (-12.34 to 11.22). ORs for Weeks 9-12 CA, comparing active medication to placebo among BD smokers were: varenicline, 2.61 (0.68-9.95); bupropion, 1.29 (0.31-5.37), NRT, 0.71 (0.14-3.74). Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P < 0.001) and CA rates were lower (22.8% versus 13.3%; P = 0.008) in BD than NPC.Limitations Study not powered to detect differences in safety and efficacy in the BD subcohort; generalizability limited to stably treated BD without current substance use disorders.Conclusions Smokers with BD had higher risk of NPSAEs and were less likely to quit overall than NPC smokers. Among smokers with BD, NPSAE risk difference estimates for active treatments versus placebo ranged from 1% lower to 6% higher. Efficacy of varenicline in smokers with BD was similar to EAGLES main outcomes; bupropion and NRT effect sizes were descriptively lower. Varenicline may be a tolerable and effective cessation treatment for smokers with BD.Trial registration ClinicalTrials.gov identifier (https://clinicaltrials.gov/): NCT01456936.
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A post-hoc analysis suggests a higher abstinence rate with varenicline compared to bupropion or nicotine replacement therapy.
“A post-hoc analysis suggests a higher abstinence rate with varenicline compared to bupropion or NRT (79)”
From The detrimental effects of smoking on the course and outcome in adults with bipolar disorder—A narrative review (2023) · cites this paper as [79]
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- Authors
- Heffner, J. L., Evins, A. E., Russ, C., Lawrence, D., Ayers, C. R., McRae, T., Aubin, L. S., Krishen, A., West, R., & Anthenelli, R. M.
- Affiliations
- Fred Hutch Cancer Center (US)
- Harvard University (US)
- Pfizer (United States) (US)
- University of California San Diego (US)
- University College London (GB)
- Corresponding author
- Heffner, Jaimee L.
- ORCID
- Venue
- Journal of Affective Disorders
- Publisher
- Elsevier BV
- Published
- 2019-09
- Volume
- 256
- Pages
- 267-277
- ISSN
- 0165-0327 (ISSN-L)
- PMC
- PMC8936081
- OpenAlex
- W2948176554
- Cited by
- 23
- References
- 33
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 3 · 2023: 10 · 2022: 2 · 2021: 4 · 2020: 1 · 2019: 1
- FWCI
- 1.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Affective Disorders (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- Pfizer
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Keywords
- bipolar disorder, smoking cessation, varenicline, bupropion, nicotine replacement therapy, neuropsychiatric adverse effects, continuous abstinence, psychiatric comorbidity, smoking cessation counseling
- MeSH terms
- Varenicline, Bipolar Disorder, Counseling, Female, Humans, Male, Middle Aged, Random Allocation, Smoking, Smoking Cessation, Bupropion, Treatment Outcome, Nicotinic Agonists, Tobacco Use Cessation Devices
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