A randomized controlled open comparative trial of varenicline vs nicotine patch in adult smokers: efficacy, safety and withdrawal symptoms (the VN-SEESAW study)
Open accessAbstract
BACKGROUND: It has been suggested that anti-smoking therapy gives encouraging results, but this has not been verified by well-randomized study protocols. The present study was a randomized controlled trial of varenicline vs nicotine patch in adult smokers for comparison of efficacy, safety and withdrawal symptoms. METHODS AND RESULTS: The 32 adult smokers were randomly divided into a varenicline group (VG, n=16) and a nicotine patch group (NG, n=16). The primary endpoints were the 12- and 24-week smoking-abstinence rates, safety and withdrawal symptoms including stress. No significant difference in abstinence rates was observed between the 2 groups over weeks 9-12 (71.4% vs 78.6% in the VG and NG, respectively), and weeks 9-24 (64.3% vs 71.4%, respectively). The frequencies of inability to concentrate at 2, 4, and 8 weeks, and wakeful nights at 2 weeks were higher in the VG than in the NG. Adverse side-effects associated with a gastrointestinal disorder occurred in 14 cases and 1 case in the VG and NG, respectively, and skin allergy was seen in 0 and 9 cases, respectively. CONCLUSIONS: The selection of treatment depends on the balance of desired acuteness of cessation of smoking and side-effects, such as psychiatric and gastrointestinal problems or skin allergy.
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Two open-label randomized controlled trials were unable to confirm significant improvements with varenicline over NRT in continuous abstinence at 52 weeks following short-term treatment.
“Two open label, randomized controlled trial were unable to confirm significant improvements with varenicline over NRT in continuous abstinence rates at 52 weeks following short term treatment [213, 242, 243].”
From Mechanistic insights into nicotine withdrawal (2011) · cites this paper as [243]
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- Authors
- Tsukahara, H., Noda, K., & Saku, K.
- Affiliations
- Fukuoka University (JP)
- Venue
- Circulation Journal
- Publisher
- Japanese Circulation Society
- Published
- 2010
- Volume
- 74
- Issue
- 4
- Pages
- 771-778
- ISSN
- 1346-9843 (ISSN-L)
- 1347-4820
- OpenAlex
- W2063418581
- Cited by
- 50
- References
- 15
- Citations by year
- 2025: 1 · 2024: 3 · 2023: 4 · 2021: 3 · 2020: 2 · 2019: 1 · 2018: 2 · 2017: 2 · 2016: 3 · 2015: 3 · 2014: 4 · 2013: 4 · 2012: 10
- FWCI
- 4.55
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Circulation Journal (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Fukuoka University
- Central Research Institute, Fukuoka University
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nicotinic Acetylcholine Receptors Study
- Keywords
- varenicline, nicotine patch, smoking cessation, nicotine replacement therapy, smoking abstinence, withdrawal symptoms, stress, adverse effects, gastrointestinal diseases, skin allergy, treatment efficacy
- MeSH terms
- Varenicline, Administration, Cutaneous, Adult, Benzazepines, Emotions, Female, Humans, Male, Middle Aged, Nicotine, Quinoxalines, Risk Factors, Smoking, Stress, Psychological, Substance Withdrawal Syndrome, Incidence, Smoking Cessation, Treatment Outcome, Nicotinic Agonists, Endpoint Determination
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