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Cited by 184Smoking Behavior and CessationPharmacovigilance and Adverse Drug ReactionsSubstance Abuse Treatment and Outcomes

A double-blind study evaluating the long-term safety of varenicline for smoking cessation

Williams, Kathryn E., Reeves, Karen R., Billing, Clare B., Pennington, Ann M., Gong, Jason·2007·Current Medical Research and Opinion
DOI 10.1185/030079907x182185
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Abstract

OBJECTIVE: We assessed the safety of long-term varenicline administration for smoking cessation. METHODS: In this randomized, double-blind, multicenter trial, eligible adult smokers (18-75 years) who smoked an average of > or =10 cigarettes/day were randomized to either varenicline 1 mg twice daily (BID) or placebo for 52 weeks. Subjects made weekly clinic visits until week 8, and then every 4 weeks until week 52, with a follow-up visit at week 53. The target quit date was the morning of the week 1 clinic visit. Brief counseling was provided at each visit, and vital signs, adverse events (AEs), and smoking status were documented. Other laboratory measures were collected at specified visits. RESULTS: A total of 251 subjects were randomized to varenicline and 126 to placebo. Approximately half of the subjects in each arm completed the study (53.8% varenicline; 46.8% placebo). Treatment-emergent AEs were observed in 96.4% of varenicline- and 82.5% of placebo-treated subjects during the study. Common varenicline-associated AEs were nausea (40.2%), abnormal dreams (22.7%), and insomnia (19.1%). Most AEs were considered mild or moderate in intensity. AEs leading to discontinuation of varenicline treatment included nausea (7.6%), insomnia (3.2%), and abnormal dreams (2.4%). A single varenicline-related serious AE, bilateral subcapsular cataracts, was observed. At week 52, 7-day point prevalence abstinence rates were 36.7% (varenicline) and 7.9% (placebo). CONCLUSIONS: Varenicline 1 mg BID can be safely administered for up to 1 year. Varenicline was also a more effective smoking cessation aid than placebo throughout the study, supporting both its short- (12-week) and long-term (52-week) efficacy.

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  • Three other trials comparing a combination to patch alone have not replicated this result.

    “Three other trials comparing a combination to patch alone have not replicated this result (109–111).”

    From Tobacco addiction (2008) · cites this paper as [109]

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Authors
Williams, K. E., Reeves, K. R., Billing, C. B., Pennington, A. M., & Gong, J.
Affiliations
Pfizer (United States) (US)
Corresponding author
Williams, Kathryn E.
Venue
Current Medical Research and Opinion
Publisher
Informa Healthcare
Published
2007-03-05
Volume
23
Issue
4
Pages
793-801
ISSN
  • 0300-7995 (ISSN-L)
  • 1473-4877
DOI
10.1185/030079907x182185
OpenAlex
W2133053824
Cited by
184
References
19
Citations by year
2026: 4 · 2025: 3 · 2024: 7 · 2023: 6 · 2022: 6 · 2021: 5 · 2020: 9 · 2019: 4 · 2018: 5 · 2017: 4 · 2016: 14 · 2015: 7 · 2014: 5 · 2013: 7 · 2012: 11
FWCI
15.96
Type
journal article
Language
en
Open access
closed
Locations
  • Current Medical Research and Opinion (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Keywords
varenicline, smoking cessation, long-term safety, adverse events, nausea, insomnia, nicotine dependence, smoking abstinence, nicotine receptor partial agonist
MeSH terms
Varenicline, Smoking Prevention, Adolescent, Adult, Aged, Benzazepines, Double-Blind Method, Female, Humans, Male, Middle Aged, Placebos, Quinoxalines, Time, Time Factors, Smoking Cessation, Treatment Outcome

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