Journal of Public Health

, Volume 20, Issue 4, pp 355–365

Long-term efficacy and safety of varenicline for smoking cessation: a systematic review and meta-analysis of randomized controlled trials

  • Yubei Huang
  • Weiqin Li
  • Li Yang
  • Yuan Jiang
  • Yangfeng Wu
Review Article

DOI: 10.1007/s10389-011-0476-5

Cite this article as:
Huang, Y., Li, W., Yang, L. et al. J Public Health (2012) 20: 355. doi:10.1007/s10389-011-0476-5



To evaluate the long-term efficacy and potential risk of psychiatric side effects of varenicline for smoking cessation compared with placebo or nicotine replacement therapy.

Subject and methods

Systematic search of electronic databases (MEDLINE, EMBASE, Cochrane Central Register, SCI) up to March 2011. Two reviewers independently determined the eligibility of randomized controlled trials comparing varenicline with placebo, or nicotine replacement therapy with follow-up of at least 12 months. Information was independently extracted by 2 reviewers.


Ten trials involving 6,375 smokers were included in the meta-analysis. The pooled risk ratios (RR) for continuous abstinence was 2.83 (95% CI: 2.20–3.63) at 52 weeks for varenicline (1 mg, twice per day) versus placebo. Varenicline seemed to be more effective in smokers with chronic obstructive pulmonary disease (RR, 3.33) than smokers with cardiovascular diseases (RR, 2.64) or health smokers (RR, 2.52), non-Asian smokers than Asian smokers (2.98 vs. 1.94), elder smokers than younger smokers (2.87 vs. 2.52), female smokers than male smokers (2.98 vs. 1.94). The five predominant reported adverse events for varenicline compared to placebo were vomiting, nausea, abnormal dreams, constipation, and dysgeusia. There was no sufficient evidence that varenicline was associated with an increased risk of psychiatric side effects (RR, 1.45, 95% CI: 0.90–2.32).


Varenicline therapy compared with placebo is associated with a favorable effect on smoking cessation at the end of 52 weeks. However, the psychiatric adverse events related with varenicline should be further studied with larger qualified study. People with preexisting mental illnesses should be prudently treated with varenicline.


VareniclineSmoking cessationSystematic reviewMeta-analysisTrials

Supplementary material

10389_2011_476_MOESM1_ESM.doc (46 kb)
Appendix 1The search strategy (DOC 46 kb)

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Yubei Huang
    • 1
  • Weiqin Li
    • 2
  • Li Yang
    • 3
  • Yuan Jiang
    • 4
  • Yangfeng Wu
    • 1
    • 5
  1. 1.Department of Epidemiology and Biostatistics, School of Public HealthPeking University Health Science CenterBeijingChina
  2. 2.Tianjin Women’s and Children’s Health CenterTianjinChina
  3. 3.Department of Preventive Medicine, School of Medical radiology and Public healthSuZhou UniversityJiangsuChina
  4. 4.National Office of Tobacco Control, Chinese Center of Disease Prevention and ControlBeijingChina
  5. 5.The George Institute for Global HealthBeijingChina