title: Varenicline for tobacco dependence: panacea or plight?
abstract: BACKGROUND
  This review examines the postmarketing experience with varenicline, including case reports, newer clinical trials and secondary analyses of large clinical datasets.
  
  
  METHODS
  Varenicline has been shown to be an effective treatment in a broad range of tobacco users with medical, behavioral and diverse demographic characteristics. Recent studies finding excellent safety and efficacy in groups of smokers with diseases including chronic obstructive pulmonary disease are particularly encouraging and call for increased use of this medication for smoking cessation. Despite case reports of serious neuropsychiatric symptoms in patients taking varenicline, including changes in behavior and mood, causality has not been established. Recent analyses of large datasets from clinical trials have not demonstrated that varenicline is associated with more depression or suicidality than other treatments for smoking cessation.
  
  
  CONCLUSIONS
  Now that additional clinical trials in specific populations and observational studies on treatment-seeking smokers outside of clinical trials have been published, we can be confident that varenicline remains the most efficacious monotherapy for smoking cessation and that its side-effect profile remains good. The risk-to-benefit ratio of receiving varenicline to quit smoking must include the increased chances of quitting smoking and avoiding the sizeable risks of smoked-caused disease and death that remain if tobacco addiction is not properly treated.
authors.affiliation: UMDNJ-Robert Wood Johnson Medical School, 317 George St, Suite 105, 08901, New Brunswick, New Jersey, USA. williajm@umdnj.edu
authors.forename: Jill M
authors.initials: JM
authors.lastname: Williams
authors.forename: Michael B
authors.initials: MB
authors.lastname: Steinberg
authors.forename: Marc L
authors.initials: ML
authors.lastname: Steinberg
authors.forename: Kunal K
authors.initials: KK
authors.lastname: Gandhi
authors.forename: Rajiv
authors.initials: R
authors.lastname: Ulpe
authors.forename: Jonathan
authors.initials: J
authors.lastname: Foulds
mesh_terms: D000818:Animals; D001552:Benzazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D009538:Nicotine / Q000627:therapeutic use; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011810:Quinoxalines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016540:Smoking Cessation / Q000379:methods*; D020340:Tobacco Use Cessation / Q000379:methods; D014029:Tobacco Use Disorder / Q000534:rehabilitation; D014030:Tobacco, Smokeless; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D009538:Nicotine; D000068580:Varenicline