title: Safety of Varenicline for Smoking Cessation in Psychiatric and Addicts Patients.
abstract: The safety of varenicline in the treatment of tobacco dependence has been questioned, in psychiatric patients. However, most published studies have not included psychiatric patients.
  
  
  OBJECTIVE
  Assess the safety of varenicline for smoking cessation in patients with psychiatric disorders.
  
  
  METHODS
  This is a prospective, longitudinal, multicenter study. The sample is composed of three groups (patients with psychotic disorder, patients with alcohol dependence disorder and patients addicts in methadone maintenance treatment). Patients were recruited consecutively between September 2008 and June 2009 from 11 centers. All patients received a standardized smoking cessation program with varenicline and psychological support. Adverse events of the drug were monitored at weeks 1, 2, 4, 6, 8, and 12 of treatment. Bivariate analysis has been used.
  
  
  RESULTS
  None of the 90 patients included, presented a serious adverse event. The most frequent adverse effect was dry mouth (28.9%), followed by the presence of flatulence (27.8%), abnormal dreams (27.8%), and nausea (22%), especially between weeks 2 and 6 of treatment. None of the patients referred intense suicidal ideation, although two referred to moderate suicidal ideation, which was solved in one case and in the other, treatment was discontinued. Four participants (4.4%) abandoned treatment because of gastrointestinal symptoms. The initial dose of varenicline was reduced in 25% of patients during the study.
  
  
  CONCLUSIONS
  Gastrointestinal adverse events are the most incident in this sample of psychiatric patients and no exacerbation of psychiatric symptoms was detected, thus indicating a good safety record for varenicline use for smoking cessation in psychiatric patients.
authors.affiliation: a Mental Health Department , Althaia Xarxa Assistencial Universitària , Manresa , Spain.|b Tobacco Control Unit, Institut Català d'Oncologia , L'Hospitalet , Spain (ICO-IDIBELL).|c Department of Clinical Sciences , School of Medicine, Universitat de Barcelona , Barcelona , Spain.
authors.forename: Antonia
authors.initials: A
authors.lastname: Raich
authors.affiliation: b Tobacco Control Unit, Institut Català d'Oncologia , L'Hospitalet , Spain (ICO-IDIBELL).|d Alcohology and Psychiatry Unit, Hospital Clínic , Barcelona , Spain.
authors.forename: Montse
authors.initials: M
authors.lastname: Ballbè
authors.affiliation: e Psychiatry Department, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, CIBERSAM , Barcelona , Spain.
authors.forename: Gemma
authors.initials: G
authors.lastname: Nieva
authors.affiliation: f Mental Health and Addictions Department , Hospital de Mataró , Mataró , Spain.
authors.forename: Margarita
authors.initials: M
authors.lastname: Cano
authors.affiliation: f Mental Health and Addictions Department , Hospital de Mataró , Mataró , Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Fernández
authors.affiliation: e Psychiatry Department, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, CIBERSAM , Barcelona , Spain.
authors.forename: Eugeni
authors.initials: E
authors.lastname: Bruguera
authors.affiliation: b Tobacco Control Unit, Institut Català d'Oncologia , L'Hospitalet , Spain (ICO-IDIBELL).|c Department of Clinical Sciences , School of Medicine, Universitat de Barcelona , Barcelona , Spain.
authors.forename: Esteve
authors.initials: E
authors.lastname: Fernández
mesh_terms: D000328:Adult; D003376:Counseling; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D001523:Mental Disorders; D008875:Middle Aged; D011446:Prospective Studies; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods*; D019966:Substance-Related Disorders; D061485:Tobacco Use Cessation Devices / Q000009:adverse effects*; D000068580:Varenicline / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000068580:Varenicline
keywords: Smoking cessation; alcohol dependence; methadone treatment; psychotic disorder; varenicline