title: Safety of varenicline among smokers enrolled in the lung HIV study.
abstract: BACKGROUND
  The prevalence of smoking is high among the human immunodeficiency virus (HIV)-infected population, yet there are few studies of tobacco dependence treatment in this population. This paper reports the safety of varenicline versus nicotine replacement therapy (NRT) and describes preliminary results about the effectiveness of varenicline versus NRT in HIV-infected smokers.
  
  
  METHODS
  Participants completed 12 weeks of telephone counseling and either varenicline or NRT. Varenicline was encouraged as the preferred intervention; NRT was used for those unable/unwilling to take varenicline. Adverse events (AEs), related to pharmacotherapy, were monitored. Biochemically confirmed abstinence at 3 months was examined. Inverse probability of treatment weighted logistic regression models was fit to compare participants on varenicline to those on NRT.
  
  
  RESULTS
  Among participants on varenicline (n = 118), the most common AEs were nausea, sleep problems, and mood disturbances. One person reported suicidal ideation; there were no cardiovascular complications. There were no differences in the varenicline AE profile between participants on combination antiretroviral therapy (ART) and those not on ART. The percentages of confirmed abstainers were 11.8% in the NRT group and 25.6% in the varenicline group. The odds of being abstinent were 2.54 times as great in the varenicline group compared with the NRT group in the propensity weighted model (95% CI 1.43-4.49).
  
  
  CONCLUSIONS
  In this preliminary study, the safety profile of varenicline among HIV-infected smokers resembles findings among smokers without HIV. In addition, varenicline may be more effective at promoting abstinence in this population. Future randomized clinical trials are warranted.
authors.affiliation: College of Public Health, The Ohio State University, Columbus, OH 43210, USA. aferketich@cph.osu.edu
authors.forename: Amy K
authors.initials: AK
authors.lastname: Ferketich
authors.forename: Philip
authors.initials: P
authors.lastname: Diaz
authors.forename: Kristine K
authors.initials: KK
authors.lastname: Browning
authors.forename: Bo
authors.initials: B
authors.lastname: Lu
authors.forename: Susan L
authors.initials: SL
authors.lastname: Koletar
authors.forename: Nancy R
authors.initials: NR
authors.lastname: Reynolds
authors.forename: Mary Ellen
authors.initials: ME
authors.lastname: Wewers
mesh_terms: D000328:Adult; D001552:Benzazepines / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000627:therapeutic use; D011446:Prospective Studies; D011810:Quinoxalines / Q000627:therapeutic use*; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D011810:Quinoxalines; D009538:Nicotine; D000068580:Varenicline