title: Safety of varenicline tartrate and counseling versus counseling alone for smoking cessation: a randomized controlled trial for inpatients (STOP study).
abstract: BACKGROUND
  Inpatient medical settings offer an opportunistic environment for initiating smoking cessation interventions to patients reflecting on their health. Current evidence has shown the superior efficacy of varenicline tartrate (VT) for smoking cessation compared with other tobacco cessation therapies; however, recent evidence also has highlighted concerns about the safety and tolerability of VT. Given these apprehensions, we aimed to evaluate the safety and effectiveness of VT plus quitline-counseling compared to quitline-counseling alone in the inpatient medical setting.
  
  
  METHODS
  Adult patients (n = 392, 20-75 years) admitted with a smoking-related illnesses to 3 hospitals were randomized to receive either 12 weeks of varenicline tartrate (titrated from 0.5mg daily to 1mg twice daily) plus quitline-counseling (VT+C), (n = 196) or quitline-counseling alone (n = 196).
  
  
  RESULTS
  VT was well tolerated in the inpatient setting among subjects admitted with acute smoking-related illnesses (mean age 52.8±2.89 and 53.7±2.77 years in the VT+C and counseling alone groups, respectively). The most common self-reported adverse event during the 12-week treatment phase was nausea (16.3% in the VT+C group compared with 1.5% in the counseling alone group). Thirteen deaths occurred during the study period (n = 6 were in the VT+C arm compared with n = 7 in the counseling alone arm). All of these subjects had known comorbidities or developed underlying comorbidities.
  
  
  CONCLUSIONS
  VT appears to be a safe and well-tolerated opportunistic treatment for inpatient smokers who have related chronic disease. Based on the proven efficacy of varenicline from outpatient studies and our recent inpatient evidence, we suggest it be considered as part of standard care in the hospital setting.
authors.affiliation: Clinical Practice Unit, Basil Hetzel Research Institute, Adelaide, South Australia, Australia; Respiratory Medicine, Queen Elizabeth Hospital, Adelaide, South Australia, Australia; kristin.carson@health.sa.gov.au.
authors.forename: Kristin Veronica
authors.initials: KV
authors.lastname: Carson
authors.affiliation: Clinical Practice Unit, Basil Hetzel Research Institute, Adelaide, South Australia, Australia; Respiratory Medicine, Queen Elizabeth Hospital, Adelaide, South Australia, Australia;
authors.forename: Brian James
authors.initials: BJ
authors.lastname: Smith
authors.affiliation: Clinical Practice Unit, Basil Hetzel Research Institute, Adelaide, South Australia, Australia; Respiratory Medicine, Queen Elizabeth Hospital, Adelaide, South Australia, Australia;
authors.forename: Malcolm Philip
authors.initials: MP
authors.lastname: Brinn
authors.affiliation: Thoracic Medicine, Concord Repatriation General Hospital, Sydney, New South Wales, Australia;
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Peters
authors.affiliation: Division of Surgery, Queen Elizabeth Hospital, Adelaide, South Australia, Australia;
authors.forename: Robert
authors.initials: R
authors.lastname: Fitridge
authors.affiliation: Stroke Research Programme, University of Adelaide, Adelaide, South Australia, Australia;
authors.forename: Simon A
authors.initials: SA
authors.lastname: Koblar
authors.affiliation: Stroke Research Programme, University of Adelaide, Adelaide, South Australia, Australia; Stroke Unit, Queen Elizabeth Hospital, Adelaide, South Australia, Australia;
authors.forename: Jim
authors.initials: J
authors.lastname: Jannes
authors.affiliation: Cardiolgoy Department, Queen Elizabeth Hospital, Adelaide, South Australia, Australia;
authors.forename: Kuljit
authors.initials: K
authors.lastname: Singh
authors.affiliation: Clinical Practice Unit, Basil Hetzel Research Institute, Adelaide, South Australia, Australia; Respiratory Medicine, Queen Elizabeth Hospital, Adelaide, South Australia, Australia;
authors.forename: Antony J
authors.initials: AJ
authors.lastname: Veale
authors.affiliation: Pharmacy, Queen Elizabeth Hospital, Adelaide, South Australia, Australia;
authors.forename: Sharon
authors.initials: S
authors.lastname: Goldsworthy
authors.affiliation: Discipline of General Practice, Flinders University, Adelaide, South Australia, Australia;
authors.forename: John
authors.initials: J
authors.lastname: Litt
authors.affiliation: Cancer Council of South Australia, Adelaide, South Australia, Australia;
authors.forename: David
authors.initials: D
authors.lastname: Edwards
authors.affiliation: Respiratory Medicine, Queen Elizabeth Hospital, Adelaide, South Australia, Australia;
authors.forename: Khin Moe
authors.initials: KM
authors.lastname: Hnin
authors.affiliation: University of South Australia, Adelaide, South Australia, Australia.
authors.forename: Adrian Jeffrey
authors.initials: AJ
authors.lastname: Esterman
mesh_terms: D000328:Adult; D000368:Aged; D001552:Benzazepines / Q000008:administration & dosage* / Q000009:adverse effects; D003376:Counseling / Q000379:methods*; D005260:Female; D006261:Headache / Q000139:chemically induced; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D011810:Quinoxalines / Q000008:administration & dosage* / Q000009:adverse effects; D012907:Smoking / Q000523:psychology / Q000628:therapy*; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology; D016896:Treatment Outcome; D000068580:Varenicline; D055815:Young Adult
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline