Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation (STOP study): A randomized controlled clinical trial

• Published in: PloS one Vol. 15; no. 4; p. e0231095
• Main Authors: Carson-Chahhoud, Kristin V, Smith, Brian J, Peters, Matthew J, Brinn, Malcolm P, Ameer, Faisal, Singh, Kuljit, Fitridge, Robert, Koblar, Simon A, Jannes, Jim, Veale, Antony J, Goldsworthy, Sharon, Hnin, Khin, Esterman, Adrian J
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 29-04-2020; Public Library of Science (PLoS)
• Subjects: Acute coronary syndromes; Adult; Aged; Biology and Life Sciences; Cardiology; Cigarette smoking; Clinical trials; Comparative analysis; Counseling; Data collection; Diseases; Drug addiction; Drug therapy; Ethics; Female; Health counseling; Health sciences; Hospital patients; Hospitals; Humans; Illnesses; Inpatients; Male; Medical research; Medicine; Medicine and Health Sciences; Middle Aged; Nicotiana - adverse effects; Nicotine; Nicotinic Agonists - administration & dosage; Outpatients; Patients; Physical Sciences; Randomization; Research and Analysis Methods; Setting (Literature); Smoking; Smoking - drug therapy; Smoking - epidemiology; Smoking - psychology; Smoking cessation; Smoking Cessation - methods; Social Sciences; Stroke; Substance abuse treatment; Tobacco; Tobacco Smoking - drug therapy; Tobacco Smoking - epidemiology; Tobacco Smoking - psychology; Treatment Outcome; Varenicline; Varenicline - administration & dosage; Queensland Australia; Australia; South Australia Australia
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0231095

Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting. We aimed to evaluate the long-term (104 week) efficacy following a standard course of inpatient-initiated varenicline tartrate plus Quitline-counselling compared to Quitline-counselling alone.
Adult patients (n = 392, 20-75 years) admitted with a smoking-related illnesses to one of three hospitals, were randomised to receive either 12-weeks of varenicline tartrate (titrated from 0.5mg daily to 1mg twice-daily) plus Quitline-counselling, (n = 196) or Quitline-counselling alone, (n = 196), with continuous abstinence from smoking assessed at 104 weeks.
A total of 1959 potential participants were screened for eligibility between August 2008 and December 2011. The proportion of participants who remained continuously abstinent (intention-to-treat) at 104 weeks were significantly greater in the varenicline tartrate plus counselling arm (29.2% n = 56) compared to counselling alone (18.8% n = 36; p = 0.02; odds ratio 1.78; 95%CI 1.10 to 2.86, p = 0.02). Twenty-two deaths occurred during the 104 week study (n = 10 for varenicline tartrate plus counselling and n = 12 for Quitline-counselling alone). All of these participants had known or developed underlying co-morbidities.
This is the first study to examine the efficacy and safety of varenicline tartrate over 104 weeks within any setting. Varenicline tartrate plus Quitline-counselling was found to be an effective opportunistic treatment when initiated for inpatient smokers who had been admitted with tobacco-related disease.