Superiority of a course of varenicline tartrate plus counselling over counselling alone for smoking cessation: a 24-month randomised controlled trial for inpatients

Introduction/aim: Current evidence suggests superior efficacy of varenicline tartrate for smoking cessation over that of other tobacco cessation therapies, however all of these publications are presented in the outpatient setting and are sponsored by Pfizer, the manufacturer of the medication. Several recent publications have also highlighted concerns around safety and tolerability, particularly amongst smokers with co-morbidities. Given these apprehensions, we aimed to evaluate the efficacy, safety and tolerability of varenicline tartrate plus Quitline-counselling compared to Quitline-counselling alone in the inpatient setting.

Methods: All adult patients (20–75 years) admitted with an acute smoking-related illness to one of three South Australian hospitals were screened for eligibility. Subjects were randomised to receive either 12-weeks of varenicline tartrate (titrated from 0.5 mg daily to 1 mg twice-daily) plus Quitline-counselling (VT + C), (n = 196) or Quitline-counselling alone, (n = 196).

Results: A total of 1959 potential subjects were screened for eligibility between August 2008 and December 2011. For the primary analysis population (intention-to-treat), the proportion of subjects who remained continuously abstinent at 12-months were significantly greater in the VT + C arm (31.1%, n = 61) compared to counselling alone (21.4%, n = 42; RR 1.45, 95%CI 1.03 to 2.03, p = 0.03). Significance was maintained at 24-months follow-up (VT + C, 29% n = 56 compared to counselling alone, 18% n = 36; p = 0.02). The most common self-reported adverse event during the 12-week treatment phase was nausea with 16.3% in the VT + C group compared with 1.5% in the counselling alone group. Thirteen deaths occurred during the treatment period (n = 6 for VT + C and n = 7 for counselling alone). All of these subjects had known or developed underlying co-morbidities.

Conclusion: This is the first study to examine the efficacy and safety of varenicline tartrate over 24-months within any setting. VT + C appears to be an effective, safe and well tolerated opportunistic treatment for inpatient smokers with tobacco-related chronic disease.