Varenicline alone/in combination with nicotine lozenges for smoking cessation.

Abstract

Introduction/Aim: Smoking cessation support offered within hospitals remain limited and interventions are ad hoc. Newer strategies are essential to facilitate long-term abstinence. The effectiveness of combination of varenicline and acute release forms of nicotine replacement therapy (NRT) is unknown. To determine if hospitalised smokers treated with varenicline and NRT lozenges achieved prolonged smoking abstinence compared to those treated with varenicline and placebo lozenges. Method(s): A double blind, placebo controlled, randomised controlled trial was conducted in five 'smoke free' Australian public hospitals. Participants were adult in-patients with a history of smoking >=10 cigarettes/day and interested in quitting. Participants were randomised to intervention or control group and followed up for 12 months. Varenicline was used at the standard dose in both groups; NRT or placebo lozenges to be used when there was an urge to smoke (maximum 15 lozenges/day). Additional 12-weeks treatment was available on request for those who met the standard criteria. Behavioural support through Quitline was available to both groups. Outcomes included biochemically-verified prolonged abstinence, self-reported abstinence and adverse events (AEs). Intention to treat and per protocol analysis were performed. Result(s): Participants (n = 320) had a mean [SD] age of 52.5[12.1] years; 57.2% were male. At 12 months, self-reported prolonged abstinence (47 [29.9] vs 30 [19.1]; p = 0.029 - Odds Ratio [OR]= 1.79; 95% confidence interval [CI] 1.06 - 3.03) and self-reported 7-day point prevalence abstinence (48 [30.6] vs 31 [19.7]; p = 0.030; 1.77 [1.06 - 2.98]) favoured combination therapy. Groups were similar in terms of biochemically validated prolonged abstinence (8.3% vs 3.8%; p = 0.101) and AEs experienced (nausea, abnormal dreams, trouble sleeping and headaches) (74.5% vs 68.3%; p = 0.266). Conclusion(s): The combination of varenicline and NRT lozenge was well tolerated and improved self-reported abstinence rates. Varenicline may be used in combination with an acute release oral dose form of NRT for better cessation outcomes, without compromising its safety.