Abstract
BackgroundSmoking rates are high in adults with anxiety disorders (ADs), yet little is known about the safety and efficacy of smoking‐cessation pharmacotherapies in this group.MethodsPost hoc analyses in 712 smokers with AD (posttraumatic stress disorder [PTSD], n = 192; generalized anxiety disorder [GAD], n = 243; panic disorder [PD], n = 277) and in a nonpsychiatric cohort (NPC; n = 4,028). Participants were randomly assigned to varenicline, bupropion, nicotine‐replacement therapy (NRT), or placebo plus weekly smoking‐cessation counseling for 12 weeks, with 12 weeks follow‐up. General linear models were used to test the effects of treatment group, cohort, and their interaction on neuropsychiatric adverse events (NPSAEs), and continuous abstinence weeks 9–12 (treatment) and 9–24 (follow‐up).ResultsNPSAE incidence for PTSD (6.9%), GAD (5.4%), and PD (6.2%) was higher versus NPC (2.1%), regardless of treatment. Across all treatments, smokers with PTSD (odds ratio [OR] = 0.58), GAD (OR = 0.72), and PD (OR = 0.53) had lower continuous abstinence rates weeks 9–12 (CAR9–12) versus NPC. Varenicline demonstrated superior efficacy to placebo in smokers with GAD and PD, respectively (OR = 4.53; 95% confidence interval [CI] = 1.20–17.10; and OR = 8.49; 95% CI = 1.57–45.78); NRT was superior to placebo in smokers with PD (OR = 7.42; 95% CI = 1.37–40.35). While there was no statistically significant effect of any treatment on CAR9–12 for smokers with PTSD, varenicline improved 7‐day point prevalence abstinence at end of treatment in this subcohort.ConclusionIndividuals with ADs were more likely than those without psychiatric illness to experience moderate to severe NPSAEs during smoking‐cessation attempts, regardless of treatment. While the study was not powered to evaluate abstinence outcomes with these subgroups of smokers with ADs, varenicline provided significant benefit for cessation in those with GAD and PD, while NRT provided significant benefit for those with PD.
Highlights
Individuals with anxiety disorders (ADs) smoke tobacco at rates 2–3 fold higher than those without mental health conditions (Cougle, Zvolensky, Fitch, & Sachs‐Ericsson, 2010; Lasser et al, 2000; McCabe et al, 2004)
Our results from the largest, prospective, placebo‐controlled randomized controlled trials (RCTs) of smoking cessation medications in smokers with AD provide evidence that varenicline, bupropion, and nicotine‐replacement therapy (NRT) are generally well tolerated in smokers with PTSD, generalized anxiety disorder (GAD), and panic disorder (PD), and that varenicline and NRT aid quitting in these diagnostic subgroups, albeit at rates lower than in smokers without mental health conditions
The psychiatric neuropsychiatric adverse event (NPSAE) events that comprised the primary safety outcome had to be severe enough to interfere significantly with functioning, it is possible that hyperarousal to symptoms in smokers with AD contributed to a greater occurrence of NPSAEs
Summary
Individuals with anxiety disorders (ADs) smoke tobacco at rates 2–3 fold higher than those without mental health conditions (Cougle, Zvolensky, Fitch, & Sachs‐Ericsson, 2010; Lasser et al, 2000; McCabe et al, 2004). With approximately 20% (n = 787) of the EAGLES psychiatric cohort having a primary AD diagnosis, it is the largest sample of smokers with AD ever enrolled in a placebo‐ and active‐controlled RCT for smoking cessation treatments, and the first to compare all three first‐line smoking cessation aids head‐to‐head in such smokers In this planned secondary analysis we compare the safety and efficacy of varenicline, bupropion, NRT, and placebo across AD subcohorts (PTSD, GAD, and PD), and compare clinical characteristics and rates of clinically significant neuropsychiatric adverse events (NPSAEs) and cessation in smokers with AD versus a cohort of smokers without psychiatric disorders
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