Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial

Anthenelli, Robert M.; Gaffney, Michael; Benowitz, Neal L.; West, Robert; McRae, Thomas; Russ, Cristina; Lawrence, David; Aubin, Lisa St; Krishen, Alok; Evins, A. Eden

doi:10.1007/s11606-019-04858-2

Cited by 16 publications

(7 citation statements)

References 34 publications

(30 reference statements)

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“…Although the psychiatric 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. We also found that compared with smokers without mental health conditions, diagnostic subgroups of smokers with AD had higher baseline levels of state anxiety, histories of suicidal ideation/behavior, and were more likely to be white females—variables we have previously reported were independently associated with heightened NPSAE risk (Anthenelli et al, ). However, our data on the incidence of these events in subtypes of smokers with AD provides some reassurance that they occur relatively infrequently and are not related to any specific pharmacotherapy.…”

Section: Discussionsupporting

confidence: 71%

Efficacy and safety of pharmacotherapies for smoking cessation in anxiety disorders: Subgroup analysis of the randomized, active‐ and placebo‐controlled EAGLES trial

et al. 2019

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Background Smoking 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. Methods Post 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). Results NPSAE 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. Conclusion Individuals 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.

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Section: Discussionsupporting

confidence: 71%

Efficacy and safety of pharmacotherapies for smoking cessation in anxiety disorders: Subgroup analysis of the randomized, active‐ and placebo‐controlled EAGLES trial

et al. 2019

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“…Prior secondary analysis of the EAGLES trial data demonstrated main effects in sex and race. Females had greater rates of NPSAEs than males ( Anthenelli et al., 2019 ), and adults who identified as Black had lower rates of moderate-to-severe NPSAEs than adults who identified as White ( Nollen et al., 2021 ). Our results indicate that sex and race interact, and that this difference is driven by higher rates in non-White women.…”

Section: Discussionmentioning

confidence: 99%

Sex effects in predictors of smoking abstinence and neuropsychiatric adverse events in the EAGLES trial

McKee

Lawrence

Saccone

et al. 2023

Drug and Alcohol Dependence Reports

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“…Clinicians still tend to avoid prescribing these drugs during a mental health crisis when people may also have diminished capacity to provide consent. Arguably, given the evidence from the EAGLES trial supporting the safety and efficacy of varenicline and bupropion for those with mental illness, this approach could be reconsidered [ 65 , 66 ], and these treatments should certainly be offered more assertively to service users in the community.…”

Section: Discussionmentioning

confidence: 99%

There’s no smoke without fire: Smoking in smoke-free acute mental health wards

et al. 2021

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Background People who smoke with serious mental illness carry disproportionate costs from smoking, including poor health and premature death from tobacco-related illnesses. Hospitals in New Zealand are ostensibly smoke-free; however, some mental health wards have resisted implementing this policy. Aim This study explored smoking in acute metal health wards using data emerging from a large sociological study on modern acute psychiatric units. Methods Eighty-five in-depth, semi-structured interviews were conducted with staff and service users from four units. Data were analysed using a social constructionist problem representation approach. Results Although high-level smoke-free policies were mandatory, most participants disregarded these policies and smoking occurred in internal courtyards. Staff reasoned that acute admissions were not the time to quit smoking, citing the sceptres of distress and possibly violence; further, they found smoking challenging to combat. Inconsistent enforcement of smoke-free policies was common and problematic. Many service users also rejected smoke-free policies; they considered smoking facilitated social connections, alleviated boredom, and helped them feel calm in a distressing environment – some started or increased smoking following admission. A minority viewed smoking as a problem; a fire hazard, or pollutant. No one mentioned its health risks. Conclusion Psychiatric wards remain overlooked corners where hospital smoke-free policies are inconsistently applied or ignored. Well-meaning staff hold strong but anachronistic views about smoking. To neglect smoking cessation support for people with serious mental illness is discriminatory and perpetuates health and socioeconomic inequities. However, blanket applications of generic policy are unlikely to succeed. Solutions may include myth-busting education for service users and staff, local champions, and strong managerial support and leadership, with additional resourcing during transition phases. Smoke-free policies need consistent application with non-judgemental NRT and, potentially, other treatments. Smoking cessation would be supported by better designed facilities with more options for alleviating boredom, expressing autonomy, facilitating social connections, and reducing distress.

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Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial

Cited by 16 publications

References 34 publications

Efficacy and safety of pharmacotherapies for smoking cessation in anxiety disorders: Subgroup analysis of the randomized, active‐ and placebo‐controlled EAGLES trial

Efficacy and safety of pharmacotherapies for smoking cessation in anxiety disorders: Subgroup analysis of the randomized, active‐ and placebo‐controlled EAGLES trial

Sex effects in predictors of smoking abstinence and neuropsychiatric adverse events in the EAGLES trial

There’s no smoke without fire: Smoking in smoke-free acute mental health wards

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