Mental health related adverse events of cytisine and varenicline in smokers with and without mental health disorders: Secondary analysis of a randomized controlled trial

IF 3.7 2区医学 Q1 PSYCHOLOGY, CLINICAL Addictive behaviors Pub Date : 2024-08-29 DOI:10.1016/j.addbeh.2024.108148

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Abstract

Introduction

Little is known about the adverse events (AEs) of cytisine versus varenicline among individuals with mental health disorders (MHDs), highlighting the necessity for further exploration to inform clinical practice. This secondary analysis of clinical trial data aimed to investigate the effect of varenicline vs. cytisine regarding mental-health-related AEs (MH-related AEs) on smokers with and without MHDs.

Methods

Australian daily smokers interested in quitting were randomised to varenicline (84 days) or cytisine (25 days) and categorised by self-reported MHD diagnosis or treatment in the past year (MHD or non-MHD groups). Treatment adherence was assessed by self-reported number of doses taken during the active treatment phase via two check-in calls (at one month), while AEs were evaluated through four phone interviews: two check-in calls (one month) and follow-up calls at four and seven months. Logistic regression analysis compared MH-related AEs between groups, including only participants taking at least one dose.

Results

Of 1452 smokers 246 reported MHDs, 725 received cytisine and 727 received varenicline. Median number of doses taken was comparable between MHD (34 cytisine and 12 varenicline) and non-MHD (33 cytisine and 13 varenicline) groups. MH-related AEs were: 14.1 % (n = 30) in MHD (12.5 % in cytisine and 15.4 % in varenicline), and 11.8 % (n = 126) in non-MHD group (10.9 % in cytisine and 13.7 % in varenicline). No significant difference in MH-related AE occurrence was identified between medication groups (aOR=0.96, 95 % CI 0.4 to 2.2, p-value = 0.94).

Conclusion

Comparable MH-related AEs were observed between smokers with and without MHDs, suggesting that cytisine, like varenicline, may be well-tolerated by those with MHDs. However, larger clinical trials focused on MH-related AEs are needed for more conclusive evidence.

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有精神障碍和无精神障碍吸烟者服用胞二磷胆碱和伐尼克兰后出现的与精神健康相关的不良事件：随机对照试验的二次分析

导言：人们对胞二磷胆碱与伐尼克兰在精神疾病（MHD）患者中的不良事件（AEs）知之甚少，因此有必要进行进一步研究，为临床实践提供依据。方法将有意戒烟的澳大利亚日常吸烟者随机分配到伐伦克林（84天）或胞二磷胆碱（25天）治疗方案中，并根据其自我报告的过去一年中的MHD诊断或治疗情况进行分类（MHD组或非MHD组）。治疗依从性通过两次报到电话（一个月一次）对积极治疗阶段的自我报告服药次数进行评估，而不良反应则通过四次电话访谈进行评估：两次报到电话（一个月一次）以及四月和七个月的随访电话。逻辑回归分析比较了各组之间与 MH 相关的 AEs，其中只包括至少服用一次药物的参与者。MHD组（34例胞二辛和12例伐尼克兰）和非MHD组（33例胞二辛和13例伐尼克兰）的服药次数中位数相当。与精神健康相关的不良反应有MHD组为14.1%（n = 30）（胞二磷胆碱为12.5%，伐尼克兰为15.4%），非MHD组为11.8%（n = 126）（胞二磷胆碱为10.9%，伐尼克兰为13.7%）。结论在有和没有MHD的吸烟者中观察到了可比的MH相关AE，这表明胞二辛和伐伦克林一样，MHD患者也能很好地耐受。不过，要想获得更多确凿证据，还需要进行更大规模的临床试验，重点研究与MH相关的AEs。

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来源期刊

Addictive behaviors 医学-药物滥用

CiteScore

8.40

自引率

4.50%

发文量

283

审稿时长

46 days

期刊介绍： Addictive Behaviors is an international peer-reviewed journal publishing high quality human research on addictive behaviors and disorders since 1975. The journal accepts submissions of full-length papers and short communications on substance-related addictions such as the abuse of alcohol, drugs and nicotine, and behavioral addictions involving gambling and technology. We primarily publish behavioral and psychosocial research but our articles span the fields of psychology, sociology, psychiatry, epidemiology, social policy, medicine, pharmacology and neuroscience. While theoretical orientations are diverse, the emphasis of the journal is primarily empirical. That is, sound experimental design combined with valid, reliable assessment and evaluation procedures are a requisite for acceptance. However, innovative and empirically oriented case studies that might encourage new lines of inquiry are accepted as well. Studies that clearly contribute to current knowledge of etiology, prevention, social policy or treatment are given priority. Scholarly commentaries on topical issues, systematic reviews, and mini reviews are encouraged. We especially welcome multimedia papers that incorporate video or audio components to better display methodology or findings. Studies can also be submitted to Addictive Behaviors? companion title, the open access journal Addictive Behaviors Reports, which has a particular interest in ''non-traditional'', innovative and empirically-oriented research such as negative/null data papers, replication studies, case reports on novel treatments, and cross-cultural research.