Neuropsychiatric Safety and Efficacy of Varenicline, Bupropion, and Nicotine Patch in Smokers With Psychotic, Anxiety, and Mood Disorders in the EAGLES Trial
Neuropsychiatric Safety and Efficacy of Varenicline, Bupropion, and Nicotine Patch in Smokers With Psychotic, Anxiety, and Mood Disorders in the EAGLES Trial
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DOI：
10.1097/jcp.0000000000001015
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发表时间：
2019-03-01
影响因子：
2.9
通讯作者：
Anthenelli, Robert M.
中科院分区：
文献类型：
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作者：
Evins, A. Eden;Benowitz, Neal L.;Anthenelli, Robert M.
背景：对精神障碍患者使用varenicline、安非他酮和尼古丁贴片(NRT)的神经精神病学安全性和相对有效性感兴趣。方法：我们对EAGLES(在全球戒烟研究中评估不良事件)的精神病学诊断的安全性和有效性结果进行了二次分析，这是一项为期12周的、随机、双盲、三模拟、安慰剂和活性(NRT)对照试验，在4092名有原发精神病(n=390)、焦虑症(n=792)或情绪障碍(n=2910)的亚组人群中进行了12周的随访。主要终点参数是预先指定的中、重度神经精神不良事件(NPSAE)的发生率和9-12周的持续戒断率(9-12CAR)。结果：在所有治疗中，精神障碍患者的NPSAE发生率为5.1%至6.3%，焦虑障碍患者为4.6%至8.0%，情绪障碍患者为4.6%至6.8%。在精神病学队列或任何精神病学诊断亚队列中，与NRT或安慰剂相比，Varenicline和安非他酮都没有显著增加NPSAE的作用。治疗对9-12CAR有显著影响(P<；0.0001)，诊断亚队列交互作用不显著(P=0.24)。使用varenicline的戒断率优于安非他酮、NRT和安慰剂，而使用安非他酮和NRT的戒断率优于安慰剂。在治疗效果的诊断亚队列内比较中，所有诊断组的9-12CAR与安慰剂的优势比估计值分别为：varenicline>3.00，安非他酮>1.90，NRT>1.80。结论：varenicline、安非他酮和尼古丁贴片对患有精神病、焦虑和情绪障碍的成人患者具有良好的耐受性和有效性。与安慰剂相比，varenicline、安非他酮和NRT的相对有效性在不同的精神病学诊断中没有差异。
Background: Neuropsychiatric safety and relative efficacy of varenicline, bupropion, and transdermal nicotine patch (NRT) in those with psychiatric disorders are of interest.Methods: We performed secondary analyses of safety and efficacy outcomes by psychiatric diagnosis in EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), a 12-week, randomized, double-blind, triple-dummy, placebo-and active (NRT)-controlled trial of varenicline and bupropion with 12-week follow-up, in a subset population, n = 4092, with a primary psychotic (n = 390), anxiety (n = 792), or mood (n = 2910) disorder. Primary end-point parameters were incidence of prespecified moderate and severe neuropsychiatric adverse events (NPSAEs) and weeks 9 to 12 continuous abstinence rates (9-12CAR).Results: The observed NPSAE incidence across treatments was 5.1% to 6.3% in thosewith a psychotic disorder, 4.6% to 8.0% in thosewith an anxiety disorder, and 4.6% to 6.8% in those with a mood disorder. Neither varenicline nor bupropion was associated with significantly increased NPSAEs relative toNRTor placebo in the psychiatric cohort or any psychiatric diagnostic subcohort. There was a significant effect of treatment on 9-12CAR (P < 0.0001) and no significant treatment-by-diagnostic subcohort interaction (P = 0.24). Abstinence rates with varenicline were superior to bupropion, NRT, and placebo, and abstinence with bupropion and NRT was superior to placebo. Within-diagnostic subcohort comparisons of treatment efficacy yielded estimated odds ratios for 9-12CAR versus placebo of greater than 3.00 for varenicline, greater than 1.90 for bupropion, and greater than 1.80 for NRT for all diagnostic groups.Conclusions: Varenicline, bupropion, and nicotine patch are well tolerated and effective in adults with psychotic, anxiety, and mood disorders. The relative effectiveness of varenicline, bupropion, and NRT versus placebo did not vary across psychiatric diagnoses.