Estimation of risk of neuropsychiatric adverse events from varenicline, bupropion and nicotine patch versus placebo: secondary analysis of results from the EAGLES trial using Bayes factors.
Estimation of risk of neuropsychiatric adverse events from varenicline, bupropion and nicotine patch versus placebo: secondary analysis of results from the EAGLES trial using Bayes factors.
复制标题
DOI：
10.1111/add.15440
复制
发表时间：
2021-10
期刊：
影响因子：
--
通讯作者：
West R
中科院分区：
文献类型：
--
作者：
Beard E;Jackson SE;Anthenelli RM;Benowitz NL;Aubin LS;McRae T;Lawrence D;Russ C;Krishen A;Evins AE;West R
使用阿尔法设置为0.05的经典频率假设检验进行分析，全球戒烟研究中的不良事件评估(EAGLES)没有发现足够的证据来拒绝可归因于varenicline、安非他酮或尼古丁贴片的神经精神不良事件(NPSAE)与安慰剂相比没有差异的假设。这可能是因为零假设是正确的，也可能是因为数据不敏感。本研究旨在更直接地利用贝叶斯因子对假设进行检验。EAGLES是一项随机、双盲、三模拟、对照试验。全球(五大洲16个国家)，2011年11月至2015年1月。参与者是有精神障碍的吸烟者(n=4116)和没有精神障碍的吸烟者(n=4028)。Varenicline(每天两次，每次1毫克)，安非他酮(每天两次，每次150毫克)，尼古丁贴片(每天一次，每次21毫克，每次递减)和匹配的安慰剂。结果包括：(I)中度/重度不良不良事件的综合衡量；(Ii)严重不良不良后果的综合衡量。使用贝叶斯因子和相应的稳健性区域，在全样本和子样本中计算了药物的NPSAE与数据不敏感度没有差异的相对证据。除两项比较外，所有比较的贝叶斯系数为1/3，这表明有中等到强有力的证据表明，活性药物和安慰剂之间的不良反应风险没有差异(贝叶斯系数=0.02-0.23)。在精神病组和安慰剂组中，数据是提示性的，但并不是决定性的，表明使用varenicline(贝叶斯系数=0.52)和安非他酮(贝叶斯系数=60.71)的NPSAE没有增加。在这里，稳健区排除了使用varenicline和安非他酮分别使≥增加7%和≥增加8%的风险。使用贝叶斯因素对全球戒烟研究试验中评估不良事件的第二次分析提供了中等到强有力的证据，表明在没有精神障碍病史的吸烟者中，使用varenicline、安非他酮或尼古丁贴片戒烟不会增加与使用安慰剂相比的神经精神不良事件的风险。对于有精神障碍病史的吸烟者来说，证据也表明风险没有增加，但信心更差。
Analysed using classical frequentist hypothesis testing with alpha set to 0.05, the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) did not find enough evidence to reject the hypothesis of no difference in neuropsychiatric adverse events (NPSAEs) attributable to varenicline, bupropion, or nicotine patch compared with placebo. This might be because the null hypothesis was true or because the data were insensitive. The present study aimed to test the hypothesis more directly using Bayes factors. EAGLES was a randomised, double‐blind, triple‐dummy, controlled trial. Global (16 countries across five continents), between November 2011 and January 2015. Participants were smokers with (n = 4116) and without (n = 4028) psychiatric disorders. Varenicline (1 mg twice daily), bupropion (150 mg twice daily), nicotine patch (21 mg once daily with taper) and matched placebos. The outcomes included: (i) a composite measure of moderate/severe NPSAEs; and (ii) a composite measure of severe NPSAEs. The relative evidence for there being no difference in NPSAEs versus data insensitivity for the medications was calculated in the full and sub‐samples using Bayes factors and corresponding robustness regions. For all but two comparisons, Bayes factors were <1/3, indicating moderate to strong evidence for no difference in risk of NPSAEs between active medications and placebo (Bayes factor = 0.02–0.23). In the psychiatric cohort versus placebo, the data were suggestive, but not conclusive of no increase in NPSAEs with varenicline (Bayes factor = 0.52) and bupropion (Bayes factor = 0.71). Here, the robustness regions ruled out a ≥7% and ≥8% risk increase with varenicline and bupropion, respectively. Secondary analysis of the Evaluating Adverse Events in a Global Smoking Cessation Study trial using Bayes factors provides moderate to strong evidence that use of varenicline, bupropion or nicotine patches for smoking cessation does not increase the risk of neuropsychiatric adverse events relative to use of placebo in smokers without a history of psychiatric disorder. For smokers with a history of psychiatric disorder the evidence also points to no increased risk but with less confidence.
登录
查看更多内容
影响因子：
1.4
作者：
Cahill, Kate;Stead, Lindsay F.;Polonio, Igor Bastos
通讯作者：
Polonio, Igor Bastos
使用贝叶斯来最大程度地利用不重要的结果。
影响因子：
3.8
作者：
Dienes Z
通讯作者：
Dienes Z
DOI：
10.1176/appi.ajp.2011.10111704
发表时间：
2011-12
期刊：
The American journal of psychiatry
影响因子：
--
作者：
Posner K;Brown GK;Stanley B;Brent DA;Yershova KV;Oquendo MA;Currier GW;Melvin GA;Greenhill L;Shen S;Mann JJ
通讯作者：
Mann JJ
DOI：
10.1136/bmj.h1109
发表时间：
2015-03-12
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Thomas KH;Martin RM;Knipe DW;Higgins JP;Gunnell D
通讯作者：
Gunnell D
影响因子：
17.7
作者：
Gibbons, Robert D.;Mann, J. John
通讯作者：
Mann, J. John