Department of Psychiatry and Center for Tobacco Control Research and Education, University of California, San Francisco, CA 94143-0984, USA.
BMJ. 2012 May 4;344:e2856. doi: 10.1136/bmj.e2856.
To examine the risk of treatment emergent, cardiovascular serious adverse events associated with varenicline use for tobacco cessation.
Meta-analysis comparing study effects using four summary estimates.
Medline, Cochrane Library, online clinical trials registries, and reference lists of identified articles.
We included randomised controlled trials of current tobacco users of adult age comparing use of varenicline with an inactive control and reporting adverse events. We defined treatment emergent, cardiovascular serious adverse events as occurring during drug treatment or within 30 days of discontinuation, and included any ischaemic or arrhythmic adverse cardiovascular event (myocardial infarction, unstable angina, coronary revascularisation, coronary artery disease, arrhythmias, transient ischaemic attacks, stroke, sudden death or cardiovascular related death, or congestive heart failure).
We identified 22 trials; all were double blinded and placebo controlled; two included participants with active cardiovascular disease and 11 enrolled participants with a history of cardiovascular disease. Rates of treatment emergent, cardiovascular serious adverse events were 0.63% (34/5431) in the varenicline groups and 0.47% (18/3801) in the placebo groups. The summary estimate for the risk difference, 0.27% (95% confidence interval -0.10 to 0.63; P = 0.15), based on all 22 trials, was neither clinically nor statistically significant. For comparison, the relative risk (1.40, 0.82 to 2.39; P = 0.22), Mantel-Haenszel odds ratio (1.41, 0.82 to 2.42; P = 0.22), and Peto odds ratio (1.58, 0.90 to 2.76; P = 0.11), all based on 14 trials with at least one event, also indicated a non-significant difference between varenicline and placebo groups.
This meta--analysis--which included all trials published to date, focused on events occurring during drug exposure, and analysed findings using four summary estimates-found no significant increase in cardiovascular serious adverse events associated with varenicline use. For rare outcomes, summary estimates based on absolute effects are recommended and estimates based on the Peto odds ratio should be avoided.
研究使用伐伦克林戒烟时与治疗相关的心血管严重不良事件的风险。
使用四项综合评估比较研究效果的荟萃分析。
Medline、Cochrane 图书馆、在线临床试验注册处和已确定文章的参考文献列表。
我们纳入了比较当前成年烟草使用者使用伐伦克林与非活性对照药物并报告不良事件的随机对照试验。我们将治疗相关的心血管严重不良事件定义为在药物治疗期间或停药后 30 天内发生的任何缺血性或心律失常性不良心血管事件（心肌梗死、不稳定型心绞痛、冠状动脉血运重建、冠状动脉疾病、心律失常、短暂性脑缺血发作、中风、猝死或心血管相关死亡或充血性心力衰竭）。
我们确定了 22 项试验；所有试验均为双盲、安慰剂对照；两项试验纳入了有活动性心血管疾病的参与者，11 项试验纳入了有心血管疾病史的参与者。伐伦克林组治疗相关的心血管严重不良事件发生率为 0.63%（34/5431），安慰剂组为 0.47%（18/3801）。基于所有 22 项试验的风险差异综合估计值为 0.27%（95%置信区间 -0.10 至 0.63；P = 0.15），既无临床意义也无统计学意义。相比之下，相对风险（1.40，0.82 至 2.39；P = 0.22）、Mantel-Haenszel 优势比（1.41，0.82 至 2.42；P = 0.22）和 Peto 优势比（1.58，0.90 至 2.76；P = 0.11），均基于至少有 1 项事件的 14 项试验，也表明伐伦克林与安慰剂组之间无显著差异。
这项荟萃分析——包括迄今为止发表的所有试验，重点关注药物暴露期间发生的事件，并使用四项综合评估来分析结果——未发现使用伐伦克林与心血管严重不良事件相关的显著增加。对于罕见结局，建议使用基于绝对效应的综合估计值，避免使用基于 Peto 优势比的综合估计值。
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