Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
Centre for Epidemiology and Community Medicine, Stockholm County Council, Stockholm, Sweden.
Nicotine Tob Res. 2018 Apr 2;20(5):606-613. doi: 10.1093/ntr/ntx131.
Bupropion and varenicline are non-nicotine medications used for smoking cessation that mitigate craving and withdrawal symptoms. We aim to investigate whether these drugs increase the risk of selected acute adverse outcomes when used in medical practice.
Population-based case-crossover design using data from Swedish health and administrative registers. Adult individuals diagnosed with acute myocardial infarction, stroke, suicide, suicide attempt, fall injury, or that suffered a road traffic crash from 01.10.2006 for bupropion, or from 01.03.2008 for varenicline, until 31.12.2013 were included. Different lengths of exposure periods were analyzed within the 12-week hazard period prior to the adverse outcome (1-14, 15-28, and 29-84 days). The control period was matched using the interval preceding the hazard period (85-168 days), and breaking it up into equivalent periods (85-98, 99-112, and 113-168 days). Conditional logistic regression with each case considered as one stratum was used to estimate adjusted odds ratios (OR) and confidence intervals (CI).
Neither medication was associated with consistent higher risks for any of the adverse outcomes. For bupropion and varenicline, respectively, in the 1-14 days hazard period, OR (95% CI) were: myocardial infarction 1.14 (0.55 to 2.34) and 1.06 (0.70 to 1.62); stroke 1.16 (0.39 to 3.47) and 1.26 (0.72 to 2.17), and traffic crashes 0.85 (0.39 to 1.85) and 1.48 (0.90 to 2.41). In the other periods, ORs were similar or even lower. For falls and suicidal events ORs were generally below one for both drugs.
The available evidence suggests that if prescription guidelines are properly followed regarding potential contraindications both of these medications could be considered relatively safe.
The reliable exposure and diagnosis assessment used in this nationwide register-based study, along with the number of cases gathered makes this sample one of the largest of its type to assess potential side effects associated with the use of these drugs. Neither medication was associated with consistent higher risks for any of the adverse outcomes studied.
安非他酮和伐尼克兰是非尼古丁类戒烟药物，可减轻烟瘾和戒断症状。我们旨在研究这些药物在医学实践中使用时是否会增加某些急性不良结局的风险。
使用瑞典健康和行政登记处的数据，采用基于人群的病例交叉设计。纳入 2006 年 10 月 1 日起用于安非他酮，或 2008 年 3 月 1 日起用于伐尼克兰的个体，直至 2013 年 12 月 31 日，诊断为急性心肌梗死、卒中等的患者；或自杀、自杀未遂、跌倒伤，或道路交通碰撞。在不良结局发生前 12 周的危险期内（1-14、15-28 和 29-84 天）分析不同的暴露期。使用危险期前的间隔（85-168 天）作为对照期，并将其分成相等的时期（85-98、99-112 和 113-168 天）。每个病例视为一个分层，采用条件逻辑回归估计调整后的比值比（OR）和置信区间（CI）。
两种药物均与任何不良结局的风险增加无关。在 1-14 天的危险期内，安非他酮和伐尼克兰的 OR（95%CI）分别为：心肌梗死 1.14（0.55 至 2.34）和 1.06（0.70 至 1.62）；卒中 1.16（0.39 至 3.47）和 1.26（0.72 至 2.17），以及道路交通碰撞 0.85（0.39 至 1.85）和 1.48（0.90 至 2.41）。在其他时期，OR 相似甚至更低。对于跌倒和自杀事件，两种药物的 OR 通常均低于 1。
有证据表明，如果遵循有关潜在禁忌症的适当处方指南，这两种药物均可被视为相对安全。
本研究使用全国性基于登记的可靠暴露和诊断评估，以及收集的病例数量，使本样本成为评估这些药物使用相关潜在副作用的最大样本之一。两种药物均与任何研究不良结局的风险增加无关。
