Risk of neuropsychiatric and cardiovascular adverse events following treatment with varenicline and nicotine replacement therapy in the UK Clinical Practice Research Datalink: a case-cross-over study.
Risk of neuropsychiatric and cardiovascular adverse events following treatment with varenicline and nicotine replacement therapy in the UK Clinical Practice Research Datalink: a case-cross-over study.
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DOI：
10.1111/add.15338
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发表时间：
2021-06
期刊：
影响因子：
--
通讯作者：
Douglas I
中科院分区：
文献类型：
--
作者：
Thomas KH;Davies NM;Taylor AE;Taylor GMJ;Gunnell D;Martin RM;Douglas I
伐尼克兰和尼古丁替代疗法（NRT）是最常用的戒烟药物。鉴于其广泛使用，监测不利风险仍然很重要。本研究旨在评估在英国常规护理中使用伐尼克兰和NRT相关的神经精神和心血管风险。病例交叉研究2006年至2015年临床实践研究数据链中的英国电子初级保健记录与医院和死亡率数据集相关联。在暴露和未暴露于伐尼克兰或NRT期间观察到的成年吸烟者（n = 282，429）。主要结局包括自杀、自残、心肌梗死（MI）、全因死亡和特定原因死亡[MI、慢性阻塞性肺疾病（COPD）]。在主要分析中，使用条件logistic回归比较风险期（事件发生前90天）内伐尼克兰或NRT暴露的机会与早期单个参考期（事件发生前91-180天）或多个90天参考期内暴露的机会，以增加统计学把握度。在主要分析中，使用单个参考期，伐尼克兰与主要结局之间的相关性结果不确定，而NRT与MI相关[比值比（OR）= 1.40，95%置信区间（CI）= 1.18-1.67]。使用多个参考期，伐尼克兰与自残（OR = 1.32，95% CI = 1.12-1.56）和自杀（OR = 3.56，95% CI = 1.32-9.60）风险增加相关，但与全因死亡（OR = 0.75，95% CI = 0.61-0.93）减少相关。NRT与MI相关（OR = 1.54，95% CI = 1.36-1.74），自我伤害（OR = 1.30，95% CI = 1.18-1.44）和MI死亡当使用多个参考期时，COPD（OR = 1.53，95%CI = 1.11-2.10）、COPD（OR = 1.33，95%CI = 1.14-1.56）和全因（OR = 1.28，95%CI = 1.18-1.40）。（1）尼古丁替代治疗（NRT）与心肌梗死、死亡和自残风险之间似乎存在正相关性，（2）伐尼克兰与自残和自杀风险增加之间存在正相关性，伐尼克兰与全因死亡之间存在负相关性。这些关联可能不是因果关系。它们可能反映戒烟时的健康变化（尼古丁替代疗法是为心脏病患者开的处方）或与戒烟尝试有关（暴露于两种药物均与自我伤害有关）。
Varenicline and nicotine replacement therapy (NRT) are the most commonly used medications to quit smoking. Given their widespread use, monitoring adverse risks remains important. This study aimed to estimate the neuropsychiatric and cardiovascular risks associated with varenicline and NRT as used in routine UK care. Case–cross‐over study. UK‐based electronic primary care records in the Clinical Practice Research Datalink from 2006 to 2015 linked to hospital and mortality data sets. Adult smokers (n =282,429) observed during periods when exposed and not exposed to either varenicline or NRT. Main outcomes included suicide, self‐harm, myocardial infarction (MI), all‐cause death and cause‐specific death [MI, chronic obstructive pulmonary disease (COPD)]. In primary analyses, conditional logistic regression was used to compare the chance of varenicline or NRT exposure during the risk period (90 days prior to the event) with the chance of exposure during an earlier single reference period (91–180 days prior to the event) or multiple 90‐day reference periods to increase statistical power. In the primary analyses, findings were inconclusive for the associations between varenicline and the main outcomes using a single reference period, while NRT was associated with MI [odds ratio (OR) = 1.40, 95% confidence interval (CI) = 1.18–1.67]. Using multiple reference periods, varenicline was associated with an increased risk of self‐harm (OR = 1.32, 95% CI = 1.12–1.56) and suicide (OR = 3.56, 95% CI = 1.32–9.60) but a reduction in all‐cause death (OR = 0.75, 95% CI = 0.61–0.93). NRT was associated with MI (OR = 1.54, 95% CI = 1.36–1.74), self‐harm (OR = 1.30, 95% CI = 1.18–1.44) and deaths from MI (OR = 1.53, 95% CI = 1.11–2.10), COPD (OR = 1.33, 95% CI = 1.14–1.56) and all causes (OR = 1.28, 95% CI = 1.18–1.40) when using multiple reference periods. There appear to be positive associations between (1) nicotine replacement therapy (NRT) and myocardial infarction, death and risk of self‐harm and (2) varenicline and increased risk of self‐harm and suicide, as well as a negative association between varenicline and all‐cause death. The associations may not be causal. They may reflect health changes at the time of smoking cessation (nicotine replacement therapy is prescribed for people with cardiac problems) or be associated with quit attempts (exposure to both medicines was associated with self‐harm).
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影响因子：
5.2
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