What are the effects of varenicline compared with nicotine replacement therapy on long-term smoking cessation and clinically important outcomes? Protocol for a prospective cohort study.
What are the effects of varenicline compared with nicotine replacement therapy on long-term smoking cessation and clinically important outcomes? Protocol for a prospective cohort study.
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DOI：
10.1136/bmjopen-2015-009665
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发表时间：
2015-11-05
期刊：
影响因子：
2.9
通讯作者：
Munafò MR
中科院分区：
文献类型：
--
作者：
Davies NM;Taylor G;Taylor AE;Thomas KH;Windmeijer F;Martin RM;Munafò MR
吸烟是导致健康不佳和过早死亡的一个可避免的主要原因。帮助患者成功戒烟的治疗对健康和预期寿命具有重要影响。伐尼克兰是一种可以帮助吸烟者成功戒烟的药物。然而，有人担心它可能会造成不良影响，例如抑郁症、自残和自杀以及心血管疾病的发生率增加。在这项研究中，我们旨在研究伐尼克兰与其他戒烟药物疗法相比对戒烟、卫生服务使用、全因和特定原因死亡率以及身心健康状况的影响。在这个项目中，我们将研究伐尼克兰与尼古丁替代疗法相比对以下方面的影响：（1）长期戒烟以及这些影响是否因区域水平剥夺而异； (2) 以下临床重要结果：全科医疗率和住院率；全因死亡率和呼吸系统疾病和心血管疾病导致的死亡；以及呼吸道疾病、心肌梗塞或抑郁和焦虑的初级保健诊断。该研究基于临床实践研究数据链 (CPRD) 中的一组服用戒烟药物的患者。我们将使用三种方法来克服混杂因素：多变量调整Cox回归、倾向得分匹配Cox回归和工具变量回归。预计用于分析的总样本量将至少为 180 000。后续行动将以“事件”或由于登记结束或死亡而进行审查（以最早者为准）结束。本研究不需要伦理批准。该项目已获得CPRD 独立科学咨询委员会(ISAC) 的批准。我们将通过国际同行评审期刊上的出版物和国际会议上的演讲来传播我们的研究结果。
Smoking is a major avoidable cause of ill-health and premature death. Treatments that help patients successfully quit smoking have an important effect on health and life expectancy. Varenicline is a medication that can help smokers successfully quit smoking. However, there are concerns that it may cause adverse effects, such as increase in the occurrence of depression, self-harm and suicide and cardiovascular disease. In this study we aim to examine the effects of varenicline versus other smoking cessation pharmacotherapies on smoking cessation, health service use, all-cause and cause-specific mortality and physical and mental health conditions. In this project we will investigate the effects of varenicline compared to nicotine replacement therapies on: (1) long-term smoking cessation and whether these effects differ by area level deprivation; and (2) the following clinically-important outcomes: rate of general practice and hospital attendance; all-cause mortality and death due to diseases of the respiratory system and cardiovascular disease; and a primary care diagnosis of respiratory illness, myocardial infarction or depression and anxiety. The study is based on a cohort of patients prescribed these smoking cessation medications from the Clinical Practice Research Datalink (CPRD). We will use three methods to overcome confounding: multivariable adjusted Cox regression, propensity score matched Cox regression, and instrumental variable regression. The total expected sample size for analysis will be at least 180 000. Follow-up will end with the earliest of either an ‘event’ or censoring due to the end of registration or death. Ethics approval was not required for this study. This project has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). We will disseminate our findings via publications in international peer-reviewed journals and presentations at international conferences.