Davies Neil M, Taylor Gemma, Taylor Amy E, Thomas Kyla H, Windmeijer Frank, Martin Richard M, Munafò Marcus R
Medical Research Council Integrative Epidemiology Unit, University of Bristol, Bristol, UK School of Social and Community Medicine, University of Bristol, Bristol, UK.
Medical Research Council Integrative Epidemiology Unit, University of Bristol, Bristol, UK School of Experimental Psychology, University of Bristol, Bristol, UK.
BMJ Open. 2015 Nov 5;5(11):e009665. doi: 10.1136/bmjopen-2015-009665.
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.
吸烟是导致健康不良和过早死亡的一个主要可避免原因。帮助患者成功戒烟的治疗方法对健康和预期寿命有重要影响。伐尼克兰是一种可帮助吸烟者成功戒烟的药物。然而，人们担心它可能会引起不良反应，如抑郁、自残和自杀以及心血管疾病发生率增加。在本研究中，我们旨在研究伐尼克兰与其他戒烟药物疗法相比，对戒烟、医疗服务利用、全因死亡率和特定病因死亡率以及身心健康状况的影响。
在本项目中，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）长期戒烟情况以及这些影响是否因地区贫困程度而异；（2）以下具有临床重要性的结果：全科医疗和医院就诊率；全因死亡率以及呼吸系统疾病和心血管疾病导致的死亡；以及呼吸系统疾病、心肌梗死或抑郁和焦虑的初级保健诊断。该研究基于从临床实践研究数据链（CPRD）中开具这些戒烟药物的患者队列。我们将使用三种方法来克服混杂因素：多变量调整的Cox回归、倾向评分匹配的Cox回归和工具变量回归。分析的总预期样本量至少为180,000。随访将在最早出现“事件”或因注册结束或死亡而被截尾时结束。
本研究无需伦理批准。该项目已获得CPRD独立科学咨询委员会（ISAC）的批准。我们将通过在国际同行评审期刊上发表以及在国际会议上进行报告来传播我们的研究结果。
