Medical and Payer Evidence, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK
Medical and Payer Evidence, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
BMJ Open. 2023 Apr 26;13(4):e070022. doi: 10.1136/bmjopen-2022-070022.
In patients with chronic obstructive pulmonary disease (COPD), the risk of certain cardiovascular (CV) events is increased by threefold to fivefold in the year following acute exacerbation of COPD (AECOPD), compared with a non-exacerbation period. While the effect of severe AECOPD is well established, the relationship of moderate exacerbation or prior exacerbation to elevated risk of CV events is less clear. We will conduct cohort studies in multiple countries to further characterise the association between AECOPD and CV events.
Retrospective longitudinal cohort studies will be conducted within routinely collected electronic healthcare records or claims databases. The study cohorts will include patients meeting inclusion criteria for COPD between 1 January 2014 and 31 December 2018. Moderate exacerbation is defined as an outpatient visit and/or medication dispensation/prescription for exacerbation; severe exacerbation is defined as hospitalisation for COPD. The primary outcomes of interest are the time to (1) first hospitalisation for a CV event (including acute coronary syndrome, heart failure, arrhythmias or cerebral ischaemia) since cohort entry or (2) death. Time-dependent Cox proportional hazards models will compare the hazard of a CV event between exposed periods following exacerbation (split into these periods: 1-7, 8-14, 15-30, 31-180 and 181-365 days) and the unexposed reference time period, adjusted on time-fixed and time-varying confounders.
Studies have been approved in Canada, Japan, the Netherlands, Spain and the UK, where an institutional review board is mandated. For each study, the results will be published in peer-reviewed journals.
在慢性阻塞性肺疾病（COPD）患者中，与非加重期相比，COPD 急性加重（AECOPD）后一年内发生某些心血管（CV）事件的风险增加了三倍至五倍。虽然严重 AECOPD 的影响已得到充分证实，但中度加重或既往加重与 CV 事件风险升高的关系尚不清楚。我们将在多个国家开展队列研究，以进一步描述 AECOPD 与 CV 事件之间的关系。
将在常规收集的电子医疗记录或理赔数据库中开展回顾性纵向队列研究。研究队列将包括 2014 年 1 月 1 日至 2018 年 12 月 31 日期间符合 COPD 纳入标准的患者。中度加重定义为门诊就诊和/或因加重而配药/开处方；重度加重定义为因 COPD 住院。主要观察终点为（1）自队列入组后首次因 CV 事件（包括急性冠状动脉综合征、心力衰竭、心律失常或脑缺血）住院的时间，或（2）死亡的时间。时间依赖性 Cox 比例风险模型将比较在加重后（分为以下时期：1-7、8-14、15-30、31-180 和 181-365 天）暴露期间和非暴露参考时间段内发生 CV 事件的风险，同时调整时间固定和时间变化的混杂因素。
在加拿大、日本、荷兰、西班牙和英国已经批准了这些研究，这些国家都要求机构审查委员会的批准。对于每项研究，结果都将发表在同行评议的期刊上。
