Division of Cardiology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China.
School of Pharmacy, National Defense Medical Center, Taipei, Taiwan, Republic of China.
Mayo Clin Proc. 2018 Oct;93(10):1462-1473. doi: 10.1016/j.mayocp.2018.05.030. Epub 2018 Aug 10.
To examine the risk of cardiovascular disease (CVD) from tiotropium added to inhaled long-acting β agonists (LABAs) and inhaled corticosteroids (ICSs) in a nationwide population with chronic obstructive pulmonary disease (COPD).
This nested case-control study included 65,966 patients with COPD treated with LABAs and ICSs identified from the Taiwan nationwide health care claims database from January 1, 2007, through June 30, 2011. Cases were all patients with a first primary diagnosis of ischemic heart disease, heart failure, stroke, or arrhythmia from inpatient or emergency care settings during follow-up, and each was matched with 4 disease risk score-matched controls from risk sets. The use of tiotropium in the year before the index/event date was measured, stratified by duration since therapy initiation, concomitant COPD medications, and dosage form. Conditional logistic regression models were used to estimate odds ratios of the CVD risk from add-on tiotropium therapy.
From the study cohort, with a mean age of 70.3 years (interquartile range, 61.8-79.4 years), 3188 CVD cases (incidence rate, 6.2 [95% CI, 6.0-6.4] cases per 100 person-years) and 12,349 matched controls were identified. The new use of tiotropium was associated with a 1.88-fold (95% CI, 1.44-2.46) increased CVD risk within 30 days of therapy initiation, and the association was sustained up to 60 days after treatment initiation (adjusted odds ratio, 1.71; 95% CI, 1.08-2.70). The risk persisted across all tiotropium regimens, with a case-crossover analysis, and in comparison with new add-on theophylline therapy.
Tiotropium newly added to LABA/ICS combination therapy was associated with an increased cardiovascular risk in patients with COPD.
在患有慢性阻塞性肺疾病（COPD）的全国性人群中，研究噻托溴铵联合吸入长效β激动剂（LABA）和吸入皮质类固醇（ICS）治疗对心血管疾病（CVD）的风险。
本巢式病例对照研究纳入了 2007 年 1 月 1 日至 2011 年 6 月 30 日期间从台湾全国性医疗保健理赔数据库中筛选出的接受 LABA 和 ICS 治疗的 65966 例 COPD 患者。病例均为随访期间因住院或急诊治疗首次诊断为缺血性心脏病、心力衰竭、中风或心律失常的患者，每位患者均与风险组中 4 位疾病风险评分匹配的对照相匹配。在索引/事件日期之前的一年中测量了噻托溴铵的使用情况，按治疗开始后时间、同时使用的 COPD 药物和剂型进行分层。采用条件逻辑回归模型估计附加噻托溴铵治疗对 CVD 风险的比值比。
在研究队列中，患者的平均年龄为 70.3 岁（四分位距，61.8-79.4 岁），3188 例 CVD 病例（发生率为 6.2 [95%CI，6.0-6.4]例/100 人年）和 12349 例匹配对照。在治疗开始后 30 天内，噻托溴铵的新使用与 CVD 风险增加 1.88 倍（95%CI，1.44-2.46）相关，并且这种关联持续至治疗开始后 60 天（调整后的比值比，1.71；95%CI，1.08-2.70）。在病例交叉分析中，与新附加茶碱治疗相比，所有噻托溴铵方案的风险均持续存在。
在 COPD 患者中，LABA/ICS 联合治疗中新添加噻托溴铵与心血管风险增加相关。
