Respiratory Epidemiology, GSK, Brentford, Middlesex, UK.
Clinical Practice Research Datalink, MHRA, London, UK.
Int J Chron Obstruct Pulmon Dis. 2021 Mar 10;16:629-642. doi: 10.2147/COPD.S291931. eCollection 2021.
Umeclidinium bromide (UMEC) and umeclidinium/vilanterol (UMEC/VI) received European approval for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) in 2014. This study examined prescribing patterns, possible off-label prescribing, potential safety-related outcomes and adherence of these medications in routine clinical practice post-approval.
This retrospective, multi-database, longitudinal observational study of new users of UMEC, UMEC/VI, or other long-acting bronchodilators (LABD) analyzed data from UK electronic health record databases (primary care cohort), linked to hospital data (linked cohort). Off-label prescribing, safety outcomes (cardiovascular, respiratory, and mortality), treatment patterns, and medication adherence were assessed.
In the primary care cohort (new users of UMEC n=3875; UMEC/VI n=2224; other LABD n=32,809), two-thirds of UMEC users were prescribed concomitant inhaled corticosteroids/long-acting β-agonists. Possible off-label prescribing, defined as use in patients without COPD, was similar for UMEC (7.0%) and UMEC/VI (8.8%), but higher for new users of other LABD (18.0%). There were 547 UMEC users and 512 UMEC/VI users in the linked cohort. In both cohorts, incidence rates (IRs) of cardiovascular outcomes were similar for UMEC and UMEC/VI users (myocardial infarction IR per 1000 person-years [95% CIs]: UMEC 6.9 [4.4, 10.2]; UMEC/VI 6.8 [3.5, 11.9]). IRs of pneumonia and acute COPD exacerbations (AECOPD) were slightly higher among UMEC users compared with UMEC/VI users (AECOPD IR per 1000 person-years [95% CIs]: UMEC 979 [931, 1030]; UMEC/VI 746 [687, 811]). Adherence (medication possession ratio ≥80%) was 64% for UMEC and UMEC/VI.
Most new users of UMEC were receiving multiple-inhaler triple therapy. Off-label prescribing was uncommon for new users of UMEC and UMEC/VI. Incidence of cardiovascular and respiratory outcomes was as expected for these drug classes. This study provides evidence that UMEC and UMEC/VI are being prescribed appropriately and their safety profile remains unchanged.
乌美溴铵（UMEC）和乌美溴铵/维兰特罗（UMEC/VI）于 2014 年获得欧洲批准，用于慢性阻塞性肺疾病（COPD）患者的维持治疗。本研究评估了这些药物在获得批准后的常规临床实践中的处方模式、可能的超说明书使用、潜在的安全性相关结局和依从性。
这项回顾性、多数据库、纵向观察性研究纳入了新使用乌美溴铵、乌美溴铵/维兰特罗或其他长效支气管扩张剂（LABD）的患者，分析了来自英国电子健康记录数据库（初级保健队列）和医院数据（链接队列）的数据。评估了超说明书使用、安全性结局（心血管、呼吸和死亡率）、治疗模式和药物依从性。
在初级保健队列中（新使用乌美溴铵的患者 n=3875；新使用乌美溴铵/维兰特罗的患者 n=2224；新使用其他 LABD 的患者 n=32809），三分之二的乌美溴铵使用者同时处方吸入性皮质激素/长效β-激动剂。乌美溴铵（7.0%）和乌美溴铵/维兰特罗（8.8%）的可能超说明书使用定义为用于无 COPD 的患者，与其他 LABD 的新使用者（18.0%）相似。链接队列中包括 547 名乌美溴铵使用者和 512 名乌美溴铵/维兰特罗使用者。在两个队列中，乌美溴铵和乌美溴铵/维兰特罗使用者的心血管结局发生率（IR）相似（每 1000 人年的心肌梗死 IR[95%CI]：乌美溴铵 6.9[4.4,10.2]；乌美溴铵/维兰特罗 6.8[3.5,11.9]）。与乌美溴铵/维兰特罗使用者相比，乌美溴铵使用者的肺炎和急性 COPD 加重（AECOPD）发生率略高（每 1000 人年的 AECOPD IR[95%CI]：乌美溴铵 979[931,1030]；乌美溴铵/维兰特罗 746[687,811]）。乌美溴铵和乌美溴铵/维兰特罗的药物依从性（用药量≥80%）为 64%。
大多数新使用乌美溴铵的患者同时使用了多种吸入三联疗法。新使用乌美溴铵和乌美溴铵/维兰特罗的超说明书使用并不常见。这些药物类别的心血管和呼吸结局发生率与预期相符。本研究提供了证据表明，乌美溴铵和乌美溴铵/维兰特罗的使用是合理的，且其安全性没有改变。
