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在英国初级保健环境中,乌美溴铵/维兰特罗与吸入性皮质类固醇/长效β激动剂治疗慢性阻塞性肺疾病患者的疗效比较。

Comparative Effectiveness of Umeclidinium/Vilanterol versus Inhaled Corticosteroid/Long-Acting β-Agonist in Patients with Chronic Obstructive Pulmonary Disease in a Primary Care Setting in England.

机构信息

R&D Global Medical, GSK, Brentford, Middlesex, UK.

Real-World Evidence, Adelphi Real World, Bollington, Cheshire, UK.

出版信息

Int J Chron Obstruct Pulmon Dis. 2023 Apr 19;18:643-659. doi: 10.2147/COPD.S405498. eCollection 2023.

Abstract

PURPOSE

To compare adherence to once-daily umeclidinium/vilanterol (UMEC/VI), a long-acting muscarinic antagonist/long-acting β-agonist (LAMA/LABA), and twice-daily inhaled corticosteroids (ICS)/LABA single-inhaler dual therapy in patients with chronic obstructive pulmonary disease (COPD) in a primary care cohort in England.

PATIENTS AND METHODS

Active comparator, new-user, retrospective cohort study using CPRD-Aurum primary care data and linked Hospital Episode Statistics secondary care administrative data. Patients without exacerbations in the previous year were indexed on first/earliest prescription date of once-daily UMEC/VI or twice-daily ICS/LABA as initial maintenance therapy between July 2014-September 2019. Primary outcome: medication adherence at 12 months post-index, defined as proportion of days covered (PDC) ≥80%. PDC represented proportion of time over the treatment duration that the patient was theoretically in possession of the medication. Secondary outcomes: adherence at 6, 18, and 24 months post-index, time-to-triple therapy, time-to-first on-treatment COPD exacerbation, COPD-related and all-cause healthcare resource utilization (HCRU), and direct health-care costs. A propensity score was generated and inverse probability of treatment weighting (IPTW) was used to balance potential confounders. Superiority was defined as >0% difference between treatment groups.

RESULTS

In total, 6815 eligible patients were included (UMEC/VI:1623; ICS/LABA:5192). At 12 months post-index, weighted odds of a patient being adherent were significantly greater with UMEC/VI versus ICS/LABA (odds ratio [95% CI]: 1.71 [1.09, 2.66]; p=0.0185), demonstrating superiority of UMEC/VI. Patients taking UMEC/VI were statistically significantly more adherent than those taking ICS/LABA at 6, 18, and 24 months post-index (p<0.05). Differences in time-to-triple therapy, time-to-moderate COPD exacerbations, HCRU, and direct medical costs were not statistically significant between treatments after IPTW was applied.

CONCLUSION

At 12 months post-treatment initiation, once-daily UMEC/VI was superior to twice-daily ICS/LABA in medication adherence among patients with COPD without exacerbations in the previous year, newly initiating dual maintenance therapy in England. The finding was consistent at 6, 18, and 24 months.

摘要

目的

比较每日一次乌美溴铵/维兰特罗(UMEC/VI)、长效毒蕈碱拮抗剂/长效β-受体激动剂(LAMA/LABA)与每日两次吸入皮质类固醇(ICS)/LABA 单一吸入器双联治疗在英格兰初级保健队列中慢性阻塞性肺疾病(COPD)患者中的依从性。

方法

采用 CPRD-Aurum 初级保健数据和链接的医院病例统计二级保健管理数据的活性对照、新使用者、回顾性队列研究。在 2014 年 7 月至 2019 年 9 月期间,无既往加重的患者以首次/最早的每日一次 UMEC/VI 或每日两次 ICS/LABA 处方日期为索引,作为初始维持治疗。主要结局:12 个月时的药物依从性,定义为比例天数覆盖(PDC)≥80%。PDC 表示在治疗期间,患者理论上拥有药物的时间比例。次要结局:12、6、18 和 24 个月时的依从性、三联治疗时间、首次治疗 COPD 加重时间、COPD 相关和全因医疗资源利用(HCRU)和直接医疗保健成本。生成倾向评分并使用逆概率治疗加权(IPTW)来平衡潜在的混杂因素。优越性定义为治疗组之间差异>0%。

结果

共纳入 6815 例合格患者(UMEC/VI:1623 例;ICS/LABA:5192 例)。在索引后 12 个月时,与 ICS/LABA 相比,UMEC/VI 患者的依从性加权优势明显更大(优势比[95%CI]:1.71[1.09,2.66];p=0.0185),表明 UMEC/VI 的优越性。与接受 ICS/LABA 治疗的患者相比,接受 UMEC/VI 治疗的患者在索引后 6、18 和 24 个月时的依从性明显更高(p<0.05)。应用 IPTW 后,在三联治疗时间、中度 COPD 加重时间、HCRU 和直接医疗费用方面,两种治疗方法之间无统计学差异。

结论

在开始治疗后 12 个月时,与无既往一年加重的 COPD 患者新开始接受英格兰双联维持治疗相比,每日一次 UMEC/VI 在药物依从性方面优于每日两次 ICS/LABA。在 6、18 和 24 个月时的发现一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1df3/10122847/3e4d7b3cd15d/COPD-18-643-g0001.jpg

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