糠酸氟替卡松/乌美溴铵/维兰特罗与布地奈德/格隆溴铵/富马酸福莫特罗在美国慢性阻塞性肺疾病患者中的疗效比较

Comparative Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol and Budesonide/Glycopyrrolate/Formoterol Fumarate among US Patients with Chronic Obstructive Pulmonary Disease.

作者信息

Mannino David, Weng Stephen, Germain Guillaume, Boudreau Julien, Tardif-Samson Anabelle, Forero-Schwanhaeuser Sergio, Laliberté François, Gravelle Patrick, Compton Chris H, Noorduyn Stephen G, Paczkowski Rosirene

机构信息

COPD Foundation, Lexington, KY, USA.

Pulmonary Epidemiology Research Laboratory, University of Kentucky, Kentucky, KY, USA.

出版信息

Adv Ther. 2025 Feb;42(2):1131-1146. doi: 10.1007/s12325-024-03088-1. Epub 2024 Dec 28.

DOI:10.1007/s12325-024-03088-1

PMID:39731707

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11787206/

Abstract

INTRODUCTION

Chronic obstructive pulmonary disease (COPD) is associated with exacerbations which can reduce quality of life and increase mortality. Single-inhaler triple therapy (SITT) is recommended for maintenance treatment of COPD among patients experiencing exacerbations despite dual-therapy use. This real-world comparative effectiveness study compared the impact of SITTs, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), and budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM), on COPD exacerbations and mortality.

METHODS

Medicare Fee-for-Service (FFS) patients with COPD initiated on FF/UMEC/VI or BUD/GLY/FORM were identified from the Komodo Research healthcare claims dataset (01/01/2016-12/31/2023). Overlap weighting based on high-dimensional propensity scores evaluated from patient characteristics was used to adjust for baseline confounding. Primary outcome was annualized rate of moderate-severe COPD exacerbations (per patient-year; PPY) compared using rate ratios (RRs) with 95% confidence intervals (CIs) from weighted Poisson regression models. Secondary and exploratory outcomes were risk of moderate-severe COPD exacerbations and all-cause mortality, respectively, evaluated using Kaplan-Meier analysis and hazard ratios (HR) with 95% CIs from Cox proportional hazard models. A secondary analysis was conducted among a mutually exclusive population with Medicare Advantage, Medicaid, or commercial insurance.

RESULTS

Overall, 32,312 FF/UMEC/VI and 12,230 BUD/GLY/FORM Medicare FFS patients were included. After weighting, median follow-up was 9 months. Compared with BUD/GLY/FORM, FF/UMEC/VI users had a 12% lower rate of annualized moderate-severe COPD exacerbations [0.80 and 0.91 PPY; RR (95% CI): 0.88 (0.85-0.92); P < 0.001] and a 10% lower risk of moderate-severe exacerbations at 12 months post-initiation [HR (95% CI): 0.90 (0.87-0.93); P < 0.001], driven by moderate exacerbations. FF/UMEC/VI compared with BUD/GLY/FORM users had 11% lower risk of all-cause mortality at 12 months post-initiation [5.6% vs. 6.4%; HR (95% CI): 0.89 (0.80-0.98); P = 0.020]. Results were consistent among patients with Medicare Advantage, Medicaid, or commercial insurance.

CONCLUSIONS

In this real-world comparative effectiveness study, FF/UMEC/VI was associated with significantly lower rate and risk of COPD exacerbations than BUD/GLY/FORM.

摘要

引言

慢性阻塞性肺疾病（COPD）与病情加重相关，这会降低生活质量并增加死亡率。对于尽管使用了双联疗法但仍有病情加重的COPD患者，推荐使用单吸入器三联疗法（SITT）进行维持治疗。这项真实世界的比较有效性研究比较了SITT、糠酸氟替卡松/乌美溴铵/维兰特罗（FF/UMEC/VI）和布地奈德/格隆溴铵/富马酸福莫特罗（BUD/GLY/FORM）对COPD病情加重和死亡率的影响。

方法

从科莫多研究医疗保健索赔数据集（2016年1月1日至2023年12月31日）中确定开始使用FF/UMEC/VI或BUD/GLY/FORM的医疗保险按服务付费（FFS）COPD患者。基于从患者特征评估的高维倾向评分进行重叠加权，以调整基线混杂因素。主要结局是中重度COPD病情加重的年化率（每患者年；PPY），使用加权泊松回归模型的率比（RR）及95%置信区间（CI）进行比较。次要和探索性结局分别是中重度COPD病情加重的风险和全因死亡率，使用Kaplan-Meier分析及Cox比例风险模型的风险比（HR）及95%CI进行评估。在具有医疗保险优势、医疗补助或商业保险的互斥人群中进行了二次分析。

结果

总体而言，纳入了32312名使用FF/UMEC/VI的医疗保险FFS患者和12230名使用BUD/GLY/FORM的患者。加权后，中位随访时间为9个月。与BUD/GLY/FORM相比，使用FF/UMEC/VI的患者中重度COPD病情加重的年化率降低了12%[0.80和0.91 PPY；RR（95%CI）：0.88（0.85 - 0.92）；P < 0.001]，并且在开始治疗12个月时中重度病情加重的风险降低了10%[HR（95%CI）：0.90（0.87 - 0.93）；P < 0.001]，这是由中度病情加重驱动的。与使用BUD/GLY/FORM的患者相比，使用FF/UMEC/VI的患者在开始治疗12个月时全因死亡率风险降低了11%[5.6%对6.4%；HR（95%CI）：0.89（0.80 - 0.98）；P = 0.020]。在具有医疗保险优势、医疗补助或商业保险的患者中结果一致。