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慢性阻塞性肺疾病中多种吸入器三联疗法的启动:来自美国回顾性数据库研究的治疗模式分析。

Initiation of Triple Therapy with Multiple Inhalers in Chronic Obstructive Pulmonary Disease: An Analysis of Treatment Patterns from a U.S. Retrospective Database Study.

机构信息

1 Comprehensive Health Insights, Humana, Louisville, Kentucky.

2 GlaxoSmithKline, Research Triangle Park, North Carolina.

出版信息

J Manag Care Spec Pharm. 2018 Nov;24(11):1165-1172. doi: 10.18553/jmcp.2018.24.11.1165.


DOI:10.18553/jmcp.2018.24.11.1165
PMID:30362922
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10397697/
Abstract

BACKGROUND: Evidence suggests that real-world treatment patterns of chronic obstructive pulmonary disease (COPD) do not always follow evidence-based treatment recommendations such as those of the Global Initiative for Chronic Obstructive Lung Disease, which recommends treatment escalation based on disease progression. This U.S. database study evaluated treatment patterns in patients with COPD, focusing on time to initiation of triple therapy using multiple inhalers. OBJECTIVES: To (a) estimate time from diagnosis to initiation of long-acting muscarinic antagonist (LAMA) monotherapy, inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) dual therapy, or LAMA/LABA dual therapy; (b) estimate time to initiation of triple therapy from LAMA monotherapy and ICS/LABA or LAMA/LABA dual therapies; and (c) estimate the likelihood of patient progression to triple therapy. METHODS: This study was a retrospective analysis of patients with COPD newly started on LAMA monotherapy, ICS/LABA, or LAMA/LABA therapy between July 1, 2010, and March 31, 2013, as identified in Humana's research database. Patients who were fully insured with commercial or Medicare Advantage insurance plans and were aged ≥ 40 years at index with at least 1 hospitalization, 1 emergency department, or 1 medical office visit claim with a COPD diagnosis in the pre-index year were included in the analysis. Time from diagnosis to initiation of index therapy and time to triple therapy after index therapy were assessed. Multivariable logistic regression models were used to estimate the likelihood of progression to triple therapy. RESULTS: Of 13,541 patients with a confirmed diagnosis of COPD, 4,000 received LAMA monotherapy; 8,207 received ICS/LABA therapy; and 77 received LAMA/LABA therapy at index; mean time (± SD) from COPD diagnosis to initiation of triple therapy was 178 (± 134) days, 185 (± 130) days, and 252 (± 124) days, respectively. During the study, 28% (n = 1,130) of patients receiving LAMA monotherapy and 20% (n = 1,647) of patients receiving dual therapy (ICS/LABA, n = 1,615; LAMA/LABA, n = 32) progressed to triple therapy. Of the patients who progressed to triple therapy, 63% and 57% of patients receiving monotherapy and dual therapy, respectively, progressed in the 12 months after the index date. In the 12 months before initiation of triple therapy, approximately 50% of patients in the LAMA monotherapy, ICS/LABA, and LAMA/LABA therapy groups had an exacerbation. In the multivariable analysis, discontinuation of therapy, smoking history, and concomitant use of xanthenes and short-acting beta2-agonists were significant predictors of progression from index therapy to triple therapy. CONCLUSIONS: Approximately 25% of patients with COPD progressed to triple therapy within 12 months of initiating treatment with monotherapy or dual therapy. Exacerbations were reported in only 50% of these patients, indicating that the other 50% may have escalated to triple therapy for other reasons. Treatment discontinuation, smoking history, the use of a LAMA, and concomitant medication use were significant predictors of progression to triple therapy. DISCLOSURES: This study was a GlaxoSmithKline-sponsored collaborative research study (HO-14-16145). GlaxoSmithKline funded this study and had a role in study design, data analysis, data interpretation, and writing of this report. Stemkowski is a paid employee of Comprehensive Health Insights, which is a wholly owned subsidiary of Humana and was contracted to conduct the study. No funding was provided to Comprehensive Health Insights for manuscript development. At the time of the study, Lane and Tao were paid employees of Comprehensive Health Insights. Stanford is an employee of and stockholder in GlaxoSmithKline.

摘要

背景:有证据表明,慢性阻塞性肺疾病(COPD)的实际治疗模式并不总是遵循基于证据的治疗建议,例如全球慢性阻塞性肺疾病倡议(GOLD)所推荐的那样,根据疾病进展情况逐步升级治疗。这项美国数据库研究评估了 COPD 患者的治疗模式,重点关注使用多种吸入器开始三联疗法的时间。

目的:(a)估计从诊断到开始长效抗胆碱能药物(LAMA)单药治疗、吸入皮质类固醇(ICS)/长效β2-激动剂(LABA)联合治疗或 LAMA/LABA 联合治疗的时间;(b)估计从 LAMA 单药治疗和 ICS/LABA 或 LAMA/LABA 联合治疗开始三联疗法的时间;(c)估计患者进展为三联疗法的可能性。

方法:这是一项对 2010 年 7 月 1 日至 2013 年 3 月 31 日期间 Humana 研究数据库中开始接受 LAMA 单药治疗、ICS/LABA 或 LAMA/LABA 治疗的 COPD 新患者进行的回顾性分析。患者需满足以下条件:完全有商业或 Medicare Advantage 保险计划,索引时有≥1 次住院、≥1 次急诊就诊或≥1 次医疗办公室就诊,且在索引前一年有 COPD 诊断。评估从诊断到开始指数治疗的时间和从指数治疗开始到三联治疗的时间。采用多变量逻辑回归模型估计进展为三联疗法的可能性。

结果:在 13541 例确诊 COPD 的患者中,4000 例接受 LAMA 单药治疗;8207 例接受 ICS/LABA 治疗;77 例在索引时接受 LAMA/LABA 治疗;从 COPD 诊断到开始三联治疗的平均时间(±SD)分别为 178(±134)天、185(±130)天和 252(±124)天。在研究期间,28%(n=1130)接受 LAMA 单药治疗的患者和 20%(n=1647)接受双重治疗(ICS/LABA,n=1615;LAMA/LABA,n=32)的患者进展为三联治疗。在进展为三联治疗的患者中,分别有 63%和 57%的单药和双重治疗患者在索引日期后 12 个月内进展。在开始三联治疗前的 12 个月内,LAMA 单药、ICS/LABA 和 LAMA/LABA 治疗组的约 50%患者发生了加重。在多变量分析中,停止治疗、吸烟史以及同时使用黄嘌呤类药物和短效β2-激动剂是从指数治疗进展为三联治疗的显著预测因素。

结论:大约 25%的 COPD 患者在开始单药或双重治疗后的 12 个月内进展为三联治疗。这些患者中只有 50%报告了加重,表明其他 50%可能因其他原因升级为三联治疗。停止治疗、吸烟史、使用 LAMA 和同时使用药物是进展为三联治疗的显著预测因素。

披露:这项研究是葛兰素史克(GSK)赞助的合作研究项目(HO-14-16145)。GSK 资助了这项研究,并参与了研究设计、数据分析、数据解释和报告的编写。Stemkowski是 Comprehensive Health Insights 的受薪员工,该公司是 Humana 的全资子公司,负责进行这项研究。Comprehensive Health Insights 没有获得用于报告开发的资金。在研究期间,Lane 和 Tao 是 Comprehensive Health Insights 的员工。斯坦福是 GSK 的员工和股东。

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