医疗保险优势计划中慢阻肺患者起始乌美溴铵/维兰特罗或丙酸氟替卡松/沙美特罗治疗的症状负担和 GOLD 分类。

Symptom Burden and GOLD Classification in Medicare Advantage Patients with COPD Initiating Umeclidinium/Vilanterol or Fluticasone Propionate/Salmeterol Therapy.

机构信息

US Value Evidence & Outcomes, GlaxoSmithKline, Research Triangle Park, NC, USA.

Optum, Eden Prairie, MN, USA.

出版信息

Int J Chron Obstruct Pulmon Dis. 2020 Oct 29;15:2715-2725. doi: 10.2147/COPD.S265037. eCollection 2020.

DOI:10.2147/COPD.S265037

PMID:33149569

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7605915/

Abstract

BACKGROUND

Long-acting muscarinic antagonist/long-acting β-agonist (LAMA/LABA) provide greater improvements in lung function and symptoms than inhaled corticosteroid (ICS)/LABA in patients with chronic obstructive pulmonary disease (COPD). This study evaluated symptom burden and Global Initiative for Obstructive Lung Disease (GOLD) categorization among patients who recently initiated umeclidinium/vilanterol (UMEC/VI; LAMA/LABA) or fluticasone propionate/salmeterol (FP/SAL; ICS/LABA) single-inhaler dual therapy.

METHODS

COPD-diagnosed Medicare Advantage enrollees aged ≥65 years were identified from the Optum Research Database (ORD). Eligible patients had ≥1 pharmacy claim for UMEC/VI or FP/SAL in the 6-month period before sample identification, with no evidence of triple therapy (ICS/LAMA/LABA), asthma, or lung cancer. Symptom burden was assessed via cross-sectional surveys using the COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) dyspnea scale. Patients were classified into GOLD categories using patient-reported symptoms and claims-based exacerbation history. Treatment groups were balanced on potential confounders using inverse probability of treatment weighting (IPTW). CAT and mMRC scores were analyzed with generalized linear regression models using IPTW propensity scores.

RESULTS

The final analytic sample included 789 respondents (UMEC/VI: N=392; FP/SAL: N=397). Approximately 66% patients were classified as GOLD B when assessing symptoms with CAT and mMRC together, or CAT alone; more patients were classified as GOLD A (~~40%) than GOLD B (~~36%) using mMRC alone. Proportions of patients in each GOLD group were similar between treatment cohorts. Post-IPTW multivariable modeling showed similar symptom burden between treatment groups.

CONCLUSION

After controlling for baseline characteristics, symptom burden was similar between patients receiving UMEC/VI or FP/SAL. GOLD classification using mMRC produced more conservative results compared with CAT, potentially underestimating patient symptoms. Many patients receiving FP/SAL were classified as GOLD A or B, despite GOLD recommending non-ICS-containing therapy in these patients. These findings support the need for routine assessment of symptoms in patients with COPD.

摘要

背景

长效毒蕈碱拮抗剂/长效β-激动剂（LAMA/LABA）在慢性阻塞性肺疾病（COPD）患者中的肺功能和症状改善方面优于吸入性皮质类固醇（ICS）/LABA。本研究评估了近期开始使用乌美溴铵/维兰特罗（UMEC/VI；LAMA/LABA）或丙酸氟替卡松/沙美特罗（FP/SAL；ICS/LABA）单一吸入双重疗法的患者的症状负担和全球倡议对阻塞性肺疾病（GOLD）分类。

方法

从 Optum Research Database（ORD）中确定年龄≥65 岁的 Medicare Advantage 参保者的 COPD 诊断。合格患者在样本确定前的 6 个月内至少有 1 次 UMEC/VI 或 FP/SAL 的药房配药记录，且无三联疗法（ICS/LAMA/LABA）、哮喘或肺癌的证据。使用 COPD 评估测试（CAT）和改良的医学研究委员会（mMRC）呼吸困难量表通过横断面调查评估症状负担。使用患者报告的症状和基于索赔的加重史将患者分类为 GOLD 类别。使用逆概率治疗加权（IPTW）对潜在混杂因素对治疗组进行平衡。使用基于 IPTW 倾向评分的广义线性回归模型分析 CAT 和 mMRC 评分。

结果

最终分析样本包括 789 名应答者（UMEC/VI：N=392；FP/SAL：N=397）。当同时使用 CAT 和 mMRC 评估症状或仅使用 CAT 评估症状时，约 66%的患者被归类为 GOLD B；单独使用 mMRC 时，更多的患者被归类为 GOLD A（~~40%）而不是 GOLD B（~~36%）。在治疗组之间，每个 GOLD 组的患者比例相似。IPTW 后多变量模型显示治疗组之间的症状负担相似。

结论

在控制基线特征后，接受 UMEC/VI 或 FP/SAL 的患者的症状负担相似。与 CAT 相比，使用 mMRC 进行 GOLD 分类会产生更保守的结果，可能低估了患者的症状。尽管 GOLD 建议在这些患者中使用不含 ICS 的治疗方法，但许多接受 FP/SAL 的患者被归类为 GOLD A 或 B。这些发现支持对 COPD 患者进行常规症状评估的必要性。