Kern David M, Davis Jill, Williams Setareh A, Tunceli Ozgur, Wu Bingcao, Hollis Sally, Strange Charlie, Trudo Frank
HealthCore, Inc., 123 Justison St, Suite 200, Wilmington, DE, 19801-5134, USA.
AstraZeneca Pharmaceuticals, 1800 Concord Pike, Wilmington, DE, 19850, USA.
Respir Res. 2015 Apr 23;16(1):52. doi: 10.1186/s12931-015-0210-x.
Inhaled corticosteroid/long-acting β2-agonist combinations (ICS/LABA) have emerged as first line therapies for chronic obstructive pulmonary disease (COPD) patients with exacerbation history. No randomized clinical trial has compared exacerbation rates among COPD patients receiving budesonide/formoterol combination (BFC) and fluticasone/salmeterol combination (FSC) to date, and only limited comparative data are available. This study compared the real-world effectiveness of approved BFC and FSC treatments among matched cohorts of COPD patients in a large US managed care setting.
COPD patients (≥40 years) naive to ICS/LABA who initiated BFC or FSC treatments between 03/01/2009-03/31/2012 were identified in a geographically diverse US managed care database and followed for 12 months; index date was defined as first prescription fill date. Patients with a cancer diagnosis or chronic (≥180 days) oral corticosteroid (OCS) use within 12 months prior to index were excluded. Patients were matched 1-to-1 on demographic and pre-initiation clinical characteristics using propensity scores from a random forest model. The primary efficacy outcome was COPD exacerbation rate, and secondary efficacy outcomes included exacerbation rates by event type and healthcare resource utilization. Pneumonia objectives included rates of any diagnosis of pneumonia and pneumonia-related healthcare resource utilization.
Matching of the identified 3,788 BFC and 6,439 FSC patients resulted in 3,697 patients in each group. Matched patients were well balanced on age (mean=64 years), gender (BFC: 52% female; FSC: 54%), prior COPD-related medication use, healthcare utilization, and comorbid conditions. During follow-up, no significant difference was seen between BFC and FSC patients for number of COPD-related exacerbations overall (rate ratio [RR]=1.02, 95% CI=[0.96,1.09], p=0.56) or by event type: COPD-related hospitalizations (RR=0.96), COPD-related ED visits (RR=1.11), and COPD-related office/outpatient visits with OCS and/or antibiotic use (RR=1.01). The proportion of patients diagnosed with pneumonia during the post-index period was similar for patients in each group (BFC =17.3%, FSC =19.0%, odds ratio=0.92 [0.81,1.04], p=0.19), and no difference was detected for pneumonia-related healthcare utilization by place of service.
This study demonstrated no difference in COPD-related exacerbations or pneumonia events between BFC and FSC treatment groups for patients new to ICS/LABA treatment in a real-world setting.
ClinicalTrials.gov identifier NCT01921127 .
吸入性糖皮质激素/长效β2受体激动剂联合制剂（ICS/LABA）已成为有加重病史的慢性阻塞性肺疾病（COPD）患者的一线治疗方案。迄今为止，尚无随机临床试验比较接受布地奈德/福莫特罗联合制剂（BFC）和氟替卡松/沙美特罗联合制剂（FSC）治疗的COPD患者的加重率，仅有有限的比较数据。本研究比较了在美国大型管理式医疗环境中，匹配队列的COPD患者中已获批的BFC和FSC治疗方案的实际疗效。
在一个地域多样的美国管理式医疗数据库中，识别出2009年3月1日至2012年3月31日期间开始使用BFC或FSC治疗、未使用过ICS/LABA的COPD患者（≥40岁），并随访12个月；索引日期定义为首次处方取药日期。排除在索引日期前12个月内有癌症诊断或长期（≥180天）口服糖皮质激素（OCS）使用史的患者。使用随机森林模型的倾向评分，将患者按1:1的比例在人口统计学和起始治疗前临床特征方面进行匹配。主要疗效指标为COPD加重率，次要疗效指标包括按事件类型划分的加重率和医疗资源利用情况。肺炎指标包括任何肺炎诊断率和与肺炎相关的医疗资源利用情况。
在识别出的3788例BFC患者和6439例FSC患者中进行匹配，每组各有3697例患者。匹配后的患者在年龄（平均=64岁）、性别（BFC组：52%为女性；FSC组：54%为女性）、既往COPD相关药物使用情况、医疗利用情况和合并症方面平衡良好。在随访期间，BFC组和FSC组患者的总体COPD相关加重次数（率比[RR]=1.02，95%置信区间=[0.96,1.09]，p=0.56）或按事件类型划分的情况均无显著差异：COPD相关住院（RR=0.96）、COPD相关急诊就诊（RR=1.11）以及COPD相关的使用OCS和/或抗生素的门诊/门诊就诊（RR=1.01）。每组患者在索引日期后被诊断为肺炎的比例相似（BFC组=17.3%，FSC组=19.0%，优势比=0.92[0.81,1.04]，p=0.19），且在不同服务地点的与肺炎相关的医疗利用情况方面未检测到差异。
本研究表明，在真实世界中，对于新使用ICS/LABA治疗的患者，BFC和FSC治疗组在COPD相关加重或肺炎事件方面无差异。
ClinicalTrials.gov标识符NCT01921127 。
