Simeone Jason C, Luthra Rakesh, Kaila Shuchita, Pan Xiaoyun, Bhagnani Tarun D, Liu Jieruo, Wilcox Teresa K
Real-World Evidence, Evidera, Waltham, MA.
HEOR Value Demonstration Team, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Int J Chron Obstruct Pulmon Dis. 2016 Dec 22;12:73-83. doi: 10.2147/COPD.S122013. eCollection 2017.
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends triple therapy (long-acting muscarinic receptor antagonists, long-acting beta-2 agonists, and inhaled corticosteroids) for patients with only the most severe COPD. Data on the proportion of COPD patients on triple therapy and their characteristics are sparse and dated. Objective 1 of this study was to estimate the proportion of all, and all treated, COPD patients receiving triple therapy. Objective 2 was to characterize those on triple therapy and assess the concordance of triple therapy use with GOLD guidelines.
This retrospective study used claims from the IMS PharMetrics Plus database from 2009 to 2013. Cohort 1 was selected to assess Objective 1 only; descriptive analyses were conducted in Cohort 2 to answer Objective 2. A validated claims-based algorithm and severity and frequency of exacerbations were used as proxies for COPD severity.
Of all 199,678 patients with COPD in Cohort 1, 7.5% received triple therapy after diagnosis, and 25.5% of all treated patients received triple therapy. In Cohort 2, 30,493 COPD patients (mean age =64.7 years) who initiated triple therapy were identified. Using the claims-based algorithm, 34.5% of Cohort 2 patients were classified as having mild disease (GOLD 1), 40.8% moderate (GOLD 2), 22.5% severe (GOLD 3), and 2.3% very severe (GOLD 4). Using exacerbation severity and frequency, 60.6% of patients were classified as GOLD 1/2 and 39.4% as GOLD 3/4.
In this large US claims database study, one-quarter of all treated COPD patients received triple therapy. Although triple therapy is recommended for the most severe COPD patients, spirometry is infrequently assessed, and a majority of the patients who receive triple therapy may have only mild/moderate disease. Any potential overprescribing of triple therapy may lead to unnecessary costs to the patient and health care system.
慢性阻塞性肺疾病全球倡议组织（GOLD）建议仅对最严重的慢性阻塞性肺疾病（COPD）患者采用三联疗法（长效毒蕈碱受体拮抗剂、长效β2受体激动剂和吸入性糖皮质激素）。关于接受三联疗法的COPD患者比例及其特征的数据稀少且陈旧。本研究的目标1是估计所有COPD患者以及所有接受治疗的COPD患者中接受三联疗法的比例。目标2是描述接受三联疗法的患者特征，并评估三联疗法的使用与GOLD指南的一致性。
这项回顾性研究使用了2009年至2013年IMS PharMetrics Plus数据库中的索赔数据。队列1仅用于评估目标1；在队列2中进行描述性分析以回答目标2。使用经过验证的基于索赔的算法以及加重的严重程度和频率作为COPD严重程度的替代指标。
在队列1的所有199,678例COPD患者中，7.5%在诊断后接受了三联疗法，所有接受治疗的患者中有25.5%接受了三联疗法。在队列2中，确定了30,493例开始接受三联疗法的COPD患者（平均年龄=64.7岁）。使用基于索赔的算法，队列2中34.5%的患者被分类为轻度疾病（GOLD 1），40.8%为中度（GOLD 2），22.5%为重度（GOLD 3），2.3%为极重度（GOLD 4）。根据加重的严重程度和频率，60.6%的患者被分类为GOLD 1/2，39.4%为GOLD 3/4。
在这项大型美国索赔数据库研究中，所有接受治疗的COPD患者中有四分之一接受了三联疗法。尽管三联疗法是推荐给最严重的COPD患者的，但肺活量测定很少进行评估，并且大多数接受三联疗法的患者可能只有轻度/中度疾病。三联疗法的任何潜在过度处方都可能给患者和医疗保健系统带来不必要的费用。
