BACKGROUND The combination of two long acting bronchodilators with an inhaled corticosteroid, known as Triple Therapy (TT), is a usual clinical practice for patients affected by chronic obstructive pulmonary disease (COPD). This analysis aimed to identify subjects with COPD treated with extemporaneous combination of ICS/LABA and LAMA (namely open TT) and to describe the pharmacological strategy, the spirometry use, the exacerbations occurrence and the costs, in the perspective of the Italian National Health System (NHS). METHODS Through record linkage of administrative data (ReS database) of about 12 million inhabitants in 2014, a cohort of patients aged ≥45, without asthma and treated with open TT (index date) was selected. Specific drugs, oxygen supply and exacerbations were described in one year before the index date, while spirometry tests over two years before the index date. All these resources utilization, the persistence to the open TT, and integrated costs of the above healthcare services were analysed for 1-year follow-up. RESULTS In 2014, 10,352 patients (mean age 74 ± 9; males 66.0%) with COPD and treated with open TT were identified (prevalence 160.6 per 100,000 inhabitants aged ≥45). During the previous year, the 44.0% of this cohort was already treated with open TT, 7.0% did not received any drugs for obstructive airway diseases, 11.1% needed home oxygen therapy, and 28.7% experienced at least an exacerbation. In the follow-up year, the 37.5% of the cohort was found persistent to the open TT, 17.0% needed oxygen therapy, and the 30.9% underwent an exacerbation. Spirometry was performed on 45.7% of patients in the two previous years, while on 33.3% in the subsequent year. In the follow-up, on average, every patient of the cohort costed to the NHS €5,295: 48.2% for hospitalizations, 41.2% for drugs and 10.6% for outpatient services. CONCLUSIONS This large observational study based on claims data reliably identified subjects with COPD treated with open TT and their burden on the NHS. Moreover, it could describe the real clinical management of the open TT, before the marketing of the fixed one. These findings are useful for health policymakers in order to promote the appropriate utilization of both currently marketed and future therapies.

中文翻译：

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慢性阻塞性肺疾病的开放式三联疗法：来自大型意大利索赔数据库的处方，病情加重和医疗费用模式。

背景技术两种长效支气管扩张剂与吸入性糖皮质激素的组合，被称为三联疗法（TT），是受慢性阻塞性肺疾病（COPD）影响的患者的常规临床实践。这项分析旨在确定使用ICS / LABA和LAMA（即开放TT）临时联合治疗的COPD患者，并从意大利国家卫生系统的角度描述药理策略，肺活量测定法使用，病情加重和费用（NHS）。方法通过2014年约1200万居民的行政数据（ReS数据库）的记录链接，选择了年龄≥45岁，无哮喘且接受开放TT（索引日期）治疗的患者队列。在索引日期之前的一年中描述了特定药物，氧气供应和恶化情况，而在指标日期之前两年进行肺活量测试。对所有这些资源利用，开放TT的持久性以及上述医疗服务的综合成本进行了为期一年的跟踪分析。结果2014年，确定了10352例COPD并接受开放TT治疗的COPD患者（平均年龄74±9；男性66.0％）（每100,000名≥45岁的居民中的患病率为160.6）。在上一年中，该队列中的44.0％已接受开放TT治疗，7.0％未接受任何阻塞性气道疾病药物，11.1％需要家庭氧气治疗，28.7％至少恶化了。在随访的一年中，发现该人群中有37.5％的患者坚持开放TT治疗，其中17.0％的患者需要氧气治疗，而30.9％的患者则恶化了。前两年对45.7％的患者进行了肺活量测定，而对33例患者进行了肺活量测定。第二年为3％。在随访中，该队列的每位患者平均花费5295欧元：住院费用为48.2％，药物费用为41.2％，门诊费用为10.6％。结论基于索赔数据的这项大型观察性研究可靠地确定了经开放TT治疗的COPD患者及其对NHS的负担。而且，它可以描述固定式TT上市之前实际的开放式TT临床管理。这些发现对卫生政策制定者很有用，以促进对当前上市和未来疗法的适当利用。结论基于索赔数据的这项大型观察性研究可靠地确定了经开放TT治疗的COPD患者及其对NHS的负担。而且，它可以描述固定式TT上市之前实际的开放式TT临床管理。这些发现对健康政策制定者很有用，以促进对当前上市和未来疗法的适当利用。结论基于索赔数据的这项大型观察性研究可靠地确定了经开放TT治疗的COPD患者及其对NHS的负担。而且，它可以描述固定式TT上市之前实际的开放式TT临床管理。这些发现对卫生政策制定者很有用，以促进对当前上市和未来疗法的适当利用。