Pulmonology Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain; CIBERES, Instituto de Salud Carlos III, Madrid, Spain.
Care Pharmacy, Madrid Health Service (SERMAS), Madrid, Spain.
Chest. 2022 Nov;162(5):1017-1029. doi: 10.1016/j.chest.2022.06.033. Epub 2022 Jul 3.
COPD is a leading cause of death and disability. COPD therapy goals include reducing exacerbations and improving symptom control. Single-inhaler triple therapy (SITT) or multiple-inhaler triple therapy (MITT) is indicated for patients with frequent exacerbations despite bronchodilator therapy. No available evidence compares SITT vs MITT in Spain in terms of treatment persistence, exacerbations, and other outcomes.
Do COPD patients in Spain initiating SITT vs MITT have improved persistence, exacerbations, and health care resource utilization?
This real-world, observational, retrospective cohort study analyzed electronic health records in the Spanish National Healthcare System BIG-PAC database to identify COPD patients aged ≥ 40 years initiating SITT or MITT (using two or three inhalers) between June 1, 2018 and December 31, 2019. Comparative data on persistence (allowing up to 60 days without prescription refill), exacerbation rates, and health care resource utilization and costs during 12-month follow-up were analyzed. Multivariate adjusted analyses were performed.
Eligible patients (N = 4,625) initiating SITT (n = 1,011) or MITT (n = 3,614) had a mean age of 70.9 years; most were male (73.9%) with mainly moderate (62.0%) or severe (26.5%) airflow limitation. Between-cohort baseline characteristics were similar. At 12-month follow-up, SITT patients had higher persistence (hazard ratio [HR] = 1.37; 95% CI = 1.22-1.53; P < .001), reduced risk of exacerbations (HR = 0.68; 95% CI = 0.61-0.77; P = .001), and lower all-cause mortality risk (HR = 0.67; 95% CI = 0.63-0.71, P = .027), compared with MITT patients. SITT was associated with significantly reduced health care resource use (mean annual cost savings: €403 vs MITT). For both SITT and MITT, persistence was associated with improved exacerbation rates vs nonpersistence, and substantial adjusted mean annual cost savings (€2,115 and €2,700, respectively).
Patients initiating SITT had a clinically relevant improvement in persistence leading to reductions in mortality, incidence of exacerbations, and health care resource use with consequent mean cost savings.
慢性阻塞性肺疾病（COPD）是导致死亡和残疾的主要原因。COPD 治疗目标包括减少加重和改善症状控制。对于尽管接受了支气管扩张剂治疗但仍频繁加重的患者，建议使用三联单吸入器疗法（SITT）或三联多吸入器疗法（MITT）。在西班牙，尚无可用的证据比较 SITT 与 MITT 在治疗持续时间、加重和其他结局方面的差异。
在西班牙，开始使用 SITT 或 MITT 的 COPD 患者的治疗持续时间、加重和卫生保健资源利用是否有所改善？
本项真实世界、观察性、回顾性队列研究分析了西班牙国家卫生保健系统 BIG-PAC 数据库中的电子健康记录，以确定在 2018 年 6 月 1 日至 2019 年 12 月 31 日期间开始使用 SITT 或 MITT（使用两种或三种吸入器）的年龄≥40 岁的 COPD 患者。在 12 个月的随访期间，对治疗持续时间（允许有 60 天无处方补充）、加重率以及卫生保健资源利用和成本进行了比较数据分析。进行了多变量调整分析。
符合条件的患者（N=4625）中，开始使用 SITT（n=1011）或 MITT（n=3614）的患者平均年龄为 70.9 岁；大多数为男性（73.9%），主要为中度（62.0%）或重度（26.5%）气流受限。两组患者的基线特征相似。在 12 个月的随访中，SITT 组患者的治疗持续时间更高（风险比[HR] =1.37；95%CI=1.22-1.53；P<.001），发生加重的风险降低（HR=0.68；95%CI=0.61-0.77；P=.001），全因死亡率风险降低（HR=0.67；95%CI=0.63-0.71，P=.027），与 MITT 组相比。与 MITT 相比，SITT 组与显著降低的卫生保健资源利用相关（平均每年节省成本：€403 与 MITT）。对于 SITT 和 MITT，与非持续治疗相比，治疗持续时间与改善的加重率相关，同时带来了显著的调整后平均年度成本节省（分别为€2115 和 €2700）。
开始使用 SITT 的患者的治疗持续时间有了明显的改善，从而降低了死亡率、加重发生率和卫生保健资源的使用，进而带来了平均成本的节省。
