Demkowicz Brandon J, Rader Kevin, Wang Shirley V, Kesselheim Aaron S, Feldman William B
Department of Statistics, Harvard University, Cambridge, Massachusetts, United States of America.
Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.
PLoS Med. 2025 May 14;22(5):e1004596. doi: 10.1371/journal.pmed.1004596. eCollection 2025 May.
Fluticasone-salmeterol is available in both metered-dose and dry powder inhaler formulations for the treatment of chronic obstructive pulmonary disease (COPD). Metered-dose inhalers are associated with substantially higher greenhouse gas emissions than dry powder inhalers; however, data on their comparative effectiveness and safety in COPD remain limited. We aimed to compare the effectiveness and safety of fluticasone-salmeterol delivered via metered-dose inhaler (Advair HFA) versus dry powder inhaler (Advair Diskus) among patients with COPD treated in routine care.
We conducted a retrospective cohort study using Optum's de-identified Clinformatics DataMart (January 1, 2007 to November 30, 2023). The study included 202,052 commercially insured patients aged 40 years or older with COPD who had continuous insurance coverage for 180 days prior to cohort entry and had not initiated any inhaled corticosteroid-long-acting β₂-agonist during that period. Patients receiving fluticasone-salmeterol via a metered-dose inhaler (exposure) were compared to those receiving these drugs via a dry powder inhaler (referent), with stabilized inverse probability of treatment weighting applied for covariate adjustment. The primary effectiveness outcome was the incidence of first moderate or severe COPD exacerbation within 365 days of cohort entry. The primary safety outcome was the incidence of first pneumonia hospitalization during the same period. Use of fluticasone-salmeterol via metered-dose inhaler was associated with a similar hazard of first moderate or severe COPD exacerbation (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.99 to 1.08) and first pneumonia hospitalization (HR, 1.06; 95% CI, 0.98 to 1.14) compared to the dry powder inhaler. Primary study limitations include potential residual confounding despite weighting and short follow-up times.
In this cohort study comparing two brand-name fluticasone-salmeterol inhalers prescribed for COPD in routine clinical practice, effectiveness and safety outcomes were similar for patients receiving metered-dose and dry powder versions.
氟替卡松-沙美特罗有定量吸入器和干粉吸入器两种剂型，用于治疗慢性阻塞性肺疾病（COPD）。定量吸入器的温室气体排放量远高于干粉吸入器；然而，关于它们在COPD中的比较有效性和安全性的数据仍然有限。我们旨在比较在常规治疗的COPD患者中，通过定量吸入器（信必可都保HFA）与干粉吸入器（信必可都保）递送氟替卡松-沙美特罗的有效性和安全性。
我们使用Optum的去识别化临床信息数据库（2007年1月1日至2023年11月30日）进行了一项回顾性队列研究。该研究纳入了202,052名年龄在40岁及以上的商业保险COPD患者，这些患者在队列进入前连续参保180天，且在此期间未开始使用任何吸入性糖皮质激素-长效β₂受体激动剂。将通过定量吸入器接受氟替卡松-沙美特罗治疗的患者（暴露组）与通过干粉吸入器接受这些药物治疗的患者（参照组）进行比较，并应用稳定的逆概率处理加权法进行协变量调整。主要有效性结局是队列进入后365天内首次发生中度或重度COPD急性加重的发生率。主要安全性结局是同期首次因肺炎住院的发生率。与干粉吸入器相比，通过定量吸入器使用氟替卡松-沙美特罗导致首次中度或重度COPD急性加重的风险相似（风险比[HR]，1.03；95%置信区间[CI]，0.99至1.08），首次因肺炎住院的风险也相似（HR，1.06；95%CI，0.98至1.14）。主要研究局限性包括尽管进行了加权但仍存在潜在的残余混杂因素以及随访时间较短。
在这项比较常规临床实践中为COPD患者开具的两种品牌氟替卡松-沙美特罗吸入器的队列研究中，接受定量吸入器和干粉剂型的患者的有效性和安全性结局相似。
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