每日一次、单吸入器、固定剂量组合的糠酸莫米松/茚达特罗/格隆溴铵治疗伴有或不伴有持续性气流受限的哮喘患者的疗效：来自 IRIDIUM 研究的事后分析。
Efficacy of once-daily, single-inhaler, fixed-dose combination of mometasone/indacaterol/glycopyrronium in patients with asthma with or without persistent airflow limitation: Post hoc analysis from the IRIDIUM study.
机构信息
Division of Pulmonology and UCT Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.
出版信息
Respir Med. 2023 May;211:107172. doi: 10.1016/j.rmed.2023.107172. Epub 2023 Mar 9.
BACKGROUND
A novel, once-daily, fixed-dose combination of mometasone furoate/indacaterol acetate/glycopyrronium bromide (MF/IND/GLY) delivered via Breezhaler® is the first inhaled corticosteroid/long-acting ꞵ-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) therapy approved for the maintenance treatment of asthma in adults inadequately controlled on ICS/LABA combination. In patients with asthma and persistent airflow limitation (PAL), maximal treatment, especially with combination is suggested. This post hoc analysis of data from the IRIDIUM study assessed the efficacy of MF/IND/GLY in asthma patients with and without PAL.
METHODS
Patients with post-bronchodilator FEV ≤80% of predicted and FEV/FVC ratio of ≤0.7 were categorised as PAL subgroup and the remaining as the non-PAL subgroup. Lung function parameters (FEV, PEF, and FEF) and annualised asthma exacerbations rates were evaluated in both subgroups across the treatment arms: once-daily high-dose MF/IND/GLY (160/150/50 μg), high-dose MF/IND (320/150 μg) and twice-daily high-dose fluticasone/salmeterol (FLU/SAL; 500/50 μg).
RESULTS
Of the 3092 randomised patients, 64% (n = 1981) met the criteria for PAL. Overall, there was no evidence of treatment difference between PAL and non-PAL subgroups (interaction P-value for FEV, FEF, PEF, moderate or severe exacerbations, severe exacerbations and all exacerbations were 0.42, 0.08, 0.43 0.29, 0.35 and 0.12, respectively). In the PAL subgroup, high-dose MF/IND/GLY versus high-dose MF/IND and high-dose FLU/SAL improved trough FEV (mean difference: 102 mL [P < 0.0001] and 137 mL [P < 0.0001]) and reduced moderate or severe (16% and 32%), severe (25% and 39%) and all exacerbations (19% and 38%), respectively.
CONCLUSIONS
Once-daily fixed-dose MF/IND/GLY was efficacious in asthma patients with and without persistent airflow limitation.
背景
福莫特罗/格隆溴铵/糠酸莫米松（MF/IND/GLY）每日一次固定剂量复方制剂通过 Breezhaler®给药，是首个用于治疗对吸入性糖皮质激素/长效β2-受体激动剂（ICS/LABA）联合治疗控制不佳的成人哮喘维持治疗的吸入性皮质类固醇/长效β2-受体激动剂/长效毒蕈碱拮抗剂（ICS/LABA/LAMA）疗法。在持续性气流受限（PAL）的哮喘患者中，尤其是在接受联合治疗的患者中，建议进行最大程度的治疗。这项 IRIDIUM 研究的事后分析评估了 MF/IND/GLY 在有和没有 PAL 的哮喘患者中的疗效。
方法
支气管扩张剂后 FEV 低于预计值的 80%且 FEV/FVC 比≤0.7 的患者被归类为 PAL 亚组，其余患者被归类为非 PAL 亚组。在治疗臂中，评估了这两个亚组的肺功能参数（FEV、PEF 和 FEF）和年化哮喘加重率：每日一次高剂量 MF/IND/GLY（160/150/50μg）、高剂量 MF/IND（320/150μg）和每日两次高剂量氟替卡松/沙美特罗（FLU/SAL；500/50μg）。
结果
在 3092 名随机患者中，64%（n=1981）符合 PAL 标准。总体而言，PAL 和非 PAL 亚组之间没有证据表明治疗存在差异（FEV、FEF、PEF、中重度加重、重度加重和所有加重的交互 P 值分别为 0.42、0.08、0.43、0.29、0.35 和 0.12）。在 PAL 亚组中，高剂量 MF/IND/GLY 与高剂量 MF/IND 和高剂量 FLU/SAL 相比，改善了谷值 FEV（平均差异：102mL[P<0.0001]和 137mL[P<0.0001]），并减少了中重度（16%和 32%）、重度（25%和 39%）和所有加重（19%和 38%）。
结论
每日一次固定剂量 MF/IND/GLY 对有和没有持续性气流受限的哮喘患者均有效。
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