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Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD
Thorax ( IF 9.0 ) Pub Date : 2023-05-01 , DOI: 10.1136/thorax-2022-219620
Susan Muiser 1, 2 , Kai Imkamp 2, 3 , Dianne Seigers 3 , Nynke J Halbersma 3 , Judith M Vonk 2, 4 , Bart H D Luijk 5 , Gert-Jan Braunstahl 6 , Jan-Willem van den Berg 7 , Bart-Jan Kroesen 8 , Janwillem W H Kocks 2, 3, 9, 10 , Irene H Heijink 2, 3, 11 , Helen K Reddel 12, 13 , Huib A M Kerstjens 2, 3 , Maarten van den Berge 2, 3
Affiliation  

Background Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). Methods Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax budesonide/formoterol 160/4.5 µg 2 inhalations twice daily+1 prn) or fixed-dose therapy (Diskus fluticasone propionate/salmeterol combination (FSC) 500/50 µg 1 inhalation twice daily+salbutamol 100 µg prn) for 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. Results In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 µg/day vs 1747 µg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). Conclusions This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety. Data are available on reasonable request. Please contact the corresponding author in case of interest in potential data access.

中文翻译:

COPD 患者布地奈德/福莫特罗维持和缓解治疗与氟替卡松/沙美特罗固定剂量治疗的比较

背景 使用吸入皮质类固醇 (ICS)/福莫特罗的维持和缓解疗法 (MART) 可有效减少哮喘的恶化。我们的目的是比较其与固定剂量氟替卡松/沙美特罗在慢性阻塞性肺疾病 (COPD) 中的疗效。方法 患有 COPD 且在过去 2 年内有 ≥ 1 次急性加重的患者被随机分配到开放标签 MART(Spiromax 布地奈德/福莫特罗 160/4.5 µg 2 次吸入,每天两次 + 1 prn)或固定剂量治疗(丙酸氟替卡松/沙美特罗组合) (FSC) 500/50 µg 1 次吸入,每天两次 + 沙丁胺醇 100 µg prn),为期 1 年。主要结果是中度/重度恶化的发生率,定义为口服泼尼松龙和/或抗生素治疗。结果 总共有 195 名患者被随机分组​​(MART Bud/Form n=103;固定剂量 FSC n=92)。在恶化率方面,MART 和 FSC 治疗之间没有显着差异(分别为 1.32 对 1.32 / 年,比率为 1.05(95% CI 0.79 至 1.39);p=0.741)。未观察到肺功能参数或健康状况的差异。MART 的总 ICS 剂量显着低于 FSC 治疗(布地奈德当量分别为 928 µg/天和 1747 µg/天,p<0.05)。相似比例的患者报告了不良事件(MART Bud/Form:73% vs 固定剂量 FSC:68%,p=0.408)和肺炎(MART:5% vs FSC:1%,p=0.216)。结论 这项针对 COPD 患者的 MART 研究发现,布地奈德/福莫特罗 MART 可能与氟替卡松/沙美特罗固定剂量治疗在中度至重度 COPD 患者中具有相似的疗效,但每日 ICS 剂量较低。需要关于长期安全性的进一步证据。可应合理要求提供数据。如果对潜在的数据访问感兴趣,请联系相应的作者。
更新日期:2023-04-13
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