Kaplan Alan, Chapman Kenneth R, Anees Syed M, Mayers Irvin, Rochdi Driss, Djandji Michel, Préfontaine David, McIvor Andrew
Family Physician Airways Group of Canada, University of Toronto, Toronto, ON, Canada,
Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.
Int J Chron Obstruct Pulmon Dis. 2019 Jan 18;14:249-260. doi: 10.2147/COPD.S185485. eCollection 2019.
In contrast to randomized controlled trials (RCTs), changes in maintenance pharmacotherapy in clinical practice occur without a washout period. The Prospective cohort study for the real-life effectiveness evaluation of glycOpyrronium With indacatERol combination in the management of COPD in Canada (POWER) study evaluated the real-life effectiveness of indacaterol/glycopyrronium (IND/GLY) following a direct switch from a long-acting muscarinic antagonist (LAMA, tiotropium) or long-acting β-agonist (LABA)/inhaled corticosteroid (ICS) maintenance treatment (salmeterol/fluticasone [SFC]).
POWER was a single-cohort, prospective, multicenter, interventional study in which patients with moderate-to-severe COPD, who remained symptomatic on their current treatment of once-daily (od) tiotropium 18 µg or twice-daily (bid) SFC (any dose), were switched to treatment with open-label IND/GLY 110/50 µg od for 16 weeks. Effectiveness end points were change from baseline in trough FEV, transition dyspnea index (TDI) total scores, and COPD assessment test (CAT) scores at 16 weeks.
Trough FEV improved by 175 mL at Week 16 in patients who switched to IND/GLY. The change was 176 mL (95% CI: 135-217) when switched from tiotropium and 172 mL (95% CI: 85-258) when switched from SFC fixed-dose combination (FDC). At Week 16, significant improvements were observed in the mean TDI total scores (Δ=2.5) and CAT scores (Δ=-6.5) after the switch to IND/GLY treatment (both <0.0001). Additionally, IND/GLY was well tolerated in patients with moderate-to-severe COPD, and no safety signal was observed.
In clinical practice settings, a direct switch from previous treatment with either tiotropium or SFC to IND/GLY was safe and provided superior clinically significant improvements in lung function and patient-related outcomes in patients with moderate-to-severe COPD.
NCT02202616.
与随机对照试验（RCT）不同，临床实践中维持药物治疗的改变是在没有洗脱期的情况下发生的。加拿大格隆溴铵与茚达特罗联合用于慢性阻塞性肺疾病（COPD）管理的现实生活有效性评估前瞻性队列研究（POWER）评估了从长效毒蕈碱拮抗剂（LAMA，噻托溴铵）或长效β受体激动剂（LABA）/吸入性糖皮质激素（ICS）维持治疗（沙美特罗/氟替卡松[SFC]）直接转换后茚达特罗/格隆溴铵（IND/GLY）的现实生活有效性。
POWER是一项单队列、前瞻性、多中心干预性研究，中度至重度COPD患者，目前接受每日一次（od）18μg噻托溴铵或每日两次（bid）SFC（任何剂量）治疗且仍有症状，改为开放标签IND/GLY 110/50μg od治疗16周。有效性终点为16周时与基线相比的谷值FEV变化、过渡性呼吸困难指数（TDI）总分以及慢性阻塞性肺疾病评估测试（CAT）分数。
改为IND/GLY治疗的患者在第16周时谷值FEV改善了175 mL。从噻托溴铵转换时变化为176 mL（95% CI：135 - 217），从SFC固定剂量组合（FDC）转换时为172 mL（95% CI：85 - 258）。在第16周时，改为IND/GLY治疗后，平均TDI总分（Δ = 2.5）和CAT分数（Δ = -6.5）有显著改善（均P < 0.0001）。此外，IND/GLY在中度至重度COPD患者中耐受性良好，未观察到安全信号。
在临床实践环境中，从中度至重度COPD患者先前的噻托溴铵或SFC治疗直接转换为IND/GLY是安全的，并且在肺功能和患者相关结局方面提供了显著的临床改善。
NCT02202616。
