a Clinic of Social and Family Medicine, Faculty of Medicine , University of Crete , Crete , Greece.
b Novartis Pharma AG , Basel , Switzerland.
COPD. 2017 Aug;14(4):375-381. doi: 10.1080/15412555.2017.1324837. Epub 2017 Jun 8.
In this pooled analysis, we compared the effect of indacaterol/glycopyrronium (IND/GLY) by sex versus other commonly used chronic obstructive pulmonary disease (COPD) treatments and placebo. Male and female patients with moderate-to-very-severe COPD who had participated in six randomized controlled trials were included in the analysis. Baseline demographics and disease characteristics were analyzed by sex, and any differences noted. The effects of IND/GLY versus salmeterol/fluticasone (SFC), glycopyrronium, tiotropium and placebo, on lung function and the patient-reported outcomes (health status, dyspnea, rescue medication use and symptoms) were assessed by sex after 26 weeks treatment. The analysis population comprised 4719 men and 1389 women. Most baseline parameters differed significantly between men and women. Nonetheless, despite these differences in baseline characteristics, IND/GLY significantly improved lung function versus placebo (p < 0.0001) and all active comparators (p < 0.01) in men and women. Overall, IND/GLY showed better improvement in dyspnea and health status compared with all other treatments in both sex. Greater reduction of rescue medication use was observed with IND/GLY versus placebo and other treatments (all p < 0.01 expect IND/GLY versus SFC). Although some variability was observed, improvements in health status, dyspnea, rescue medication use and symptoms were generally larger in women than in men. Irrespective of sex, IND/GLY provided superior efficacy to monotherapy or SFC in both men and women. Small differences in efficacy response by sex were observed, which should be evaluated further in prospective clinical studies. Nevertheless, the benefits observed with IND/GLY confirm dual bronchodilator as the preferred therapy in patients with moderate-to-very-severe COPD regardless of sex.
在这项汇总分析中，我们比较了茚达特罗/格隆溴铵（IND/GLY）与其他常用慢性阻塞性肺疾病（COPD）治疗药物和安慰剂的疗效差异，并按性别进行了比较。纳入了参加过六项随机对照试验的中重度至极重度 COPD 男性和女性患者，分析了按性别分层的基线人口统计学和疾病特征，并记录了任何差异。在 26 周治疗后，按性别评估了 IND/GLY 与沙美特罗/氟替卡松（SFC）、格隆溴铵、噻托溴铵和安慰剂相比对肺功能和患者报告的结局（健康状况、呼吸困难、急救药物使用和症状）的影响。分析人群包括 4719 名男性和 1389 名女性。大多数基线参数在男性和女性之间存在显著差异。尽管存在这些基线特征差异，但与安慰剂和所有活性对照药物相比，IND/GLY 在男性和女性中均显著改善了肺功能（p<0.0001）。总体而言，与所有其他治疗药物相比，IND/GLY 在两性中均能更好地改善呼吸困难和健康状况。与安慰剂和其他治疗药物相比（除 IND/GLY 与 SFC 相比外，p<0.01），IND/GLY 观察到急救药物使用减少更大。尽管存在一些差异，但与男性相比，女性的健康状况、呼吸困难、急救药物使用和症状改善通常更大。无论性别如何，与单药治疗或 SFC 相比，IND/GLY 在男性和女性中均提供了更好的疗效。观察到了性别对疗效反应的微小差异，这应在未来的临床研究中进一步评估。然而，无论性别如何，使用 IND/GLY 观察到的获益均证实，对于中重度至极重度 COPD 患者，双支气管扩张剂治疗是首选疗法。
