Respiratory Medicine, Kyoto University, 54 Kawahara Shogoin Sakyo, Kyoto, 606-8507, Japan.
Medicine Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
Adv Ther. 2022 Oct;39(10):4692-4706. doi: 10.1007/s12325-022-02268-1. Epub 2022 Aug 10.
Real-world evidence is needed to optimize pharmacotherapy for chronic obstructive pulmonary disease (COPD). The effectiveness of inhaled tiotropium/olodaterol according to baseline symptoms and previous COPD treatment and predictors of response were assessed.
This was a post hoc analysis of a 52-week post-marketing surveillance study of tiotropium/olodaterol in 1255 Japanese patients with COPD of all severities. We analyzed change in total COPD Assessment Test (CAT) score and lung function (forced expiratory volume in 1 s [FEV] and forced vital capacity [FVC]). Patient subgroups were analyzed based on baseline CAT score (< 10 [n = 184], ≥ 10 [n = 507]) and previous COPD treatment (treatment-naive [n = 407], previously treated [n = 848], treatment with long-acting muscarinic antagonist monotherapy [n = 161]).
In the CAT ≥ 10 subgroup, tiotropium/olodaterol showed statistically significant improvements in mean total CAT score (- 6.2; 95% confidence interval [CI] - 7.2, - 5.1), FEV (0.109 L; 95% CI 0.059, 0.159) and FVC (0.171 L; 95% CI 0.096, 0.245), which continued through Week 52. CAT score and lung function improvement were greatest in treatment-naive patients: - 7.6 (95% CI - 9.2, - 6.1) mean total CAT score, 0.177 L (95% CI 0.076, 0.279) mean FEV and 0.178 L (95% CI 0.036, 0.319) mean FVC. Baseline factors associated with treatment response (total CAT score improvement ≥ 2 points) were: shorter COPD duration (odds ratio [OR] 0.91; 95% CI 0.87, 0.96), total CAT score ≥ 10 (OR 3.86; 95% CI 2.46, 6.06) and treatment-naive status (OR 1.86; 95% CI 1.12, 3.07). Baseline total CAT scores ≥ 13 predicted responses to tiotropium/olodaterol in all previous COPD treatment subgroups including treatment-naive patients.
Tiotropium/olodaterol improved symptoms and lung function in Japanese COPD patients. Our results support the possible use of tiotropium/olodaterol in treatment-naive patients and those with total CAT scores ≥ 10.
Clinicaltrials.gov Identifier for parent study: NCT02850978.
需要真实世界的证据来优化慢性阻塞性肺疾病（COPD）的药物治疗。评估了根据基线症状和既往 COPD 治疗以及反应预测因子使用噻托溴铵/奥达特罗的吸入治疗的效果。
这是噻托溴铵/奥达特罗上市后 52 周监测研究的一项事后分析，该研究纳入了所有严重程度的 1255 例日本 COPD 患者。我们分析了总 COPD 评估测试（CAT）评分和肺功能（1 秒用力呼气量[FEV]和用力肺活量[FVC]）的变化。根据基线 CAT 评分（<10[ n=184]，≥10[n=507]）和既往 COPD 治疗（初治[ n=407]、既往治疗[n=848]、长效毒蕈碱拮抗剂单药治疗[n=161]）对患者亚组进行了分析。
在 CAT≥10 亚组中，噻托溴铵/奥达特罗治疗可显著改善平均总 CAT 评分（-6.2；95%置信区间[CI]：-7.2，-5.1）、FEV（0.109 L；95%CI：0.059，0.159）和 FVC（0.171 L；95%CI：0.096，0.245），这种改善持续到第 52 周。初治患者的 CAT 评分和肺功能改善最大：总 CAT 评分平均降低 7.6（95%CI：-9.2，-6.1），FEV 平均增加 0.177 L（95%CI：0.076，0.279），FVC 平均增加 0.178 L（95%CI：0.036，0.319）。与治疗反应相关的基线因素（总 CAT 评分改善≥2 分）包括：COPD 病程较短（比值比[OR]：0.91；95%CI：0.87，0.96）、总 CAT 评分≥10（OR：3.86；95%CI：2.46，6.06）和初治状态（OR：1.86；95%CI：1.12，3.07）。基线总 CAT 评分≥13 可预测所有既往 COPD 治疗亚组（包括初治患者）对噻托溴铵/奥达特罗的反应。
噻托溴铵/奥达特罗改善了日本 COPD 患者的症状和肺功能。我们的结果支持在初治患者和总 CAT 评分≥10 的患者中使用噻托溴铵/奥达特罗。
该研究的母体研究在美国临床试验数据库的注册号为：NCT02850978。
