Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Respiratory Medicine, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
NPJ Prim Care Respir Med. 2015 Nov 5;25:15067. doi: 10.1038/npjpcrm.2015.67.
Patients with chronic obstructive pulmonary disease (COPD) who were naive to anticholinergics before the TIOtropium Safety and Performance In Respimat (TIOSPIR) trial may reflect patients seen in practice, in particular in primary care. In addition, investigating safety in these patients avoids the potential bias in patients who previously received anticholinergics and may be tolerant of their effects.
The aim of this study was to evaluate whether patients naive to anticholinergic therapy who were treated with tiotropium Respimat 2.5 or 5 μg had different safety and efficacy outcomes than patients treated with tiotropium HandiHaler 18 μg.
A post hoc analysis of patients who were not receiving anticholinergics before TIOSPIR (N=6,966/17,135) was conducted. Primary end points were risk of death from any cause and risk of COPD exacerbation. Secondary outcomes included severe exacerbation and major adverse cardiovascular events (MACE). Additional analysis of exacerbations was carried out in anticholinergic-naive patients with moderate (GOLD II) disease.
Anticholinergic-naive patients had less severe disease than the total TIOSPIR population. Discontinuations because of anticholinergic side effects were infrequent (0.9% overall). Similar to the primary study, patients in the tiotropium Respimat groups had no difference in the risk of death or risk of any or severe exacerbation than patients treated with tiotropium HandiHaler. Risk of MACE was similar across the Respimat and HandiHaler groups. Rates of exacerbations in the subgroup of patients with moderate disease were similar across the Respimat and HandiHaler groups.
Tiotropium Respimat and HandiHaler have similar safety and efficacy profiles in patients who are naive to anticholinergic therapy.
在 TIOtropium Safety and Performance In Respimat（TIOSPIR）试验之前未使用过抗胆碱能药物的慢性阻塞性肺疾病（COPD）患者可能反映了实际中见到的患者，尤其是在初级保健中。此外，在这些患者中调查安全性可避免先前接受过抗胆碱能药物且可能耐受其作用的患者的潜在偏倚。
本研究旨在评估与接受噻托溴铵 HandiHaler 18μg 治疗的患者相比，未接受过抗胆碱能治疗的噻托溴铵 Respimat 2.5μg 或 5μg 治疗的患者的安全性和疗效是否存在差异。
对 TIOSPIR 中未接受抗胆碱能药物治疗的患者（N=6966/17135）进行了一项事后分析。主要终点是任何原因导致的死亡风险和 COPD 加重风险。次要结局包括严重加重和主要不良心血管事件（MACE）。在中度（GOLD II）疾病的抗胆碱能药物治疗患者中进行了对加重的额外分析。
与 TIOSPIR 总人群相比，抗胆碱能药物治疗患者的疾病严重程度较轻。由于抗胆碱能副作用而停药的情况很少见（总体为 0.9%）。与主要研究相似，噻托溴铵 Respimat 组的患者在死亡风险或任何或严重加重风险方面与噻托溴铵 HandiHaler 组的患者无差异。MACE 风险在 Respimat 和 HandiHaler 组之间相似。在中度疾病患者亚组中，加重的发生率在 Respimat 和 HandiHaler 组之间相似。
在抗胆碱能药物治疗患者中，噻托溴铵 Respimat 和 HandiHaler 的安全性和疗效相似。
