噻托溴铵随机对照临床试验中美国参与者恶化情况的事后汇总分析。

A post hoc pooled analysis of exacerbations among US participants in randomized controlled trials of tiotropium.

机构信息

Pulmonary/Critical Care, University of Texas Health Science Center, 111E, 7400 Merton Minter Blvd, San Antonio, TX 78229, USA.

出版信息

Respir Med. 2013 Dec;107(12):1912-22. doi: 10.1016/j.rmed.2013.07.020. Epub 2013 Aug 20.

DOI:10.1016/j.rmed.2013.07.020

PMID:23969305

Abstract

BACKGROUND

Exacerbations are a defining outcome of chronic obstructive pulmonary disease (COPD). We evaluated the effect of tiotropium on COPD exacerbations and related hospitalizations among patients from the USA enrolled in clinical trials.

METHODS

Data were pooled from six randomized, double-blind, placebo-controlled trials (6 to ≥ 12 months' duration) of tiotropium in patients with COPD. Exacerbations were defined retrospectively as an increase in or new onset of >1 respiratory symptom lasting for ≥ 3 days and requiring treatment with systemic corticosteroids and/or antibiotics. Time to first exacerbation or hospitalization and exacerbation rates were analyzed at 6 months, and at 1 year for studies ≥ 1 year.

RESULTS

In total, 4355 patients (tiotropium, 2268, placebo, 2087; mean age 66.5 years; forced expiratory volume in 1 s [FEV1] 1.03 L [35.5% predicted]) were analyzed at 6 months and 2455 at 1 year (tiotropium 1317, placebo 1138; mean age 65.5 years; FEV1 1.03 L [37.0% predicted]). Tiotropium delayed time to first exacerbation or first hospitalized exacerbation at 6 months (hazard ratios [HRs], 0.80, 0.65, respectively; p < 0.001 vs placebo) and 1 year (HRs, 0.73 and 0.55; p < 0.001 vs placebo) and reduced exacerbation rates and hospitalization rates (6 months: HRs, 0.79, 0.64; 1 year: HRs, 0.78, 0.56, respectively; all p < 0.01 vs placebo). Tiotropium significantly reduced exacerbations, irrespective of inhaled corticosteroid use at baseline. Tiotropium was not associated with an increased risk of cardiac-related events.

CONCLUSIONS

Tiotropium significantly reduced the risk and rates of exacerbations and hospitalizations among US patients with COPD.

摘要

背景

加重是慢性阻塞性肺疾病（COPD）的一个重要结局。我们评估了噻托溴铵对美国入组临床试验的 COPD 患者加重事件和相关住院的影响。

方法

汇总了噻托溴铵治疗 COPD 的 6 项随机、双盲、安慰剂对照临床试验（6-≥12 个月）的数据。加重事件通过回顾性定义为呼吸症状持续≥3 天且需要全身皮质激素和/或抗生素治疗的症状增加或新出现。在 6 个月时和对于≥1 年的研究在 1 年时分析首次加重或住院的时间和加重率。

结果

共有 4355 例患者（噻托溴铵组 2268 例，安慰剂组 2087 例；平均年龄 66.5 岁；第 1 秒用力呼气容积占预计值的百分比[FEV1]1.03 L [35.5%]）在 6 个月时进行了分析，2455 例在 1 年时进行了分析（噻托溴铵组 1317 例，安慰剂组 1138 例；平均年龄 65.5 岁；FEV1 1.03 L [37.0%]）。噻托溴铵延迟了首次加重或首次住院加重的时间（6 个月：风险比[HR]分别为 0.80、0.65，p<0.001 与安慰剂相比；1 年：HR 分别为 0.73 和 0.55，p<0.001 与安慰剂相比），并降低了加重率和住院率（6 个月：HR 分别为 0.79、0.64；1 年：HR 分别为 0.78、0.56，均 p<0.01 与安慰剂相比）。无论基线时是否使用吸入皮质激素，噻托溴铵都显著降低了加重事件的风险。噻托溴铵与心脏相关事件的风险增加无关。