Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial
Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial
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DOI：
10.1016/s0140-6736(09)61298-8
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发表时间：
2009-10-03
期刊：
影响因子：
168.9
通讯作者：
Tashkin, Donald P.
中科院分区：
文献类型：
--
作者：
Decramer, Marc;Celli, Bartolome;Tashkin, Donald P.
背景药物治疗对慢性阻塞性肺疾病（COPD）的有益作用已得到充分证实。然而，在疾病的早期阶段治疗的数据很少。我们研究了噻托溴铵对一个大的亚组中的中度COPD患者的结局的影响。方法了解噻托溴铵（UPLIFT）研究的潜在长期影响功能是一项随机，双盲，安慰剂对照试验进行了487个中心在37个国家。5993例40岁或以上的COPD患者被随机分配接受4年的噻托溴铵（18 μ g; n=2987）或匹配安慰剂（n=3006）每日一次治疗，通过吸入装置给药。通过计算机生成的四个区组进行随机化，并根据研究中心进行分层。在预先指定的亚组分析中，我们研究了噻托溴铵在慢性阻塞性肺疾病全球倡议（GOLD）II期疾病患者中的作用。主要终点是从第30天开始直至双盲治疗结束期间使用支气管扩张剂前1秒用力呼气量（FEV（1））和使用支气管扩张剂后FEV的年下降率。该分析包括所有至少有三次肺功能测量的患者。该研究注册于ClinicalTrials.gov，编号NCT 00144339。结果2739例受试者（平均年龄64岁[SD 9]）在随机化时患有GOLD II期疾病（噻托溴铵，n=1384;对照，n=1355），平均支气管扩张剂后FEV（1）为1.63 L（SD 0.37;预测值的59%）。噻托溴铵组1218例患者和对照组1157例患者在第30天后进行了3次或3次以上支气管扩张剂给药后肺功能测量，并被纳入分析。噻托溴铵组使用支气管扩张剂后平均FEV（1）的下降率低于对照组（43 mL/年[SE 2] vs 49 mL/年[SE 2]，p= 0.024）。对于使用支气管扩张剂前的肺功能，噻托溴铵组1221例患者和对照组1158例患者进行了3次或3次以上测量，并纳入分析。使用支气管扩张剂前FEV（1）的平均下降率在两组之间没有差异（35 mL/年[SE 2] vs 37 mL/年[SE 2]; p=0.38）。采用St乔治呼吸问卷测量的健康状况，噻托溴铵组在所有时间点均优于对照组（p
Background The beneficial effects of pharmacotherapy for chronic obstructive pulmonary disease (COPD) are well established. However, there are few data for treatment in the early stages of the disease. We examined the effect of tiotropium on outcomes in a large subgroup of patients with moderate COPD.Methods The Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) study was a randomised, double-blind, placebo-controlled trial undertaken in 487 centres in 37 countries. 5993 patients aged 40 years or more with COPD were randomly assigned to receive 4 years of treatment with either once daily tiotropium (18 mu g; n=2987) or matching placebo (n=3006), delivered by an inhalation device. Randomisation was by computer-generated blocks of four, with stratification according to study site. In a prespecified subgroup analysis, we investigated the effects of tiotropium in patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II disease. Primary endpoints were the yearly rates of decline in prebronchodilator forced expiratory volume in 1 s (FEV(1)) and in postbronchodilator FEV beginning on day 30 until completion of double-blind treatment. The analysis included all patients who had at least three measurements of pulmonary function. This study is registered with ClinicalTrials.gov, number NCT00144339.Findings 2739 participants (mean age 64 years [SD 9]) had GOLD stage II disease at randomisation (tiotropium, n=1384; control, n=1355), with a mean postbronchodilator FEV(1) of 1.63 L (SD 0.37; 59% of predicted value). 1218 patients in the tiotropium group and 1157 in the control group had three or more measurements of postbronchodilator pulmonary function after day 30 and were included in the analysis. The rate of decline of mean postbronchodilator FEV(1) was lower in the tiotropium group than in the control group (43 mL per year [SE 2] vs 49 mL per year [SE 2], p=0024). For prebronchodilator pulmonary function, 1221 patients in the tiotropium group and 1158 in the control group had three or more measurements and were included in the analysis. The rate of decline of mean prebronchodilator FEV(1) did not differ between groups (35 mL per year [SE 2] vs 37 mL per year [SE 2]; p=0.38). Health status, measured with the St George's Respiratory Questionnaire, was better at all timepoints in the tiotropium group than in the control group (p