Efficacy of tiotropium in COPD patients from Asia: A subgroup analysis from the UPLIFT trial
Efficacy of tiotropium in COPD patients from Asia: A subgroup analysis from the UPLIFT trial
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DOI：
10.1111/j.1440-1843.2011.01982.x
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发表时间：
2011-07-01
期刊：
影响因子：
6.9
通讯作者：
Tashkin, Donald
中科院分区：
文献类型：
--
作者：
Fukuchi, Yoshinosuke;Fernandez, Lenora;Tashkin, Donald
背景和目的：对慢性阻塞性肺病以外的呼吸系统疾病的研究表明，不同地区的患者对药物的反应可能不同。我们报告了对从先前报道的 4 年慢性阻塞性肺病试验中招募到亚洲中心的患者进行的亚组分析。方法：对每日 18 μg 噻托溴铵治疗 COPD 的随机、双盲、安慰剂对照试验进行亚组分析。主要终点是 FEV1 下降率。次要终点包括各个时间点的肺量测定、健康相关的生活质量（圣乔治呼吸问卷）、病情加重和死亡率。结果：5992 名患者中，362 名来自亚洲中心（100 名来自日本）。平均年龄 66 岁，95% 为男性，13% 目前吸烟，BMI：21 kg/m(2)；支气管扩张后 FEV(1)：预计 44%；圣乔治呼吸问卷总分：44 分。尽管亚洲患者的年下降幅度较小，但未观察到 FEV1 下降率的治疗效果。亚洲患者早晨使用支气管扩张剂前的 FEV(1) 和用力肺活量有所改善 (P < 0.05)。噻托溴铵减少了病情加重次数（比率（95% 置信区间 (CI)）：0.73 (0.57-0.94)）。病情加重和住院病情加重（噻托溴铵/对照）的风险比（95% CI）分别为 0.81（0.62-1.05）和 0.85（0.61-1.19）。使用噻托溴铵后，圣乔治呼吸问卷总分提高了 1.5-6.1 个单位（第 18、24、30 和 36 个月 P < 0.05）。 34 名噻托溴铵患者（18.5%）和 42 名对照患者（23.6%）发生了致命事件。结论：在亚洲的 COPD 患者中，经过 4 年的治疗，噻托溴铵可改善肺功能、改善健康相关的生活质量并减少病情加重。
Background and objective: Studies in respiratory diseases other than chronic obstructive pulmonary disease suggest potentially differing responses to medications among patients from different regions. We report a subgroup analysis of patients recruited to Asian centres from a previously reported 4-year COPD trial. Methods: Subgroup analysis from a randomized, double-blinded, placebo-controlled trial of tiotropium 18 mu g daily in COPD. Primary end-point was rate of decline in FEV(1). Secondary end-points included spirometry at individual time points, health-related quality of life (St George's Respiratory Questionnaire), exacerbations and mortality. Results: Of 5992 patients, 362 ere from Asian centres (100 from Japan). Mean age 66 years, 95% men, 13% current smokers, BMI: 21 kg/m(2); post-bronchodilator FEV(1): 44% predicted; St George's RespiratoryQuestionnaire total score: 44 units. No treatment effect was observed for rate of decline in FEV1 although annual decline was less in Asian patients. Morning pre-bronchodilator FEV(1) and forced vital capacity improved in Asian patients (P < 0.05). Tiotropium reduced number of exacerbations (rate ratio (95% confidence interval (CI)): 0.73 (0.57-0.94)). Hazard ratios (95% CI) for exacerbations and hospitalized exacerbations (tiotropium/control) were 0.81 (0.62-1.05) and 0.85 (0.61-1.19), respectively. St George's Respiratory Questionnaire total score improved by 1.5-6.1 units (P < 0.05 for months 18, 24, 30 and 36) with tiotropium. Fatal events occurred in 34 tiotropium(18.5%) and 42 control (23.6%) patients. Conclusions: In COPD patients from Asia, tiotropium improves lung function, improves health-related quality of life and reduces exacerbations over 4 years of treatment.