The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide
The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide
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DOI：
10.1164/rccm.200707-973oc
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发表时间：
2008-01-01
影响因子：
24.7
通讯作者：
Stockley, Robert A.
中科院分区：
文献类型：
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作者：
Wedzicha, Jadwiga A.;Calverley, Peter M. A.;Stockley, Robert A.
理由。急性加重是慢性阻塞性肺疾病（COPD）发病率和死亡率的主要驱动因素。目的：我们比较了长效吸入性支气管舒张剂/吸入性支气管舒张剂联合治疗的相对疗效。（沙美特罗/丙酸氟替卡松）50/500 μ g，每日两次，长效支气管扩张剂（噻托溴铵）18 μ g每日一次预防重度和极重度COPD的急性加重和相关结果。在这项为期2年的双盲、双模拟平行研究中，共有1,323名患者（平均年龄64岁，使用支气管扩张剂后的FEV 1，39%预测值）被随机分组。其他终点包括通过圣乔治呼吸问卷（SGRQ）测量的健康状况、死亡率、不良事件和退出研究。噻托溴铵组退出研究的概率比沙美特罗/丙酸氟替卡松组高29%（P = 0.005）。沙美特罗/丙酸氟替卡松组和噻托溴铵组的模型年急性加重率分别为1.28和1.32（率比，0.967; 95%置信区间[CI]，0.836-1.119]; P = 0.656）。沙美特罗/丙酸氟替卡松组第2年的SGRQ总分低于噻托溴铵组，具有统计学显著性（差异2.1个单位; 95% CI，0.1-4.0; P = 0.038）。沙美特罗/丙酸氟替卡松组的死亡率显著较低;该组有21例（3%）患者死亡，噻托溴铵组有38例（6%）患者死亡（P = 0.032）。与噻托溴铵组相比，沙美特罗/丙酸氟替卡松组报告的肺炎更多（P = 0.008）。结论：我们发现沙美特罗/丙酸氟替卡松组与噻托溴铵组之间的急性加重率无差异。更多患者在接受噻托溴铵治疗期间未能完成研究。发现对健康状况有统计学显著性的微小有益影响，沙美特罗/丙酸氟替卡松治疗患者的死亡率意外降低。
Rationale. Exacerbations are key drivers of morbidity and mortality in chronic obstructive pulmonary disease (COPD).Objectives: We compared the relative efficacy of the long-acting inhaled bronchoclilator/antiinflammatory combination (salmeterol/ fluticasone propionate) 50/500 mu g twice daily and the long-acting bronchodilator (tiotropium) 18 mu g once daily in preventing exacerbations and related outcomes in severe and very severe COPD.Methods: A total of 1,323 patients (mean age, 64 yr, post-bronchodilator-FEV1, 39% predicted) were randomized in this 2-year, double-blind, double-dummy parallel study.Measurements and Main Results: Primary endpoint was health care utilization exacerbation rate. Other end points included health status measured by St. George's Respiratory Questionnaire (SGRQ), mortality, adverse events, and study withdrawal. Probability of withdrawing from the study was 29% greater with tiotropium than salmeterol/fluticasone propionate (P = 0.005). The modeled annual exacerbation rate was 1.28 in the salmeterol/fluticasone propionate group and 1.32 in the tiotropium group (rate ratio, 0.967; 95% confidence interval [CI], 0.836-1.119]; P = 0.656). The SGRQ total score was statistically significantly lower at 2 years on salmeterol/ fluticasone propionate versus tiotropium (difference 2.1 units; 95% CI, 0.1-4.0; P = 0.038). Mortality was significantly lower in the salmeterol/fluticasone propionate group; 21 (3%) of patients in this group died compared with 38 (6%) in the tiotropium group (P = 0.032). More pneumonias were reported in the salmeterol/fluticasone propionate group relative to tiotropium (P = 0.008).Conclusions: We found no difference in exacerbation rate between salmeterol/fluticasone propionate and tiotropium. More patients failed to complete the study while receiving tiotropium. A small statistically significant beneficial effect was found on health status, with an unexpected finding of lower deaths in salmeterol/fluticasone propionate-treated patients.