Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials
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DOI：
10.1016/s0140-6736(09)61252-6
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发表时间：
2009-08-01
期刊：
影响因子：
168.9
通讯作者：
Rabe, Klaus F.
中科院分区：
文献类型：
--
作者：
Fabbri, Leonardo M.;Calverley, Peter M. A.;Rabe, Klaus F.
背景慢性阻塞性肺疾病（COPD）患者的治疗选择很少。磷酸二酯酶-4抑制剂罗氟司特的有效性和安全性已在中重度COPD患者的研究中进行了研究，但未在同时接受长效吸入性支气管扩张剂治疗的患者中进行研究。罗氟司特对已经接受沙美特罗或噻托溴铵治疗的中重度COPD患者肺功能的影响进行了调查。方法在两项双盲、多中心研究中，在门诊进行，经过4周的导入，年龄大于40岁的中重度COPD患者被随机分配到口服罗氟司特500 μ g或安慰剂组，每天一次，持续24周，除沙美特罗（M2-127研究）或噻托溴铵（M2-128研究）外。主要终点为使用支气管扩张剂前1秒用力呼气量（FEV 1）的变化。分析是通过意向治疗进行的。这些研究已在ClinicalTrials.gov上注册，M2-127的注册号为NCT 00313209，M2- 128的注册号为NCT 00424268。结果在沙美特罗加罗氟司特试验中，466名患者被分配接受罗氟司特治疗，467名患者接受安慰剂治疗;在噻托溴铵加罗氟司特试验中，371名患者被分配接受罗氟司特治疗，372名患者接受安慰剂治疗。与安慰剂相比，罗氟司特持续改善平均使用支气管扩张剂前FEV 1 49 mL（p
Background Patients with chronic obstructive pulmonary disease (COPD) have few options for treatment. The efficacy and safety of the phosphodiesterase-4 inhibitor roflumilast have been investigated in studies of patients with moderate-to-severe COPD, but not in those concomitantly treated with longacting inhaled bronchodilators. The effect of roflumilast on lung function in patients with COPD that is moderate to severe who are already being treated with salmeterol or tiotropium was investigated.Methods In two double-blind, multicentre studies done in an outpatient setting, after a 4-week run-in, patients older than 40 years with moderate-to-severe COPD were randomly assigned to oral roflumilast 500 mu g or placebo once a day for 24 weeks, in addition to salmeterol (M2-127 study) or tiotropium (M2-128 study). The primary endpoint was change in prebronchodilator forced expiratory volume in 1s (FEV1). Analysis was by intention to treat. The studies are registered with ClinicalTrials.gov, number NCT00313209 for M2-127, and NCT00424268 for M2-128.Findings In the salmeterol plus roflumilast trial, 466 patients were assigned to and treated with roflumilast and 467 with placebo; in the tiotropium plus roflumilast trial, 371 patients were assigned to and treated with roflumilast and 372 with placebo. Compared with placebo, roflumilast consistently improved mean prebronchodilator FEV1 by 49 mL (p