Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials
Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials
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DOI：
10.1016/s0140-6736(09)61255-1
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发表时间：
2009-08-01
期刊：
影响因子：
168.9
通讯作者：
Martinez, Fernando J.
中科院分区：
文献类型：
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作者：
Calverley, Peter M. A.;Rabe, Klaus F.;Martinez, Fernando J.
磷酸二酯酶-4抑制剂罗氟司特可以改善某些慢性阻塞性肺疾病（COPD）患者的肺功能，预防病情加重。因此，我们研究了罗氟司特是否会减少COPD患者需要皮质类固醇的急性加重的频率。（M2-124和M2-125），采用相同设计，在门诊环境中的两个不同人群中进行，年龄大于40岁的COPD患者，伴有严重气流受限、支气管炎症状，和有急性加重史的患者被随机分配口服罗氟司特（500 μ g，每天一次）或安慰剂52周。主要终点为使用支气管扩张剂前1秒用力呼气量（FEV 1）的变化和中度（糖皮质激素治疗）或重度急性加重率。这些试验在ClinicalTrials.gov注册，M2-124的试验编号为NCT 00297102，M2- 125的试验编号为NCT 00297115。结果患者被分配到治疗组，根据吸烟状况和长效β 2受体激动剂治疗进行分层，并给予罗氟司特（n=1537）或安慰剂（n=1554）。在两项研究中，均达到了预先规定的主要终点，并且幅度相似。在汇总分析中，与安慰剂相比，罗氟司特组使用支气管扩张剂前FEV 1增加48 mL（p
Background The phosphodiesterase-4 inhibitor roflumilast can improve lung function and prevent exacerbations in certain patients with chronic obstructive pulmonary disease (COPD). We therefore investigated whether roflumilast would reduce the frequency of exacerbations requiring corticosteroids in patients with COPD.Methods In two placebo-controlled, double-blind, multicentre trials (M2-124 and M2-125) with identical design that were done in two different populations in an outpatient setting, patients with COPD older than 40 years, with severe airflow limitation, bronchitic symptoms, and a history of exacerbations were randomly assigned to oral roflumilast (500 mu g once per day) or placebo for 52 weeks. Primary endpoints were change in prebronchodilator forced expiratory volume in 1 s (FEV1) and the rate of exacerbations that were moderate (glucocorticosteroid-treated) or severe. Analysis was by intention to treat. The trials are registered with ClinicalTrials.gov, number NCT00297102 for M2-124, and NCT00297115 for M2-125.Findings Patients were assigned to treatment, stratified according to smoking status and treatment with longacting beta(2) agonists, and given roflumilast (n=1537) or placebo (n=1554). In both studies, the prespecified primary endpoints were achieved and were similar in magnitude. In a pooled analysis, prebronchodilator FEV1 increased by 48 mL with roflumilast compared with placebo (p