Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754 Auckland, New Zealand.
Drugs. 2013 May;73(7):741-53. doi: 10.1007/s40265-013-0058-7.
Inhaled glycopyrronium bromide (Seebri(®) Breezhaler(®) capsules; NVA237) is a once-daily, long-acting muscarinic receptor antagonist (LAMA) that is approved in several countries, including the EU, as a maintenance bronchodilator for the symptomatic treatment of adult patients with chronic obstructive pulmonary disease (COPD). In the randomized, controlled, phase III GLOW (GLycopyrronium bromide in chronic Obstructive pulmonary disease airWays clinical study)-1 and -2 trials, treatment with inhaled glycopyrronium bromide 50 μg once daily was associated with significantly better lung function than placebo in patients with moderate to severe COPD in terms of the trough forced expiratory volume in one second (FEV1) at 12 weeks (primary endpoint). Significant between-group differences in trough FEV1 in favour of inhaled glycopyrronium bromide were maintained for up to 52 weeks. Dyspnoea scores, health status and exacerbation rates were also improved to a greater extent in the inhaled glycopyrronium bromide than placebo groups in these trials. In the randomized, controlled, phase III GLOW3 trial, inhaled glycopyrronium bromide was associated with a significantly longer exercise endurance time than placebo after 3 weeks' treatment in patients with moderate to severe COPD. The drug was generally well tolerated over the 26-week (GLOW1) or 52-week (GLOW2) study duration, and had a tolerability profile that was generally similar to that of tiotropium bromide. Serious adverse events were consistent with those expected in patients with moderate to severe COPD. In conclusion, inhaled glycopyrronium bromide is a once-daily LAMA that is an effective bronchodilator for use in the treatment of patients with moderate to severe COPD.
吸入性格隆溴铵（Seebri® Breezhaler®胶囊；NVA237）是一种每日一次的长效毒蕈碱受体拮抗剂（LAMA），已在包括欧盟在内的多个国家获得批准，作为慢性阻塞性肺疾病（COPD）成年患者症状性治疗的维持性支气管扩张剂。在随机、对照、III 期 GLOW（GLycopyrronium bromide in chronic Obstructive pulmonary disease airWays clinical study）-1 和 -2 试验中，与安慰剂相比，每日一次吸入 50μg 格隆溴铵治疗可显著改善中重度 COPD 患者的肺功能，12 周时（主要终点）表现为谷值用力呼气量（FEV1）。在长达 52 周的时间内，吸入性格隆溴铵组的谷值 FEV1 较安慰剂组持续存在显著的组间差异。在这些试验中，与安慰剂组相比，吸入性格隆溴铵组的呼吸困难评分、健康状况和恶化率也得到了更大程度的改善。在随机、对照、III 期 GLOW3 试验中，与安慰剂相比，在 3 周治疗后，中度至重度 COPD 患者的运动耐力时间显著延长。在 26 周（GLOW1）或 52 周（GLOW2）的研究期间，该药总体耐受性良好，其耐受性与噻托溴铵相似。严重不良事件与中度至重度 COPD 患者预期的一致。总之，吸入性格隆溴铵是一种每日一次的 LAMA，是治疗中重度 COPD 患者的有效支气管扩张剂。
