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Inhaled glycopyrronium bromide: A review of its use in patients with moderate to severe chronic obstructive pulmonary disease

机译:吸入格隆溴铵:在中度至重度慢性阻塞性肺疾病患者中的应用回顾

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摘要

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.
机译:吸入式格隆溴铵(Seebri?Breezhaler®胶囊; NVA237)是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/地区获得批准,作为维持性支气管扩张剂,用于对症患者进行对症治疗慢性阻塞性肺疾病(COPD)。在随机,对照的III期GLOW(慢性阻塞性肺疾病airWays临床研究中的溴化吡咯溴铵)-1和-2试验中,对于中度患者,每天一次吸入50μg格隆溴铵吸入治疗比安慰剂显着改善肺功能在第12周(主要终点)通过一秒钟的低谷呼气量(FEV1)得出严重COPD。低谷FEV1组之间的明显差异在吸入格隆溴铵中得以维持长达52周。在这些试验中,与安慰剂组相比,吸入格隆溴铵的呼吸困难评分,健康状况和恶化率也得到了较大程度的改善。在随机,对照的III期GLOW3试验中,中重度COPD患者在治疗3周后,吸入格隆溴铵比安慰剂具有显着更长的运动耐力时间。该药物在研究26周(GLOW1)或52周(GLOW2)的过程中通常具有良好的耐受性,其耐受性概况通常与噻托溴铵相似。严重不良事件与中重度COPD患者的预期不良事件一致。总之,吸入格隆溴铵是每日一次的LAMA,是有效的支气管扩张剂,用于治疗中度至重度COPD患者。

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