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Umeclidinium/vilanterol fixed-dose combination for COPD.

机译:Umeclidinium /维兰特罗固定剂量组合用于COPD。

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Chronic obstructive pulmonary disease (COPD) mortality is projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly tobacco smoke exposure. Umeclidinium/vilanterol at 62.5/25 μg is the fixed-dose combination of a long-acting antimuscarinic agent and a long-acting β2-adrenoceptor agonist that administered as dry powder by inhalation was developed for the maintenance treatment of COPD. The combination demonstrated its efficacy in phase III studies where the amelioration of lung function translated into subjective symptomatic improvements. Its long-term safety and tolerability were demonstrated in a 52-week study. Last December, umeclidinium/vilanterol 62.5/25 μg combination was approved, as Anoro? Ellipta?, by the U.S. Food and Drug Administration (FDA) for maintenance treatment of COPD, being the first FDA-approved once-daily treatment for COPD that contains two long-acting bronchodilators in a single inhaler. It has been filed for approval with the European Medicines Agency.
机译:如果不采取干预措施来降低风险,尤其是暴露于烟草烟雾中,则慢性阻塞性肺疾病(COPD)死亡率预计在未来10年内将增加30%以上。 Umeclidinium /维兰特罗的浓度为62.5 / 25μg,是一种长效抗毒蕈碱剂和长效β2-肾上腺素受体激动剂的固定剂量组合,通过吸入以干粉的形式给药,用于COPD的维持治疗。该组合在III期研究中证明了其功效,其中肺功能的改善转化为主观症状改善。在一项为期52周的研究中证明了其长期安全性和耐受性。去年12月,umeclidinium / vilanterol 62.5 / 25μg的组合被批准为Anoro?美国食品药品监督管理局(FDA)的Ellipta?用于COPD的维持治疗,它是FDA批准的首个COPD每日一次治疗,它在一个吸入器中包含两个长效支气管扩张剂。它已提交欧洲药物管理局批准。

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