Indacaterol inhalation powder (Onbrez® Breezhaler®) is a long-acting, selective β(2)-adrenoceptor agonist that is indicated for the maintenance bronchodilator treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD). This article reviews the clinical efficacy and tolerability of indacaterol 150 and 300 μg once daily in adults with moderate to severe COPD, as well as reviewing indacaterol's pharmacological properties and results of a cost-utility analysis. Indacaterol has a fast onset of action after the first dose and is effective over 24 hours, allowing for once-daily administration. In short-term trials (≤21 days) in patients with COPD, once-daily indacaterol 150 or 300 μg significantly improved lung function, exercise endurance and lung hyperinflation relative to placebo. In large, longer-term clinical studies (12 weeks to 1 year) in patients with moderate to severe COPD, once-daily indacaterol 150 or 300 μg improved lung function (primary endpoint) significantly more than placebo, and improvements were significantly greater than twice-daily formoterol 12 μg or salmeterol 50 μg, and noninferior to once-daily tiotropium bromide 18 μg (all agents were administered via inhalation). Overall, indacaterol improved dyspnoea, use of rescue medication and general health status significantly more than placebo, salmeterol or tiotropium bromide, and the degree of improvement in these endpoints was similar to or greater than that achieved with formoterol. Improvements were sustained over the long term (1 year), with no evidence of tolerance. Combination therapy with indacaterol plus tiotropium bromide improved lung function, dyspnoea, rescue medication use and general health status significantly more than tiotropium bromide alone in patients with moderate to severe COPD. Indacaterol is generally well tolerated when used alone or in combination with tiotropium bromide in patients with COPD and has not been associated with any safety issues. The most common adverse event in clinical trials was COPD worsening, which occurred more commonly with placebo than indacaterol. Indacaterol was not associated with an increased risk of cardiovascular adverse events. In a cost-utility analysis from a German healthcare payer perspective, once-daily indacaterol 150 μg was dominant (i.e. more effective with lower total costs) to once-daily tiotropium bromide 18 μg and twice-daily salmeterol 50 μg in the treatment of patients with COPD. In conclusion, indacaterol provides a valuable option for the maintenance treatment of adults with COPD.

译文

:茚达特罗吸入粉(Onbrez®Breezhaler®)是一种长效选择性β(2)-肾上腺素受体激动剂,适用于维持支气管扩张剂治疗慢性阻塞性肺疾病(COPD)的成人气流阻塞。本文回顾了茚达特罗150和300μg每天一次在中度至重度COPD成人中的临床疗效和耐受性,并回顾了茚达特罗的药理特性和成本-效用分析的结果。茚达特罗在首次给药后起效迅速,并在24小时内有效,允许每天一次给药。在COPD患者的短期试验(≤21天)中,相对于安慰剂,每日一次茚达特罗150或300μg可以显着改善肺功能,运动耐力和肺过度充气。在针对中度至重度COPD患者的大型长期临床研究中(12周至1年),茚达特罗每天150或300μg的肺功能改善(主要终点)显着高于安慰剂,并且改善幅度明显大于安慰剂的2倍-每日服用福莫特罗12微克或沙美特罗50微克,且不低于每日一次噻托溴铵18微克(所有药物均通过吸入给药)。总体而言,茚达特罗对呼吸困难,使用急救药物和一般健康状况的改善明显超过安慰剂,沙美特罗或噻托溴铵,并且这些终点的改善程度与福莫特罗相似或更高。长期(1年)持续改善,没有任何耐受性的证据。中度至重度COPD患者联合使用茚达特罗和溴化噻托溴铵联合治疗可改善肺功能,呼吸困难,抢救药物使用和一般健康状况,明显优于单纯使用噻托溴铵。慢性阻塞性肺病患者单独或与噻托溴铵联用时,茚达特罗通常具有良好的耐受性,并且没有任何安全性问题。在临床试验中最常见的不良事件是COPD恶化,安慰剂比茚达特罗更常见。茚达特罗与心血管不良事件风险增加无关。在从德国医疗保健付款人的角度进行的成本-效用分析中,在治疗患者方面,每日一次茚达特罗150微克占每天一次噻托溴铵18微克和沙美特罗两次50微克的主导地位(即总成本更低)。与COPD。总之,茚达特罗为成人COPD的维持治疗提供了有价值的选择。

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