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首页> 外文期刊>Clinical drug investigation >Treatment comparison of budesonide/formoterol with salmeterol/fluticasone propionate in adults aged > or =16 years with asthma: post hoc analysis of a randomized, double-blind study.
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Treatment comparison of budesonide/formoterol with salmeterol/fluticasone propionate in adults aged > or =16 years with asthma: post hoc analysis of a randomized, double-blind study.

机译：布地奈德/福莫特罗与沙美特罗/丙酸氟替卡松在大于或等于16岁的哮喘患者中的治疗比较：一项随机，双盲研究的事后分析。

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BACKGROUND: Three fixed maintenance-dose inhaled corticosteroid/long-acting beta(2)-agonist (ICS/LABA) combinations for the treatment of asthma are currently available: salmeterol/fluticasone propionate (Seretide/Advair/Adoair) budesonide/formoterol (Symbicort) and beclometasone/formoterol (Foster). All of these combinations have proven efficacy in terms of controlling symptoms, improving lung function and reducing the rate of exacerbations compared with ICSs and LABAs administered separately. Budesonide/formoterol is also approved for use as maintenance and reliever therapy in a number of countries (Symbicort SMART). Many of the studies supporting the use of budesonide/formoterol combination therapies have included populations of adolescents and adults aged >11 years. OBJECTIVE: This post hoc analysis compared the efficacy of ICS/LABA fixed maintenance-dose treatment with budesonide/formoterol and salmeterol/fluticasone propionate versus budesonide/formoterol maintenance and reliever therapy in patients with persistent asthma aged > or =16 years. METHODS: Following 2-weeks' run-in, 2866 adults aged > or =16 years were randomized to: fixed maintenance-dose budesonide/formoterol 640 microg/18 microg per day, salmeterol/fluticasone propionate 100 microg/500 microg per day plus terbutaline as needed, or budesonide/formoterol 320 microg/9 microg per day plus additional inhalations as needed (budesonide/formoterol maintenance and reliever therapy). Outcome measures included time to first severe asthma exacerbation (primary outcome) and number of severe asthma exacerbations. RESULTS: Budesonide/formoterol maintenance and reliever therapy prolonged time to first severe exacerbation versus budesonide/formoterol and salmeterol/fluticasone propionate fixed maintenance dose (p = 0.037 and p = 0.0089, respectively). Compared with salmeterol/fluticasone propionate fixed maintenance-dose treatment, fixed maintenance-dose budesonide/formoterol reduced the risk of hospitalizations/emergency-room visits by 28% (relative rate [RR] 0.72; 95% CI 0.53, 0.98; p = 0.034) and budesonide/formoterol maintenance and reliever therapy by 37% (RR 0.63; 95% CI 0.46, 0.87; p = 0.0043). All treatments provided similar improvements in lung function, asthma control days and asthma-related quality of life. CONCLUSIONS: Budesonide/formoterol fixed maintenance dose or maintenance and reliever therapy provides similar improvements in current asthma control and reduces the future risk of hospitalizations/emergency-room treatments versus salmeterol/fluticasone propionate fixed maintenance-dose treatment, providing additional clinical benefit to asthma patients aged > or =16 years.
机译：背景：目前有三种固定剂量的吸入性糖皮质激素/长效β（2）-激动剂（ICS / LABA）组合可用于治疗哮喘：沙美特罗/丙酸氟替卡松（Seretide / Advair / Adoair）布地奈德/福莫特罗（Symbicort） ）和倍氯米松/福莫特罗（Foster）。与单独施用的ICS和LABA相比，所有这些组合在控制症状，改善肺功能和降低病情恶化方面均已证明具有疗效。布地奈德/福莫特罗还被批准在许多国家（Symbicort SMART）用作维持和缓解疗法。许多支持使用布地奈德/福莫特罗联合疗法的研究都包括青少年和11岁以上的成年人。目的：本事后分析比较了布地奈德/福莫特罗和沙美特罗/丙酸氟替卡松丙酸酯的ICS / LABA固定维持剂量治疗与布地奈德/福莫特罗维持和缓解治疗在≥16岁持续性哮喘患者中的疗效。方法：经过2周的磨合，将2866名年龄≥16岁的成年人随机分为：固定剂量的布地奈德/福莫特罗每天640微克/ 18微克，沙美特罗/丙酸氟替卡松100微克/ 500微克每天加必要时可使用特布他林，或布地奈德/福莫特罗每天320微克/ 9微克，并根据需要另外吸入（布地奈德/福莫特罗维持和缓解治疗）。结果指标包括首次严重哮喘发作的时间（主要结局）和严重哮喘发作的次数。结果：与布地奈德/福莫特罗和沙美特罗/丙酸氟替卡松固定维持剂量相比，布地奈德/福莫特罗维持和缓解治疗延长了首次严重加重的时间（分别为p = 0.037和p = 0.0089）。与固定剂量的沙美特罗/丙酸氟替卡松相比，固定剂量的布地奈德/福莫特罗固定治疗使住院/急诊就诊的风险降低了28％（相对比率[RR] 0.72; 95％CI 0.53，0.98; p = 0.034 ）和布地奈德/福莫特罗维持和缓解治疗的比例为37％（RR 0.63; 95％CI 0.46，0.87; p = 0.0043）。所有治疗在肺功能，哮喘控制天数和哮喘相关生活质量方面均提供了类似的改善。结论：与沙美特罗/丙酸氟替卡松固定维持剂量治疗相比，布地奈德/福莫特罗固定维持剂量或维持和缓解疗法在当前的哮喘控制方面提供了类似的改善，并降低了住院/急诊室治疗的未来风险，为哮喘患者提供了额外的临床益处年龄>或= 16岁。

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