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首页> 外文期刊>Pulmonary therapy. >An Integrated Analysis of Fluticasone Furoate/Vilanterol (FF/VI) Versus FF Safety Data Across Phase II and III Asthma Studies
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An Integrated Analysis of Fluticasone Furoate/Vilanterol (FF/VI) Versus FF Safety Data Across Phase II and III Asthma Studies

机译：跨阶段II和III哮喘研究的氟替卡松富尿酸酯/维生素A（FF / VI）与FF安全性数据的综合分析

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Introduction An integrated analysis was performed using safety data from 18 randomized, parallel-group studies from the fluticasone furoate/vilanterol (FF/VI) GSK asthma clinical study program. Efficacy data from four pivotal studies were also analyzed. Methods Data were integrated from 18 Phase IIb and Phase III clinical studies. Key treatment arms were FF/VI 200/25?μg, FF/VI 100/25?μg, FF 200?μg, FF 100?μg, VI [with inhaled corticosteroids (ICSs)] 25?μg, and placebo. Safety endpoints included adverse events (AEs), AEs of special interest, 24-h urinary cortisol, vital signs, electrocardiograms, and asthma composite endpoints (defined as asthma-related hospitalizations, intubations, or death). Key efficacy endpoints included lung function assessments and symptomatic measures. Results In total, 7229 patients were randomized to one of six key treatment groups. The most frequently experienced AEs across key treatment groups were headache, nasopharyngitis, and upper respiratory tract infection. A greater incidence of local steroid effects was reported with FF-containing treatment groups versus placebo. No statistically significant difference was observed in asthma composite endpoint (asthma-related hospitalizations, intubations, or death) analysis of all FF/VI doses versus all ICS doses. A statistically significant difference in trough forced expiratory volume in one second (FEV1), 0–24?h weighted mean FEV1, and rescue-free and symptom-free 24?h periods was reported between FF/VI and FF treatment groups in all studies except one (NCT01165138). Conclusion There was no evidence of an increased safety risk associated with FF/VI versus FF, VI, or placebo. FF/VI improved lung function and symptomatic endpoints versus FF alone. These data support the positive benefit:risk ratio of FF/VI versus FF alone and of having two approved FF/VI strengths to ensure appropriate treatment for patients with different asthma severity. Funding GSK.
机译：简介使用来自氟替卡​​松糠酸酯/维兰特罗（FF / VI）GSK哮喘临床研究计划的18项随机平行研究的安全性数据进行了综合分析。还分析了来自四个关键研究的功效数据。方法数据来自18项IIb和III期临床研究。关键治疗组为FF / VI 200 /25μg，FF / VI 100 /25μg，FF200μg，FF100μg，VI [含吸入性糖皮质激素（ICSs）]25μg和安慰剂。安全终点包括不良事件（AE），特别令人关注的AE，24小时尿皮质醇，生命体征，心电图和哮喘综合终点（定义为与哮喘有关的住院，插管或死亡）。主要功效终点包括肺功能评估和对症措施。结果总共将7229例患者随机分为六个关键治疗组之一。关键治疗组中最常出现的AE是头痛，鼻咽炎和上呼吸道感染。据报道，含FF的治疗组与安慰剂相比，局部类固醇作用的发生率更高。在所有FF / VI剂量与所有ICS剂量的哮喘复合终点（哮喘相关的住院，插管或死亡）分析中，未观察到统计学显着差异。一秒钟内的低谷强迫呼气量（FEV 1 ），0–24？h加权平均FEV 1 以及无抢救和无症状的统计差异显着24在所有研究中，FF / VI和FF治疗组之间的hh期间均已报告，只有一项研究（NCT01165138）。结论没有证据表明与FF，VI或安慰剂相比，FF / VI有增加的安全风险。与仅使用FF相比，FF / VI改善了肺功能和症状终点。这些数据支持FF / VI与单独FF的正效益：风险比，以及具有两个已批准的FF / VI强度，以确保针对不同哮喘严重程度的患者进行适当治疗。资助GSK。

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