Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.
Cape Cornwall Surgery, Penzance, Cornwall, UK St. Just.
Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618796987. doi: 10.1177/1753466618796987.
In recognition of the value of long-term real-world data, a postauthorization safety study of the inhaled corticosteroid (ICS) fluticasone propionate and long-acting β-agonist (LABA) formoterol fumarate (fluticasone/formoterol; Flutiform) was conducted.
This was a 12-month observational study of outpatients with asthma aged ⩾ 12 years in eight European countries. Patients were prescribed fluticasone/formoterol according to the licensed indication, and independently of their subsequent enrolment in the study. They were then treated according to local standard practice. The study objectives were to evaluate the safety and effectiveness of fluticasone/formoterol under real-world conditions.
The safety population for this study comprised 2539 patients (mean age 47.7 years; 94.3% aged ⩾ 18 years; 63.4% female). Most patients (1538/2539, 60.6%) had switched to fluticasone/formoterol from another ICS/LABA, primarily due to lack of efficacy (1150/2539, 45.3%). Three quarters (77.4%) of patients were treated for 12 months, and 80.6% continued fluticasone/formoterol treatment after the study. Adverse events (AEs) occurred in 60.0% patients, and 10.2% had AEs considered possibly related to fluticasone/formoterol [most commonly asthma exacerbation (2.0% patients), dysphonia (1.8%) and cough (1.1%)]. Thirty-six severe AEs, but no serious AEs, were considered possibly related to fluticasone/formoterol. The proportion of patients with controlled asthma (based on Asthma Control Test score ⩾ 20) increased from 29.4% at baseline to 67.4% at study end (last observation carried forward). The proportion of patients experiencing at least one severe exacerbation decreased from 35.8% in the year prior to enrolment to 9.8% during the study. Improvements from baseline to study end were also observed in Asthma Quality of Life scores and physician/patient reports of satisfaction with treatment.
In this real-world postauthorization safety study, fluticasone/formoterol demonstrated a safety profile consistent with that seen in controlled clinical trials, with effectiveness in improving asthma control.
为了认识到长期真实世界数据的价值，对吸入性皮质类固醇（ICS）丙酸氟替卡松和长效β-激动剂（LABA）富马酸福莫特罗（丙酸氟替卡松/福莫特罗；Flutiform）进行了一项上市后安全性研究。
这是一项在 8 个欧洲国家的年龄 ⩾12 岁的门诊哮喘患者中进行的为期 12 个月的观察性研究。根据许可的适应证，为患者处方丙酸氟替卡松/福莫特罗，而不考虑他们随后是否参加该研究。然后根据当地的标准实践对他们进行治疗。该研究的目的是评估在真实世界条件下丙酸氟替卡松/福莫特罗的安全性和有效性。
该研究的安全性人群包括 2539 例患者（平均年龄 47.7 岁；94.3%年龄 ⩾18 岁；63.4%为女性）。大多数患者（2539 例中的 1538 例，60.6%）从另一种 ICS/LABA 转为使用丙酸氟替卡松/福莫特罗，主要是因为疗效不佳（2539 例中的 1150 例，45.3%）。四分之三（77.4%）的患者接受了 12 个月的治疗，80.6%的患者在研究结束后继续使用丙酸氟替卡松/福莫特罗治疗。60.0%的患者发生了不良事件（AE），10.2%的患者发生了可能与丙酸氟替卡松/福莫特罗有关的 AE[最常见的是哮喘加重（2.0%的患者）、发声困难（1.8%）和咳嗽（1.1%）]。36 例严重 AE，但无严重 AE，被认为可能与丙酸氟替卡松/福莫特罗有关。基于哮喘控制测试评分 ⩾20，哮喘得到控制的患者比例从基线时的 29.4%增加到研究结束时的 67.4%（末次观察结转）。在入组前一年至少经历过一次严重加重的患者比例从 35.8%下降到研究期间的 9.8%。从基线到研究结束，哮喘生活质量评分和医生/患者对治疗满意度的报告也有所改善。
在这项上市后安全性的真实世界研究中，丙酸氟替卡松/福莫特罗的安全性与对照临床试验所见一致，有效性可改善哮喘控制。
