Voorham Jaco, Roche Nicolas, Benhaddi Hicham, van der Tol Marianka, Carter Victoria, van Boven Job F M, Bjermer Leif, Miravitlles Marc, Price David B
Observational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore.
Hôpitaux Universitaires Paris Centre, Cochin Hospital (APHP), University Paris Descartes (EA2511), Paris, France.
BMJ Open. 2018 Oct 27;8(10):e022051. doi: 10.1136/bmjopen-2018-022051.
Budesonide/formoterol (BF) Spiromax is an inhaled corticosteroid/long-acting β-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.
Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.
Comparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95% CI -0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.
Among UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.
布地奈德/福莫特罗（BF）准纳器是一种吸入性糖皮质激素/长效β受体激动剂的固定剂量组合（FDC）吸入器，旨在尽量减少常见的吸入器使用错误，并在哮喘和慢性阻塞性肺疾病（COPD）中提供可靠且一致的剂量输送。我们评估了从另一种FDC吸入器更换为BF准纳器后，与继续使用原吸入器相比，BF准纳器的非劣效性。
将换用BF准纳器的哮喘和/或COPD患者与未换用者按1:3进行匹配。数据来自英国的最佳患者护理研究数据库和临床实践研究数据链。主要终点是达到疾病控制的患者比例（使用风险领域控制（RDC）算法）；次要终点包括：急性加重率、短效β受体激动剂（SABA）使用情况和治疗稳定性（达到RDC；维持治疗无变化）。非劣效性定义为95%置信区间下限高于-10%，采用条件逻辑回归并对相关混杂因素进行校正。
将385例换用BF准纳器的匹配患者（哮喘253例；COPD 132例）与1091例未换用者（哮喘743例；COPD 348例）进行比较，结果显示BF准纳器在RDC方面具有非劣效性（校正差异：+6.6%；95%置信区间-0.3%至13.5%）。在哮喘患者中，换用BF准纳器的患者与使用都保的患者相比，急性加重次数更少（校正率比（RR）0.76；95%置信区间0.60至0.99；p=0.044）；使用高剂量SABA的可能性更低（校正比值比（OR）0.71；95%置信区间0.52至0.98；p=0.034）；使用SABA吸入器的次数更少（校正RR 0.92；95%置信区间0.86至0.99；p=0.019）；并且更有可能实现治疗稳定性（校正OR 1.44；95%置信区间1.02至2.04；p=0.037）。在COPD患者中，这些终点指标未观察到显著差异。
在英国的哮喘和COPD患者中，BF准纳器在实际应用中的疾病控制效果不劣于都保。在哮喘患者中，与继续使用都保相比，换用BF准纳器与急性加重次数减少、SABA使用减少以及治疗稳定性改善相关。
