Zhou Esther H, Kang Elizabeth M, Seymour Sally, Iyasu Solomon
Food and Drug Administration, Office of Surveillance and Epidemiology and.
J Asthma. 2014 Dec;51(10):1061-7. doi: 10.3109/02770903.2014.936452. Epub 2014 Jul 17.
To evaluate changes in the dispensing patterns of long-acting beta2-adrenergic agonist (LABA) in pediatric and adolescent asthma patients in relation to multiple Food and Drug Administration (FDA) regulatory activities from 2003 to 2011.
We estimated LABA dispensing to pediatric asthma patients across three periods: 2003-2004 (after the first labeling change), 2005-2009 (after regulatory activities in 2005 and before 2010 LABA labeling change) and 2010-2011 (after 2010 LABA labeling change), using the IMS Health Plan Claims database. We estimated dispensing patterns over time for single-ingredient (SI) LABA and fixed-dose combination (FDC) of inhaled corticosteroid (ICS) and LABA (FDC-ICS/LABA). We also evaluated prior use of non-LABA asthma-control medication (ACM) before LABA initiation.
Of the 147 862 pediatric and adolescent asthma patients who initiated a LABA during the entire study period, the majority (96%) were FDC-ICS/LABA initiators. The proportion of SI-LABA among any LABA initiators was small and declined (9%, 4% and 2%, trend test p < 0.001) for the three periods. Among the patients who initiated, the proportions with prior use of an ACM (1-90 days prior) were 35%, 36% and 39% for the three periods.
The significant decline in the proportion of SI-LABA initiation over these years is consistent with FDA's recommendations. However, the favorable trend cannot be solely attributed to FDA activities as changes to clinical practice guidelines, and media publicity may have played a role. Investigating the reasons for the low ACM use before LABA initiation may inform approaches to further improve appropriate use of LABA in young asthma patients.
评估2003年至2011年期间,儿科和青少年哮喘患者长效β2肾上腺素能激动剂(LABA)的配药模式变化与美国食品药品监督管理局(FDA)多项监管活动之间的关系。
我们利用艾美仕市场研究公司(IMS Health)的医保理赔数据库,估算了三个时间段内儿科哮喘患者的LABA配药情况:2003 - 2004年(首次标签变更后)、2005 - 2009年(2005年监管活动后且2010年LABA标签变更前)以及2010 - 2011年(2010年LABA标签变更后)。我们估算了单成分(SI)LABA以及吸入性糖皮质激素(ICS)与LABA的固定剂量组合(FDC - ICS/LABA)随时间的配药模式。我们还评估了在开始使用LABA之前非LABA哮喘控制药物(ACM)的先前使用情况。
在整个研究期间开始使用LABA的147862名儿科和青少年哮喘患者中,大多数(96%)是FDC - ICS/LABA的起始使用者。在所有LABA起始使用者中,SI - LABA的比例较小且在三个时间段内呈下降趋势(9%、4%和2%,趋势检验p < 0.001)。在开始使用LABA的患者中,三个时间段内先前使用过ACM(提前1 - 90天)的比例分别为35%、36%和39%。
这些年SI - LABA起始比例的显著下降与FDA的建议一致。然而,这一良好趋势不能仅归因于FDA的活动,因为临床实践指南的变化以及媒体宣传可能也起到了作用。调查在开始使用LABA之前ACM使用比例较低的原因,可能为进一步改善年轻哮喘患者LABA的合理使用方法提供依据。