Zhou Esther H, Seymour Sally, Goulding Margie R, Kang Elizabeth M, Major Jacqueline M, Iyasu Solomon
Division of Epidemiology, Office of Surveillance and Epidemiology.
Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
J Asthma Allergy. 2017 Mar 16;10:67-74. doi: 10.2147/JAA.S124395. eCollection 2017.
Emerging safety issues associated with long-acting beta-agonist (LABA) have led to multiple regulatory activities by the US Food and Drug Administration (FDA) since 2003, including Drug Safety Communications (DSCs) in 2010. These DSCs had three specific recommendations for the safe use of LABA products in adult asthma treatment.
We examined the initiation of LABA-containing products for adult asthma treatment using an intermittent time series approach in a claims database from 2003 to 2012. We assessed the alignment of dispensing patterns with the following 2010 FDA recommendations: 1) contraindicated use of single-ingredient (SI)-LABA without an asthma controller medication (ACM); 2) a LABA should only be used when asthma is not adequately controlled on inhaled corticosteroids (ICSs) or ACM; and 3) step-down asthma therapy (e.g., discontinue LABA) when asthma control is achieved.
There were 477,922 adults (18-64 years old) dispensed a new LABA during 2003-2012. Among LABA initiators, patients who initiated an SI-LABA and who did "not" have an ACM dispensed on the same date decreased from >9% in 2003 (the initial labeling change) to <2% post 2010 DSCs (-value <0.0001 in the segmented regression model). The proportion of asthma patients dispensed an ICS in 6 months prior to initiating LABA treatment did not increase. The proportion of patients with longer than 4 months of continuous treatment did not decrease over the study period.
Although the decrease in SI-LABA initiation is consistent with FDA's recommendations, low ICS dispensing before initiating a LABA and LABA continuation practices require further efforts to move toward the recommended safe practices.
自2003年以来，与长效β受体激动剂（LABA）相关的新出现的安全问题导致美国食品药品监督管理局（FDA）开展了多项监管活动，包括2010年发布的药物安全通讯（DSC）。这些DSC对LABA产品在成人哮喘治疗中的安全使用提出了三项具体建议。
我们在一个2003年至2012年的索赔数据库中，采用间断时间序列方法研究了用于成人哮喘治疗的含LABA产品的起始使用情况。我们评估了配药模式与2010年FDA以下建议的一致性：1）禁止单独使用单一成分（SI）-LABA而不使用哮喘控制药物（ACM）；2）仅在吸入性糖皮质激素（ICS）或ACM不能充分控制哮喘时才使用LABA；3）哮喘得到控制时逐步减少哮喘治疗（例如，停用LABA）。
2003年至2012年期间，有477,922名18至64岁的成年人开始使用新的LABA。在开始使用LABA的患者中，同一天开始使用SI-LABA且“未”使用ACM的患者比例从2003年（初始标签变更时）的>9%降至2010年DSC发布后<2%（分段回归模型中的P值<0.0001）。在开始LABA治疗前6个月内使用ICS的哮喘患者比例没有增加。在研究期间，连续治疗超过4个月的患者比例没有下降。
虽然SI-LABA起始使用的减少与FDA的建议一致，但在开始使用LABA前ICS配药率较低以及LABA持续使用的情况需要进一步努力以实现推荐的安全做法。
