Stockl Karen M, Le Lisa, Harada Ann S M, Zhang Shaoang
Prescription Solutions, 2300 Main Street, Mail Stop CA134-0404, Irvine, CA 92614, USA.
Am J Health Syst Pharm. 2008 Aug 15;65(16):1533-8. doi: 10.2146/ajhp070685.
The utilization of controller medications before initiating a long-acting beta(2)-adrenergic agonist (LABA) before and after the Food and Drug Administration (FDA) alerts is examined.
Electronic claims from a health insurer in the Western United States were examined during two distinct identification periods: before FDA alerts (October 1, 2003, through September 30, 2005) and after FDA alerts (December 1, 2005, through September 30, 2006). Identified patients were at least 12 years old, newly initiated on an LABA, and continuously enrolled during the preperiod (six months before the identification date). Previous controller use was defined as a prescription for an inhaled corticosteroid, mast-cell stabilizer, theophylline, leukotriene modifier, or oral or injectable corticosteroid during the preperiod.
Overall, 18,115 patients were identified before the alerts and 7,347 after the alerts. Use of a controller before an LABA was observed in 40% of patients with asthma only, 37% with chronic obstructive pulmonary disease (COPD) only, 65% with COPD plus asthma, and 21% with no asthma or COPD diagnosis. Controller use decreased significantly after FDA alerts as compared with before FDA alerts for patients with asthma only (38% versus 41%, p = 0.005) and patients with no asthma or COPD (17% versus 23%, p < 0.0001).
Previous use of a controller medication before initiation of an LABA was observed in 40% of study patients with a diagnosis of asthma, 37% with COPD, 65% with COPD and asthma, and 21% of patients with no diagnosis of asthma or COPD. Use of a controller medication decreased significantly in patients with asthma or no diagnosis of asthma or COPD following alerts issued by FDA regarding the increased risk of asthma-related death in patients receiving LABAs.
研究在美国食品药品监督管理局(FDA)发出警示前后,启动长效β₂肾上腺素能激动剂(LABA)之前使用控制性药物的情况。
对美国西部一家健康保险公司的电子索赔数据在两个不同的识别期进行检查:FDA发出警示之前(2003年10月1日至2005年9月30日)和FDA发出警示之后(2005年12月1日至2006年9月30日)。确定的患者年龄至少为12岁,新开始使用LABA,并在前期(识别日期前六个月)持续参保。前期使用控制性药物的定义为在前期开具吸入性糖皮质激素、肥大细胞稳定剂、茶碱、白三烯调节剂或口服或注射用糖皮质激素的处方。
总体而言,在发出警示之前识别出18115名患者,发出警示之后识别出7347名患者。仅患有哮喘的患者中,40%在使用LABA之前使用了控制性药物;仅患有慢性阻塞性肺疾病(COPD)的患者中,37%使用了控制性药物;患有COPD加哮喘的患者中,65%使用了控制性药物;未诊断出哮喘或COPD的患者中,21%使用了控制性药物。与FDA发出警示之前相比,仅患有哮喘的患者(38%对41%,p = 0.005)以及未诊断出哮喘或COPD的患者(17%对23%,p < 0.0001)在FDA发出警示之后控制性药物的使用显著减少。
在诊断为哮喘的研究患者中,40%在开始使用LABA之前曾使用过控制性药物;诊断为COPD的患者中,37%使用过;患有COPD和哮喘的患者中,65%使用过;未诊断出哮喘或COPD的患者中,21%使用过。在FDA发出关于接受LABA治疗的患者哮喘相关死亡风险增加的警示后,患有哮喘或未诊断出哮喘或COPD的患者控制性药物的使用显著减少。