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KAREN M. STOCKL, PHARM.D., is Manager, Outcomes Research; LISA LE, M.S., is Senior Biostatistician; ANN S. M. HARADA, PH.D., M.P.H., is Director, Clinical Analytics; and SHAOANG ZHANG, PH.D., is Manager, Biostatistics, Prescription Solutions, Irvine, CA.

Address correspondence to Dr. Stockl at Prescription Solutions, 2300 Main Street, Mail Stop CA134-0404, Irvine, CA 92614 (karen.stockl{at}rxsol.com).

Purpose. The utilization of controller medications before initiating a long-acting β2-adrenergic agonist (LABA) before and after the Food and Drug Administration (FDA) alerts is examined. Methods. 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. Results. 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). Conclusion. 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. Index terms: Asthma; Drug use; Food and Drug Administration (U.S.); Labeling; Leukotriene antagonists; Lung diseases; Mast-cell stabilizers; Respiratory smooth muscle relaxants; Steroids, cortico-; Sympathomimetic agents; Theophylline