Long-acting beta₂-adrenergic agonist in pediatric and adolescent asthma patients, 2003–2011

Abstract

Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

• Asthma
• FDA regulatory activity
• LABA dispensing patterns

Acknowledgements

We thank Margie Goulding, PhD, Lead Epidemiologist, Office of Surveillance and Epidemiology, Office of Pharmacovigilance and Epidemiology/Division of Epidemiology II, for the thoughtful comments and suggestions.

Contributors’ Statements

E. H. Z. designed the study, carried out the analyses, drafted and revised the manuscript and approved the final manuscript as submitted.

E. M. K. carried out the analyses, drafted the manuscript, reviewed and revised the manuscript and approved the final manuscript as submitted.

S. S. assisted in the study design and data interpretation, critically reviewed and edited the manuscript and approved the final manuscript as submitted.

S. I. conceptualized and designed the study, supervised the study process and interpreted the results, critically reviewed and edited the manuscript and approved the final manuscript as submitted.