title: Changing patterns of asthma medication use related to US Food and Drug Administration long-acting β2-agonist regulation from 2005-2011.
abstract: BACKGROUND
  Safety concerns associated with long-acting β2-agonists (LABAs) have led to many US Food and Drug Administration (FDA) regulatory activities for this class of drugs. Little is known about the effect of these regulatory activities on use of LABA-containing agents or other asthma medications.
  
  
  METHODS
  We created rolling cohorts of pediatric and adult asthmatic patients in the Mini-Sentinel Distributed Database between January 2005 and June 2011. The proportions of asthmatic patients using LABA-containing products, inhaled corticosteroids (ICSs), leukotriene modifiers, short-acting β2-agonists, oral corticosteroids, other bronchodilators, and no medications were measured on a monthly basis, and the changes were evaluated by using interrupted time series with segmented regression analysis.
  
  
  RESULTS
  When the 2005 regulatory activity was announced, there were statistically significant decreases in the use of fixed-dose ICS-LABA agents in children (-0.98 percentage points) and adults (-1.24 percentage points). Increased use of ICSs and leukotriene modifiers was observed just after the regulatory activities were announced in both children and adults. Although of smaller magnitude, continued favorable changes in the use of LABA agents were observed after the 2010 FDA regulatory activity.
  
  
  CONCLUSIONS
  The 2005 and 2010 FDA regulatory activities might have contributed to reduced use of LABA agents, as intended; however, their effect, independent of other factors, cannot be determined. Use of other classes of asthma medications was similarly affected.
authors.affiliation: Center for Clinical and Outcomes Research, Kaiser Permanente Georgia, Atlanta, Ga; Evidence Space, Hamilton, Bermuda.
authors.forename: Melissa G
authors.initials: MG
authors.lastname: Butler
authors.affiliation: Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
authors.forename: Esther H
authors.initials: EH
authors.lastname: Zhou
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.
authors.forename: Fang
authors.initials: F
authors.lastname: Zhang
authors.affiliation: Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
authors.forename: Yu-te
authors.initials: YT
authors.lastname: Wu
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.
authors.forename: Ann Chen
authors.initials: AC
authors.lastname: Wu
authors.affiliation: Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Levenson
authors.affiliation: Department of Medicine and Biostatistics, Vanderbilt University School of Medicine, Nashville, Tenn.
authors.forename: Pingsheng
authors.initials: P
authors.lastname: Wu
authors.affiliation: Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
authors.forename: Sally
authors.initials: S
authors.lastname: Seymour
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.
authors.forename: Sengwee
authors.initials: S
authors.lastname: Toh
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.
authors.forename: Aarthi
authors.initials: A
authors.lastname: Iyer
authors.affiliation: Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
authors.forename: Solomon
authors.initials: S
authors.lastname: Iyasu
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, Mass. Electronic address: meghan_baker@harvardpilgrim.org.
authors.forename: Meghan A
authors.initials: MA
authors.lastname: Baker
mesh_terms: D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004335:Drug and Narcotic Control / Q000266:history; D005260:Female; D049674:History, 21st Century; D006801:Humans; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D018927:Anti-Asthmatic Agents
keywords: Long-acting β(2)-agonist; US Food and Drug Administration; asthma; drug safety; medication use