Longitudinal Trends in Incident and Prevalent use of Long-Acting Beta-2 Agonists: An Interrupted Time Series Analysis

This request estimates the longitudinal trend in incident and prevalent use of long-acting beta-2 agonist (LABA) with and without a long-term asthma controller medication (ACM) among asthma patients in the Sentinel Distributed Database (SDD) before and after a 2010 FDA Drug Safety Communication. 

The study period includes data from January 1, 2006 through September 30, 2015. We distributed this request to 16 Sentinel Data Partners on April 6, 2020.

This analysis includes eight reports:

• Incidence Report 1: This report focuses on longitudinal rates in incident use with the dispensing of single ingredient long-acting beta-2 agonists (SI-LABAs) as the numerator.
• Incidence Report 2: This report focuses on longitudinal rates of incident LABA users in the presence of ACM or fixed dose combination LABAs (FDC-LABA) dispensings among LABA-naive patients with asthma.
• Incidence Report 3: This report focuses on longitudinal rates of incident LABA users in the presence of ACM or FDC-LABA dispensings among LABA-naive patients with poorly-controlled asthma. This definition of poorly-controlled asthma requires three instances of short-acting beta-2 agonist (SABA) canisters in the baseline period.
• Incidence Report 4: This report focuses on longitudinal rates of incident LABA users in the presence of ACM or FDC-LABA dispensings among LABA-naive patients with poorly-controlled asthma. This definition of poorly-controlled asthma does not include the requirement of three instances of SABA canisters in the baseline period.
• Prevalence Report 1: This report focuses on longitudinal rates in prevalent use with the dispensing of SI-LABAs as the numerator.
• Prevalence Report 2: This report focuses on longitudinal rates of prevalent LABA users in the presence of ACM or FDC-LABA dispensings among LABA-naive patients with asthma.
• Prevalence Report 3: This report focuses on longitudinal rates of prevalent LABA users in the presence of ACM or FDC-LABA dispensings among LABA-naive patients with poorly-controlled asthma. This definition of poorly-controlled asthma requires three instances of SABA canisters in the baseline period.
• Prevalence Report 4: This report focuses on longitudinal rates of prevalent LABA users in the presence of ACM or FDC-LABA dispensings among LABA-naive patients with poorly-controlled asthma. This definition of poorly-controlled asthma does not include the requirement of three instances of SABA canisters in the baseline period.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.