Safety of SABA In Patients With Asthma Versus ICS

In a recent meta-analysis, published in Advances in Therapy, researchers evaluated the tolerability and safety of SABA short-acting β2-agonist (SABA) reliever monotherapy in adults and adolescents with asthma, noting that SABA overuse may be associated with increased risk of adverse events (AEs).

According to the study’s lead author, Thitiwat Sriprasart, the data showed that mortality was rare with SABA monotherapy, and the rates of serious AEs (SAEs) and discontinuation due to AEs (DAEs) was similar between SABA- and inhaled corticosteroid (ICS)-based treatment groups.

Evaluating SABA Safety in Patients With Asthma

Researchers ultimately analyzed 24 randomized controlled trials published between January 1996 and December 2021. Eligible patients were aged 12 years or older and were treated with fixed-dose or as-needed inhaled SABA reliever monotherapy, ICS monotherapy, or ICS plus long-acting β2-agonist (LABA). The team used fixed-effects models to compare mortality, SAEs, and DAEs between the treatment groups.

The authors reported that 1 death unrelated to treatment was reported in each ICS, ICS plus LABA, and fixed-dose SABA group, with no treatment-related deaths observed. The rates of both SAEs and DAEs were under 4%, according to the authors.

Of note, DAEs were more frequent in the SABA groups compared with ICS groups, which they authors considered may be due to worsening of asthma symptoms being classified as an AE. They noted that SAE risk was comparable between the treatment groups.

Investigators acknowledged the analysis was limited by the publication and reporting bias inherent in literature reviews, as well as a lack of data on individual patient characteristics, particularly in older reports. Authors also noted the long-term effects of SABA use could not be determined given the follow-up duration in the studies.

Overall, “this comprehensive meta-analysis of data available from published clinical trials indicates that treatment with SABA as a reliever therapy does not result in increased mortality or excess SAEs in adult and adolescent patients when used within prescribed limits for symptom relief,” the authors ended.

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