Safety of LABAs in Asthma Confirmed in Combined Analysis

By Joe Elia

Edited by Richard Saitz, MD, MPH, FACP, DFASAM

The safety of long-acting β₂ agonists (LABAs) as combination therapy for asthma has received further reassurance by the publication of a combined analysis of separate FDA-mandated trials in the New England Journal of Medicine. (The drugs' labels featured a boxed warning for over a decade, which the FDA removed in 2017.)

LABA manufacturers separately conducted safety trials, which they agreed to harmonize to enable a combined analysis by an independent oversight committee. The trials encompassed a total of some 36,000 patients with asthma. Patients underwent randomization either to treatment with a LABA plus an inhaled glucocorticoid, or with the glucocorticoid alone.

In the noninferiority trials, the rate of asthma-related intubation or death (the composite primary outcome) did not differ significantly between the two regimens. The rate of asthma exacerbations, however, was modestly lower on combination therapy (9.8% vs. 11.7%).

Separately, FDA officials present the data behind their decision to remove the boxed warning.