LABA Safety Confirmed in FDA-Mandated Trials

Combination therapy with a long-acting β₂ agonist (LABA) plus an inhaled glucocorticoid is not associated with an increased risk of serious asthma-related events and death compared with treatment with an inhaled glucocorticoid alone, according to new research.¹
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These findings emerged from a combined analysis (N = 36,010) of separate trials mandated by the US Food and Drug Administration (FDA). In 2010, the FDA required 4 companies marketing LABAs to conduct trials geared towards evaluating the safety of combination therapy with a LABA plus an inhaled compared with an inhaled glucocorticoid alone in adolescents and adults.

For the present analysis, a composite of asthma-related intubation or death served as the primary outcome, and post hoc secondary outcomes included serious asthma-related events and asthma exacerbations.

Results indicated that, out of 36,010 patients included in the analysis, 3 asthma-related intubations and 2 asthma-related deaths occurred in 4 patients. Of these, 2 intubations occurred in the inhaled glucocorticoid group vs 1 intubation in the combination therapy group, and both asthma-related deaths occurred in the combination-therapy group.

A total of 108 (0.60%) of 18,006 patients treated with an inhaled glucocorticoid alone experienced at least 1 composite event compared with 119 (0.66%) of 18,004 patients treated with combination therapy. Relative risk in the combination-therapy group was determined to be 1.09.

At least 1 asthma exacerbation occurred in 2100 (11.7%) patients in the inhaled-glucocorticoid group vs 1768 (9.8%) in the combination-therapy group, with a relative risk of 0.83.

“Combination therapy with a LABA plus an inhaled glucocorticoid did not result in a significantly higher risk of serious asthma-related events than treatment with an inhaled glucocorticoid alone but resulted in significantly fewer asthma exacerbations,” the researchers wrote.

The FDA removed the boxed warning from the labels of drugs containing both an inhaled corticosteroid and a LABA in December 2017 as a result of these findings.²

—Christina Vogt

Reference:

1. Busse WW, Bateman ED, Caplan AL, et al. Combined analysis of asthma safety trials of long-acting β₂ agonists. N Engl J Med. 2018; 378:2497-2505. doi:10.1056/NEJMoa1716868

2. FDA in brief: FDA approves removal of boxed warning from some inhaled medications used to treat asthma and chronic obstructive pulmonary disease [press release]. US Food and Drug Administration. December 21, 2017. https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm590021.htm Accessed on June 28, 2018.