Combination ICS, LABA Inhaler Use Safe for Asthma Treatment

Combination asthma therapies containing inhaled corticosteroids and long-acting beta agonists (LABAs) do not significantly raise the risk of serious asthma-related events in adults compared with inhaled corticosteroid monotherapy, according to results from the largest asthma safety trial in the United States. The study findings were published online in the New England Journal of Medicine.

“Our report should provide assurance to physicians and patients alike that this type of combination therapy is safe for adults when used as prescribed,” said lead author William Busse, MD, a professor at the University of Wisconsin School of Medicine and Public Health, in a university press release. “Not only did the study show that these combination therapies do not pose a higher risk than monotherapies alone, we found that they significantly decrease the number of asthma exacerbations in adults.”  

The study merged data from 4 prospective, randomized, controlled trials comparing the safety of combination therapy consisting of a LABA and an inhaled corticosteroid with treatment using an inhaled corticosteroid alone. In 2010, the US Food and Drug Administration, prompted by safety concerns over LABAs, mandated the 4 pharmaceutical companies marketing such drugs perform the trials. The FDA had also issued a black box warning for all products containing LABAs.

The final report was an independent joint oversight committee’s analysis of the FDA-mandated trials. Out of a total 36,010 patients, the committee identified 3 asthma-related intubations (2 in patients receiving inhaled corticosteroids and 1 in a patient receiving combination therapy) and 2 asthma-related deaths (both in patients receiving combination therapy) involving a total 4 patients.

Among patients who received combination therapy, 0.66% experienced at least 1 composite event (hospitalization, intubation, or death), compared with 0.60% of patients who received an inhaled corticosteroid alone, according to the study.

However, the proportion of patients who experienced 1 or more asthma exacerbations was 9.8% with combination therapy; with an inhaled corticosteroid alone, the proportion was 11.7%.

Dr. Busse told Pharmacy Today the findings are “very positive, very reassuring, to the point where the FDA has removed the black box warning.” Such a reversal, he continued, is a “very unusual event for them.” 

To be safe in adults with asthma, LABAs must always be used in combination with an inhaled corticosteroid, he emphasized, and not as monotherapy.

—Jolynn Tumolo

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