September 23, 2016
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Serious asthma-related events comparable for Advair, fluticasone

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Serious asthma-related events associated with the administration of Advair Diskus did not spike in children requiring daily asthma therapy compared with those assigned fluticasone propionate monotherapy, according to data from the VESTRI safety trial.

“A 2008 meta-analysis conducted by the FDA showed a higher risk of asthma-related events among patients receiving [long-acting beta-agonists (LABAs)] than among patients not receiving these medications,” David A. Stempel, MD, of respiratory clinical development at GlaxoSmithKline, and colleagues wrote. “In a subsequent meta-analysis, a higher risk of serious asthma-related events was observed with salmeterol than with non-LABA agents among patients who received no inhaled glucocorticoids and among those who received inhaled glucocorticoids as background maintenance medication or in an inhaler that was separate from the one with salmeterol.”

In response to an FDA request, GlaxoSmithKline researchers addressed questions raised on an increased risk for hospitalizations in children who used combined glucocorticoid-LABA therapies. Stempel and colleagues conducted an international, double blind, active-comparator, 26-week trial (VESTRI) to examine whether Advair Diskus (fluticasone/salmeterol, GlaxoSmithKline) was noninferior to fluticasone monotherapy regarding the risk for asthma-related events in children aged 4 to 11 years. The patients had histories of asthma exacerbations 1 year previously and consistently used asthma medication 4 weeks before study enrollment. Patients were randomly assigned fluticasone/salmeterol (n = 3,107) or fluticasone (n = 3,101) for the study period.

The researchers calculated that the cohort would provide the trial with “90% power to show the noninferiority of fluticasone/salmeterol vs. fluticasone” if 43 patients had a composite serious asthma-related event. Among the cohort, 27 patients in the fluticasone/salmeterol arm and 21 patients who received fluticasone monotherapy were hospitalized for serious asthma-related events (HR = 1.28; 95% CI, 0.73-2.27). The researchers wrote that 8.5% of patients in the fluticasone/salmeterol group experienced severe asthma exacerbations, compared with 10% in the fluticasone monotherapy group (HR = 0.86; 95% CI, 0.73-1.01).

“Asthma-related deaths are uncommon in children, and no association with LABAs has been reported previously,” the researchers wrote. “No deaths or asthma-related intubations occurred in our trial. The hospitalization rate in our trial was approximately 1.5 hospitalizations per 100 patient-years with each treatment, which is consistent with the incidence observed by the U.S. National Surveillance of Asthma among children 5 to 14 years of age.” – by Kate Sherrer

Disclosure: The study was funded by GlaxoSmithKline. Stempel reports being an employee of and holding stock in GlaxoSmithKline. Please see the full study for a list of all other authors’ relevant financial disclosures.