“Results of this long-term safety study show that budesonide/formoterol has a tolerability profile similar to that of budesonide and consistent with findings from studies in predominately white populations with asthma,” the authors conclude.
Dr. Randall W. Brown, at the University of Michigan School of Public Health in Ann Arbor, and colleagues point out that there is relatively little information about the long-term safety and efficacy of a combined inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) in African American patients with asthma. There is some evidence that the efficacy of LABA therapy may be lower and risks higher in African Americans than white asthmatic patients.
While the efficacy and safety of budesonide/formoterol administered through a pressurized metered-dose inhaler (pMDI) have been demonstrated relative to budesonide over 12 weeks in African Americans, the current 52-week study is the first to assess long-term outcomes in this population.
The investigators randomized 742 such patients previously on medium or high doses of inhaled corticosteroids to receive either 320 mcg budesonide plus 9 mcg formoterol twice-daily via pMDI or 320 mcg budesonide twice-daily by pMDI.
Over the course of the study, the incidence of asthma exacerbations was 7.7% with budesonide/formoterol compared with 14.0% with budesonide only (p=0.006), the team found. Furthermore, the time to first exacerbation was longer with the combination compared with budesonide alone.
Rates of headache, the most common adverse effect, were 9.5% in the combination group versus 7.7% in the ICS-only arm, according to the report. Corresponding rates of nasopharyngitis were 6.9% versus 8.0%, while sinusitis occurred in 4.9% and 6.3% of the two groups, respectively.
There were no serious adverse effects attributable to the treatment drugs.
No patient on budesonide/formoterol was hospitalized for asthma exacerbation compared to four patients in the budesonide-only group, the authors report. Also, the number or unscheduled physician visits, emergency department visits, and days of adjunctive asthma medication use were all lower with the combination inhaler than the ICS-only inhaler.
However, Dr. Brown and colleagues remark, “Conclusions from these data are limited because many of these events occurred with low frequency.”
Overall, they conclude, “The results support the use of a budesonide/formoterol pMDI in African American patients aged 12 years or older with moderate-to-severe persistent asthma whose symptoms are not adequately controlled with an ICS alone.”