In a long-term safety trial in patients 12 years and older treated for 52 weeks with DULERA 100 mcg/5 mcg (n=141), DULERA 200 mcg/5 mcg (n=130) or an active comparator (n=133), safety outcomes in general were similar to those observed in the shorter 12 to 26 week controlled trials. No asthma-related deaths were observed. Dysphonia was observed at a higher frequency in the longer term treatment trial at a reported incidence of 7/141 (5%) patients receiving DULERA 100 mcg/5 mcg and 5/130 (%) patients receiving DULERA 200 mcg/5 mcg. No clinically significant changes in blood chemistry, hematology , or ECG were observed.
The aim of this article is to bring less well recognised adverse effects of inhaled corticosteroids to the attention of prescribers. Whilst inhaled steroids have a more favourable side effect profile than systemic steroids, they are not free from adverse effects. The dose of inhaled steroids used should be carefully monitored, and kept at the lowest dose necessary to maintain adequate control of the patient’s disease process. Be particularly aware of the cumulative effect of co-prescribing various dose forms of corticosteroids (inhaled, intranasal, oral and topical preparations).