The incidence of common adverse events in Table 1 below is based upon pooled data from three 12-week, double-blind, placebo-controlled clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and older were treated with 2 inhalations of Symbicort 80/ or Symbicort 160/ twice daily. The Symbicort group was composed of mostly Caucasian (84%) patients with a mean age of 38 years, and a mean percent predicted FEV 1 at baseline of 76 and 68 for the 80/ mcg and 160/ mcg treatment groups, respectively. Control arms for comparison included 2 inhalations of budesonide HFA metered dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) mcg, or placebo (MDI and DPI) twice daily. Table 1 includes all adverse events that occurred at an incidence of > 3% in any one Symbicort group and more commonly than in the placebo group with twice-daily dosing. In considering these data, the increased average duration of patient exposure for Symbicort patients should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.
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).