SAN FRANCISCO – Using inhaled budesonide daily for chronic asthma for a mean of 16 years from childhood into adulthood didn’t cause more cataracts or significantly change intraocular pressure or vision in a prospective, longitudinal, placebo-controlled study.
Among 300 Danish patients taking inhaled budesonide for chronic asthma, 148 underwent eye examinations 15-20 years after the start of the study, as did 53 of 163 healthy siblings in the control group. The exams detected two posterior subcapsular cataracts that were outside the central 3-mm zone, but both were in the control group and none in the budesonide group, Dr. Søren Pedersen and his associates reported at the annual meeting of the American Academy of Allergy, Asthma and Immunology.
Nineteen cataracts in the budesonide group would have been needed to demonstrate a statistically significant 5% increased risk for cataracts, a poststudy power analysis found.
Average vision measurements were identical between groups (1.04 in each eye), said Dr. Pedersen of the University of Southern Denmark, Kolding. Intraocular pressures did not differ significantly between groups, with average measurements of 13.8 mm Hg in each eye of the asthma patients, and averages of 14.5 mm Hg in the right eyes and 14.2 mm Hg in the left eyes of the control group.
“This is a very strong finding” of safety with long-term inhaled budesonide, he said in an interview.
Patients took a mean daily dose of 385 mcg of budesonide and accumulated a mean dose of 2.3 g. Increased intraocular pressures (higher than 21 mm Hg) were seen in five patients (3.4%) and in one sibling in the control group (1.9%), a nonsignificant difference between groups. The accumulated dose of budesonide was not significantly associated with intraocular pressure, Dr. Pedersen said.
The study is part of a larger study that began with 270 children, including 62 with asthma who did not use inhaled corticosteroids, all of whom were evaluated for cataracts, bruises, growth, bone mineral density, and clinical effects of inhaled budesonide 4-6 years after treatment started, with no adverse effects found. At that point, 32 children in the control group dropped out, the other 30 shifted to the budesonide group, and 163 healthy siblings became the new control group. Patients were followed with various evaluations every 1-2 years.
The mean age of those who had eye exams 15-20 years into the study was 26 years for patients and 28 years for siblings. A total of 68% of patients and 47% of controls were male. Treatment duration ranged from 3 to 22 years. Daily budesonide dose ranged from 50 to 1,220 mcg. The accumulated budesonide dose ranged from less than 1 g to 8.8 g.
The ophthalmologist who performed all of the eye exams did not know which subjects were patients and which were controls.
Previous studies of the risk of posterior subcapsular cataracts from oral or inhaled steroids were cross-sectional studies with little or no information on the dose of inhaled corticosteroid used, he said.
AstraZeneca, which markets budesonide, funded the study. Dr. Pedersen said there were no other conflicts of interest.