Association between intraocular pressure and budesonide inhalation therapy in asthmatic patients.
BACKGROUND
The extent to which inhaled glucocorticoids increase the risk of intraocular pressure elevation has been controversial.


OBJECTIVE
The authors attempt to assess such risk attributable to budesonide, an inhaled glucocorticoid for asthma therapy.


METHODS
Data were pooled from four prospective, randomized, double-blind, parallel-group, placebo-controlled, multicenter clinical trials of 12 to 20 weeks in duration. One thousand two hundred and fifty-five patients, 6 to 70 years of age whose intraocular pressures (IOPs) were less than 23 mmHg at screening were randomized to receive placebo or inhaled budesonide at doses ranging from 100 to 800 microg, administered twice daily. Intraocular pressure was measured at screening and at the end of double-blind treatment. Intraocular change was compared between budesonide and placebo, accounting for the confounding effects of gender, race, age, history of diabetes, history of hypertension, clinical trial, systemic glucocorticoid use during the trials, ophthalmic glucocorticoid use during the trials, and prior oral glucocorticoid use.


RESULTS
No budesonide treatment effect on the IOP was evident either in the crude analysis or after adjustment for possible confounding factors. For patients exposed to budesonide at a total daily dose of 1600 microg for 20 weeks, there was no difference in IOP change compared with the placebo controls.


CONCLUSIONS
No association with an increased IOP was observed in asthmatic patients treated with budesonide at daily doses ranging from 200 to 1600 microg for durations of 12 to 20 weeks. The subgroup analysis, which focused on the highest dose and longer term therapy was reassuring, as was the overall result.
Duh
M S
MS
Product Safety and Surveillance, Astra Pharmaceuticals, LP, Westborough, Massachusettes, USA.
Walker
A M
AM
Lindmark
B
B
Laties
A M
AM
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged
D001993:Bronchodilator Agents; D019819:Budesonide