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Abstract #15808 Published in IGR 2-3
Association between intraocular pressure and budesonide inhalation therapy in asthmatic patients
Duh MS; Walker AM; Lindmark B; Laties AMAnnals of Allergy Asthma and Immunology 2000; 85: 356-361
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 12-20 weeks in duration. One thousand two hundred and fifty-five patients, six 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 100-800 μg, administered twice daily. IOP 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 μg 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 200-1600 μg for durations of 12-20 weeks. The subgroup analysis, which focused on the highest dose and longer term therapy was reassuring, as was the overall result.
Dr. M.S. Duh, Product Safety and Surveillance, Astra Pharmaceuticals, LP, Westborough, MA, USA
Classification:
11.15 Other drugs in relation to glaucoma (Part of: 11 Medical treatment)
