Study objective: To assess the effect of bromfenac sodium, a nonnarcotic analgesic drug under development, on the pharmacokinetics and pharmacodynamics of glyburide in patients with type II diabetes.
Design: Randomized, double-blind, placebo-controlled, multiple-dose study with a two-period crossover design.
Patients: Eleven men and one woman (age 36-64 yrs) whose diabetes was responsive to oral sulfonylurea therapy.
Interventions: Placebo or bromfenac 50 mg was given as a single oral dose 3 times/day for the first 3 days of the study. On days 4-6, patients received the alternative treatment. For at least 3 months before and during the study, patients took their usual single daily dose of glyburide 10 mg.
Measurements and main results: Bromfenac concentrations were measured by high-performance liquid chromatography with ultraviolet detection. Glyburide concentrations were measured by gas chromatography with nitrogen-phosphorus detection. Glycemia was measured repeatedly on day 3 of each treatment. Pharmacokinetic analysis was performed with noncompartmental techniques. No significant differences in the pharmacokinetics of glyburide or in the pharmacodynamic response of serum glucose levels were observed between placebo and bromfenac. Intersubject variability of concentrations was modest for glyburide and glucose, with a CV of 43% or less.
Conclusion: Glyburide levels are not changed during concomitant administration of bromfenac.