EPROSARTAN, AN ANGIOTENSIN-II RECEPTOR ANTAGONIST, DOES NOT AFFECT THE PHARMACODYNAMICS OF GLYBURIDE IN PATIENTS WITH TYPE-II DIABETES-MELLITUS

The potential for eprosartan, a nonbiphenyl tetrazole angiotensin II r eceptor antagonist, to affect the 24-hour plasma glucose profiles in t ype II diabetic patients treated with glyburide was investigated in th is randomized, placebo-controlled, double-blind (eprosartan-placebo ph ase only), two-period, period-balanced, crossover study. All patients received a stable oral dose (3.75-10 mg/day) of glyburide for at least 30 days before the first dose of double-blind study medication was ad ministered. Patients were randomized to receive either 200-mg oral dos es of eprosartan twice daily or matching oral placebo doses concomitan tly with glyburide for 7 days during each treatment period. After a mi nimum washout period of 14 days, patients were crossed over to the alt ernate treatment. Serial samples to measure glucose concentrations in plasma were collected over a 24-hour period on the day before administ ration of eprosartan or placebo and again on day 7. Mean glucose conce ntrations were comparable between treatment groups before administrati on of eprosartan or placebo. The point estimate (90% confidence interv al) for the ratio of the average mean 24-hour plasma glucose concentra tions of eprosartan + glyburide to placebo + glyburide after 7 days of administration was 0.96 (0.90, 1.01). Eprosartan did not significantl y alter the 24-hour plasma glucose profile in patients with type II di abetes mellitus who were previously stabilized on glyburide.