The efficacy and tolerance of one or two daily doses of eprosartan in essential hypertension

Objective The primary objective of this double-blind, parallel-group, place bo-controlled, multicentre study was to compare the antihypertensive effica cy of one versus two daily doses of eprosartan, a novel nonbiphenyl, nontet razole angiotensin II receptor antagonist, in 243 patients with mild to mod erate hypertension (sitting diastolic blood pressure greater than or equal to 95 to less than or equal to 114 mmHg). Patients and methods The patients were randomized to titrated doses of epro sartan at 400-800 mg once a day, eprosartan at 200-400 mg twice a day, or p lacebo, with the incremental dose titrated over a 9-week period. Patients r eaching target blood pressure (sitting diastolic blood pressure of less tha n or equal to 90 mmHg) continued the fixed-dose treatment for 4 weeks. The primary efficacy measure was the mean change in trough sitting diastolic bl ood pressure from baseline to the study endpoint, determined on an intent-t o-treat basis. Results By the end of the study, eprosartan had significantly reduced mean trough sitting systolic and diastolic blood pressure relative to baseline a nd to placebo. The mean +/- SD change from baseline in diastolic pressure w as -9 +/- 8.4 mmHg for the single daily dose, -9 +/- 8.5 mmHg for two doses a day and -4 +/- 8.1 mmHg for placebo (P < 0.0001 versus placebo for both eprosartan regimens). Similarly, both eprosartan regimens significantly red uced mean trough standing systolic and diastolic blood pressure. At the end of the study, the response rate in the single daily dose group (46.8%) was significantly higher than in the placebo group (25.6%). There were no sign ificant differences between the treatment groups in the number of patients whose blood pressure responded to treatment; 41.7% of those taking eprosart an once a day and 44.4% of those taking eprosartan twice a day, and who res ponded to treatment, were maintained on their original starting doses. The total daily dose required to achieve target blood pressure was comparable, whether eprosartan was administered once or twice a day. Both eprosartan re gimens were well tolerated and the incidence of adverse events with eprosar tan was similar to that of placebo. Conclusions These results demonstrate that there was no significant differe nce in antihypertensive efficacy or tolerance between eprosartan taken in o ne or in two daily doses. Both dosing regimens provided significant and cli nically meaningful reductions in blood pressure that were superior to place bo. Eprosartan in a single daily dose was shown to be an effective antihype rtensive agent. Because of the good adverse-effect profile and the simplici ty of a single daily dose, eprosartan has the potential to improve patient compliance. J Hypertens 1999, 17:129-136 (C) Lippincott Williams & Wilkins.